196 CONCISE COURSE IN PHARMACEUTICALQUALITYASSURA

should be made and should inc.

should include the
A lete list
complete HARMACEUTICAL INDUSTRY
list oof raw
materials and 197
record of the investigation fficiently specific to
intermediates
discrepancy. A written identify ates (designated
quality (designated by names
or
any special es
follow-up action. An accurate statement of the na or
conclusión and
The following information
should be recorded
at the time each action is taken (the date
by signature or electronic
be used, including the
Wh
characteristics)
unit ofquantity or ratio of each raw material
material oror intermediate to
be noted and the person
responsible should clearly
be identified
alculation for each batch size measure.
or rate the
quantity is not fixed,
uantities should be included whereuoof produetion should be included. the
password): number ana the quantity of product herever justified Variations to
The name of the product, the batch ct o
be uction location and major
The production
tailed production instructions, production equipment to be used
its reconciliationi
actually obtained and
packed, as well as the quantity
T h e datels) and timels)
of the packaging operations oSequences to be followedl including the
out the packaging operation
The name of the responsible person carrying o Ranges of process parameters to be
of the different significant steps used
The initials of the operators The methods, or
The checks made for identity
and conformity with the
packaging instructior
ctions,
reference to the methods,
critical equipment (e-g, to be used for
controls leaning, assembling) preparing he
including the results of in-process
Details of the packaging operations carried out, including references to ipment
o Sampling instructions and
in-process controls, with their acceptance critera
for keeping the
where appropriate,aaes
and the packaging lines used and, when necessary, instructions
Time limits for
completion of individual processing steps and/or the tota
product unpacked or a record of returning product that has not been packaged to the
process, where appropriate
storage area
Whenever possible, the regular check for correctness of printing (eg. batch number, o Expected yield ranges at appropriate phases of processing time. or
expiry date and other additional overprinting)
and specimen samples collected .Where appropriate, special notations and precautions to be followed, or cross
.Notes on any special problems, including details of any deviation from the references to these
packaging instructions, with written authorization by an appropriate person Instructions for storage of the intermediate or APl/semi-finished formulations to
The quantities and reference number or identification of all printed packaging assure its suitability for use; instrucions should cover the labeling (specimen labels
materials and bulk product issued, used, destroyed, or returned to stock and the and packaging materials and special storage conditions with time limits, where
quantities of product obtained; this is necessary to permit an adequate reconciliation. appropriate).
A sample of BMR -Refer Appendix I Master Formula Record is also called MFR, Master Production Record. MFR is used as
reference standard for preparing batch manufacturing record (BMR) by manufacturing units.
I is prepared by the research and development team of the company. It contains all
134 MASTEREORMULARECORD information about the manufacturing process for the product. Master Formula Record (MER)
1341 Definition: A document or set of documents specifying the starting materials with document for any. pharmaceutical product. MFR plays an important: in
their quantities and the packaging materials, together with a description of the procedures amaster
Formula records
and precautons required to produce a specified quantity ofa finished product as well as tne nSIstency for each batch manufacturing. There shall be Master relating to
processing instructions, including the in-process controls." utacturing procedures for each product and batch size to be manufactured. These
of
be prepared and endorsed by the competent technical ie. head production and
staff
1342 Mastér production instructions should include
control. A Master Formula Record is either prepared based upon eperience o
The name of the intermediate/API/formulation being manufactured and ans y
staff like manufacturing chemist or analytical chemisor, prepE
identifying document reference code, if applicable e n t qualified
e d upon batch manufacturing record of a batch size.
 ASSU GUMEN ANRPHARMACEUTICALINDUSTRY
COURSE INPHARMACEUTICALOUALITY URANCE
p O C
cONCISE page of manufach
secondary 199
h e
shall incla shall,section
MFR includes equent pages de the include-Process steps tó
of the manufacturing company. seqtensils to be used, processes 'to be be
monitored.
logo and address
chinautions to be taken for the be described. The monitored.
Product Details: Name,
shall The ist of
subsequent shall equipment
machi
Generic name.
Dosage form
name. Brand name, precaut
product page inchude any
of all ingredients page ould also include Batch Manufacturing during
Formulaamanufacturing and
Product code and Label
claim
packig, The same
Pack size and packing style
Product description: Batch size, theend of every important stage, include a
A tt h e
Shelf life and Storage
conditions nrocess quality checks during and at thestatement
end of
of the yield
with the acceptable
MFR number and date, im s important steps
MFR numberand date: Supersede are included. The process
shall include the process and stages wi
Effective batch number
head
theror the reference of the
methods/procedures to
equipment used.
to be The
Authorization by the production
and quality assurance
bling.operating the
various equipments
employed for preparing deaning
and machines required n are given. Detailed stepwise
Equipment: A list of allrequired equipment the instructions(example: checks on
materials,
pretreatments, for adding materials,
processing
manufacturing process
with capacity.
their
mixing times, temperatures, humidity etc.) is included.sequence
The requirements for storage
instructions to be followed
The precautions and special during the products is also present
Spedial instructions: nditions of
the product manufacturing and packing rhe secondary page ot packaging section of MFR should include complete list of all the
of all active materials to get the 100% of
Calculations: Include the calculation steps aging materials required tor a standard batch size,including
the active material. The calculation
is done using water or LOD to get 100% poteney. packagis quantitiessizes and types.
in all stages of the manufacturing process include line clearance checking during batch cording and batch packaging operations.
i Manufacturing Process: All steps e
written. All process steps like shifting, milling, lubricating,
granulation,
compression lnciudes reconciliation of printed and unprinted packaging materials with acoeptable limrits
Includes destruction of excess or rejected printed packaging materials Inchudes description
and coating are written in detail including the process time and yield. It also include
atmospheric conditions as temperature, humidity, and storage
conditions for every of packaging operation including any significant subsidiary operations and equipments to
be used.
step.
Packing Process: List of all packing materials with their quantity is written. Line Sampleof MFR -Refer APpendix, r t t 4 littazt , o
cearance, reconciliation of printed and unprinted packing materials should be
.s gi 3:5 SOP
3tincludedin details.
is a set of written that
instructions document a
batch. A Standard Operating Procedure (SOP)
Yield: Include the theoretical, actual yield and acceptance limit of the routine or repetitive activity which is followed by employees
in an organization. The
Primary Responsibility is of F&D and Production Department and secondary responsibility of a sucressful quality system. It provides
is of Quality Assurance Department. Accountability lies with Head-Quality Assurance
for development and use of SOPs are an integral part
in order to achieve pre-determined
'implementation of SOP.
information toperform a job properly, and consistently of
for the continual improvement
end-result. SOPs should allow
13.4.3 Steps in preparation of MFR: Production Department in association with FaD specification and quality
commitment towards protecting patients.
prepares MFR. It is divided into two sections; standards of service, and provide evidence of
1Manufachuring 2 Packaging 13.5.1 BENEFITS OF SOP
Thefist page'of both the sections shall have following details: Name, address and logo o (SOP) is a set of
wiritten inatructioris that doumeñta
Standard Operating Procedure organizatiön
the company, Dosage form, Brand Generic name Prodüct code Label claim :
name which is followed by employées in an
hould incude all ingredients and text included in product permission. Produ rOutine o r repetitive activity uninterupted
and are completed onaprescribed
Description, Shelf Life, Pack Size, Batch Size and Storage conditions. slr2 ensure that processes continue
caused.by.equipmentifailireo
shut-downs
3 Ensure against process
oedule.
facility damage.