Documentation is an essential part of good manufacturing practices in the pharmaceutical industry. Key aspects of documentation include master production records, batch records, material identification systems, laboratory records, distribution records, and complaint files. Documentation provides a complete history of each batch and helps ensure quality, traceability, and compliance with specifications and procedures. It also enables investigation of any issues that may arise.
2. INTRODUCTION:
WHAT IS DOCUMENTATION?
Document is a paper providing information especially
of an official or legal nature, written report or record.
Documentation is an integral part of good
manufacturing practices.
Documentation is any communicable material that is
used to describe explain or instruct regarding some
attributes of an object, system or procedure such as its
parts assembly, maintenance installation and uses.
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3. OBJECTIVES OF DOCUMENTS
To define specifications and procedures for all
materials and method of manufactured and
control.
To ensure that all personal concern with
manufacture know what to do and when to do it.
To ensure that authorized persons have all the
information necessary to decide whether or not
realize a batch of drug for sale.
To ensure the existence of documented
evidence , trace ability and adult trail that will
permit investigation.
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4. SCOPE
Building and Premises: Installation, Validation,
Cleaning and Maintenance.
Personnel: Training, Hygiene.
Equipment: Installation, Calibration, Validation,
Maintenance and Cleaning
Materials : Specifications, Testing, Ware housing,
Use Rejection/ Disposal
Processing: Individual steps in the process of
manufacturing include controls
Finished goods : Specifications, Testing, Storage,
Distribution and Rejection and disposal.
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5. CHARATERISTIC OF
DOCUMENT
Have a clear title
Have an identification number
Be approved by authorized person
Have a date of issue
Have a due date of version
List to whom it has been issued
Page numbers
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6. Where the documents carry instructions
The instructions shall be precise and not
ambiguous.
They shall be for each individual step and not
combined
Where the entry of data
Sufficient space shall be provided for making
entry
Heading shall be clearly indicate
All entries shall be in ink
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7. All entries shall be clear and legible
Person making the entries shall confirm the entry by
signing
An error in the entry shall be so corrected that the
original entry is lost
Such corrections shall be also included and dated
Documentation system should provide for a periodic
review and revision
Such revised versions shall also be approved by
authorized persons
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8. PROCEDURE FOR DOCUMENTATION
11.EQUIPMENT CLEANING AND USE.EQUIPMENT CLEANING AND USE
RECORDRECORD
A written record of major equipment cleaning,
maintenance, and use shall be included in individual
equipment logs that show date, time, product, and lot
number of each batch processed.
If equipment is dedicated to manufacture of one
product, then individual equipment logs are not required,
provided that lots or batches of such product follow in
numerical order and are manufactured in numerical
sequence
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9. In case where dedicated equipment is employed , the
records of cleaning, maintenance , and use shall be
part of the batch record
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The persons performing and double –checking the
cleaning and maintenance shall date and sign the
log indicating that the work was performed .
Entries in the log shall be in chronological order
10. A separate log, which may be a separately bound
volume , or consecutive pages in a bound or loose leaf
format or a number of individual records or logs
required for each piece of major equipment that is not
dedicated to the manufacture of a single product.
As new computerized technology becomes available, it
is possible to move to paperless control of
manufacturing process
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11. Advantages of computerized technology
◦ more consistent control
◦ only approved personnel can perform a
process
◦ processing can be prevented until any prior
steps or checks are performed
◦ Precise recording of the times of operation is
possible.
Electronic signature involves a personal
password and a personal magnetic card with a
secure system to manage allocation and
review
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12. 2.2.PACKAGING AND LABELINGPACKAGING AND LABELING
RECORDSRECORDS
These records include the following
• The identity and quality of each shipment lot of
components
• Drug product containers, closures and labeling
• The name of the supplier and the suppliers lot
number
• the receiving code as specified and the date of
receipt.
• The name and location of the prime
manufacture(if manufacturer and supplier are
different)
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13. 13• The results of any test or examination performed.
• An individual inventory record of each component
contain the information about ,use of each
component , lot & batch of drug product, its
container and closure For each component the use of
each lot of component is required.
• Documentation of, the examination and review of
labels and labelling for conformity with established
specifications.
• The disposition of rejected components, drug
product containers , closure, and labelling.
14. • Most regulations require identification and recording
of the name of the producer of components , product
containers, closures and labeling
• It helps to evaluate the producer’s facility or integrity
and the raw materials which may have different
impurity profiles, processability, and stability
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15. 33.MASTER PRODUCTION RECORD.MASTER PRODUCTION RECORD
• The master production and controlled records for
each drug product describe all aspects of its
manufacture, packaging and control.
• To assure uniformity from batch to batch , master
production and control records for each drug
product , should be prepared, dated and signed by
one person and independently checked , dated ,
and signed by at least a second person
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16. The preparation of master production and control
records should be described in a written procedure that
should be followed
Master production record is a product-specific document
complied , checked, authorized and approved by
competent technical personnel from product
development, production , packaging, quality control
• Competence means the possession of knowledge ,
through academic training and experience , to allow
proper compilation and checking
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17. The individuals involved with each master record
are required specially to sign , not initial , the
document
•Master formula record shall also be open for review
•Changes, if any, shall also be approved by
designated persons responsible for production and
quality control
•For manufacturing and packaging operations it is
important to have master production and control
records for each batch size in order to eliminate the
need for recalculation of quantities of components ,
packaging materials , and in- process samples
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18. Master production record shall include
1. The name and strength of the product and a
description of the dosage form
The product name is usually the manufacturer’s
patent or proprietary name.
Pharmaceutical products which are manufactured
with more than one strength should be obvious in
the master formulation.
Should also provide physical characteristics of
the product
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19. 2. The name and weight or measure of each active
ingredient per dosage unit or per unit
weight of the drug product , and a statement of the
total weight or measure of any dosage unit.
3. A complete list of components designated by names
or codes sufficiently specific to indicate any special
quality characteristics.
Components are usually specified by the name and by
an internally generated code
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20. This double identification, helps to reduce the
potential for usage of incorrect components –
particularly if the chemical name is complex or
similar to other materials
Eg : different varieties of same compound such as
hydrated / anhydrous/crystalline/powder
4. An accurate statement of the weight or measure
of each components , in case of using the same
weight system for each component
Weight expressed in both kilos and mgs
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21. 5.A statement concerning any calculated excess of
components
Variations from theoretical in the amount of
components are permitted provided they are justified
in the master records .
Variations includes the adjustment of the amounts of
components in response to assay variations , the
amounts required will vary between different batches
of components and it is not possible to include a
standard overage in the master production record
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22. 6 A statement of theoretical and practical yields at
different stages of manufacture with minimum and
maximum limits, beyond which investigation is
required should be included.
Production management personnel are usually
more concerned about overall variance than the
individual yield variances on each batch
7 Complete manufacturing and control instruction ,
sampling and testing procedures , specifications ,
special notations and precautions to be followed.
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23. The master manufacturing records should clearly identify
Equipment to be utilized designated by name and number.
Step-wise manufacturing process with details of conditions
such as time, temperature , speed and sequence of adding
ingredients .
Critical in process- checks and controls, including limits.
Special precautions and hazardous conditions that may
exist and the necessary safety equipment to be used.
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24. Theoretical yields and actual yields.
Space for signature and date, of operator /
supervisor checking each significant step.
A description of the drug product containers,
closures, and packaging material, including inserts,
signed and dated by the person responsible for
approval of such labelling.
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25. 4.BATCH MANUFACTURING RECORD
It is a product and batch specific document designed to
give a complete and reliable picture of the of each batch of
every product.
It should be compiled , checked, approved and authorized
by competent technical persons responsible for production
and quality control
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26. Batch manufacturing record include
Date
Identity of individual major equipment and lines used
Specific identification and quantities of materials used
whether or not the material appears ,or, tested in the
finished product for each batch of component or in-
process material used.
In-processing and laboratory control results
A statement of the actual yield and as percentage of
theoretical yield at appropriate phases of processing.
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27. Signed authorization if there is any deviation
from the master formula record and/ or batch
manufacturing process.
Complete labeling control record including
specimens or copies of all labeling used.
Description drug product containers and
closures.
Any sampling performed.
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28. Identification of the persons performing and
directly supervising or checking each significant
step in the operations.
Reconciliation of materials received , used,
rejected and/or destroyed
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29. 5.MATERIAL IDENTIFICATION SYSTEMS
Raw material, components, and other supplies.
Each material should be assigned a specific
number that clearly identifies the material.
Different physical and chemical forms of the
material should be provided with different
numbers.
Receivals of raw materials and components .
Each received should be allocated a sequential
stock or receival number. When more than one
supplier lot is included in the receival , each lot
should be given a separate number.
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30. Manufacturing batch number.
Each scheduled manufacturing batch should be given in
a sequential number. Batches manufactured in different
departments are given in a different letter prefix. A
control number is assigned to bulk of batch after its
quality assurance.
Product formulations are assigned unique identification
,this allowing differentiation between products by both
name and number.
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31. • Packaging control numbers are designated to
each packaging order to provide a means of
correlating packaging and bulk product and also
used as the number to be used in the event of
customer complaint or recalls
66.REVIEW OF RECORDS.REVIEW OF RECORDS
• All the production and control records ,
packaging and labeling records should be
reviewed and approved by quality control unit to
determine compliance with all approved written
procedures before a batch is released or
distributed.
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32. A checklist that defines the specific documents
that should be in the batch record and what is to
be checked on each document is normally used
• Batch record is current and approved as an
accurate copy.
• Correct, released , components were used in
manufacturing.
• Correct quantities of components were used in
manufacturing.
• All components are within the retest dating
period .
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33. Manufacturing control document is properly
completed
Correct product was packaged
Correct packaging components were used
Labelling bears the correct control numbers
Yields and accountability are within action levels
Packaging control document was properly
completed
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34. Test data, in-process and control laboratory are
within specifications
• Control samples have been taken
• Written investigation of any deviation from
procedure with approvals
When production deviations occur they must be
documented , investigated, and appropriate
levels of management must be involved in the
review of the data and in any decision making
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35. 7.LABORATORY RECORDS
A . It should include the complete data derived
from the tests necessary to assure the established
specification and standard, including examination
and assay.
A description of the sample received for the testing
with identification of source.
Quantity, lot number, or other distinctive code,
date and date of sample was received for testing
We have to mention the container number.
B . A statement of each method used in the testing of
the sample.
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36. If the method employed in the pharmacopoeia or in
any other recognized standard , the reference will
suffice.
C . The test methodology may de modified with
time and it is important that the retained records
clearly indicate which methodology was actually
used.
This is usually done by indicating the monographs
reference number and issue date. Superceded
monographs which related the retained records
must be retained.
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37. D.A statement of the result and how they compare with
established standards of identity, strength, quality and
purity for the component, drug product tested.
E . Records must indicates who performed each
test( printed and typed names should also be shown)
Complete records shall be maintained of any
modification of an established method employed in
testing.
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38. Complete records should be maintained of any
standardization of laboratory working standards,
reagent and their solution.
Record for periodic calibration for laboratory
instruments, apparatus, gauges, and recording devices
and all stability testing performed as per the
requirement.
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39. 8.DISTRIBUTION RECORDS.
It contain name and strength of the product and
description of the dosage form, name and
address of the consignee, date quantity shipped,
and lot or control number of the drug product.
Distribution records include a wide range of
documentation such as invoices, bill of lading
customer receipts, and internal warehouse
storage and inventory records.
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40. 9.COMPLAINTS FILE
Complaints received from consumers, professionals,
and the trade serve as a primary means of obtained
feedback about product quality after distribution .
The records of production, packaging, and
distribution of drug and the retained samples provide
the basis for assessing the validity and seriousness of
the alleged deviation that precipitated the complaint.
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41. The evaluation of complaints serves several valuable
purposes
- First, there is the urgent need to confirm whether
consumers are potentially at risk and to initiate any
appropriate action.
- second value is the review of the product and its
production process to establish whether any modifications
are required
- Third is the need to rapidly respond to the customer
there by attempting to maintain confidence in the product
and company
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42. Where complaints continue it may be worth
considering a field evaluation of the product to obtain
more extensive information on the potential problem.
Various surveys have shown that only a proportion
of those people receiving substandard product will
actually complain.
This needs to be remembered when evaluating the
extend of a problem
A written record of each complaint should be
maintained in a file designated for drug product
complaints.
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43. The different record should include the following
information, where known:
the name and strength of the drug product, lot
number, name of complaint and reply to complaint.
The written record should also include the findings
of the investigation and follow up.
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44. The record or copy of the record of the investigation
should be maintained at the establishment where the
investigation occurred.
Where an investigation is not conducted ,the written
record should include the reason that an investigation was
found not to be necessary and the name of the responsible
person making such a determination
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