2. DOCUMENTATION
Document is any written statement or proof.
An essential part of quality assurance.
Defines the specification for all materials and
methods of manufacture and control.
Provides an audit trial.
Ensures the authorized person to have all the
necessary information.
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3. OBJECTIVES
Define the manufacturers system of
information and control.
To minimize the risk of misinterpretation
inherent in oral communication.
To follow uniform procedures.
To allow tracing of batch history.
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4. AIM
1. To define the specifications for all materials.
2. To define methods to manufacture and control.
3. To ensure that all personnel connected with
manufacture and control know what to do &
when to do.
4. To ensure that all personnel authorized to
release a batch for sale or reject it have all the
information that is necessary to take the
decision. 4
5. To provide information during investigation
, if a batch is suspected to have defects.
To make available data for validation ,
review and statistical analysis.
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6. Revised M schedule has the following
elements which are related to
documentation:
• Specifications and Standards.
• Master Formulae Records.
• Batch Production and Control Records
(BPCR).
• Batch Packaging Records (BPR).
• Calibration and Validation records.
• Quality control records.
• Distribution records. 6
7. STANDARD OPERATING
PROCEDURES
“SOP is a set of instructions complied by an
organization to help workers to carry out the
complex routine operation”.
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8. AIM
1. Create the culture where quality objective are
transparent and well understand.
2. They form the backbone of the pharmaceutical.
3. To achieve efficiency.
4. To achieve quality output.
5. To achieve uniformity of performance.
6. To achieve uniformity of quality.
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9. SOP writing style
SOPs shall be written in concise, step by step,
easy to read and follow format.
Information should not be complicated.
Should be simple and short.
Routine procedures that are short and require
few decisions can be written using simple step
format.
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10. Cont…..
Long procedures with more than 10 steps,
with few decisions should be written along
with graphical format or hierarchical steps.
Procedure that require many decisions
should be written along with flow chart.
Include the requirements for document
identification and control, accountability and
traceability, responsibility.
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11. While writing SOP
Write in present tense.
Avoid ambiguity.
Be concise.
Keep the words short and get to point.
Move from one step to another in logical
manner.
Highlight exception.
Highlight warning.
Reduce the word count where possible without
altering the meaning of the text.
Introduce acronyms without explaining what it
means. 11
13. General format for SOP
1. SOP number:
2. Title:
3. Department:
4. Date:
5. Revision number:
6. Effective date:
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14. MASTER FORMULA
RECORD
“Written procedures that give the complete
description of all aspects of its manufacture,
packing and control with an intention to
ensure the purity , identity, quality and
strength of each dosage unit throughout its
shelf life”
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15. Cont…
Prepared by research and development
team.
Include all information about the
manufacturing process for the product.
Used as a reference standard for preparing
Batch Manufacturing Records (BMR) by
manufacturing units.
Also called Master Manufacturing Record,
Master Production Record.
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16. It includes the following information:
1. Specifying a fixed formulation.
2. Identifying quality criteria for components.
3. Providing a set of manufacturing
instructions.
4. Describing systematic sampling
procedure.
5. Using precise assays, tests etc.
6. Establishing methods for ensuring
complete accountability for all materials
including packing and labeling.
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19. Steps to prepare MFR
Production department in association with
R&D, shall prepare MFR.
Prepare as per the format associated with
SOP.
Divided into two parts:
1. Packaging part.
2. Manufacturing part.
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22. BATCH FORMULA RECORD
BPR is a documentation which shows that
significant manufacturing processes and in-
process controls were accomplished in
accordance with master formulation record for
that product
Required to be maintained for each batch of
the product manufactured.
Product and batch specific document which
gives an entire picture of manufacturing
history of each batch of every product.
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24. It include:
1. Name of the product
2. Trade name
3. Specification of raw material.
4. Name of raw material.
5. Specification of container, closure and
packing material.
6. Name of item.
7. Weighment sheet.
8. Dispensing instructions.
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25. Cont….
List of equipment and machinery.
Dispensing instructions.
Packaging requirements.
Packaging instructions.
Precautions to be taken.
Finished product specifications.
Expiry date.
Review due on.
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26. BFR should have following
columns:
Serial number.
Name of ingredients.
Reference of specifications of ingredients.
Quantity to be added.
Overages to be added.
Quantity added per batch or per lot.
Below that give the calculation step for every
active ingredient, ensuring that the active
material shall be compensated for assay
values less than 100% which could be due to
less potency or higher moisture content. 26
28. QUALITY AUDIT
“A systematic and independent examination
to determine whether quality activities and
related results comply with planned
arrangements, and whether these
arrangements are implemented effectively
and are suitable to achieve objectives”.
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30. Basic types
Imposed upon manufacturer or supplier
1. Regulatory
2. Customer or potential customer.
3. Third party( on behalf of customer)
Performed by manufacturer:
1. Internal
2. External
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31. THREE TIER APPROACH
Internal audits are carried out by organization of
its own system, procedures and facilities.
Internal audits are required for business
prospective.
One possible system for internal audit is three tier
approach.
Carried out by corporate compliance group.
External consulters may be used. 31
32. Cont….
To assess the readiness for regulatory
audit.
To have an expert view on specific critical
activity.
Three tier auditors are highly trained,
experienced or specialist with an expert
knowledge of GMP and other regulatory
requirements for pharmaceuticals.
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33. AUDIT PLAN
Required for effective audit at low cost.
A comprehensive list of the specific audit
procedures that the audit team needs to
perform to gather sufficient appropriate
evidence on which to base their opinion on
the financial statements.
Audit planning is carried out before start of
audit.
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34. When planning the engagement, the auditor
needs to develop and document a plan that
describes the procedures to be performed to
assess the risk of material misstatement at
the financial statement and assertion level.
The auditor must then carefully plan the
nature, timing and extent of control tests and
substantive tests that are designed to mitigate
these risks to an acceptable level.
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36. Audit Documentation
Written record of the basis for the auditor’s
conclusion that provides the support for the
auditor’s representations, whether those
representations are contained in the
auditor’s report or otherwise.
It includes records of the planning and
performance of the work, the procedures
performed, evidence obtained
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37. AUDIT REPORT
Financial records and accounts of the
company.
The audit reporting is the communication of
audit conclusions after having carried out the
audit process in accordance with the audit
plan.
Signed written document which presents the
purpose, scope and results of the audit.
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38. The content of audit report
Whether the financial information disclosed in
the financial statements has been prepared
using acceptable accounting policies.
Whether the said policies are consistently
applied year after year.
Whether the financial information complies
with the relevant regulations and statutory
requirements.
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39. Basic elements
Title .
Addressee.
Opening or introductory paragraph.
1. Identification of financial statement audited.
2. A statement on the responsibility of the entity’s management and
that of auditor.
Scope paragraph.
1. A reference to the auditing and standards generally accepted in
India.
2. A description of work performed by the auditor.
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40. Opinion paragraph
1. A reference to the financial reporting framework used to
prepare the financial statement.
2. Expression of opinion on the financial statement.
Date of the report.
Place of signature.
Auditor’s signature.
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41. SPECIFICATIONS
Authorized and dated specifications for
starting materials, packaging materials,
finished products, intermediates and bulk
products.
Approved and maintained by the QC
department.
Periodic review is necessary.
In India, D&C act requires the drugs to comply
with standards as laid down in the 2nd
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42. TESTING PROCEDURES
After having prepared the specifications for
materials and finished products , QC department
should prepare test procedures for testing
materials.
The items which are official in any
pharmacopoeia or any other recognized book of
standards can be tested as per test procedures.
Methods should give accurate results.
These should be validated before adopting for
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43. DISTRIBUTION RECORDS
Written data related to distribution of drug
products from the manufacturer to the
distributors.
Purpose is to ensure that adequate data is
available to access trade
A distribution register should be maintained
for detailed information about distribution of
each batch of drug product.
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44. Cont….
Contain name and strength of the product ,
description of the dosage form, name and
address of the consignee, data quantity
shipped, lot or control number of the drug
product.
Include invoices, bill of lading, customer
receipts, internal warehouse storage and
inventory records.
An inventory card is maintained to find out the
stock position quickly. 44
