This document discusses specifications and certificates of analysis (COA), which are important documentation in the pharmaceutical industry. It provides details on the purpose, scope and required contents of specifications for raw materials, packaging materials, in-process materials, finished products, and preparation of containers. It also covers the purpose, contents and examples of COAs, which report analytical results for batches to ensure they meet specifications. COAs should include batch information, test acceptance criteria, results, and approval. Electronic COAs are also commonly used if appropriate controls are in place for the computer system generating them.

1. DOCUMENTATION:
SPECIFICATIONS &
CERTIFICATE OF
ANALYSIS (COA)
HARSHAVARDHAN V
KONDHARE
SEM II
DEPT. OF DRUG REGULATORY
AFFAIRS
GUIDED BY : Mrs PREETI K TAMANE
POONA COLLEGE OF PHARMACY
15-2-2015
SEM II
DRA III UNIT III DOCUMENTATION

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SPECIFICATIONS

4. Specifications
A document describing in detail the requirements with which the
product obtained during manufacture have to conform.
– A document specification contains several parts:
 A description of the audience(s) for the document;
 A detailed outline giving the structure and contents of the
document;
 A work plan showing who is responsible for each part of the
document;
 What the deadlines are for completing each task.
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5. Specifications: Purpose
– Three purposes for document specifications:
– In the workplace, formal document specifications serve three
important functions:
 Economy of effort,
 Work planning,
 Writing organization.
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6. Specifications: Scope
They should be included for-
– raw materials and packaging materials
– product containers and closures.
– in-process and bulk products
– finished products
– preparation of containers and closures
– For raw materials and packaging materials – should include
a) Designated name and internal code reference;
b) Reference, if any, to a pharmacopoeial monograph;
c) Qualitative and quantitative requirements with acceptance limits;
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7. Specifications: Scope
d) Name and address of manufacturer or supplier and original manufacturer of
the material;
e) Specimen of printed material;
f) Directions for sampling and testing or reference to procedures;
g) Storage conditions;
h) Maximum period of storage before re-testing.
– For product containers and closures
a) Comply with the pharmacopoeial requirements.
b) Validated specifications and procedures should be strictly followed to avoid any
effect on quality of product.
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8. Specifications: Scope
c) Written schedule of cleaning shall be laid down and followed for bottles.
– For in-process and bulk products
a) Authenticated specification must be present.
– For finished products – should include
a) Designated name of the product and the code reference;
b) Formula or a reference to the formula and the pharmacopoeial reference;
c) Directions for sampling and testing or a reference to procedures;
d) Dosage form and package details;
e) Qualitative and quantitative requirements, with the acceptance limits for
release;
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9. Specifications: Scope
f) Storage conditions and precautions,
g) Shelf-life.
– For preparation of containers and closures
a) Schedule ×include requirements of machinery, equipment and premises
required for preparation of containers and closures.
b) Specifications can be as per the requirement of the manufacturer.
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10. Document Name Retention Time Responsible Person
Specifications 7 Years Technical Service Manager
Raw Material Specification 13 Years from the date of
receipt
Laboratory Manager
Finished Product
Specifications
13 Years from the date of
production
Laboratory Manager
Packaging Material
Specification
7 Years Laboratory Manager
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CERTIFICATE OF
ANALYSIS
(COA)

12. Certificate of Analysis
– Certificate of Analysis is a document issued by Quality Assurance
that confirms that a regulated product meets its product
specification. They commonly contain the actual results obtained
from testing performed as part of quality control of an individual
batch of a product.
– Should be prepared and issued by the company responsible for the
material.
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13. Certificate of Analysis:
Purpose and Scope
– Purpose is to report analytical results for a specific batch of-
 Raw materials
 Component
 API
 Finished product
 Other similar item.
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14. Certificate of Analysis:
Contents
– COA should be approved by an appropriate representative from the testing site &
contain:
 Vendor or supplier information
 Product information (name and strength)
 Results for the specific batch, with name of test acceptance criteria and result for each
test.
 Conformance statement
 Reference to method and specification document
 Reference of data source
 Approval and date
 Expiration date or retest information.
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15. Certificate of Analysis:
Contents
– Information needed for COA :
 Name and unique batch number
 Manufacturer
 Manufacturing date
 Retest date
 Expiry date
 Transport instruction
 Storage condition
 Content of reference substance
 Note on calculation of the contents
 Special remark on handling requirement if any
 All the required tests with their specifications and results.
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16. Certificate of Analysis:
eCOA
– Certificates of Analysis issued from computer systems without a handwritten
signature are common and are acceptable provided the appropriate controls are
in-place. The following considerations should be met:
 Access to the computer system, entering and editing of data should be limited to
authorized personnel. Authentication by username and password. Confirmation of the
integrity and accuracy should be completed during implementation and then
periodically checked thereafter.
 Data entered into a computer system from which information is extracted for a COA and
changes made thereafter should be accompanied by time- and date-stamped audit
trails.
– With these criteria met, the issuance of electronically generated COAs is
acceptable provided the COA includes contact information.
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17. Certificate of Analysis:
Some Examples
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REFERENCES

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1. THE DRUGS AND COSMETICS ACT, 1940 (As amended up to the 30th June, 2005)
and THE DRUGS AND COSMETICS RULES, 1945 (As amended up to the 30th June,
2005), SCHEDULE M, 17. Specification, 22.5 Records of Analysis.
2. Dan Creinin, Certificates of Analysis Confirm Control, February 1, 2005
3. www.pharmout.net
White Paper, How to Implement Good Documentation Practices, Version 01, 2013.
4. www.drugregulations.org/ documentation in pharmaceutical industry.
5. http://www.sigmaaldrich.com/united-kingdom/technical-services/c-of-
a.html#sthash.vFEeMLDB.dpuf
6. www.csv-qa.com/ computer system validation/audit trials

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