SOP for Preparation of Certificate of Analysis (CoA)

1.0 OBJECTIVE:

To lay down the procedure for preparation of Certificate of Analysis (COA) for Intermediate (Blend/ Core/ Coated/ Composite), Finished Product, Raw Material and Packaging Material for Domestic / Export products.

2.0 SCOPE:

This standard operating procedure (SOP) is applicable for the preparation of COA for Intermediate, Finished Product, Raw Material and Packaging material for ANDA products and Domestic / Export product by Quality Control Department and Quality Assurance Department at [Company name].

3.0 RESPONSIBILITY:

Quality Control Personnel: To prepare Analytical report and COA from raw data and record of analysis.

Quality Assurance Personnel: To prepare COA on requirement basis.

Head Quality Assurance: To ensure the compliance of the SOP and approval/Authorization of COA

4.0 PROCEDURE:

4.1 Direction for Preparation of COA for Regulatory submissions Batches.

4.2 In case of Any Regulatory submissions, the result of the analysis along with raw data are submitted by QC Dept. to QA Department.

4.2.1 The QA personnel shall prepare the COA 

4.2.2 COA includes information but not limited to

4.2.2.1 Name of the product

4.2.2.2 Batch No./ Lot No.

4.2.2.3 Manufacturing Date

4.2.2.4 Expiry Date /Valid up to

4.2.2.5 Manufactured by/ Supplier 

4.2.2.6 Date of Analysis

4.2.2.7 A. R. No.

4.2.2.8 COA No.

4.2.2.9 Batch size

4.2.2.10 Sampling done

4.2.3 The COA shall contain the test information like test performed, specification and results.

4.2.4 The COA prepared shall be signed and dated by one person and shall be approved by second person.

4.2.5 Procedure for collecting data for Intermediate (Blend) stage.

4.2.5.1 While preparing the COA for Blend stage the QA personnel shall take the required test parameters, specification and result from the record of analysis and respective protocol as case may be.

4.2.6 Procedure for collecting data for Intermediate (In-process) stage.

4.2.6.1 While preparing the COA for in-process stage the QA personnel shall take the required test parameters, specification and result from the record of analysis and respective protocol.

4.2.6.2 When the test is performed for start, middle and end stage the COA shall be prepared by taking the average value of above stages for specified parameters.

4.2.6.3 All result obtained from quality control department shall be considered for preparation of COA.

4.2.6.4 If any test parameter to be taken in COA which is not performed by QC department the data shall be taken from BMR/ IPQA result.

4.2.6.5 The results may be given as minimum and maximum for the required test parameter. E.g. Hardness, Thickness, Diameter etc.

4.2.6.6 Similarly the COA shall be prepared for the Composite stage by taking the required test parameters, specification and result from record of analysis and respective protocol.

4.2.7 Procedure for collecting data for Finished Product stage.

4.2.7.1 While preparing the COA for Finished Product stage the QA personnel shall take the required test parameter, specification and result from the record of analysis or respective protocols.

4.2.8 Direction for Preparation of COA for Raw Material / Packing material /Water in case of Regulatory submission.

4.2.8.1.1 The COA for any regulatory submission for Raw Material / Packaging Material shall be prepared by QA department by taking required test parameters, specification and result from the Analytical report prepared by QC department.

4.2.8.1.2 The COA shall be prepared in current date with respect to the specification.

4.2.8.1.3 The COA includes information as Point No. 4.2.2 

4.3 Direction for Preparation of Analytical Report for Domestic / Export Product

4.3.1 Procedure for Preparation of Analytical Report for Finished Product stage.

4.3.1. Analyst will submit the raw data of analysis to section head for checking of raw data & preparation of Analytical Report.

4.3.1.2 Analyst will prepare the Analytical Report based on the data available from raw data / record of analysis.

4.3.1.3 COA includes information as point No.4.2.2.

4.3.1.4 The Analyst will take the required test parameter, specification & result from the raw data & record of analysis.

4.3.1.5 Section head will send the Analytical Report along with the raw data/ record of analysis to analyst for verification. The analyst after verifying the Analytical Report against the raw data / record of analysis will put sign in the analyzed by column and forward the same back to section head.

4.3.1.6 Section head will check the data and put sign in Analytical Report in checked by column and forward the same to QC manager / Designee for approval.

4.3.1.7 QC Manager / Designee will check the data and put the sign in approved by column in Record of Analysis.

4.3.1.8 The details required for preparing COA may vary as per the party requirement or as per the technical analytical document (TAD).

4.3.1.9 The COA shall be prepared on [Company] letterhead with head office address for the export products and with [company] location address for the domestic products or as per the specific requirements and authorized by QA Head.

4.3.1.10 If any additional COA required by party or as per the need based the same can be provided which is authorized by Head QA by taking the computerized printout with preprinted Analyst, Checked By and Approver name.

4.3.2 Procedure for Preparation of Analytical report (COA) by QC Department for Raw Material / Packaging Material 

4.3.2.1 After completion of required test the analyst will submit the raw data / record of analysis to section head for verification.

4.3.2.2 Section Head will verify the details for the correctness.

4.3.2.3 Raw data & record of analysis submitted to QA for review.

4.3.2.4 After QA review the raw data and record of analysis are Approved /Rejected by Q A Head or Designee and send back to section head in QC.

4.3.2.5 Section head will send this raw data and record of analysis to the QC personnel analyst for COA preparation.

4.3.2.6 COA includes information as point No.4.2.2

4.3.2.7 Quality control personnel will take the required test parameters, specification and result from the raw data and record of analysis.

4.3.2.8 Quality control personnel will put sign in Prepared by date column. Analyst will then forward the COA along with raw data / record of analysis to QC manager / Designee for approval.

4.3.2.9 QC Manager / Designee will put sign in approved by date column.

5.0 ANNEXURE (S):