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a, j LUCENT BIOTECH LIMITED (uNrr-r)
'155/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar {Uttarakhand)
Department QUALITY ASSURANCE Paqe No.

I [te CHANGE CONTROL FORM l of 5
A, CHANGE RELATED TO:
BMR/BPR Equipment Design

Utility
/Configuration
Standard Operaling
Procedure
Testing Procedure
M Specifications
Process
Facility
Vendor
Printed Packing
lnstrument Others
Materials
B. EXISTING PROCEDURE (IF NEEDED, ADD ATTACHMENT):
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lB LUCENT BIOTECH LIMITED tuNrr,r)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakha nd)
Department QUALITY ASSURANCE Pa e No
I rfle CHANGE CONTROL FORM 2 of 5
E. ATTACHMENTS / SUPPORTING DATA / PLANNED DEVIATION DATA:
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Initialed By
(Sign/Date): 4]fr;\1o1-
F. EVALUATION'(YES/NO):
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Check Points Major impact Potential No lmpact
tmpact
Product ldentily
Product Stability
Category: Crilical Major tvtinorf{

Checked By QA:
&1ii,31,."i.4-r,"> (Sign/Date)
G. RISK ASSESSMENT:
Done By QA: Checked By QA:

(Signi Date) . (Sign/Date)
Format No QNO23|F02-01
( ,- . ,-i] COPY
LivlA)iLRcoirY S,r;r:
LUCENT BIOTECH LIMITED 1ur.rrr,rr1

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Utta.akhand )
Department OUALITY ASSURANCE

CHANGE CONTROL FORM
H, NAME OF IMPACTED DEPARTMENT:

Review & Comment by
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Format No QAJ023/F02-01
CONT^ '' '.i) COPY
MASTER COPY
LUCENT BIOTECH LIMITED (uNrrrD
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar {Unarakhand)
QUALITY ASSURANCE
CHANGE CONTROL FORM
I. ACTION PLAN TO BE TAKEN (IF NEEDED, ADD ATTACHMENT}:

Action Plan To be Taken lmpacted Document Reference
Number (lf any)
I eo,.. roo,t'lrne-yr4 9oA 9[loet- sa 104 foo.l-oL

tl\tr !Q, ^r'ovr\ 6A loos - o L
Checked By QA:
(Signi Date) Eii,ii,li.i' "' 41,4 * -
J. PROPOSED TARGETED DATE: 1 o5\ 2p ?-
Done By QA: Reviewed By:

(Sign/Date) {Sign/Date)
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K. PROPOSED CHANGE APPROVAL:
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MASTER COPY
,,''| LUCENT BIOTECH LIMITE
165/3, Nalhera, Anantpur, Puhana, Roorkee, Dislt: Haridwar {Uttarakha nd)
Department QUALITY ASSURANCE Paqe No.
Title CHANGE CONTROL FORM 5 oFs
L. ACTION PLAN IMPLEMENTED (IF NEEDED, ADD ATTACHMENT):
lmpacted Document
lmplemented VeYified
Action Pian To be Taken Refetence Number
No. Date By QA
(lf any)
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No. Period (Department {QA Head)
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NEW CHANGE CONTROL RAISED:
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STANDARD OPERATING PROCEDURE For Restricted Circulation
LUCENT BIOTECH LIMITED (uNrr.r)

155/3, Nalhela, Anantpur, Puhana, Roorkee, Distl: Haridwar (Uttarakhand)
DeDartment OUALITY ASSURANCE

Numbering System for Master Formula Record, Batch Manufaciuring
Title
Record, Batch Packinq Record and Specification
SOP No. Effective Date Review Date SuDersedes No- Revision No. Page No.
QA/003-03 QAio03-02 03 1of 5
1.0 Objective
1 1 To lay down the procedure Numbering System of Master Formula Record, Batch
Manufacturing Record, Batch Packing Record and Specification.
2.0 Scope
21 This SOP is applicable for Numbering System of Master Formula Record, Batch
lvlanufacturing Record, Batch Packing Record and Specification at Lucent Biotech
Ltd (Unit-ll).
3.0 Responsibility
3.1 Officer QA
3.2 Head Production
4.0 Accountability
4.'1 Head - QA
5.0 Procedure:
5 1 Numbering System of MFR, BMR and BPR:
5.1.1 l\4aster formula record, Batch Manufacturing Record, Batch Packing Record
number is an alphanumeric component document reference number
5 1 2 The first three lefter will indicate document type as below:
"MFR" documents type as Master Formula Record
"BMR" documents type as Batch l\4anufacturing Record.
'BPR" documents type as Batch Packing Record
cor(]
Authors Designation Signature Date
Prepared By Officer QA
Checked By Executive QA
Approved By Head QA
Authorized By Head Plant
Format No. : QAJ001/F01-00
STANDARD OPERATING PROGEOURE For Restricted Circulation
LUCENT BIOTECH LIMITED (uNrr.rD

t65/3, Nalhera, Anantpur, Puhana, Roo*ee, Distt: Ha.idwar (uttarakha nd)
Department QUALITY ASSURANCE

Title Approval Procedure of Siqnature SDecimen
SOP No. Effective Date Review Date Suoersedes No. Revision No. Page No.
QA/o05-02 zclo;irczt lglo>fzoz.3 QA/005-01 02 1of 5
1.0 Objective
1.1 To lay down the procedure for maintaining the specimen signatures.
2.0 Scope
2.1 This procedure is applicable to use of signatures of all the staff of all Departments
working in at Lucent Biotech Ltd (Unit-ll).
3.0 Responsibility
3.1 Offlcer Human Resource
3.2 Otficer/ Executive QA - To add the signature in Master Signature List during joining.
4.0 Accountability
4.'1 Head - QA jfuu'q-r,o
5.0 Procedure
5.1 Quality Assurance system related documentation should be signed by "Plant Head".
5.2 Production and QC documentation should be signed by Head -QA
53 Organization authorized Black pen for Production, QA and QC and Green Pen for
IPQA personnel.
5.4 'Authorized Person" means that any person signing the documents should have
suffcient knowledge, training and expertise to adequately review and approve data,
information conclusions and recommendations contained therein.
5.5 This procedure is required to maintain specimen signatures of employees, so that,

. The signature / initial on records / documents match with the specimen
signatures which are maintained in the respective departments.
Authors Designation Signature Daie
Prepared By Ofricer QA f,{i!!e=r i" I or l)cal
Checked By Executive QA ,)'c I oll zo., t
Approved By Head QA K'qtl .
Lr)o) )l
lZ<,
Authorized By Head Plant LLI':'L lLeL\
Format No. i QA,/001iF01-00
LUCENT BIOTECH LIMITED ruHrr-rr)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwa. (Uttarakharrd)

Title Approval Procedure of Siqnature Specimen
SOP No. Effective Date Review Date Supersedes No. Revision No. Page No.
QA/o05-02 Tala>17.'Ll I t lotlzozg QAi005-01 02 2oI 5
. No operating personnel can repudiate / disown the activity recorded.

5.6 lt is possible to determine the person who has recorded the activity.
5.7 The specimen signature of each individual shall be recorded on a List of Technical
Staffs Signatory as per the formal (Refer Annexure-l).
5.8 Ouality Assurance department has to maintain the authorized signatory list of all the
department employees in a file.
5.9 The individual shall sign / initial on the authorized signatory list against the columns
provided, matching to the regular signature / initial.
5.10 lf the employee is transferred from t to another department,
his / her signature will be transferrei
5. 11 The specimen signature and initials ime of new recruitment
from time to time and Iist shall be updated every two years.
5.12 Whenever a new employee joins the organization, it is the responsibili\r of the QA
department head to request for the specimen of Technical Staffs Sig natory and
get the same fllled and updated
6.0 Annexure
Sr. No Annexure Title
1 Annexure I List of Technical Staffs Signatory

Prepared By Officer QA -dir- ''l zt'lo)laa)l
Checked By Executive OA r4{* 2-c laLlLa Ll
Approved By Head QA 2 c lo z,l ze t
Authorized By
Format No. : QA,/001/F01-00
Head Plant
-tu,--- L. I az l2rt) |
LUCENT BIOTECH LIMITED {uNrr-I)

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwaa (Uttarakharrd)

SOP No. Effective Date Review Date Suoersedes No. Revision No. Page No.
aAio05-02 2-olo zlz"z t lq loL l)<,Ll QA/o05-01 02 3of5
7.O History of Review
Supersedes C.C. Approval

Date
No,
C.C. No.
Date
Reason For Review
14to2t2017 NIL NIL NIL New SOP
15t02t2019 oA,/005-00 cct19too4 16t02t20't9 Periodic Review
19t92t2021 QAJo05-01 cct2'U011 19t02t2021 Periodic Review
8. 0 References
Sr. No Reference
Current Good l\ranufacturing Practices (WHO
'l CGMP
cGMP quidelines)
2 SOP On SOP QAJo01-00
9.0 Abbreviations
SOP : Standard Operating Procedure
CGMP : Current Good l\4anufacturing Practice
F : Format
QA : Quality Assurance
C.C. No. : Change Control Number

Prepared By Officer QA =tV t^.qa 7o I o't- l7;'y1
Checked By Executive QA .-#.; Lo 10212 oz I
Approved By Head QA t"Iotl zo) t
Authorized By Head Plant ,44t-" 2c ioLl t,:t t
Format No : QAJ001/F01-00
LUCENT BIOTECH LIMITED {uNrr.n)

'165/3, Nalhera, Anantpur, Puhana; Roorkee, Distt Haridwar (lrtlarakha nd)
Deparlment OUALITY ASSURANCE

Title ADDroval Procedure of Siqnature Soecimen
SOP No. Effective Date Review Date Supersedes No. Revision No, Page No.
QA/o05-02 t"l ct ltt tt \q lo'Ll2 az3 QAio05-01 02 4of5
10.0 Distribution List:

S. No. DeoU Distributed to Copy No.
1. Head of department - Quality Assurance Master Copy
2. Office - Quality Assurance I
2 Head of department - Quality Control 2
4. Head of department - Production 3
5. Head of department - Store 4
6. Head of department - Engineering 5
7. Head of department - Personnel & Administration 6

Prepared By Officer QA dnrqr ')-olst-lzc >t
Checked By Executive CIA n9n, 2, lc Ll2e Z I
Approved By Head QA +1- L c) t >l z,':t r
Authorized By Head Plant ) 2-o laLl LEL\
Format No. : OAJ001/Fo'l -00
LUCENT BIOTECH LIMITED (uNrr-l)

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Disti: Haridwar (UttaEkharrd)

SOP No. Effective Date Review Date SuDersedes No. Revision No. P€ge No.
QA,to05-02 2olalL.t J 141<'s-)z.i-3 QA/005-01 02 5of5
ArrnexureJ
LUCENT BIOTECH LIMITED ruxrr-rn
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar {Uttarakhand)
Department QUALIry ASSURANCE Paqe No.

Title List Of Technical Staffs Signatory 1af 1
S. No. Name of Signatory DepartmenUDesignation lnitials Full S ignature
-ffipz!'Lu'
Format No. QAJ005/F01-00

Prepared By Officer QA &u,r,r- 7c lr'Ll Lc Ll
Checked By Executive OA fi(=, i- yt l,,r)zazl
Approved By Head QA .Yd!i' LcloLl2-"Zi
Authorized By Head Plant )i-- 2r'ls2 lya y'
Format No. : QA/001/F01-00
LUCENT BIOTECH LIMITED (uNrr-[)

165/3, Nalhera, Ananlpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)

Numbering System for Master Formula Record, Batch Manufacturing
Title
Record. Batch Packinq Record and Soecification
SOP No. Effeciive Date Review Date Supersedes No. Revision No. Page No.
QA/003-02 2<'lozl>ozi lq luL)zo4 QA/o03-01 02 1of 5
1.0 Objective
11 fo by down the procedure Numbering System of lvlaster Formula Record, Balch
Manufacturing Record, Batch Packing Record and Speciflcation.
2.0 Scope
21 This SOP is applicable for Numbering System of Master Formula Record, Batch
Manufacturing Record, Batch Packing Record and Speciflcation at Lucent Biotech
Ltd (Unit-ll).
3.0 Responsibility
3 1 Officer QA
3.2 Head Production
4.0 Accountability
4.1 Head - QA
Procedure:
5.1 Numbering System ofMFR, BMR and BPR:
5.1.1 Master formula record, Batch Manufacturing Record, Batch Packing Record
number is an alphanumeric component document reference number.
5.1 .2 The first three letter will indicate document type as below:
"lvlFR" documents type as Master Formula Record.
"BlVlR" documents type as Batch Manufacturing Record.
"BPR' documents type as Batch Packing Record.
Prepared By Officer QA Lc lo L I Lt'll
Checked By Executive QA ctl' , 1G lo] lzcr I
Approved By Head QA r"3!4- 20laLlzo2 \
Authorized By Head Plant ,p Zo j
"2l>iLj
LUCENT BIOTECH LIMITED (uNrr-[)

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwa. (Uttatakhand)

Numbering System for Master Formula Record, Batch Manufacluring
Title
Record. Batch Packinq Record and Specification
SOP No. Effective Date Review Date SuDersedes No. Revision No. Page No.
QAJo03-02 2<lo zltezi Ie I az)2"23 QAio03-0r 02 2ofs
5.1.3 The forth character is (4 slash
5.1.4 Fifth character having indicates dosage form as below "T" Tablets "C"
Capsule.
5.1.5 The sixth character is (4 slash
5.1.6 The Seventh, eighth & ninth digits indicate the serial No. Like "001, 002,
003... ........999" - Serial No.
5.1.7 The tenth digit indicate the '-" Dash.
5.1.8 The Last two digits indicate the "Revision Number" (00)
5.2 Based on the above system the MFR, BMR & BPR document reference
5.2.1 MFR/T/001-00 (as per the above sydtem)

5.2.2 BMR/T/001-00 (as perthe above system)
5.2 3 BPR/T/001-00 (as perthe above system)
5.3 Numbering System of Specification (Finished ProducG):
5.3.1 The specification number is an alphanumeric component document
reference number.
5.3 2 The first three letter will indicate document type as below:
"SPEC" documents type as Speciflcation.
5.3 3 The next letter indicates dosage form as below:
"T" Tablets
"C" Capsule
5.3 4 The three digits indicate the Serial No. Like "001" - Serial No.
5.3.5 The Last two digits indicate the "Revision Number"

Prepared By Officer QA aFitl^ra1- )-. | 0).lLC1l
Checked By Executive QA pq Lc lotlu,zt
Approved By Head QA FU{= 2-alo)l La1
Authorized By Head Plant A4r' I olo ) )>c2 |
LUCENT BIOTECH LIMITED tuHtr-ttt
'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Utlarakhartd)
Deoartment OUALITY ASSURANCE

Title
Record, Batch Packing Record and Specitication
SOP No. Effective Date Review Date Supersedes No. Revision No. Page No-
QA/003-02 2oforlzoui lqlotlt"ts QA/003-01 02 3 of 5
5.4 Based on the above system the Specification Number as:

5.4.1 SPEC/T/001-00 (as per the above system)
5.4.2 SPEC/C/001-00 (as per the above system)
5.5 Numbering System of Specification (Raw Materials & Packing Materials):

5.5.1 The speciflcation number is an alphanumeric component document reference
number.
5.5.2 The first three letterwill indicate document type as below:
5.5 3
!l t9
5 5.4 The three digits indicate the Serial No. Like "001" - Serial No.
5.6.1 SPEC/R|VI/001-00 (as per the above system)

5.5.'l SPEC/PM/o01-00 (as per the above system)
6.0 Annexufe
NIL NIL NIL

Prepared By Officer QA -d "2"lo>l> ctl
Checked By Executive QA 2-()lotlLotl
Approved By Head QA tr'.1 ?c)sz\ro-) r
Authorized Bv
Format No. : OA,/001/F01-00
Head Plant
'X=' Z<.l lz.2 l
LUCENT BIOTECH LIMITED {uNrr-rD

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakharrd)
Department QUA LITY ASSURANCE

Numbering System for Master Formula Record, Batch Manufac turing
Title
Record, Batch Packinq Record and Specification
SOP No. Effective Date Review Date Superedes No. Revision No, Page No.
QA/o03-02 2.1 oLl2- aLl I ctl atlzozj QA.to03-01 02 4ol5
7.0 History of Review
Su persedes C.C. Approval
Date C.C. No. Reason For Review
No. date
16t12t2017 NIL NL NL New SOP
15t02t2019 QA,/003-00 cct19t004 16t02t2019 Periodic Review
19t02t2021 QA,/o03-01 cct2'1011 19t02t2021 Periodic Review
8.0 References
Sr. No Reference Reference code
Current Good Manufacturing Practices (WHO
1
cGMP guidelines)
2 soPonsoP Jft*
9.0 Abbreviations
QA : Quality Assurance
QC ; Quality Control
CC NO i Change Control Number
CGMP : Current Good Manufacturing Praclice
BMR : Batch Manufacturing Record
BPR : Batch Packing Record
MFR : l\.4aster Formula Record
RM : Raw Materials
Pl\4 : Packing l\ilaterials
Prepared By Officer QA .i\cn^! 1olc,t-lzc.s
Checked By ExEcutive QA . fl(tr-, 2slatl zo tl
ApproYed By
Authorized By
Head QA
Head Plant
I 2tlc Llz"t t
*-,' 1 (,iO lZcLl

Format No. : QA,/001/F0'l-00
LUCENT BIOTECH LIMITED ruHrru

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Unarakharid)
DeDartment QUALITY ASSURANCE

Numbering System for Master Formula Record, Batch Manufaciuring
Title
Record, Batch Packing Record and Specification
SOP No. Effective Date Review Date Supersedes No, Revision No. Page No.
QA/o03-02 Zalotlzoz 1 1\ | oLlz,z-j QA/003-0'l 02 5of5
'10.0 Distribution List:
S. No. Dept/Distributed to Copy No.
1. Head of department - Quality Assurance N4aster Copy
2. Qualltu Control Deoartment- HOD 2
4. Head of department - Warehouse 4

Prepared By Officer QA 2olol ;.o.L I
Checked By Executive QA .=ry-.' >alaLl rcLl
Approved By Head QA 2-oloLl2 c tl
Authorized By Head Plant )-/ L< )ot)t"z)
Format No. : QA"/001/F01-00
STANDARD OPERATING PROCEDURE For Restricted Circ ulation
LUCENT BIOTECH LIMITED (uNrr-rD

165/3, Nalhe,a, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhan d)
Procedure for Preparation, Approval, Oistribution Control, Revision
Title and Destruction of Standard Operating Procedure
(SOP on SOP)
SOP No. Effective Date Review Date SuDersedes No Revision No. Page No,
oA/001-02 lq lsLl20zl tZlo LlLo4 QAio0t -01 02 1 ol23
'1.0 Objective
11 To establish a procedure to be used as a guide for writing Standard Operating

Procedure.
1.2 To ensure that company's all operations are covered by written procedure
specifying actual working methods.
1.3 To revise exisling operating procedure as and when required.
2.0 scope (}-, -rlf tb

,(.r"
2.1 This procedure is applicable for the preparation of various SOPS to all depa rtmenls
of Lucent Biotech Ltd (Unit-ll)
2.2This SOP describes written instructions how to prepare detailed & specify, how a
tesvoperation or administrative procedure is to be performed
Responsibility
3.'l lt is the joint responsibility of the originating department (User department) and
other related department. Quality Assurance department has to check & verify the
following:
3.1.1 The Technicality of the procedure.
3 1 2 Checking and Training of SOP
3.1.3 The format and numbering system followed
3.2 Quality Assurance department endorses the copy and issue the respective SOP
to user department
3.2 Quality Assurance department holds the 'I\/IASTER COPY" of all the
departments SOPs.
Prepared By Officer QA 5)-!.,j ll loLl zoLi
Checked By Executive QA tq I oi
l!a 2l
Approved By Head QA {1[cz[ -rv r1
Authorized By Head Plant .t.'5,q-'-
.,- t'tloLI)cll
LUCENT BIOTECH LIMITED tuHrr.lr

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhan d)
Deparlment QUALIry ASSURANCE
Procedure for Preparation, Approval, Distribution Control, Rev ision
(SOP on SOP)
SOP No. Effective Date Review Date Supersedes No Revision No. Page No.
QA/00't-02 lq lo LlLo'Ll lbloLl2.-Lf QA/001-01 02 2 of 23
4.O Accountability
4.1 Head - QA
5.0 Procedure
5.1 The procedure for signing the SOP must be as follows:
5.1 1 All the SOP'S must be signed with date by the person responsible for the
preparation of the SOP in the specified column 'Prep?red By". along with
designation.
"TA/:\
5 1.2 Concerned Department Executive/Head oeffil0tPchelt the SoP and
sign with date in the specified column '''thecked By" along with
designation.
5.1.3 The SOP will be approved by the Head QA or His/her nominee will
Approved the SOP and sign with date in the specified column "Approved
By" along with designation.
5. 1.4 The SOP will be authorized by the Plant Head or His/Her nominee witl
Approved the SOP and sign with date in the specified column "Authorized
5.1.5 Only Standard to be used for the writing of SOP, it can be taken in a soft
copy form by the OA department and each SOP to be write/ prepared only
in this format (format No QAJ001/F01-00)
52 The format and contents of standard operating procedure must include the
Jollowing
(Refer Annexure ll -SOP Format)
Prepared By Officer QA '&ruvr-r ll lo zJ t'"t t
Checked By
Approved By
Executive QA ,-49^, tQ lo zl 2czi
Head QA tl,U. I ql6Ll Lczi
Authorized By Head Plant ) ,,- lct lorlu,qrl
Format No : OA/001/t 01-00
LUCENT BIOTECH LIMITED {uNrr.r)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (l,Jttarakhand)

Procedure for Preparation, Approval, Distribution Control, Reyision
(SOP on SoP)
QA/00't-02 l9lor lr-c zi IZ Li,L3
loLl QA/001-01 02 3 of 23
5.2.1 Write STANDARD OPERATING PROCEDT,RE on the top of page in left
side which having font Arial, Bold & Font size 12 in uppercase and right
side on the top of page should be written For Restricted Circulation in
font Arial, Bold & Font size 12.
5.2.2 fhe Header will remain as per SOP format (Ref; Annexure-ll) font should
be used in Arial.
52.3 The Company Logo shall be printed at the top left portion of each page
5,2,4 LUCENT BIOTECH LTD. (UNIT
at the middle portion of each pag
14 and Address and (UNlTJl) in
5.2.5 Department: To write the na

Arial, Bold & Font size '12 in uppercase.
5.2 6 Titfe: Title of SOP in font Arial. Bold & Font size 12. ll should be self
descriptjve.
5 2.7 SOP No. : write in font Arial, Bold & Font size 12
Numbering of SOP
SOP number shall consist of I characters.
o First two characters denote "Department or section code" eg. QA for
Quality Assurance, QC for Quality control, WH for Warehouse. (Refer
Table 1 .1).
. Third character denotes Slash (i)
. Fourth, Fifth & Sixth characters denote serial number of SOP, starting
from "001"onwards.
. Seventh character denotes Desh \ ./.

Prepared By Officer QA :S:1\-j i cll 0Ll )rLl
Checked By Executive QA +*\1 lqloil)n2,
Approved By Head QA fi.s1-- iqlo!,rci)
Authorized By Head Plant tq loz Jro2/
LUCENT BIOTECH LIMITED (uNrr.r)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Disft: Haridwar (Uttaaakhan d)
Procedure for Preparation, Approval, Distribution Conlrol, Rev ision
(SOP on SOPI
SOP No. Effective Date Review Date SuDersedes No Revision No. Page No.
QA/001-02 I q or,l)-cLi
I ll,lotlto'zj QA/001-01 02 4 of 23
. Eighth & Ninth Characters denote reversion number of SOP, starting
from "00"onwards.
5.2.8 Effective Date: The effective daie is the date from which the SOP shall
be effective. Training should be given to all concern before
implementation of the SOP. The effective date should be written by hand
with black colour rnk ball pan as DD/MlVl/YYfy. (Date/MonthfYear)
5 2.9 Review Date: This is the date before which the SOP shall be reviewed
Generally the review date shall
The SOP can also be reviewed b
required. QA shall assign the
date. As when required SOP will be reviewed before or after one month.
5.2.10 Supersedes No. writes in font Arial, Bold & Font size 12 l1s contain
previous SOP number
5 2.11 Revision No,: The current revision no. shall be print in the revision no.
As this is new SOP hence the revision no shall be 00. After first revision
of SOP it shall be written as 01 and so on.
5.2.'l2Page No.: The page no. of a SOP should be as X oI Y. Where X is
number of that page and Y is the total number of pages of the SOP.
52.13Footerof SOP (All Pages): The footer format shall also be in font Arial,
Bold & Font size 12, the contents following details:
Prepared By : Officer or designee of respective department
Checked By : Executive of respective department
Approved BY : Head QA
Authorized BY : Plant Head.
Authors Designation Signatu re Date
Prepared By Officer QA fl,r.t"'r I tl I oLiLr,Ll
Checked By Executive QA l-t- Iq I 0!i .ri)/
Approved By Head QA u!+-- lc\la'LlLo2l
Authorized By Head Plant )- ,- ttlo,:,lzoui
STANDARD OPERATING PROCEDURE For Restricted Circ rlation
LUcENT BIOTECH LIMITED ruNrr-I)
165/3, Nalhe.a, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)

Procedure for Preparation, Approval, Distribution Control, Revision
(SOP on SOP)
QAio01-02 tqi0lllc rt ?'lozluz3
| QA/001-01 02 5 of 23
5.2.'14Prcparcd by, Checked by, Approved by and Authorized By shall be
fllled by deputed person for his job and he/she put their signature ./date in
Black ink colour
TABLE 1.1
Sr. DeDartment ID Sr. DeDartment ID

Quality Assurance QA 10 HR and Personnel HR
2 Ouality Control QC 11 Production PR
3 Microbiology MB 12 General GN
Tablet Section TS 13 Accounts AC
6 Capsules Section CS 15 Security SC
8 Engineering/Maintenance EN '17 F&D FD
9 Warehouse WH 18 R.g'{atory, RA
+(Srr€,
5.3 Content Part:
1.0 Objective - To deflne the purpose ofthe procedure.

2.0 Scope - To define the area of application of the procedure.
3.0 Responsibility - Write here the designation and responsibilities of
the person / persons who are directly responsible for the operation
mentioned in the 'Objective' of the SOP
4.0 Accountability -This section shall indicate the designation of the
person who shall be accountable for compliance of the standard
^â..li^^ ^.^^6.1' 'ra
5.0 Procedure - To describe briefly and clearly the actual way of
carrying out the operation.

Prepared By Officer QA lct I cLlLn )l
---t'{1--, lq lo!l2a jl
Approved By Head QA tQ Jorlzi::1
,l
lq rcLlL(,Ll
Format No. : OA,/001/F0'1-00
STANDARO OPERATING PROCEDURE For Restricted Circulation
LUCENT BIOTECH LIMITED (uNrr.n)

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Oistl: Haridwar (ljttarakhand)
Oepartment QUALITY ASSURANCE

Procedure for Preparation, Approval, Distribution Control, Rewision
(SOP on SOPI
SOP No. Effective Date Revie\.y Date Supersedes No Revision No. Page No.
QA/o01-02 lcl lozl>ot\ l2'l o.tizx'tl QAio0t-01 02 6 of 23
. SOP text shall be written in simple and clear language in Font
Style, "Arial", with a Font size of'12'and space between the
lines shall be 1.15 lines. 44 size white paper shall be used for
printing.
. Bold letters shall be used for Heading and / or Subheadings
. All SOP shall be written in English language, and in local
language, lf required.
. References: References shall be mentioned in the procedure if
applicable.
6,0 Annexure-Annexure s
related to the activity.
Annexure shall have a

SOP number and shall be written at the bottom, left of the page
7.0 History of review - To describe briefly and cleady the review
history of the document.
8.0 Reference- To describe the reference of SOPS.
9.0 Abbreviation- The Abbreviations used in lhe SOP shall be
described in this section.
10.0 Distribution List: This section shall have the list of department for
which the SOP shall be applicable / distributed along with the no. of
copy requrred.
5 4 Format of SOP
5 4.1 The format number used for preparing the SOP is mentioned in the
bottom, left of the page Format number shall consist of total 13
characters.

Prepared By Officer QA lct loLl Le L t
Checked By Executive QA lctloLlzt'L)
Approved By Head QA !StBr ItlloLl).tt
Authorized By Head Plant '1 ,- I1 iatlzt tl
Format No. ; QA,/001/F01-00
LUCENT BIOTECH LIMITED tuNrr-rl

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
Department OUALIry ASSURANCE

(SOP on SOPI
SOP No. Effective Date Review Date SuDersedes No Revision No. Pa ge No.
QA/001-02 lcl l61l zczi \2.1aLlrELg QA/001-01 02 7 of 23
5.4.2 The first 6 characters of the tormat no shall be same as per the SOP
no. Only SOP no. will be mentioned not version no. But, it will be
consider as latest version of the SOP.
5.4.3 The Seventh character is (4 slash
5.4.4 The eighth character is 'F'which stands for format.
5 4.5 Ninth and tenth character represents the sequenlial number of format,
starting with '01' onwards.
5.4 6 Eleventh character is dash C). - .
5.4.7 Twelfth and thirteent rel{iFiMaumbe r of the

format. lf a tormat is $\ioicateo as "00" in
the revision number in the format shall be
indicated by "01", "02" and so on.
e.g. The tlrst annexure of this SOP shall bear the format no in the
following fashion. QA,/001 /F01 -00.
5.5 Approval of SOP

5.5 1 All SOPs must be drafted by concerned department and then it should
be sent to the concerned deoartment head for their comments. The
draft copy should bear the word as "DMFT" in the background on each
page as per Annexureill The department head will make the
necessary corrections in the draft matter, if required Concerned
department personnel, preparing the SOP, shall provide the final
correction soft copy along with the corrected hard copy of draft rnatter of
the SOP to the QA department. The QA person from document control
department shall check the correction done and take the inal print out
of the SOP. The QA person then circulates the final print out of SOP for
t.kin^ ci^^.1,,rae tha nare^he
^f ^^nârnA.l

Prepared By officer QA -f{'t t"r- tcllozlz.rrr
Checked By Executive QA Iq l1Ll>c 1i
Approved By Head QA
-P93,"
5]i\q1- lq loLlLaz)
Authorized By
Format No : QA,/001i F01-00
Head Plant t, l"t lotlz,'z i
STANDARD OPERATING PROCEDURE For Restricted Circ rIlation
LUCENT BIOTECH LIMITED (urutr-It

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (ljttarakhand)

Procedure for Preparation, Approval, Distribution control, Revi sion
Title and Destruction of Siandard Operating Procedure
(SOP on SOPI
SOP No. Effective Date Review Date Supersedes No Revision No, Pa ge No.
QA/o01-02 lq lo2l2ELt 12loLlzaL! QA/001-01 02 I of 23
5.5.2 Generally one week time shall be given for the review and feedb ack
5 5.3 Upon completion of signature activity, authorized person from document
control will make one photocopy of the same SOP and issues "TRAINING
COPY" for training purpose to the concerned department for training by
putting stamp in blue ink on the front top right hand corner on each pages
and shall destroy the draft copy of SOP. The final signed original SOP shall
be control by the document control person.
5.54 After completion of training the concern department shall submit the
tanning copy of SOP along with the training record to the document control
person. The document control personnel shall compile the data- of training
recoto.
5.5.5 Section Head / Deoartment Head ensure @klDconcerned
is imparted before the effective date and the ning records are
maintained as per SOP
5.5.6 All Department Head /his designee shall conducl the training on the
respective SOP as per the AnnexureJV and forward the same along with the
training details to the QA department for evaluation.
5.5.7 Head-QA/ his designee shall evaluate SOP training and training record.
5 6 Review , Distribution, Retrieval & Destruction

5 6.1 The distribution of the SOP copy to the user department shall be done
after training to all concerned personnel using the SOP.
5 6.2 All the Final signed original copies shall be stamped as "MASTER
COPY" in Green colour ink on the top center of all pages of SOP. This
original Master Copy shall be preserved well in documentation cell of QA
department
Prepared By Officer QA lql6LILa2)
Checked By Executive QA ,4t9>,.l lq l('Ll)i .l
Approved By Head QA 41.{- lll,'zlz-ort
Authorized By Head Plant ./,- Icl IoLl2c)l
Format No. : QA"/001/F0l-00
LUCENT BIOTECH LIMITED rurr-ttt
165/3, Nalhera, Anantpu,, Puhana, Roorkee, Distt: Haridwar (Lrttarakhand)

Procedure for Preparation, Approval, Distibution Control, Revision
{SOP on SOPI
SOP No. Effective Date Review Date Supersedes No Revision No. Page No-
QA/001-02 lQlorlrozr lZ o'tlz';t3
I QA/00r-01 02 of 23 I
5.6.3 Required number of copies for distribution shall be photocopied of the

MASTER COPY. Each page of photocopied document shall be stamped in
blue colour ink as "CONTROLLED COPY" on the top right hand corner on
each page of SOP duly signed and dated by QA along with copy number.
5.6.4 Copy for display purpose shall be stamped as "DISPLAY COPY" in

green ink on the front top left hand corner on each pages and issue to the
user department(s)
5.6.5 lssuance of a copy of any SOP required by external_agencies such as
customers/ govt. agencies/ regulatory / statutojt]-
statutol)t]- auditing
asencies shall be siven only with the appro!?*J f:l "':
purpose, a photocopy of Master copy, s aKen,-- srampeo as
"UNCoNTRoLLED COPY" in BLUE ink.on ttieYibht foD left hand corner of
all pages, and issued stamp put ot riliriGioe corner on bottom. And the
person who issued the uncontrolled copy put the sign and date on space
which given in stamp. The issuance shall be recorded in the log named
"lssuance of Uncontrolled copy"-Annexure Vl and shall be available with QA
deDartment.
5-6.6 OA shall write the sequential copy number along with department name
to which the SOP is issued in the document issuance and control record with
necessary signature for received by and issued by as per procedure for
document and data control.
5.6.7 In case of an additional copy is required by any department a written

request shall be raised by the concern department duly signed by the concern
department head and approved by QA head, as per Annexure-V. The

Prepared By Officer QA ird qlaLlLaL
qioLlLoLl
Checked By
Approved By
Executive QA
Head QA
--ry,)
Pi$' q loLI2-o)t
Authorized By
Format No. : QA./001/F01-00
Head Plant a,- t( lor lz ozl
LUCENT BIOTECH LIMITED tuntr-ttt

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttalakhan<J)

Procedure for Preparation, Approval, Distribution Control, Reyi sion
Title and Oestruction of Standard Operating Procedure
{SOP on SOP)
SOP No. Effective Date Review Date Supersedes No Revision No. Pa ge No.
QA/001-02 lalu j2;y1 l2lbLlL.Lr QA/001-01 02 10 ot 23
document control person shall issue the additional copy and will maintain the
recoro.
5.6.8 During revision and issuance of any SoP document control person shall
retrieve all the previously issued old version copies from the concern
departments. The retrieved copies of old version shall be destroyed by the
document control person after getting the approval of QA-Manager After
issuance of lhe new revision SOP.
5.6.9 Document control person shall put the stamp as "OBSOLETE" in RED
Ink colour (Annexure l) on center of every page in such a way that the stamp
should be over the text matter not in blank space & the old master copy or
superseded copy and archive properl
5.6.10 Revised or amended SOP'S
however the revision number 00 will
01.
5.6.11 Whenever the SOP is reviewed, the changes made shall be entered in
the "History of review" column & Reason for Change." should be in written.
5.6.12 Follow the SOP (Title: Change Conkol) during review of all existing
soP.
5 6.13 !n case if there are no changes required in the existing SOP during the
review, the same shall be mentioned in the SOP change history as
'R.eviewed, No Change" shall be valid for the next two years or reviewed
within 30 days after reviewed date.

Prepared By Officer QA "S,a-uur )q IoLl L.Li
Checked By Executive QA .ryz lq IaLl Lx2l
Approved By Head QA #b!+- lct loLl2LzJ
Authorized By Head Plant 11[a tl
zo tl
Format No : QA"/001iFol-00
LUCENT BIOTECH LIMITED {uHr-rrr

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)

{SoP on SOPI
SOP No. Effective Date Review Date SuDersedes No Revision No, Page No.
QAi001-02 loLlzaLl
l.t oL!
lzl$Lll QA/001-01 11 of 23
5.6.'14 lf QA Executive/Officer reviewed any document except SOP shall put

the stamp as REVIEWED BY (Round shape) on the bottom of the page and
put the sign and date in the space mentioned in stamp
5.6.15After reviewed any document except SOP Head QA shall put the stamp
as APPROVED BY (Round shape) on the bottom of the page and put
the sign and date in the space mentioned in stamp
5.6.16QA Executive/Offlcer shall ensure the reconciliation & destruction of
SOP (by shredding and /or alternatively by other suitable methods) and
document the same in "SOP Distribution and Destruction Log" (Ref:
Annexure Vll).
5.6.'l7All stamps referred in this SOP are given in Table
SOP shall be distributed as per the distribution list with applicable copy
no
Copy No. Deptt./ Distribr\ttqr.^" [1_0 'r
Master Copy Qua ty Assurance- Head of the-ddFaifment
1 Qua ity Assurance- Offlce
2 Qua ity Control Department- HOD
2a Qua ity Control Department- Display copy
3 Production - HOD
3a Production department- Display copy
3b Packing department-Display copy
4 Store-HOD
4a Store-Display copy
5 Engineering Department- HOD
Engineering Department- Display copy
6 Personnel & Administration -HOD
6a Personnel & Administration department- Display Copy
7 Outside parties (Uncontrolled)

Prepared By Officer QA €{1,i tq lcL lzaLi
Checked By Executive QA __-p\<_ l.llt,Ll202.l
Approved By Head QA lq lor-l2czr
Authorized By Head Plant l (l laL lLozl
STANDARD OPERATING PROCEDURE For Restricted Circ |llation
LUCENT BIOTECH LIMITED ruNrr.rD
'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar {uttarakhand)

Procedure for Preparation, Approval, Distribution Control, Revi sion
(SOP on SOP)
oAi001-02 lct azl>ct1
I l2lozlzcz\ QAio01-01 02 12 ot 23
6.0 Annexure

'l Annexure I Stamps
2 Annexure ll SOP Format
3 Annexure lll SOP Draft Format
Annexure lV SOP Training Record
5 Annexure V Request form for Additional SOP Copies
6 Annexure Vl lssuance of Unconlrolled CoDV
7 Annexure Vll SOP Distribution and Destruction Log
History of Review \9)'>

Abdroval Reason For
C.C. No.
Review
16t02t2017 New SOP
'15to2t2019 cct19too4 't6t02t2019 Periodic Review
19tO2t202'l cct2'|o11 Periodic Review
8.0 References
Sr. No Reference Reference Code
World Health Organization 2006, Geneva

1 WHO TRS 937
(WHO Technical Report Series, No. 937)
2 cG N4P
cGMP guidelines)
3 In House Specification IHS

Prepared By Officer QA i.,^ :. I q I c,tl zc t-t
Checked By
Approved By
Executive QA
Head QA
-_p4 ' lqlcrll..zt
ct I c,Ll2rL
trel,,t _
Authorized By Head Plant I. lq IoLlL.Ll
Format No. ; QA/001/F01-00
STANDARD OPERATING PROCEDURE For Restricted Circ rilation
LUCENT BIOTECH LIMITED (uNrr-u)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwat (Uttarakhand)
Deparlment QUALITY ASSURANCE

(SOP on SOP)
SOP No. Effective Date Review Date Supersedes No Revision No. Pa ge No.
QA/001-02 I ql0Ll2c2 | l2iorlzol3 QA/001-01 02 13 of 23
9.0 Abbreviations
SOP Standard Operating Procedure

QA Ouality Assurance
QC Quality Control
cc No Change Control Number
cGMP Current Good l\ranufacturing Practice
tHs In House Specification
WHO TRS World Health Organization Technical report series
F Format

S. No. DepU Distributed to CôU No.
1. Quality Assurance- Head of the department _l 61Wle'ster-cocv
Quality Assurance- Office 1
Quality Control Department- HOD 2
Production - HOD 3
Store-HOD 4
Engineering Department- HOD 5
Personnel & Administration -HOD 6

Prepared By Officer QA -&, r-. I q I aLl232-l
Checked By Executive QA I q loL l2c) l
Approved By Head QA
-t>9-.'
qltr1 ' tclloLlLol)
Authorized By Head Plant I4latiLat I
Format No. : QA"/001/F0'1-00

LUCENT BIOTECH LIMITED tuNrr-r)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (uttatakhancl)
Department OUALIW ASSURANCE

(SOP on SOPI
QA/001-02 lq IoLlLaLl lZ I o.r-lz'3 QA/001-01 02 14 ol 23
Stamps
CONTROLLED COPY
MASTER COPY lssued by QA
Size: 50mm (L) x 9 mm (H) Sign:
Date:
r\
'V?.,\'tpL'2
z'Lra\\r Y'
OBSOLETE COPY Size: 60mm (L) Xl8 mm (H)
Sign
Date DISPLAY COPY
Sizei 60mm (L) xl8mm (H) Size: 50mm (L) x 9 mm (H)
Revision Numben
UNCONTROLLED COPY
Copy No.: Next Revision Due On:
Sign: Sign./Date:
Date:
Size: 60mm (L) xlSmm (H) Size: 60mm (L) xlSmm (H)

Prepared By Officer QA lqlorl2n.i
Checked By Executive QA f",(<r tq loLl2oL)
Approved By Head QA i$H,L" q I oLlLez)
Authorized By Head Plant )"_ \ c\lcLlLa zi
Format No. ; OA,/001/F0'l-00
STANDARD OPERATING PROCEDURE For Reslricted Circlllation
LUCENT BIOTECH LIMITED rurr-tu
165/3, Nalhera, Anantpur, Puhana, Roo*ee, Distt: Haridwar (Uttarakhancl)

(SOP on SOP)
SOP No. Effective Date Review Date Suoersedes No Revision No. Page No,
QA/o01-02 tq 02lzorl
I L"L3
lZl6Ll QA/001-01 02 15 ot 23
APPROVED BY
Sign. .........,.......
Size: 30 mm Oiameter Size: 30 mm Diameter

Prepared By Officer QA i&"*.,^ lctl aLlLeL
Checked By
Approved By
Executive QA
Head QA
-4,".-
9$\-i
l(lorlzcu
lq loLl2cLl
t
Authorized By Head Plant )",,. ll laLDaLl

LUCENT BIOTECH LIMITED (uNr-n)

165/3, Nalhera, Anantpur, Puhana, Roo*ee, Oistt: Haridwar (Uttarakhan d)

Procedure for Preparation, Approval, Oistribution Control, Revi sion
Title and Destruction of Standaid Operating Procedure
(SOP on SOPI
QA/00 t -02 lglt,zfrcr; l2lozlzoz3 QA/o01-01 02 16 of 23
Annexure ll
SOP FORMAT
@
Department
LUCENT BIOTECH LIMITED ruHr-rn
165/3, Nalhera, Anantp!r, Puhane, lqbalpur Road, Roorkee
Title
1.0 Objective
2.O Scope
3.0 Responsibility
4.O Accountability
5.0 Procedure
6.0 Annexure
Supersedes C.C. Approval Reason For

Date C.C. No.
No. date Review

Prepared By Officer QA fia; lcll6ylLott
Checked By Executive QA lq IsLlLozt
Approved By Head QA !h1.4- Icl loLl La)l
Authorized Bv Head Plant ).- Icl I o t,lzot-i
Format No. : QA,/001/F0l-00
LUCENT BIOTECH LIMITED ruNrr.rr)

'165/3, Nalhera, Anantpur, Puhana, Roo*ee, Distt: Haridwar (lJttarakhand)
Department QUALIW ASSURANCE

I tl|e and Destruction of Standard Operating Procedure
ISOP on SOP)
QA/o01-02 )qlD>l)-oLl lll ozlz"23 QAi00141 17 ot 23
Annexure ll
LUCENT BIOTECH LIMITED ruNrrru

165/3, Nalhera, Anantpur, Puhana, lqbalpur Road, Roorkee
Department
Title
8.0 References
Sr. No Reference Referdnce Code^

^
..-ffipv)119'-'2
9.0 Abbreviations
l0-0 DistributionList:
Sr. No. DepU Distributed to copy No.
Authors Desiqnation Siqnature Date

Prepared Bv
Checked Bv
Approved Bv
Authorized Bv
Format No. QA/o01/F01-00

Prepared By Officer QA tl>c.t
lTla
Checked By
Approved By
Executive QA
Head QA
,'ry*
gi+ -- l\ lozltc'.t
I q l azlzoLt
Authorized By Head Plant '1 t4ioL))oLl
LUCENT BIOTECH LIMITED {uNrr )
'165/3, Nalhera, Anantpu,, Puhana, Roorkee, Distt Haridwar (Uttatakhancl)

(SOP on SOP)
SOP No. Effective Date Review Date Supersedes No Revision No, Pa ge No.
QA,t001-02 lq loLlLcLl l2'ln LlLo'L\ QA/001-01 02 18 ol23
Annexure lll
SOP DRAFT FORMAT

165/3, Nalhera, Anantpur, Puhana, lqbalput Road, Roorkee
Departnent
Title
1.0 Objective 'v->- >

Scope
.4 bilror
3.0 Responsibility
4.0 Accountability
5.0 Procedure
6.0 Annexure
7.O History of Revi
c.C. Approval date Reason For Review

Prepared By Officer QA Ill o>lzr
'i
Checked By Executive QA I I IILILoLJ
Approved By Head QA ,ttr\i- lg IoLl20Ll
Authorized By Head Plant I d IbLILALI
Format No. ; QA,/001/Fo'l -00
STANDARD OPERATING PROCEDURE For Restricted Circ rllation
LUCENT BIOTECH LIMITED ruNrr{)

165/3, Nalhera, Ananlpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)

Title and Destruclion of Standard Operating Procedure
(SOP on SOPI
QAi001-02 1a lotlzoLl It I ozl>"zz QA/001-01 02 l9 of 23
Annexure lll
LUCENT BIOTECH LIMITED rurrr-rrr

Departnent
Title
8.0 References
9.0 Abbreviations

Copy No.
Authors iqnation Siqnature
Checked B
Authorized B
Format No. OA,/001/F02-00

Prepared By Officer QA {}.iL, ll lo t-i 2o t1
Checked By Executive QA ,*tr- Iq I orlz"zl
Approved By Head QA JLllr4-- I l l oLl L.lt
Authorized By Head Plant ), ,- tqloLlLaLl
Format No. : QA,/001/F0'l -00
STANOARD OPERATING PROCEDURE For Restricted CircrJlation
LUCENT BIOTECH LIMITED {uNrrrD

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Hatidwar (uttarakhand)

(SOP on SOP)
SOP No. Effective Date Review Date Supersedes No Revision No. Page No,
QA/o01-02 lQl,';.lz-o,1 GlbLl2aL3 QA/001-01 02 20 ol 23
Anncxure lV
LUCENT BIOTECH LIMITED ruHrr-rrr

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt Haridwar (Uttarakhand)
Title SOP Traininq Record

SOP Title;
SOP No:
Name of Trainer:
Date of Training:
tv'b
Sr Adequacy
Trainee's Trainer's
Names of Trainee Department certified yes Sign ature
No Signature
No
Format No OA,/001/F03-00
Authors Designation Signature

Prepared By
Checked By

LUCENT BIOTECH LIMITED (uNrr-r)

(SoP on SOPI
QA/001-02 I q l02-l2o2l tZIoiz" 2,3 QA/001-01 02 2a of 23
Annexure V
LUCENT BIOTECH LIMITED (uNrr,[)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Utta.akhand)
Title Request for Additional Copv
1. Initiating Department
Name :
2. Document Name :
3. Document Number :
. "ftvqr:---.'
4. No. of copy required :
5. Reason for additional coov:-

6.
Signature & date:
(Officer/Executive- Iniliating Dept.) (Head - Initiating Dept.)
7 Approved / Not Approved
Signature & Date:

(Head- Quality)
Format No. OA"/001/F04-00

Prepared By Officer QA '4Vr-i. lqlltr2r'Li
Checked By Executive QA .4.- I q la>lyc tt
Approved By Head QA t!!l' I q loLl)-nLl
Authorized By Head Plant \,,,- I q lotlzal't
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LUCENT BIOTECH LIMITED tuNrrrD

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhal| d)

Title Approval Procedure of Signature Specimen ,
SOP No. Effective Date I Review Date I Supersedes No.J Revision No. Page No'
QAJo05-03 rqtull,Lo r\ | Utorl1"rsl QA/oos-o2 | og lr"re
1.0 Objective
1.1 To lay down the procedure for maintaining the specimen signatures.
2.0 Scope
2.1 This procedure is applicable lo use of signatures ot all the staff of all Departments
working in at Lucent Biotech Ltd (Unit-ll).
3.0 Responsibility
3.1 Officer Human Resource
3 2 Officer/ Executive QA - To add the signature in Master Signature List during joining
4.O Accountability
41 Head-QA
5.0 Procedure
5.1 Oualit Assurance system related documentation should be signed by'Plant Head"
5.2 Production and QC documentation should be signed by Head -QA
5.3 Organization authorized Black pen for Production, QA and QC and Green Pen for
IPQA personnel.
54 "Authorized Person" means that any person signing the documents should have
sufficient knowledge, training and expertise to adequately review and approve data,
inJormation conclusions and recommendations contained therein.
5.5 This procedure is required to maintain specimen signatures of employees, so that,

. The signature / initial on records / documents match with the specimen
signatures which are maintained in the respective departments.

Authors Designation Date
r^Signature
Prepared By Officer QA t-l rqloz\ Lo )\
Checked By Executive QA r ix\DLt ttral
Approved By Head QA LNvr \ r-orl
Authorized By Head Plant --.,(v,-.-
-&:-- U\ \u r-t ro r-g
Format No. : QA/001/F01-00
LUCENT BIOTECH LIMITED tururrrt
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt Haridwar (UttarakhaDd)

Title Approval Procedure ot Siqnature Specimen
2otG
QA/005-03 tq\o rl ?r' 2 \ lvtrLl zC QA/005-02 03
. No operating personnel can repudiate / disown the activity recorded

5.6 lt is possible to determine the person who has recorded the activity.
5.7 The specimen signature of each indjvidual shall be recorded on a List of Technical
Staffs Signatory as per the format (Refer Annexure-l).
5.8 Quality Assurance department has to maintain the authorized signatory list of all the
department employees in a file.
5.9 The individual shall sign / initial on the authorized signatory list against the columns
provided, matching to the regular signature / initial.
5.10 lf the employee is transferred from the present department to another department,
his / her signature will be transferred to the new department.
5.11 The specimen signature and initials shall be added at the time of new recruitment
from time to lime and list shall be updated every two years.
5.12 Whenever a new employee joins the organization, it is the responsibility of the QA
department head to request for the specimen of Technical Staffs Signatory and
get the same filled and updated
6.0 Annexure
1 Annexure I List of Technical Staffs Signatory

Prepared By Officer QA 'l--.-. rgzl
rqloLl
Checked By Executive OA Y.'N. \q\urt 2o 2 )
Approved By Head QA '--4'r^44' lq\bLI tje 21
Authorized By Head Plant U l9\orl 2r r ",
Format No. : Qtu001/F01-00
itJ+-,s7;i r':.li;
STANDARD OPERATING PROCEDURE For Restricted Cireulation
LUCENT BIOTECH LIMITED (urtr-tt)
'165/3, Nalhera, Anantpur, Puhana, Roorkee, Disft: Haridwar (UttarakhaD d)

Title ADDroval Procedure of Siqnature Specimen
SOP No. Effective Date Review Date Supersedes No. Revision No. Page No,
QA/005-03 tq\ur-tpz^ taloz.[)"zs QAio05-02 03 3of6

No. Date
18t0212017 NIL NIL NIL New SOP
't5t02t2019 QAJo05-00 cct19t004 't6t02t2019 Periodic Review
19t02t2021 QAJo05-01 cct21t011 19t0212021 Periodic Review
'19to2t2023 QA,/o05-02 ccl23l0't3 19t12t2023 Periodic Review
8.0 References

Current Good Manufacturing Practices WHO
1 cGMP
cGMP quidelines)
SOP On SOP QAJ001-00
9.0 Abbreviations
CGMP : Current Good Manufacturing Practice
F : Format
QA ; Ouality Assurance
C.C. No : Change Control Number

Prepared By Officer QA _t,* lc\lr'? \ \1co?
Checked By
Approved By
Executive QA
Head QA
-p+-
,(v^@2,-
totor\ r.rir
tq\02\ rDr!
Authorized By
Head Plant ,4--' l!X\b.yl 1rr\
LUCENT BIOTECH LIMITED tuHr-tD

165/3, Nalhera, Ananlpu., Puhana, Roorkee, Distl: Haridwar (t ttarakharDdl

Title ApDroval Procedure of Signature Specimen
QA/005-03 lqlo).l q09?-\ tgtezl?oLS QA/005-02 03 4ot6
10.0 DistributionList;
S. No. DeDU Distributed to Copy No.
1. Head of department - Ouality Assurance Master Copy
') Office - Quality Assurance 1
Head of department - Ouality Contro 2

5. Head of department - Store
Head of department - Engineering 5
7. Head of department - Personnel & Administration 6
Authors Designation /Signature Date

Prepared By Officer QA rq\u L\ 'Io 2\
Checked By Executive QA tq\b'LL 1c'2\
Approved By Head QA i'au).- tq\orl 2c i\
Authorized By Head Plant lQ\or\ rtr r:
STANDARD OPERATING PROCEDURE
@,rr@ For Restricted Circulation
LUCENT BIOTECH LIMITED 1ut.tnrtl
'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwaa (Uttatakharrd)

Tiile Approval Procedure of Siqnature Specimen
SOP No. Effective Date Revie\rv Oate Suoersedes No. Revision No. Page No.
QA/o05-03 tqtu r,\ zo z.l tll orJ > z-E QA/005-02 03 5oto
Annexure-l
LUCENT BIOTECH LIMITED tunr-nt
@
DeDartment
'165/3, Nalhera, Anantpur, Puhana, Roorkee,
QUALITY ASSURANCE
Distt Haridwar (uttarakhand)
Paqe No,
Title List Of Technical Staffs Signatory 1ol1
S. No. Name of Signatory DepartmenVDesi gnation lnitials Full Si gnature
Authors Designation Agnature Date

Prepared By Officer QA >{_ 19 I od r-o rr,
Checked By Executive QA .+e9- ^
:/ (w9-
l\f, lrell lIJ)\
Approved By Head QA l.Q \or\rc ir
Authorized By Head Plant Lq\o u\ te z5
Formal No. : QA"/001/F01-00
rpU.,ttq!d
LUCENT BIOTECH LIMITED tuHtr'rtl
'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhan d)

Title ADDroval Procedure of Siqnature Specimen
QAi005-03 rltu).m>3 QA/o05-02 UJ Gof6

[Vlo zl to r,q

Prepared By Otficer QA P- rq\orl rc zl
checked By Executive QA 4 rq \bLl 14r t\
Approved By Head QA {V- I q\uz\ \-{r,)4-
Lq.\u L\ 1412 !
Authorized By
Head Plant
-k
In r r. n-rr :-r (loP.,l
ii ,'il-D I r- ',
LUCENT BIOTECH LIMITED tuHtr-tt)

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakharrd)
QUALITY ASSURANCE
Record. Batch Packinq Record and
Review Date SuDersedes No, Revision No. Page No.
1.0 Objective
1.1 To lay down the procedure Numbering System of Master Formula Record, Batch
Manufacturing Record, Batch Packing Record and Specificalion.
Scope
2.1 This SOP is applicable for Numbering System of Master Formula Record, Batch
Manufacturing Record, Batch Packing Record and Specification at Lucent Biotech
Ltd (Unit-ll)
3.0 Responsibility
3 1 Officer QA
3.2 Head Production
4.0 Accountability
4.1 Head - QA
5.0 Procedure:
5.1 Numbering System ofMFR, BMR and BPR:
5.1.1 Master formula record, Batch Manufacturing Record, Batch Packing
number is an alphanumeric component document reference number'
51.2 The first three letter will indicate document type as below:
"lVlFR" documents type as Master Formula Record.
"BMR" documents type as Batch Manufacturing Record.
'BPR' d ocume nts typeeas
as Batch Packing Record
Authors Designation ;E!gnature Date
Prepared By Officer QA lu lD?-.12rt 2 5
Checked By Executive QA .=&\ tqtbLt Lct 13
Approved By Head QA {- [9, [q\uL\ 10 L\
-)":- Lq\PL(te z'3
STANDARD OPERATING PROCEDURE For Restricted CirGulation
LUCENT BIOTECH LIMITED IUNITJD

'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhan d)

Title
Record. Batch Packinq Record and Specification
QA/003-03 lqlhl I .)' )-,\ lvlo).1 rrf5 QA/003-02 03 2ot5
5.1.3 The forth character is (4 slash
5.1.4 Fifth character having indicates dosage form as below "T" Tablets "C"
Capsule.
5.1.5 The sixth character is (4 slash
5.1.6 The Seventh, eighth & ninth digits indicate the Serial No. Like ''001' 002,
003...........999" - Serial No.
5.1.7 The tenth digit indicate the "-" Dash.
5.1.8 The Last two digits indicate the 'Revision Numbei' (00)
5.2 Based on the above system the MFR, BMR & BPR document reference
numDer as :
5.2.'l MFR/T/oo1-00 (as per the above system)

5.2.2 B|\4R/T/001-00 (as per the above system)
5.2 3 BPR/T/001-00 (as per the above system)
5.3 Numbering System of Specification (Finished Products):
5.3 1 The specification number is an alphanumeric component document
reference number
5.3.2 The first three letter will indicate document type as below:
"SPEC" documents type as Specification
5.3.3 The next letter indicates dosage form as below:
"T" Tablets
"C" Capsule
5.3.4 The three digits indicate the Serial No. Like"001"-Serial No.
Authors Designation Fig nature Date

Prepared By Officer QA 'J{- lq\ ,zl 2cz\
Checked By Executive QA c{ lQ\ot'[ 2p u<
Approved By Head QA vt- tq \s1,t 2@ !1,
Authorized By
No
Head Plant ,4.."' !\\rrz-{ to r-._
Format : QA,/001/F01-00
iiir,fs-isa
iq,t- I

165/3, Nalhera, Anantpur, P!hana, Roorkee, Distt: Haridwar (Utlarakhan d)
Department QUA LITY ASSURANCE

Title Record, Batch Packing Record and Specification
QA/o03-03 tq to r-l ro r.r tElu, ts 2<
QA/o03-02 03 3of5
5.4.1 SPEC/T/001-00 (as per the above system)
5 4.2 SPEC/C/001-00 (as per the above system)
5.5 Numbering System of Specification (Raw Materials & Packing Materials):

5.5.1 The specjfication number is an alphanumeric component documenl reference
number.
5.5.2 The first three letterwill indicate document type as below:
'SPEC" documents type as Specificatlon.
5 5.3 The next two letter indicates as below
"RM" Raw l\4aterials
"PM" Packing Materials
5 5.4 Thethreedigits indicate the Serial No. Like"001'-Serial No.
55 5 The Last two digits indicate the "Revision Number"
5.6 1 SPEC/RMioo1-00 (as per the above system)

5.5.1 SPEC/P|\4/001-00 (as per the above system)
6.0 Annexure
NL NIL NL
Authors Designation Sjgnature Date

Prepared By Officer QA 'P-- lq\0L\1oL\
Checked By Executive QA \q\o) -t 2.9 ?
Approved By Head QA ? w.a- \q\ o ul rrrrr
-4,,., tq\o L[ .Io z\
Format No. : QAJ001i F01-00
4 r c-itr lJ
,jiru ! Li a'n!'.'i
STANDARD OPERATING PROCEDURE For Restricted CirEulation
LUCENT BIOTECH LIMITED turun-tu

165/3, Nalhera, Anantpur, Puhana, Roorkee, Diste Haridwar (uttatakhan d)
Depa rtrnent OUALITY ASSURANCE

Title
Record, Batch Packing Record and qpecification
QA/003-03 tq I D?-l )Dr\ tv \c?,110 z< QA/003-02 03 4ol 5
7.0 Historv of Review

No. date
161O2t2017 NIL NL NIL New SOP
15tO2t2019 QA/003-00 cct19too4 16t02t2019 Periodic Review
19t02t2021 QA,/003-01 cct21to11 19tO2t2021 Periodic Review
19t02t2023 QA/003-02 cct23t013 19tO2t2023 Periodic Rewiew
8.0 References
Sr. No Reterence Reference Code
1 cGMP
cGlvlP guidelines)
2 SOP on SOP QAJ001-00
9.0 Abbreviations
SOP ; Standard Operating Procedure
OA : Quality Assurance
QC : Quality Control
CC NO : Change Control Number
CGMP : Current Good lvlanufacturing Practice
BMR : Batch Manufacturing Record
BPR : Batch Packing Record
l\,lFR : Master Formula Record
RlVl : Raw l\4aterials
Plil : Packing Materials
Authors Designation qignature Date
Prepared By Officer QA 'F'.._- Irl\0zl ,r, ) \
Checked By Executive QA frf:>'*-- uc \or-.\ r-e ir.
Approved By Head QA .>'44\U-\ te \ur.4.rriz r
Authorized By Head Plant 19\ot-4 ur L1
ii,JlASTER. OP'r


Title
Record, Batch Packing Record and Spec!!gq!!on
QA.to03-03 lq ioLtro2 ! tUtD'r lors QA/o03-02 03 5of5
10.0 Distribution List;
S. No, Dept./Distributed to Copy No.
1. Head of deoartment - Oualitv Assurance Master Copy
Quality Control Department- HOD 2
Head of deoartment - Production 3
Head of department - Warehouse 4
Authors Designation Fiqnatu re Date

Prepared By Officer QA 'ts-i_ r.c\ \oL\\ 1(J )
Checked By Executive QA ,b<-= tq\orl t, L\
Approved By Head QA .{ \1J lq\oL[ uJ L\
Authorized By Head Plant ,.*z' tQ \ur-L'rp r-'".
STANDARD OPERATING PROCEDURE
lltf{tit:I For Restricted Circulation
LUCENT BIOTECH LIMITED (uNrr-rl

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar {Uttarakhan d)

Procedure for Preparation, Approval, Distribution control, Rev ision
(SOP on SOPI
SOP No. Effective Date Review Date Supersedes No ReYision No. Page No
QAJo01-03 tqlorl.-nLl tBlb2l20x5 QA/001-02 03 1 ot 23
1.0 Objective
'1.1 To establish a procedure to be used as a guide for writing Standard Operating
Procedure.
1.2 To ensure that company's all operations are covered by written pracedure
specifying actual working methods.
1.3 To revise existing operating procedure as and when required.
2-0 Scope
2.1This procedure is applicable for the preparation of various SOPS to all departments
oJ Lucent Biotech Ltd (Unit-ll)
2.2This SOP describes written instructjons how lo prepare detailed & specify, how a
test/operation or administrative procedure is to be performed
3.0 Responsibility
3.1 lt is the joint responsibility of the originating department (User department) and
other related department. Quality Assurance depariment has to check & verify the
following:
3.1.1 The Technicality of the procedure.
3.1 2
Checking and Training of SOP.
3.1.3 The format and numbering syslem followed.
3.2 Quality Assurance department endorses the copy and issue the respective SOP
to user department
3 2 Quality Assurance department holds the 'IVIASTER COPY" of all the

departments SOPs.
Authors Designation Siqnature Date
Prepared By Officer QA 'P- lq o2 2A2Z
Checked By Executive QA r'lS.--- l'l b2- 2!23
Approved By Head QA :6-rGL- i9 bL Lb t-3
Authorized By Head Plant / tq oL 1aL2
Format No. : QAJ001/F0.1-00
i<
.;l'iA
STANDARD OPERATING PROCEDURE For Restricted Clrculation
LUCENT BIOTECH LIMITED ruHrr-rr
'165/3, Nalhera, Anantpur, Puhana, Roorkee, D;stt: Haridwar {Uttarakharrd)

Procedure for Preparation, Approval, Distribution Control, te\risio
(SOP on SOP)
SOP No. Effective Date Review Date Supersedes No Revision No, Page
QAJ001-03 lq lo2l)o23 I lcz,l 20 5 QA/00't-02 03 2of
4.0 Accountability
4.1 Head - QA
5.0 Procedure
5.1 The procedure for signing the SOP must be as follows:
5.1.1 All the SOP'S must be signed with date by the person responsible for the
preparation oI the SOP in the specified column 'Prepared By" along with
designation.
5.1 2 Concerned Department Executive/Head designee will check the SOP and
sign with date in the specilled column "Checked By" along with
designation.
5.1.3 The SOP will be approved by the Head QA or His/her nominee will
Approved the SOP and sign with date in the specifled column "Approved
5.1.4 The SOP will be authorized by the Plant Head or His/Her norninee will
Approved the SOP and sign with date in the specifled column "Authorized
5.1.5 Only Standard lo be used for the writing of SOP, it can be taken in a soft
copy form by the QA department and each SOP to be write/ prepared only
in this format (format No.QAJ001/F01-00).
5.2 The format and contents of standard operating procedure must include the
following
(Refer Annexure ll -SOP Format)
Authors Designation Sip.qature Date
Prepared By Ofticer QA l9 lo 2l r ncz
Checked By
Approved By
Executive QA t!- lc1 lo 2 2o 13
Authorized By
Head QA
Head Plant
-W'- P lo2, 2b 13
.r|lbz- Lb23
i
LUCENT BIOTECH LIMITED (uNrr-I)

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt Haridwar (ljttarakhan d)

Procedure for Preparation, Approval, Distribution Control, Rew ision
{SOP on SOP}
SOP No. Effective Date Review Date Supersedes No Revision No. P age No
QAi001-03 1c1 lp yl Lo2-3 lBlozltots QA/001-02 03 3ot23
5.2.1 Write STANDARD OPERATING PROCEDURE on the top of page tn leFl
side which having font Arial, Bold & Font size 12 in uppercase a nd nght
side on the top of page should be written For Restricted Circulation in
font Arial, Bold & Font size 12.
5.2.2 fhe Header will remain as per SOP format (Ref: Annexure-ll) font should
be used in Arial.
52.3 The Company Logo shall be printed at the top left portion of each page.
5.2.4 LUCENT BIOTECH LTD. (UNlTll): The Company name shall be prinled
at the middle portion of each page in uppercase in Arial, Bold & font size
14 and Address and (UNIT-ll) in Arial, Bold & font size 10.
5.2 5 Department: To write the name of the originating department in font

Arial, Bold & Font size 12 in uppercase.
5.2.6 Title; Title of SOP in font Arial. Bold & Font size 12. lt should be self
descriptive.
5.2 7 SOP No. ; wfite in font Arial, Bold & Font size 12
Numbering of SOP
SOP number shall consist of I characters.
. First two characters denote "Department or section code" eg. QA for
Quality Assurance, OC for Quality control, WH for Warehouse. (Refer
Table 1 .1).
. Third character denotes Slash (/).
. Fourth, Fifth & Sixth characters denote serial number of SOP, starting
from "001"onwards.
. Seventh character denotes Desh C).
Authors Designation gignatu re Dale

Prepared By Officer QA 'JZ=- 19 loz lu,x
Checked By Executive QA - lYl\ ,c oLl t^t?
Approved By Head QA lC lb'Ll Lc2-2
Authorized By Head Plant \ct I bz-l zo )3
''
)'| -\
'':i--1
^-?-r'
j-\!j, '
*r.y,j__-,)
)r-.

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwat (Uttatakhan d

Procedure for Preparation, Approval, Distribution conlrol, Rev rston
(SOP on SoP)
QAJo01-03 tqlozlzczz t ftlrt2lztzg QA/001-02 03 4 ol 23
. Eighth & Ninth Characters denote reversion number of SOP, starting
from "00"onwards
5.2.8 Effective Date: The effective date is the dale from which the SOP shall
be effective. Training should be given to all concern before
implementation ofthe SOP. The effectlve date should be written by hand
with black colour ink ball pan as DD/MMlf/YY. (Date/Month^/ear).
5.2.9 Review Date: This is the date before which the SOP shall be reviewed.
Generally the review date shall be after 2 years from its effective date,
The SOP can also be reviewed before its predetermined review period, if
required. QA shall assign the review date, 2 years from the effective
date. As when required SOP will be reviewed before or after one month
5.2 10 Supersedes No. writes in font Arial, Bold & Font size 12. lts contain
previous SOP number.
5.2.11Revision No.; The current revision no. shall be print in the revision no.
As this is new SOP hence the revision no. shall be 00. After first revision
of SOP it shall be written as 01 and so on.
5.2.12Pa9e No.: The page no of a SOP should be as X of Y. Where X is
number of that page and Y is the total number of pages of the SOP
5.2.13Footerof SOP(All Pages): The footer format shall also be in font Arial,
Bold & Font size 12, the contents following details:
PreparedBy : Offlcer or designee of respective department
Checked By : Executive of respective department
Approved BY : Head QA
Authorized BY : Plant Head
Authors Designation qig{atu re Date
Prepared By Officer QA lQ lorl r"o r
Checked By
Approved By
Executive QA
Head QA
_,FF
-p5- rq l.,z'l
slt'zl zo)s
c^r r
Authorized By Head Plant [1 oLl 2br2
STANDARD OPERATING PROCEDURE For Restricted circulation
LUCENT BIOTECH LIMITED tuHtr-flt
'165/3, Nalhera, Anantpur, Puhana, Roo*ee, Distli Haridwar {Uftarakhan d)

Procedure for Preparation, Approval, Distribution conlrol, Rev ision
(SOP on SOP)
QA/00't -03 )'tlcLIuu IBla2llox5 QA/001-02 03 5oI23
5.2.14Prepared by, Checked by, Approved by and Authorized By shall be
filled by deputed person for his job and he/she put their signature /date in
Black ink colour.
TABLE 1.I
Sr. Department ID Sr. DeDartment ID
'10 HR and Personnel HR
1 Quality Assurance OA
2 Ouality Control 't1 Production PR
3 Microbiology MB 12 General GN
4 Tablet Section TS Accounts AC
6 Capsules Section cs 15 Security
8 Engineering/Maintenance EN 17 F&D FD
I Warehouse 'i8 Regulatory Affairs RA
5.3 Content Part:

5 6.'l All SOPS shall contain the following sections;
1.0 Objective - To define the purpose of the procedure.
2.0 Scope - To define the area of application of the procedure-
3.0 Responsibility - Write here the designation and responsibilities of
the person / persons who are directly responsible for the operation
mentioned in the 'Objective' of the SOP
4.0 Accountability -This section shall indicate thedesignation of the
person who shall be accountable for compliance of the standard
operating procedure
5.0 Procedure - To describe briefly and clearly the actual way of
carrying out the operation.
Authors Designation Sjgnatu re Date

1t-J
Prepared By
Checked By
Officer QA
Executive QA
'm, Iq/0112021
tq lor I z ozu
Approved By Head QA ). a!- tq I r,zllir:
Authorized By Head Plant ,./Y"-- 19I azl t,o ta
LUCENT BIOTECH LIMITED (uNrr.[]
165,/3, Nalhera, Ananlpur, Puhana, Roorkee, Distl: Haridwar (Uttarakhan d)

Procedure for Preparation, Approval, Dislribution Control, Rev ision
(SOP on SOPI
QAJo01-03 l1 Io zlzau lelDzlT0:15 QA/001-02 03 6of23
. SOP text shall be written in simple and clear language in Fonl
Style, "Arial", with a Font size of '12' and space between the
lines shall be 1.15 lines. A4 size white paper shall be used for
printing.
. Bold letters shall be used for Heading and / or Subheadings.
. All SOP shall be written in English language, and in local
language, lf required.
. References: References shall be mentioned in the procedure if
applicable.
6.0 Annexure-Annexure shall be formats used for recording the data,
related to the activity.
Annexure shall have a unique tormat number linked to the relevant

SOP number and shall be written at the bottom, left ot the page.
7.0 History of review - To describe briefly and clearly the review
history of the document
8.0 Reference- To describe the reference of SOPS.
9.0 Abbreviation- The Abbreviations used in the SOP shall be
described in this section.
10.0 Distribution List: This section shall have the list of deoarlrnent for
which the SOP shall be applicable / distributed along with the no of
copy requrred.
54 Format of SOP
5.4 1 The format number used for preparing the SOP is mentioned in the
bottom, lelt of the page. Format number shall consist of total 13
cnaraclers.
Authors Designation Slgnature Date

Prepared By
Checked By
Officer QA
Executive QA
'+
M<r-
)9ltLl ,-c?2
tql,. 2l 1r. )')
Approved By Head QA n lr,Ll L.,r-2
Authorized By Head Plant lq ft,Ll' ta2.,
Format No. : Qtu001/F01-00
LUCENT BIOTECH LIMITED ruN|T,rl

165/3, Nalhera, Anantpur, Puhana, Roorkec, Distt: Haridwar (Uttarakhand)

Procedure for Preparation, Approval, Distribution Control, Re\..ision
(SOP on SOPI
SOP No. Effective Date Review Date Supersedes No Revision No, P age No.
QAJ001-03 Iqllll2o2? lAlc>bou- QAJo01-02 03 7 ol 23
5.4.2 The first 6 characters of the format no. shall be same as per t he SOP
no. Only SOP no. will be mentioned not version no. But, it will be
consider as latest version of the SOP.
5.4.3 The Seventh character is (/) slash.
5.4.4 The eighth character is'F'which stands for format.
5.4.5 Ninth and tenth character represents the sequential number of format,
starting wlth'01' onwards.
5.4.6 Eleventh character is dash G).
5.4.7 Twelfth and thirteenth character represents the revision number of the
format. lf a format is made for first time it shall be indicated as in "00"
the revision number and subsequent revisions in the format shall be
indicated by "01", "02' and so on.
e.g. The first annexure of this SOP shall bear the format no in the
following fashion QAJo01/F01 -00.
5.5 Approval of SOP

5.5.1 All SOPS must be drafted by concerned department and then should it
be sent to the concerned department head for their comments. The
draft copy should bear the word as "DRAFT" in the background on each
page as per Annexurelll. The department head will rnake the
necessary corrections in the draft matter, if required. Concerned
department personnel, preparing the SOP, shall provide the flnal
correction soft copy along with the corrected hard copy of draft rnatter of
the SOP to the QA department The QA person from document control
department shall check the correction done and take the final print out
of the SOP. The QA person then crrculates the final print out of SOP for
taking signatures of the concerned persons.
Authors Designalion Fiqnatu re Date

Prepared By Officer QA r+{- lq l.') l rl.,2l
Checked By Executive QA !:r-- lct lr)) I 2 ( L<
Approved By Head QA ft: \1-{ tqloLl ) nr"
Authorized By Head Plant lq I r,t | 't r,2-?
Format No : QA"/001/F01-00
';,',i\ 'i i:ii. !:(-)?"{l
LUCENT BIOTECH LIMITED (uHrr-rrr
165/3, Nalhem, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhah d)

{SOP on SOP)
SOP No. Effective Daie Review Date Supersedes No Revision No, Page No
QA/o01-03 lqloz a tz, t8)o2l2ats QA/001-02 03 8of23
552 Generally one week time shall be given for the review and feed back.
5.5.3 Upon completion of signature activity, authorized person from d ocument
control will make one photocopy of the same SOP and issues "TRAINING
COPY" for training purpose to the concerned department for training by
putting stamp in blue ink on the front top right hand corner on each pages
and shall destroy the draft copy of SOP. The flnal signed original SOP shall
be control by the document conhol person.
5.5.4 After completion of training the concern department shall submit the
tanning copy of SOP along with the training record to the document control
person. The document control personnel shall compile the data of training
record.
5.5.5 Section Head / Department Head ensure that training to all concerned
is imparted before the effective date and the relevant training records are
maintained as oer SOP
5.56 AII Department Head /his designee shall conduct the training on the
respective SOP as per the Annexurelv and forward the same along with the
training details to the QA department for evaluation.
5.5.7 Head-QAJ his designee shallevaluate SOP training and training record.
5.6 Review, Distribution, Retrieval & Destruction

5.6 1 The distribution of the SOP copy to the user departmenl shall be done
after lraining to all concerned personnel using the SOP.
5.6.2 All the Final signed original copies shall be stamped as "MASTER
COPY" in Green colour ink on the top center of all pages of SOP. Thrs
original Master Copy shall be preserved well in documentation cell of QA
department
Authors Designation Sjq natu re Date
Prepared By
Checked By
Officer QA :H- l0 ln, i ?hrr ?
Executive QA iQ latl z.r,Lz
Approved By Head QA ft4- \tX lq lo 2l t or)
Authorized By
Format No. : QAJo01/F01-00
Head Plant A,-. Iq lbLl ,ar2
LUCENT BIOTECH LIMITED {uNrr-r)

't65/3, Nalhera, Anantpur, Puhana, Roorkee, Distl Haridwat (UttarakharDd)

Procedure for Preparation, Approval, Distribution Control, Re\/ is on
ISOP on SOPI
SOP No. Effective Dale Review Date Supersedes No Revision No, Pa
QAJo01-03 lqlr,tlzavz Itluzlza6 QA/001-02 03 9o
5.6.3 Required number of copies for distribution shall be photocopied of the

MASTER COPY. Each page of photocopied document shall be starnped In
blue colour ink as "CONTROLLED COPY" on the top right hand corner on
each page of SOP duly signed and dated by OA along with copy number.
5.6.4 Copy for display purpose shall be stamped as "DISPLAY COPY" in

green ink on the front top left hand corner on each pages and issue to the
user department(s)
5.6.5 lssuance of a copy of any SOP required by external agencies such as
/
customers/ govt. agencies/ regulatory / statutory / legal authorities auditing
agencies shall be given only with the approval of Head of Quality. For thrs
purpose, a photocopy of l\,4aster copy shall be taken, starnped as
"UNCONTROLLED COPY" in BLUE ink on the front top left hand corner of
all pages, and issued stamp put of dght side corner on bottom. And the
person who issued the uncontrolled copy put the sign and date on space
which given in stamp. The issuance shall be recorded in the log named
"lssuance of Uncontrolled copy"-Annexure Vl and shall be available with QA
department.
5.6.6 QA shallwrite the sequential copy number along with department name
to which the SOP is issued in the document issuance and control record with
necessary signature for received by and issued by as per procedure for
document and data control
5.6.7 In case of an additional copy is required by any department a written

request shall be raised by the concern department duly srgned by the concern
department head and approved by QA head, as per Annexure-V. The
Authors Designation Sjqnatu re Date

Prepared By Officer QA ! lq I n 2lLr,t
Checked By Executive QA ._F(_ tg lr,Ll LL L7
Approved By Head QA -r oq- t9laLl tuL"
Authorized By Head Plant q lc llt (,i 7
I'r
l-' 'rl-- i

LUCENT BIOTECH LIMITED rururr.rrr
165/3, Nalhera, Anantpur, Puhana, Roorkee, Disft: Haddwar (Uttarakhan

Procedure for Preparation, Approyal, Distribution Control, Re\.
{SOP on SOPI
QAJ001-03 19 loLl2a2J I0lozltczq QrJ001-02 03 I Oof23
document control person shall issue the additional copy and will maintain the
record.
5.6.8 During revision and issuance of any SOP document conhol person shall
retrieve all the previously issued old version copies from the concern
departments. The retrieved copies of old version shall be destroyed by the
document control person atter getting the approval of QA-l\4anager After
issuance of the new revision SOP
5.6.9 Document control person shall put the stamp as "OBSOLETE'' in RED
Ink colour (Annexure -l) on center of every page in such a way that the slamp
should be over the text matter not in blank space & the old master copy or
superseded copy and archive properly.
5.6.10 Revised or amended SOP'S must retain their original number i.e.
however the revision number 00 will be changed to next sequential number
01.
5.6.11 Whenever the SOP is reviewed, the changes made shall be entered in
the "History of review" column & Reason for Change." should be in written.
56.12 Follow the SOP (Title: Change Control) during review of all existing
SOP
5.6.13 In case if there are no changes required in the existing SOP during the
review, the same shall be mentioned in the SOP change history as
'Reviewed, No Change" shall be valid for the next two years or reviewed
within 30 days after reviewed date.
Authors Designation glgnature Date

] -L.L
Prepared By
Checked By
Ofticer QA
Executive QA '.#- lq lDLlLhr-?'
Lq lo Ll 2a L.
Approved By
Authorized Bv
Head QA kw- /g ia Ll 2ntL3
Head Plant n la'Ll 2cL?
Format No. : OAJ001/F01-00
LUCENT BIOTECH LIMITED ruNrr-I)
'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uitarakharrdd)

Procedure for Preparation, Approval, Dislribution Control, Rev tston
{SOP on SOP}
SOP No. Effective Date Review Date Supersedes No Revision No. Parge No.
QAJo01-03 zsQAio01-02 03 11 of 23
H la2l2a2i t0l o tlzc
5.6.14 lf QA Executive/Officer reviewed any document except SOP shall put
the stamp as REVIEWED BY (Round shape) on the bottom of the page and
put the sign and date in the space mentioned in stamp.
5.6 15 After reviewed any document except SOP Head QA shall put the stamp
as APPROVED BY (Round shape) on the bottom of the page and put
the sign and date in the space mentioned in stamp.
56.16QA Executive/Officer shall ensure the reconciliation & deslruction of
SOP (by shredding and /or alternatively by other suitable methods) and
document the same in "SOP Distribution and Destruction Log" (Ref:
Annexure Vll).
5.6.17 All slamps referred in this SOP are given in Table
SOP shall be distributed as per the distribution list with applicable copy
no.
Copy No. DeDtt./ Distribution
Master Copy Quality Assurance- Head of the department
1 Quality Assurance- Offlce
2 Quality Control Deparlmenl HOD
2a Quality Control Department- Display copy
3 Production - HOD
Production department- Display copy
3b Packing department-Display copy
4 Store-HOD
4a Store-Display copy
5 Engineering Department- HOD
Engineering Departmenf Display copy
6 Personnel & Administration -HOD
6a Personnel & Administration department- Display Copy
7 Outside parties (Uncontrolled)
Authors Designation 9ignatu re Date

Prepared By Officer QA \F,' 19 lu tl tr,t t,
Checked By
Approved By
Executive QA -ftt lq lt,t ) t r1'7
Head QA hv'St-' 19 ICLI LLL|
Authorized By
Head Plant L- tqinLl 2023
LUCENT BIOTECH LIMITED rulrr-rn
'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt Haridwar (uftarakha!T d)

Procedure for Preparation, Approval, Distribution control, Revision
(SOP on SOPI
SOP No. Effective Date Review Date Supersedes No Revision No. Page No
QA,/001-03 19 lozlta zz t0lD212c25 QA/001-02 03 12 ol 23
6.0 Annexure

Annexure I Stamps
2 Annexure ll SOP Format
3 Annexure lll SOP Draft Format
Annexure lV SOP Training Record
5 Annexure V Reouest form for Additional SoP cooies
6 Annexure Vl lssuance of Uncontrolled CopV
7 Annexure Vll SOP Distribution and Destruction Loq
7-O History of Review

Date C.C. No.
No, date Review
16t12t2017 Nil Ni Nil New SOP
15t12t2019 QA,/o01-00 cc/19/004 16t02t2019 Periodic Review
19tO2t2021 oAJo01-01 cct21to11 19tO2t2021 Periodic Review
19t02t2023 oAJo01-02 cct23t013 19t02t2023 Periodic Review
8,0 References
World Health Organization 2006, Geneva

WHO TRS 937
(WHO Technical Report Series, No 937)
2 cGMP
cGMP guidelines)
3 ln House Specification HS
Authors Designation lignature Date

Prepared By Officer QA
.,8 lqlr,1l1r,t2
Checked By Executive QA .--e>>- Lq IaLl ),n)-2
Approved By Head QA fr Ar Iq Ia LI 2-IJL?
Authorized By Head Plant lq lotl zc. c t
LUCENT BIOTECH LIMITED rurrrru
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwat {Utlarakharr d)
Departmenl QUALITY ASSURANCE

(SOP on SOP)
SOP No. Effective Date Review Date Supersedes No Revision No. Page No-
QAio01-03 19lozlzot-t tBlc'tlt:.zg QAJ001-02 03 13 of 23
9.0 Abbreviations
soP Standard Operating Procedure

QA Quality Assurance
oc Quality Control
cc No Change Control Number
CGMP Current Good Manufacturing Practice
IHS In House Specification
WHO TRS World Health Organization Technical report se nes
F Format

S. No. DeDU Distributed to Copy No.
1. Quality Assurance- Head of the department l\4aster Copy
2. Quality Assurance- Offlce 1
OualiW Control Deoartment- HOD 2

4. Production - HOD 3
Store-HOD
Engineering Department- HOD 5
Personnel & Administration -HOD 6
Authors Designation Fignatu re Date

Prepared By Officer QA '-t-r Ia lo'L t r,, a
Checked By Executive QA iq I r,L ?n12,
Approved By Head QA "4Lt-
to-l- lq luL 2t,11
Authorized By Head Plant /) Lct IDL L
Format No : QA,/001/F01-00
STANDARD OPERATING PROCEDURE For Reslricted Circulation
LUCENT BIOTECH LIMITED rurrr-rn

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt Haridwar (Uttarakharrd)

Procedure tor Preparation, Approval, Distribution Control, Revision
Title and Desiruction ot Standard Operating Procedure
(SOP on SOP)
SOP No. Effective Date Review Date Supersedes No Revision No, Page No,
QA/o01-03 19 | at l!.olt lS lo2lza't-s QA/001-02 03 14 of 23
Annexure I
Stamps
CONTROLLED COPY
MASTER COPY lssued by QA
Size: 50mm (L) x 9 mm (H) Sign:
Date:
OBSOLETE COPY Size: 60mm (L) X18 mm (H)

Sign
Date
DISPLAY COPY
Size:60mm (L) x18mm (H) Size: 50mm (L) x 9 mm (H)
UNCONTROLLED COPY Revision Number:

Copy No.: Next Revision Due On:
Sign: Sign./Date:
Date:
Size:60mm (L) x18mm (H) Size: 60mm (L) xlSmm (H)
Authors Designation 9ig nature Date

Prepared By Officer QA \ts,.. li'lrr,tlr,ar,.,
Checked By Executive QA lqt^, I zor2
-JI\
Approved By Head QA ;a.^_ lq la';l cat+
Authorized By Head Plant ()'- tq l()2J La!-3
Format No : QA,/001/F01-00
LUCENT BIOTECH LIMITED {uNrr-I)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Disttr Haridwar {Uttarakharrd)

Procedure tor Preparation, Approval, Distribution Control, Re\tis
ISOP on SOP)
SOP No. Effective Date Review Date Supersedes No Revision No. P age I'
QA/001-03 lq Ic'Ll2.aL2 lAbU2n25 QA/o01-02 UJ lSof:
APPROVED BY
Sign
Size: 30 mm Diameter Size:30 mm Diameter

Prepared By Officer QA .r- tq 6Ll 2h'ta
Checked By Executive QA Mt lq 2i L<
lt Lt
Approved By Head QA r.- Q,L ta lLr,| 2cLl
Authorized By Head Plant lq lo2l zr'r3
LUCENT BIOTECH LIMITED {uNrrr)
'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distti Haridwar {uttarakhan d}

Procedure for Preparation, Approval, oistribution Control, F levision
(SoP on SOP)
SOP No. Effective DatE Review Date Supersedes No Revision No. Page N
QAJo01-03 tq loz)tou tslozlNzc QA/001-02 03 16 of 2
Annexure ll
SOP FORMAT
LUCENT BIOTECH LIMITED tuNrr-ttt

,165/3, Nalhera, Anantpur, Puhana, lqbalput Road, Roorkee
Department
Title
SOP No. Effective Date Review Date SuDersedes No, Revision No. Page No.
1.0 Objective
2.0 Scope
3.0 Responsibility
4.O Accountability
Procedure
6.0 Annexure
I.U History of Review

Date C.C. No.
No. date Review
Authors Designation Elgnatu re Date

Prepared By Officer QA I9 laLl L.'La,
- fr\ i t lh2J 2t,1a
Approved By Head QA ArOl- tl l t LlLLL3
Authorized By
Format No. : QAJ00l/F01-00
Head Plant a,- tq l(,L ) h),1
-;-;-,-- lr.i: -, ',,
Li.i:A:\

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (uftatakhaird)

Procedure for Preparation, Approval, Distribution Control, Re\risio
(SOP on SoP)
SOP No. Effective Date Review Date Supersedes No ReYision No. Page
QAJ001-03 l9lozluzz B lltl t .ys QA/001-02 03 l7 ot
Ar!nexure
LUCENT BIOTECH LIMITED runr-tn

Department
Title
References
9.0 Abbreviations

Sr. No. DepU Distributed to Copy No.
Aulhors Desiqnation Siqnature Date

Prepared Bv
Checked Bv
Approved Bv
Authorized Bv
Format No. QAJo01/F01 -00

Prepared By Officer QA lq l02 2 nL1
Checked By Executive QA 19 loz-l 2rt 3
Approved By Head QA 1r u{ /9 /02 llatr 1
Authorized By Head Plant ,\-- q lcL 2013
ii:,,+.SlEr.
co"'i
LUCENT BIOTECH LIMITED rurrr-nr
165/3, Nalhera, Anantpur, Puhana, Roo*ee, Distt: Haridwar (Uttarakhan d)

(SOP on SOPI
oA/001-03 1c1 ls illzc,zj l0la212025 QA/001-02 03 1Aof23
Annexure lll
SOP DRAFT FORMAT
LUCENT BIOTECH LIMITED ruHrr-ru

'165/3, Nalhera, Anantpur, Puhana, lqbalp!r Road, Roo*ee
Department
Title
't.0 Objective
2.O Scope
3.0 Responsibility
4.0 Accountability
5.0 Procedure
5.0 Annexure
7.0 History of Revi
C.C. Approval date Reason For Review
Authors Designation Aig nature Date

Prepared By Officer QA '+2- lctlotl u: tz
Checked By Executive QA .-s4\- lcl lo Ll 2 o, a
Approved By Head QA lq LLl 2ati]'
Format No. : QA,/00'l/F01 -00
'qlcLl LcL3
ii*lr-{q-Cq: i

LUCENT BIOTECH LIMITED {uNrr-r)
'165/3, Nalhera, Anantpur, Puhana, Roorkee, Oistl: Haridwar (Uttarakharrd)
Deparlment OUALITY ASSURANCE

Procedure for Preparation, Approval, Distribution Control, Re\/ision
(SOP on SOP)
QAJo0't-03 lq lozlzazz tO lc vlrozE QA/001-02 03 19 of23
Annexure lll
LUCENT BIOTECH LIMITED {uN'r-r}

t65/3, Nalhera, Anantpur, Puhana,lqbalpur Road, Roorkee
Depariment
Title
SOP No. Effective Date I Review Date Supersedes No. Revision No, Page No.
8.0 References
Reference Reference Code
9.0 Abbreviations
Siqnature
Authorized
Authors Designation ,Signature Date

Prepared By Officer QA lq l^'Ll) D ) 2
Checked By Executive QA IqloL 2 cL3
Approved By Head QA ;,4-! lq lbL 2aL.:l
Authorized By Head Plant al I rt-l t t2a
trpsreigirr
STANDARD OPERATING PROCEDURE For Reslricted Circulation
LUCENT BIOTECH LIMITED (uNrr-rl

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distl: Haridwar (Uttarakhand)
Depadment QUALITY ASSURANCE

ISOP on SOP)
QA/o01-03 I9l6U2aU Ll2a75 QA/001-02 03 20 ot 23
lSlo
An nexure lV
@ Title
LUCENT BIOTECH LIMITED ruNrr.rr)
'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (t
SOP Trainino Record

ttarakhand)
SOP Title:
SOP No:
Name of Trainer:
Date of Training:
Adequacy
Sr. Trainee's Trainer's
Names of Trainee Department certilled yes / Signature Signature
No.
No
Formal No. QA/001/F03'00
Authors Designation FLgnature Date,

Prepared By Ofticer QA .Fr,- 19l nLl 70 2?
Checked By Executive 8A lq l6L Za'Li
Approved By Head QA 'r()r' 19 laY 1_aLl
Authorized By Head Plant 19 loL 2b2i
LUCENT BIOTECH LIMITED ruNrr-I)
'165/3, Nalhera, Anantpur, Puhana, Roorkee, Distg Haridwar (Uttarakhar| d)

Procedure for Preparation, Approval, Distribution Control, lev ision
(SOP on SOPI
QA,/001-03 19lo2lzoz3 lBlozbol-5 QA/001-02 03 21 of 23
An nexure V
LUCENT BIOTECH LIMITED rulrr-nr

165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt Haridwar (Utlarakharrd)
Title Request for Additional CopY
't. Initiating Department

Name :
2. Document Name :
Document Number :
No. of copy required :
5. Reason for additional coov :-

6.
Signature & date:
(Offlcer/Executive- Initiating Dept.) (Head - Initiating Dept.)
7. Approved / Not Approved
Signature & Date:

(Head- Quality)

Prepared By Ofiicer QA trtr s lr,l) 2 0'/ 1
Checked By Executive QA t4la 21 2.02 3
Approved By Head QA V QR. tq lot I tot3
Authorized By Head Plant /\,,- lq IaLl 2c'/7,
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MASTEK COPY . {lr,.

Department QUALITY ASSURANCE Paqe No.

A, CHANGE RELATED TO:

BMR/BPR Equipment Design

B. EXISTING PROCEDURE (IF NEEDED, ADD ATTACHMENT):

fn eSlA\ Qwe+dr-rs<. sC- SoQ{ +"'- Ceeqi.t.r'\(- t\^€

C, PROPOSED CHANGE tlF NEEDED, ADD ATTACHMENT):

crrQ uJc]-,^,t {!) q$-LoJ tb

cFC ?4,( a.4tri ocf-r\ g x.qv\d.rc n r\qrn-b.a-.r.

D. JUSTTFTcATToN / RATToNALE rdflClrar'rce,

Pg ?al \roQos:{ e!o-,^-s\-q lc-{ gtP{ ur't\ tq

E. ATTACHMENTS / SUPPORTING DATA / PLANNED DEVIATION DATA:

) pr.r^c!,--o-d'\l^!- d\-tl-{-$ to|b oc- LdP'

Category: Crilical Major tvtinorf{

Done By QA: Checked By QA:

LUCENT BIOTECH LIMITED 1ur.rrr,rr1

Department OUALITY ASSURANCE

H, NAME OF IMPACTED DEPARTMENT:

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I. ACTION PLAN TO BE TAKEN (IF NEEDED, ADD ATTACHMENT}:

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Done By QA: Reviewed By:

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NEW CHANGE CONTROL RAISED:

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LUCENT BIOTECH LIMITED (uNrr.r)

DeDartment OUALITY ASSURANCE

LUCENT BIOTECH LIMITED (uNrr.rD

Department QUALITY ASSURANCE

5.5 This procedure is required to maintain specimen signatures of employees, so that,

LUCENT BIOTECH LIMITED ruHrr-rr)

Department QUALITY ASSURANCE

. No operating personnel can repudiate / disown the activity recorded.

Authors Designation Signature Date

LUCENT BIOTECH LIMITED {uNrr-I)

Department QUALITY ASSURANCE

7.O History of Review

Supersedes C.C. Approval

14to2t2017 NIL NIL NIL New SOP

15t02t2019 oA,/005-00 cct19too4 16t02t20't9 Periodic Review

19t92t2021 QAJo05-01 cct2'U011 19t02t2021 Periodic Review

Authors Designation Signature Date

LUCENT BIOTECH LIMITED {uNrr.n)

Deparlment OUALITY ASSURANCE

10.0 Distribution List:

Authors Designation Signature Date

LUCENT BIOTECH LIMITED (uNrr-l)

Department QUALITY ASSURANCE

Department QUALIry ASSURANCE Paqe No.

S. No. Name of Signatory DepartmenUDesignation lnitials Full S ignature

Format No. QAJ005/F01-00

LUCENT BIOTECH LIMITED (uNrr-[)

DeDartment OUALITY ASSURANCE

LUCENT BIOTECH LIMITED (uNrr-[)

Department OUALITY ASSURANCE

5.2.1 MFR/T/001-00 (as per the above sydtem)

Authors Designation Signature Date

Deoartment OUALITY ASSURANCE