Document Maintenance in Pharmaceutical Industry. By_ NAKUL DHORE ❖ Introduction ❖ Batch Formula Record ❖ Master Formula Record ❖ SOPs ❖ Quality Audit ❖ Quality Review & Quality Documentation ❖ Reports & Documents ❖ Distribution Records ❖ MCQs Quality Assurance As per B.PHARM 3rd Year Semester-6 (PCI Syllabus New)

1. DOCUMENT
MAINTENANCE IN
PHARMACEUTICAL
INDUSTRY
BY
NAKUL DHORE
___________________________________________

2. ⦿CONTENTS_
2
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOP
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records

3. INTRODUCTION
“A Document is piece of data/ matter which provides
information that serves as an official record.”
DEFINITION_
OBJECTIVES_
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▪ Provides confirmation of performance of task.
▪ Reduces the risk of misinterpretation & errors arising
out of oral or written communication.
▪ Provides clear cut procedures to be followed.
▪ Allows calculations to be checked.
▪ Allows to check the batch history of any kind of product.
▪ Conducts an audit trial to investigate the history of any
suspected defective batch.
▪ Defines specifications & procedures for all materials and
method of manufacture & control.

4. TYPES OF DOCUMENTS
4
Quality Manual_ A company document that describes the
regulations to be followed by the company.
Policies_ Documents that describes how the specific GMP
aspects will be implemented (security, health, etc.)
SOPs_ Document containing Stepwise guidelines to
perform a task or operation.
Batch Records_ Describes Stepwise instructions for production &
packaging of products. Contains entries made
during these processes.

5. Specifications_ Documents that list the requirements that
materials & products must meet to be considered
acceptable.
Test Methods_ Document that contains stepwise instructions for
testing of materials & products. They are generally
used and completed by QC department.
Logbooks_ Collection of forms used for documenting
operation; maintenance; calibration of equipment.
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6. BATCH FORMULA RECORD
• BFR also known as Batch Manufacturing Record is a batch specific
document which gives complete outline of manufacturing history
of every batch of every product.
• Provides detailed description of all processing operations &
control. It is a recurring document.
• Gives complete history of the batch produced.
• Records should be numbered with unique batch/ identification
number + dated & signed when issued.
• Batch no. should be recorded instantly.
• Record should include date of allocation, product identity & size
of batch. 6

7. • The BFR should be checked before issuance to assure that it is the correct
version.
• Batch formula record should be prepared for each intermediate
formulation and should include complete information relating to
production and control of each batch.
• BFR is an approved copy of MFR for each batch of product being
processed, in which data has been filled in during processing of batch.
• It contains details of location where production is done, data entries,
name of operators with their signatures with dates, supporting data
records (such as cleaning records equipment calibration details, in process
& final quality control test reports, etc).
• BFR is also termed as BATCH PRODUCTION RECORD. 7

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Name & No. of Batch
Date & Time
Name of Personnel
Amount of Product
obtained
Processing Operation
Quantity of starting
material
Batch No./ Lot No. Expiry Date
Major equipments
Any additional
overprinting
BFR
CONTAINS

9. BMR Sample
9

10. MASTER FORMULA RECORD
10
• MFR is an approved master document, with instructions of how
the entire manufacturing process must be performed for each
batch size of each product to be manufactured.
• The document ensures the uniformity across batches of the same
product.
• The MFR must be prepared, signed and dated by one competent
individual, and independently checked signed and dated by
another competent person in quality department.
• MFR is used as reference standard for preparing BMR by
manufacturing units.
• It is prepared by R&D Team of the company; plays vital role in
consistency for each batch manufacturing.

11. • Steps in preparation of MFR divided into two sections_
1) Manufacturing 2)Packaging
• Basically, MFR is compilation of documents specifying the
starting materials with their quantities & packaging materials,
together with description of the procedures and precautions
required to produce a specified quantity of finished product &
in-process controls as well.
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MFR
CONTAINS
Name of the Product
Strength of the Product
Description of dosage
form
Name & weight of each
ingredient
Description of containers
& closures
A specimen/copy of each
label with date &
signature
Precautions to be
observed
Special notations if any
Instructions for storage
Procedures for sampling
and testing

13. MFR Sample
13

14. • SOP is a set of instructions which describes how a routine activity is
performed step-wise. It ensures the consistency of operation in order
to achieve desired quality.
• SOP should contain description of the task in simple language,
straightforward way covering major steps.
• It must be written by a person having sufficient knowledge &
experience about that specific task.
• Must be written in commanding & compulsive way like e.g,
✓ Switch on the Fan
× The fan is switched on
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STANDARD OPERATING PROCEDURES

15. Bring the attention of your audience over a key concept using icons or
illustrations 15
• SOPs should not have unnecessary lengthy descriptions.
• Any abbreviations used in the SOP should be mentioned at the
beginning.
• SOPs should be prepared by respective departments and then
approach to QA for reviewing its compliance with cGMP. After
QA approval SOP is signed, dated & authorized by senior
personnel of concerned department.
ELEMENTS OF SOPs_
✓ Title Page
✓ Table of contents
✓ Procedure
✓ Quality Assurance/ Quality Control
✓ References

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Sample of SOP

17. QUALITY AUDIT
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It is an independent evaluation done to review the whether the
activities are performed in a manner with respect to company’s
quality system or not.
Quality audits are performed at defined intervals, any failure in their
implementation leads revocation of quality certification.
➢ OBJECTIVES_
▪ To recommend corrective actions.
▪ To monitor improvement.
▪ To build confidence in GMP & QA system.
▪ To build interdepartmental trust, understanding & communication.
▪ To determine measures necessary for improvement.
▪ To verify if the production & control systems are operating as intended.

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HOW TO PERFORM QUALITY AUDIT
Planning
Conducting
the Audit
Analysis
of
Results
Reports &
corrective
actions
Follow
Up

19. QUALITY REVIEW
19
Quality review is an evaluation conducted at regular basis of the
pharmaceutical products , to assess the quality standard of each
drug product with a view to verify the consistency of processes &
to check the appropriateness.
• It is an effective tool to enhance the consistency of
manufacturing and overall quality of the product.
• It is a written report that is required for every drug product,
based on data collected at least annually. It is designed to
minimize the risks involved in any pharmaceutical production
that cannot be eliminated through testing the final product.
• A representative number of batches must be selected, and a
review must be done of the documents associated with them.

20. • Both approved and rejected batches must be a part of this study.
Along with this, it is also important to evaluate any complaints
received regarding the same product batches, or any returns or
recalls that have been associated with those batches
• By doing these activities it is possible to find the areas where
improvement is important.
• Performing a quality review is essential as it enables the better
understanding of processes which can guide further quality
improvements.
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21. Quality Review Includes_
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Starting materials
Packaging materials
In Process controls
Equipment qualifications
Stability studies
Finished Product test results CAPA Effectiveness
Review of previous batches
Failed batches
Deviations
Market complaints
Returns/ recalls

22. QUALITY DOCUMENTATION
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This comprises all the documents that forms a part of company’s
quality management system.
This comprises of documents such as
❑ Quality policy
❑ Quality procedures
❑ Work instructions &
❑ Records
These are arranged in a definite hierarchy based on their scope.

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Quality
Manual/
Policy
Quality
Procedures
Work
Instructions
Quality Records
Quality Documentation
Pyramid

24. Quality Manual_ Describes the quality system and what has to be
done as an organization to implement. It outlines company’s
vision, mission & goals. It states the commitment of an
organization to quality and continual improvement. It also
answers the question of why this quality system is implemented.
Quality Procedures_ Describes how the quality system will be
implemented, methods to be used, what to do, when to do,
where to do. Have more details than policy document.
Work Instructions_ It’s a department specific, and give details of
how each task is to be done. It may include diagrams, work
sheets, etc. They are represented by SOPs in pharma industry.
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Records_ It is final part in documentation system.
It contains evidences and proofs that quality policy, work
instructions and procedures have been executed as directed.
It includes BMR, QC test reports, Validation documents & so on.
❖ It includes the following sources_
❑ Calibration results
❑ Maintenance records
❑ Supplier documentation
❑ Audit results
❑ CAPAs
❑ Non-conformance investigations

26. DOCUMENTS & RECORDS
26
Documentation and records are maintained throughout the
manufacturing process and supporting process as well. It must
meet the basic requirements of Good Documentation Practices.
➢ These includes_
✓ Batch record forms
✓ Protocols & Policies
✓ SOPs & Work instructions
✓ Forms/ log sheets
✓ Specifications & checklists
✓ Training assessments & test methods
✓ Confidential agreements
✓ Audit plans & Deviation reports and so on___

27. DISTRIBUTION RECORDS
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After thorough testing and approval batches are released for
distribution by QC dept. Warehousing department must contain
records of batches released for distribution in systemic manner.
It plays parcel part during the necessity of product recall from the
market.
➢ Components of distribution Records_
✓ Name of product, its strength, description of dosage form
✓ Batch no./ Lot no. of shipped product
✓ Name and address of consignee
✓ Shipping date & quantity shipped
✓ Expiry date
✓ Date of dispatch

28. ✓ Special storage requirement
✓ Total quantity of products
✓ Precautionary measures
✓ Handling guidelines
✓ A unique number to allow identification of order.
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29. MULTIPLE CHOICE QUESTIONS
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Q1. SOPs contains stepwise guidelines to carry out an operation.
A) True B) False
Q2. ______is not a component of MFR.
A)Storage inst. B) Expiry date
C) Special notations D) Both B & C
Q3. Following is/are element/s of SOP_
A) Audit B) Procedure
C) Both B & D D) References
Q4. Quality review don’t emphasize on_
A) In process controls B) Stability studies
C) Returns/recalls D) Audits
ABCD

30. Q5. Documents and records meet the basic requirements of_________
A) GMP B) GLP
C) TQM D) GDP
Q6. Quality documentation don’t includes
A) quality policy B) work instructions
C) CAPAs D) records
Q7. Is not a component of distribution record
A) name of product B) log sheets
C) batch no D) total quantity of products
Q8. BMR contains_______
A) Name of personnel B) storage instructions
C) strength of product D) precaution 30
DCBA

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