SOP for Preparation of Certificate of Analysis

Purpose

The purpose of this SOP is to describe the format for the COA to be used in the quality control laboratory.

Scope

This procedure is applicable to all the APIs, excipients, packaging materials, and products analyzed in the QC department of PharmaInfo Pvt. Ltd.

Responsibilities

• Officer QC/Sr. Officer QC is responsible for preparing the COA of each sample.
• AM QC or Designee is responsible for verifying the results entered in the COA against the raw data sheet of the test performed by Officer QC.
• The manager QC or Designee is responsible to review and approve the results of the COA.
• The QA Manager is responsible for ensuring the procedure is being followed as per the SOP.

Procedure

• Certificate of Analysis is a legal document produced by the Quality Control department that certifies the quality of the product.
• All the materials (raw, packaging, and bulk/finished materials) that are received in the QC department shall be analyzed by the officer QC/Sr. Officer QC/Assistant Manager QC.
• All the raw data of materials/samples subjected to test analysis shall be compiled by the officer QC and prepare the Certificate of Analysis for final approval of the material/product.

Controlled Format: 

• The certificate of analysis shall be prepared in a controlled format. Each COA shall be locked for its tests and specifications. The results shall be entered manually and signed.

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Preparation of COA: 

• The particulars of COA shall be organized containing required information in a logical manner. It shall consist of the following information.

COA for Raw and Packaging Material

• The COA’s of raw materials and packaging materials shall contain the following specified information.
• The Name (Chemical name or Pharmacopoeial) of the material and its specific QC number.
• The Complete description of the material (i.e. grade, quantity received, type of container, batch number, date of manufacturing, expiry or retest date, reference standard) shall be recorded.
• Testing and Release dates shall be mentioned for the traceability of the analysis performed.
• The test method reference shall be provided that may be Pharmacopoeial or In-house. If the method is pharmacopoeial then Current pharmacopoeia shall be mentioned on the COA. The supplier and manufacturer’s name shall be mentioned for raw material and packaging material under test.
• The storage conditions of the material shall also be mentioned.

COA for Bulk and Finished Products

• The COA’s of Bulk and Finished products shall contain the following specified information.
• The Name (Pharmacopoeial) of the product, label claim, registration number, batch number, and batch size shall be mentioned on the COA.
• The date of receiving the product in the QC department and the sample quantity shall be recorded. QC number shall be given to the product.
• The Date of manufacturing and expiry shall be mentioned for the traceability of each batch.
• Testing and Release dates shall be mentioned for the traceability of the analysis performed.
• The reference shall be provided for the Pharmacopoeial or In-house method. If the method is Pharmacopoeial then Current pharmacopoeia shall be mentioned on COA.
• The COA of the finished product shall contain the Reference number of the Standard Testing method and the Specification number.

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Testing requirements

• All the physical and chemical tests that are performed shall be specified in the respective COA.
• The Specifications and acceptance criteria of each test performed shall be mentioned as per the Standard testing method.
• The actual test results performed along with its reference and raw data shall be attached with COA.
• Reporting of actual data and observations shall be entered as released, approved, or rejected along with a justification statement. A statement of expected conditions of shipping, packaging, storage, and distribution shall be written in the finished product COA, deviation from which would invalidate the certificate.
• The COA shall be prepared by Officer QC / Microbiologist, reviewed, and Approved by Manager QC.
• Any change to the format of COA shall follow the change control procedure.

Assigning COA number

• The number of COA will be given in sequence starting with “00001” for each certificate of analysis of raw material, bulk, finished product, and packaging material.

Abbreviations

COA: Certificate of analysis

QC: Quality Control

QA: Quality Assurance

Q & C: Operation A and Compliance

SD & AS: Scientific Development And Analytical Services 

SE & D: Scientific Evaluation And Development

SOP: Standard operating procedure

References

Annex 10, WHO Model Certificate of Analysis

The International Pharmaceutical Excipients Council, COA guide for pharmaceutical excipients. IPEC-EU

Revision History

Nil

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