DOCUMENTATION: SPECIFICATIONS &

CERTIFICATE OF ANALYSIS (COA)

HARSHAVARDHAN V KONDHARESEM 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

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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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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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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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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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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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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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)

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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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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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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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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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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Certificate of Analysis:Some Examples

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SAMPLE COA

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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.vF

EeMLDB.dpuf

6. www.csv-qa.com/ computer system validation/audit trials

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