SUN MOON PHARMACEUTICALS PVT. LTD.

Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtara-401 506.
STANDARD OPERATING PROCEDURE
TITLE: DOCUMENTS AND DATA CONTROL
Department : Quality Assurance SOP No. : SOP/QA/003
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 1 of 11
Prepared By Reviewed By Approved By

Sign. with
Date.

1.0 OBJECTIVE:

To lay down the procedure for Defining, Preparation, Approval, Revision and Issuance of Master
Documents at Sun Moon Pharmaceuticals Pvt. Ltd.

2.0 SCOPE:

This Procedure is applicable for documents and data control of all departments in Sun Moon
Pharmaceuticals Pvt. Ltd.

3.0 RESPONSIBILITY:

Officer/Executive / Designee: Issuance and retrieval of documents

Dept. Head / Designee : Training and implementation

QA – Head / Designee : Approval and compliance

4.0 PRECAUTIONS:

NA

5.0 PROCEDURE:

5.1 New Documents Preparation:

5.1.1 All new documents must be drafted by department Heads / Manager / Asst. Manager/
Sr. Executive/Executive or designee experienced persons.

5.1.2 Prepare the new documents as per the sequence of operations and using the format
defined in SOP on SOP. All comments shall be written directly on the draft.

5.1.3 After the draft document has been commented, the contents shall be incorporated in
the final draft and sent to concerned department Heads and QA department. The QA
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtara-401 506.
STANDARD OPERATING PROCEDURE
TITLE: DOCUMENTS AND DATA CONTROL
Department : Quality Assurance SOP No. : SOP/QA/003
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 2 of 11
Prepared By Reviewed By Approved By

Sign. with
Date.

department carries out the final review. If there is no change, it is allotted the next
number in the sequence.

5.1.4 If the document requires changes, a further draft is prepared and circulated/reviewed
until the final draft is agreed. The draft copies have to be once destroyed after final
print of document.

5.2 Preparation, Approval and Issuance of Batch Manufacturing Records/ Batch Packing
Records (BMRs/BPRs):

5.2.1 After preparation, review and Approval of all the documents, signatures of the
responsible personnel are placed on all pages a Prepared by, Reviewed by and
Approved by columns.

5.2.2 After completion of signatures QA department shall put stamp “MASTER COPY”
with Dark green ink on all pages, at top right side on the page.

5.2.3 For issuance of Request supplies of BMRs/BPRs, Production department has to

complete a “Document Requisition slip” as per Annexure–I and send to QA.

5.2.4 Quality Assurance Department will photocopy the “MASTER COPY” and put &
“ISSUED BY QA” in red ink at center bottom with signature and date on each page.

5.2.5 QA department will issue BMRs/BPRs and enter details in “BMR Issues and
Receipts Register” as per Annexure–II.

5.2.6 The head of Production department or authorized person is responsible for control of
BMRs/BPRs in his position and Records until completion.

5.2.7 After completion of manufacturing process production Head/Designee shall review

BMR/BPR and submit to QA.

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtara-401 506.
STANDARD OPERATING PROCEDURE
TITLE: DOCUMENTS AND DATA CONTROL
Department : Quality Assurance SOP No. : SOP/QA/003
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 3 of 11
Prepared By Reviewed By Approved By

Sign. with
Date.

5.3 Preparation, Approval and issuance of Protocols for Raw materials, Intermediates,
Finished products, Potable and purified water Packing materials, specification and test
method:

5.3.1 After preparation, review and Approval of all the documents, signatures of the
responsible personnel are placed on all pages a Prepared by, Reviewed by and
Approved by columns.

5.3.2 After completion of signatures QA department shall put stamp “MASTER COPY”
with green ink on all pages, at top right side on the page.

5.3.3 Quality control department shall fill “Document Requisition slip” as per
Annexure–I and send to QA.

5.3.4 Quality Assurance Department will photocopy the “MASTER COPY” QA

department stamping “ISSUED BY QA” in red ink at right hand center bottom with
signature and date on each page.

5.3.5 QC shall file & submit Intermediate product protocol after completion of analysis in
Quality Assurance department.

5.3.6 All approved Protocols/Analytical Reports of Raw material, packing material and
water analysis report is in custody of Quality control Department.

5.3.7 After completion of year from January to December QC shall submit all
Protocols/Analytical Reports of Raw material, packing material and water analysis
report in Quality Assurance department.

5.4 Issue of registers / formats:

5.4.1 For registers

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtara-401 506.
STANDARD OPERATING PROCEDURE
TITLE: DOCUMENTS AND DATA CONTROL
Department : Quality Assurance SOP No. : SOP/QA/003
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 4 of 11
Prepared By Reviewed By Approved By

Sign. with
Date.

5.4.1.1 Individual department shall fill “Document Requisition Slip” as per

Annexure–I and send to QA.

5.4.1.2 After receiving of requisition slip of registers/format book QA department

shall ensure the format number then put stamp as below.

SUN MOON PHARMACEUTICALS PVT. LTD

Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist.
Palghar, Maharhtra-401 506
Reg. No:- _____________________________
No. of Pages:- __________________________
Previous Reg. No:- ______________________
Date From:-______________to____________
Issued by :-_______________
SOP/QA/003.00

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtara-401 506.
STANDARD OPERATING PROCEDURE
TITLE: DOCUMENTS AND DATA CONTROL
Department : Quality Assurance SOP No. : SOP/QA/003
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 5 of 11
Prepared By Reviewed By Approved By

Sign. with
Date.

SUN MOON PHARMACEUTICALS PVT. LTD

Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist.
Palghar, Maharhtra-401 506
Log Book. No:- _____________________________
No. of Pages:- __________________________
Previous Reg. No:- ______________________
Date From:-______________to____________
Issued by :-_______________
SOP/QA/003.00
5.4.1.3 QA department sign in issued by column with date and issue to concern
department and enter details in as per Annexure–V

5.4.1.4 Registers, which are maintained by individual departments according to

their SOP’s, and pages in all registers, must be sequentially numbered.

5.4.1.5 Minimum stock of register is maintained by respective department.

5.4.2 For formats :

5.4.2.1 Individual department shall fill “Document Requisition Slip” as per

Annexure–I and send to QA.

5.4.2.2 Quality Assurance Department will photocopy of “MASTER COPY”

and will “ISSUED BY QA” in red ink at right hand bottom corner with
signature and date on each page.

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtara-401 506.
STANDARD OPERATING PROCEDURE
TITLE: DOCUMENTS AND DATA CONTROL
Department : Quality Assurance SOP No. : SOP/QA/003
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 6 of 11
Prepared By Reviewed By Approved By

Sign. with
Date.

5.5 Master Index of documents:

5.5.1 After preparation, review and Approval of al of Index, Format Index signatures of the
responsible personnel should place on last page a Prepared by, Reviewed by and
Approved by columns.

5.5.2 After completion of signature QA department shall put stamp “MASTER COPY”
with Dark green ink on all pages, at top right side on the page.

5.5.3 Quality Assurance Department will photocopy the “MASTER COPY” and
stamping “CONTROLLED COPY “ in red ink on top left hand corner on all pages
of Index.

5.5.4 Quality Assurance or his deputy shall issue “CONTROLLED COPY” Index to
respective department.

5.6 Changing of existing documents:

5.6.1 All master documents shall be changed as per Change Control SOP.

5.6.2 New revisions of SOPs/STPs/Documents will approved as per section 5.1.

5.6.3 Obsolete versions of documents are recalled by using the “Distribution, Retrieval and
Destruction Record”. These forms will retained with the “OBSOLETE COPY”
master document.
5.6.4 The Master of each obsolete document is stamped in red ink on all front pages with a
stamp which has the word “OBSOLETE COPY” and retained in the “Obsolete
Master Documents” file held by the QA department.

5.6.5 All controlled copies of documents will destroyed immediately under the control of
the QA department.
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtara-401 506.
STANDARD OPERATING PROCEDURE
TITLE: DOCUMENTS AND DATA CONTROL
Department : Quality Assurance SOP No. : SOP/QA/003
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 7 of 11
Prepared By Reviewed By Approved By

Sign. with
Date.

5.7 Making uncontrolled copies of documents:

5.7.1 These copies are made for information purpose only and provided to customers for
reference. QA department will stamped in red ink on each page with the words
“UNCONTROLLED COPY”. The company takes no responsibility to provide
updates of these.

5.7.2 When SOP is required to distribute out of the company’s control at Regulatory
agencies, the same is prepared by photocopying the “MASTER COPY”.

5.8 Retention period of documents:

5.8.1 For Retention period of documents as per below table;

Name of the Record Retention period

Stability Study Life time
Equipment qualification/ Validation Life time
DMFs / Variations filings Life time
Site master file / Manuals/ Validation Master Plan Life time
Technology transfer documents Life time
Master Formula records Life time
Regulatory audits Life time
Change controls / Deviation Records 6 years
Customer complaints 6 years
Equipment history records / Calibration details 6 years
Batch manufacturing records Minimum 5 years or Expiry + 1 years
Analytical data Minimum 5 years or Expiry + 1 years
OOS Investigation Minimum 5 years or Expiry + 1 years
Approved vendor list 6 years
SOPs & STPs 6 years
Internal audits / Customer audits 3 years
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtara-401 506.
STANDARD OPERATING PROCEDURE
TITLE: DOCUMENTS AND DATA CONTROL
Department : Quality Assurance SOP No. : SOP/QA/003
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 8 of 11
Prepared By Reviewed By Approved By

Sign. with
Date.

Name of the Record Retention period

Training records 3 years after service

5.9 Numbering of documents:

5.9.1 Registers:

Allocate an identification number for registers which are made up as follows:

QA/R20/01

Where,
QA : Department code
R20 : Register with Current year.
01 : Serial Number of Register starting from 01

5.9.2 Log Books:

Allocate an identification number for Log books which are made up as follows:
QA/B20/01

Where,
QA : Department code
B20 : Book with current year
01 : Serial Number of Register starting from 01

5.9.3 Validation Protocols & Reports:

Allocate an identification number for validation protocols and reports which are made
up as follows:
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtara-401 506.
STANDARD OPERATING PROCEDURE
TITLE: DOCUMENTS AND DATA CONTROL
Department : Quality Assurance SOP No. : SOP/QA/003
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 9 of 11
Prepared By Reviewed By Approved By

Sign. with
Date.

For Protocols

CVP/XXX/01

Where,
CVP : Concurrent Process Validation Protocol.
XXX : Product Code.
01 : Sequential Number

For Reports

CPV/XXX/01

Where,
CVR : Concurrent Process validation Report
XXX : Product Code.
01 : Sequential Number

5.9.4 Equipment Qualification :

Allocate an identification number for Equipment Qualification protocols and reports

which are made up as follows:

EQ/XXX/01
Where,
EQ = Equipment Qualification.
XXX = Equipment Code.
01 = Equipment Identification No.

6.0 LIST OF ATTACHMENTS / ANNEXURES:

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtara-401 506.
STANDARD OPERATING PROCEDURE
TITLE: DOCUMENTS AND DATA CONTROL
Department : Quality Assurance SOP No. : SOP/QA/003
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 10 of 11
Prepared By Reviewed By Approved By

Sign. with
Date.

ANNEXURE – I Document Requisition Slip SOP/QA/003-F01.00

ANNEXURE – II BMR/BPR Issuance & Receipt Register SOP/QA/003-F02.00
ANNEXURE – III Protocol Issuance & Receipt Register SOP/QA/003-F03.00
ANNEXURE – IV General Issuance Record SOP/QA/003-F04.00
ANNEXURE – V Log Book - Register Issuance Record SOP/QA/003-F05.00
ANNEXURE – VI Specimen Stamps SOP/QA/003-F06.00

7.0 ABBREVIATIONS:

SOP Standard Operating Procedure

NA Not Applicable
DMF Drug Master file
IQ Installation Qualification
P Protocol
R Report
BMR Batch Manufacturing Record
BPR Batch repacking record
OOS Out of specification

8.0 REFERENCE :

ICHQ7

9.0 SOP DISTRIBUTION:`

Name of Department Department Code

Quality Assurance QA
Production PD
Quality Control QC
Microbiology MB
Maintenance & Engineering MD
Human Resources HR
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtara-401 506.
STANDARD OPERATING PROCEDURE
TITLE: DOCUMENTS AND DATA CONTROL
Department : Quality Assurance SOP No. : SOP/QA/003
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 11 of 11
Prepared By Reviewed By Approved By

Sign. with
Date.

Warehouse WH

10.0 REVISION AND HISTORY:

REV. NO. REASON FOR REVISION

00 New SOP.

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
.