The document discusses specifications for raw materials, finished products, and documentation. It defines specifications and their importance in ensuring quality. Specifications include tests, acceptance criteria, and procedures for materials and products. The document outlines specifications for raw material purchasing, storage, and testing as well as finished product testing, documentation, and storage. It discusses the relationship between specifications and regulations/standards.

1. RAW MATERIALS, SPECIFICATION OF
MATERIALS AND FINISHED
PRODUCTS
1
P R E PA R E D B Y: K E Y U R R . P R A J A PAT I
M.PHARM SEM-I (Q . A)
G U I D E D B Y : M R . A N A N D K . PAT E L
D E PA R T M E N T O F Q . A
A . P. M . C . C O L L E G E O F P H A R M A C Y
H I M M AT N A G A R

2. CONTENET
 Introduction
 Raw material
• Purchase specifications,
• Maintenance of Stores,
• Selection of Vendors,
• Control on raw materials and finished dosage forms
 Specification of finished products
• Introduction
• General concepts
• Specifications for the finished product
• Specifications for documentation of the finished
product
• Specifications for storage of the finished product
• Generally acceptable specifications for drug products
2

3. INTRODUCTION
 GMP:
“Good Manufacturing Practice is a set of regulations, codes,
and guidelines for the manufacture of drug substances and
drug products, medical devices, in vivo and in vitro
diagnostic products, and foods.”
 Raw materials:
“It is the starting material used in the manufacture of
finished product”
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4. Principle
 Objective of the pharmaceutical manufacturer
 produce finished products for patient's use from a
combination of materials
 Materials combined
 Active pharmaceutical ingredients and
 Excipients (auxiliary materials)
 Packaging materials
 Materials include also
 Gases, solvents, reagents, process aids, etc.
 Special attention
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5. General requirements for materials
 Materials for cleaning, lubrication, and pest control
 Not in direct contact with product
 Suitable grade, e.g. food grade if possible
 All incoming materials and finished products
 quarantined after receipt or processing
until released for use or distribution
Maintenance of stores
Good state of repair: Walls, Ceiling Paint, Plumbing,
Electrical damages
Protection from light and Exposure to air
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6.  Storage specification
• under appropriate conditions
• orderly fashion (batch segregation)
• materials management
• stock rotation (FEFO)
 Water – suitable for use
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7. Starting Materials
 Purchasing Specifications:
 important –highly techno commercial operation
 From approved suppliers – if possible, direct from the
manufacturer
 Vendor selection and certification
 Consistency of Quality
 Capacity of plant for Volume Requirements
 Consistency of price
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8.  Inventory management:
Material management
The ABC concept
Economical lot size or order quantity(EOQ):
EOQ can give us optimum quantity which should be
ordered for purchasing and at this point balance is
reached between the factor i.e. acquisition cost and
carrying cost
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9. Where, A=annual or periodical requirement
O=ordering cost
C=carrying cost per unit
 Consignment checks
 Integrity of package
 Seal intact
 Corresponds with the purchase order
 Delivery note
 Supplier’s labels
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10.  Cleaned and labelled with information
 Examples of Labelling of Starting Materials
 Fully computerized storage system
Name of
Material and/or
internal code
Control/
Batch No.
Quarantined/Released/Rejected
Status
(Colours may be used)
Expiry date or
retest date
Date Signature
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11.  Appropriate measure to ensure identity of
contents of materials
 Use only QC released material if within shelf-life
 Dispensing
 designated persons
 written procedure
 Correct materials accurately weighed
 clean, properly labelled containers
 Independent checks and record
 material and weight or volume
 Dispensed material
 kept together and labelled
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12. Packaging materials
 Type of packaging materials:
 Primary packaging materials
 Secondary packaging materials
 Printed and Unprinted packaging materials
 Each delivery or batch: specific reference number or
identification mark
 Delivery to packaging department
 Check quantity, identity and conformity to packaging
instructions
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13.  Outdated or obsolete material
 Destroyed
 Disposal record
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14. Vendor selection and Evaluation
 This SOP describes the procedure to be followed during the
vendor assessment and vendor evaluation for purchasing of
raw materials, critical and non critical packaging
components, laboratory supplies, engineering supplies and
imported finished goods from the vendor.
 These instructions are essential for approving prospective
vendor.
 The SOP doesn’t describe the process of selection of a
contract Manufacturer.
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15. The Process of vendor assessment and evaluation is
divided into four phases.
Vendor Assessment/Selection
Phase 1: Technical discussion
Phase 2: General Vendor Audit
Phase 3: Item specific evaluation
Vendor Evaluation
Phase 4: Ongoing vendor evaluation
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16. Vendor certification
 This procedure aim to describe the process by which a
vendor may be certified to supply materials or services.
 This procedure applies to vendors that supply a material
or service to be used at any stage of manufacture by
operations.
 Here you will get the roles of each department in the
process to certify an approved vendor.
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17. Need to source
new vendor is QA, Technical,
Procurement liaise for Identify possible
identified
vendor vendors
Phase 3:
Send Supplier
YES NO Questionnaire
Item specification Accepted
Evaluation
Purchase,
Sampling and
Accepted General Vendor Testing
Audit
NO
Vendor YES
certification
Phase 4: YES NO
YES Phase 2: Discussion to
required proceed
Accepted
NO 17 17

18. Specifications
 Authorized, approved, signed and dated
 Starting, packaging materials and finished products:
include tests on identity, content, purity, quality
 Intermediates and bulk
 Water, solvents and reagents
 QC, QA or documentation centre
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19. Specifications: Starting and packaging materials
Include:
 Name (e.g. INN) and internal code
 Pharmacopoeia (if applicable)
 Qualitative and quantitative requirements and limits
Other data may include:
 Supplier
 Sampling procedure or reference
 Storage conditions, precautions
 Retest date
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20. Quality control of raw material and finished
product
Retest Dating of Raw Materials
The purpose of this procedure is:
 to describe how to run the expired stock report; to describe
how to define the requirements for the retesting and assignment
of storage period for active ingredients, excipients and raw
materials;
 to instruct retesting procedure and to determine the status of a
finished goods batch with a shorter shelf life.
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21. Archiving Laboratory Documentation
 This procedure describes retention and disposal procedures of
laboratory documentation, general laboratory documentation
system that includes
 handling of rejected raw material and finished product
reports,
 finished goods certificate of analysis,
 finished goods register,
 raw material certificate of analysis,
 procedure for long term document retention.
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22. Raw Materials-Laboratory Testing and
Documentation
 This SOP describes the procedure for
 sampling,
 location,
 pre-testing,
 testing and documentation of all raw materials and
components subject to test,
 out of specification results,
 microbiological tests and
 release procedure for passed raw materials and components.
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23. Finished Goods-Laboratory Testing and
Documentation
 This SOP describes the procedure for
 sampling, location, pre-testing,
 testing and documentation of all finished products subject to
test,
 reagents and standards to be used for analysis,
 management of out of specification results,
 microbiological tests and
 release procedure for passed finished goods.
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24. INTRODUCTION
 SPECIFICATION:
“Defined as list of tests, references to analytical
procedures, and appropriate acceptance criteria which
are numerical limits, ranges or other criteria for the
test described.”
 It establishes the set of criteria to which the drug
substance, drug product or material at any stages of
manufacture should conform that they are acceptable
for their intended use.
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25.  It describes in detail the requirements with which
products or materials used or obtained during
manufacturing have to conform.
 Conformance to specification means that the drug
substance and drug product ,when tested according to the
listed analytical procedures will meet the acceptance
criteria.
Finished product:
 A pharmaceutical product that has under gone all stages of
production and quality control including being packaged in
its final container and labeled.
 Finished product should be held under quarantine until their
final release ,after which they should be stored as usable
stock under conditions established by manufacturer.
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26.  Types of specifications
 Raw material specifications
 Container closure specifications
 Finished product specifications
 Finished product specifications
 Release specifications:
The combinations of physical, chemical, biological and
microbiological test requirements that determine whether a
drug product is suitable for release at the time of manufacture.
Stability indicating specifications:
The combination of physical, chemical, biological and
microbiological test requirements that the active ingredients
or a drug product must meet during its shelf life
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27. OBJECTIVE OF THE
SPECIFICATIONS
 The objective of specifications is to assure that each unit
contains the amount of drug claimed on the label, that all the
drug in each unit is available for complete use ,that the drug
stable in the formulation in its specific final container for
its expected shelf life ,and that it contains no toxic foreign
substance
It provide guideline on the setting and justification of
acceptance criteria and the selection of test procedure for new
drug substances of synthetic chemical origin and new drug
product made for them, which have not previously been
registered in any of the pharmacopoeia.
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28. GENERAL CONCEPTS
 Periodic and skip testing
 Release versus shelf life acceptance criteria
 In process tests
 Design and development considerations
 Parametric release
 Alternative analytical procedures
 Pharmacopoeial tests and acceptance criteria
 Evolving technologies
 Reference standard
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29. SPECIFICATIONS ON THE
FINISHED PRODUCT
I) Areas in which Quality characteristics covered by the
specifications:
 General characteristics
 Identification & assay
 Purity tests
 Pharmaceutical tests
 Safety tests
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30. II) Relationship between dossier specifications and
the Pharmacopoeia:
 The general provisions of different
Pharmacopoeias describe and define the
content and legal weight of the various sections of
its monographs and general methods.
 The applicant Should determine the most
appropriate means for reaching stated objective.
 Monographs represents the limit values of
medicinal product at the end of their shelf life.
 Specification must comply with stated
acceptance criteria.
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31. III) Relationships between the specification of a finished
product at the end of shelf life and at manufacture (at
release):
 Aim of dossier for a marketing authorization to set
quality level of the medicinal product as intended for
marketing
 Shelf life and storage conditions proposed on the
basis of level of active ingredient and level of any
break down products.
 The specification limits of the finished product at the
time of batch release are set such that the
specifications proposed at the end of shelf life are
guaranteed.
 The specifications of the finished product at
manufacture may be different from those of the
medicinal product at expiry.
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32. IV) Specifications and routine tests for the release of batches of
finished product at the time of manufacture (at release) :
 Relationship between validation of the manufacturing
process, GMP and establishment of specifications.
 Routine tests and periodic tests. Different type of tests.
 Scheme for verifying specifications
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33. V) Acceptance limits :
 Acceptance limits of pharmaco technical
parameters
 Maximum acceptable deviation in the content of
active substances “unless there is appropriate
justification”
 Acceptance limits for excipients.
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34. SPECIFICATION FOR DOCUMENTATION
OF FINISHED PRODUCT
Designated name of the product and the code reference where
applicable.
 Designated name(s) of the active ingredients(s).
 Formula or reference to formula.
 Dosage form description and the package details
Directions for sampling and testing or a reference to procedures.
 Quantitative and qualitative requirements with acceptance limit.
Storage conditions and precautions where applicable.
 Shelf life.
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35. SPECIFICATIONS FOR STORAGE
OF FINISHED PRODUCT
 Should be held in quarantine until their final release
 Separate area should be provided for the storage
 Stored according to their dosage form
 Storage areas should have adequate height and ventilation,
adequate storage equipment .
 Adjacent to finished product area, an assembling and
packaging area may be provided.
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36. GENERALLY ACCEPTABLE
SPECIFICATIONS FOR DRUG PRODUCTS
 General:
Organoleptic properties (appearance, color, odor)
Identification
Purity
PH
Moisture content
Abnormal toxicity
 Specific
 Capsules
 Emulsions
 Tablet
 Oral solutions and suspension
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37.  Oral powders
 Metered dose inhalation aerosols
 Topical and ophthalmic preparation
 Small volume parenterals
 Large volume parenterals
 Suppositories
 Drug additives
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38. REFERENCE:
1. Good manufacturing practices for pharmaceuticals. 4th
edition ,Sidney H.Willig , James R.Stoker, Marcel
Dekker INC. Page no.386-401
2. cGMP ,documentation and validation, Prof. Manohar
A.Potdar, PharmaMed press, Page no.113-149,354-360
3. Pharmaceutical dosage forms: Parentral medications
Volume 3,2nd edition ,Edited by Kenneth E.Avis,Herbert
A. Lieberman, and Leon Lachman ,Marcel Dekker INC.
Page no.58-62
38

39. 4. Pharmaceutical dosage forms: Tablets, Volume 1,2nd
edition ,Edited by Herbert A. Lieberman, Leon Lachman
and Joseph B. Schwartz , Marcel Dekker INC. Page
no.548-551
5. QA Manual by D.H.shah,Pp:125-149
6. Industrial Pharmacy, edited by Herbert A. Lieberman,
Leon Lachman ,page no.747-756
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