SOP for Preparation of Certificate of Analysis

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

This procedure is applicable to all the APIs, excipients, packaging material and products analysed in QC department of XYZ Ltd.

  • Officer QC/Sr. Officer QC is responsible to prepare the COA of each sample.
  • AM QC or Designee is responsible to verify the results entered in the COA against the raw data sheet of test performed by the Officer QC.
  • Manager QC or Designee is responsible to review and approve the results of the COA.
  • Chief Manager QC is responsible to ensure the procedure is being followed as per the SOP.
  • A 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 QC department shall be analysed 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
  • Certificate of analysis shall be prepared on a controlled format. Each COA shall be locked for its tests and specifications. The results shall be entered manually and signed.

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

A.  COA for Raw and Packaging material
  1. The COA’s of raw materials and packaging materials shall contain the following specified information.
  2. The Name (Chemical name or Pharmacopoeial) of material and its specific QC number.
  3. 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.
  4. Testing and Release dates shall be mentioned for the traceability of analysis performed.
  5. 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.
  6. The supplier and manufacturer’s name shall be mentioned for raw material and packaging material under test.
  7. The storage conditions of material shall also be mentioned.

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

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

D.  Assigning COA number
  • 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.

COA : Certificate of analysis
QC : Quality Control
QA : Quality Assurance
O & C : Operation And Compliance
SD & AS : Scientific Development And Analytical Services
SE & D : Scientific Evaluation A nd Development
Sr. : Senior
SOP : Standard operating procedure

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