SOP for Preparation of Certificate of Analysis

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Standard Operating Procedure for Preparation of Certificate of Analysis (CoA)

Standard Operating Procedure for Preparation of Certificate of Analysis (CoA)

1.0 Purpose:

To lay down a procedure for Preparation of Certificate of Analysis (CoA) and configure the COA in LIMS.

2.0 Scope:

The scope of this document is to provide a procedure for Preparation of Certificate of Analysis (CoA) of Raw Material (RM), Packaging Material (PM), Semi-Finished Product, Finished Product (FP), Pre-purchased Raw Material samples, Innovator samples, Water samples, Stability Study sample, Nitrogen Gas and Exhibit batches.

This SOP is also applicable for generation of multiple COA for same Batch No. or A.R. No. with different Product/Material name, Test name, Specification description, packing style or Date format as per requirement of different costumers with completely protecting integrity of the test results.

3.0 Responsibility:

QC Personnel: To prepare manual CoA.

Section Head QC/Designee: To check the data against prepared COA.

Head QC/Designee:

– To Approve the COA of Raw Material, Packaging Material and Pre-purchased Raw Material samples.

Head QA/Designee:

– To Approve the COA of Semi-Finished Product, Finished Product, Innovator samples Water samples, Stability Study sample, Nitrogen Gas and Exhibit batches.

4.0 Definitions:

NA

5.0 Procedure:

5.1 CoA shall be prepared manually in case of followings;

  • Manual CoA required for Product submission, Product registration.
  • CoA of Innovator (RLD) sample, Water samples.
  • Specific requirement from Customer/ Country/ Regulatory Agency.
  • Revision in specification.

5.2 In case, Raw Material CoA is required for registration or submission to Regulatory (US, EU and Canada) and / Semi-Regulatory (ROW / Emerging) Market, shall be in line with Raw Material Specification.

5.3 In case, Packaging Material CoA is required for registration or submission to Regulatory (US, EU and Canada) and / Semi-Regulatory (ROW / Emerging) Market, shall be in line with Packaging Material Specification.

5.4 In case, Semi-Finished Product CoA is required for registration or submission to Regulatory (US, EU and Canada) and / Semi-Regulatory (ROW / Emerging) Market, shall be in line with Semi-Finished Product Specification.

5.5 In case, Finished Product CoA is required for registration or submission to Regulatory (US, EU and Canada) Market, shall be in line with Finished Product Specification.

5.6 In case, Finished Product CoA is required for registration or submission to Semi-Regulatory (ROW / Emerging) Market, shall be in line with Shelf-life Specification or as per the requirement.

5.7 In case, Pre-purchased Raw Material sample CoA is required, shall be in line with respective Raw Material Specification (As per RM specification / Pharmacopoeial Specification).

5.8 Innovator/ Reference Listed Drug (RLD) sample CoA shall be prepared in line with Finished Product Specification.

5.9 Water (Purified Water and Water for Injection) Sample CoA shall be prepared in line with respective Specification.

5.10 In the absence of Manager QC, authorized deputy shall approve respective CoA.

5.11 In the absence of Manager QA, authorized deputy shall approve respective CoA.

5.12 After completion of Instrument Calibration, Certificate of Calibration, Working Standard COA shall be prepared as mentioned in respective SOPs.

5.13 Manual COA shall be prepared as per customer’s requirement based on company’s address registered in the agreement.

5.14 Collect the required Raw Data and / LIMS CoA from the Section Head.

5.15 CoA shall be prepared manually as per format given “Certificate of Analysis” as per respective format.

5.16 CoA prepared manually shall be printed on the Pre-printed Sheet. Pre-printed sheet will have “CERTIFICATE OF ANALYSIS” on the Header portion. Address of Registered Office, Address of Manufacturing Site along with Telephone Number and Fax No. will be on the Footer portion.

5.17 The Header details of the Raw Material (RM), Packaging Material (PM), Semi-Finished Product, Finished Product (FP), Pre-purchased Raw Material samples, Innovator samples, Water samples, Stability Study sample, Nitrogen Gas and Exhibit batches shall be provided as below,

5.18 Raw Material:

  • Material Name 
  • Material Code
  • Manufacturer
  • Batch No.
  • Inspection Lot No.
  • Date of Sampling
  • Control No.
  • Quantity Received.

5.19 Packaging Material :

  • Material Name 
  • Material Code
  • Manufacturer
  • Batch No.
  • Inspection Lot No.
  • Date of Sampling
  • Control No.
  • Quantity Received.

5.20 Semi-Finished Product :

  • Product Name 
  • Batch No.
  • Batch Size
  • Manufacturing Date
  • Expiry Date
  • Stage
  • Analytical Report No.

5.21 Finished Product / Exhibit Batches :

  • Product Name 
  • Batch No.
  • Batch Size
  • Manufacturing Date
  • Expiry Date
  • Pack Style
  • Analytical Report No.
  • Quantity Packed.

5.22 Innovator Sample :

  • Product Name
  • Batch No. / Lot No.
  • Expiry Date
  • Pack Style
  • Analytical Report No.

5.23 Water Sample :

  • Item Name
  • Sampling Point
  • Analytical Report No.
  • Sampling Date
  • Analysis Date
  • Result Date.

5.24 Stability Study Sample :

  • Name of the Product
  • Generic Name
  • Product Code
  • Specification ID
  • Protocol ID
  • Mfg. Date
  • Exp. Date
  • Packing Type
  • Schedule Period
  • Storage Condition
  • A.R. No.
  • Specification Rev. No.
  • Batch No.
  • Batch Size
  • Stability Starting Date
  • Pack Style
  • Schedule Date.

5.25 Nitrogen Gas :

  • Name of the Material
  • Material Code
  • Manufacturer
  • Date of Receipt
  • Quantity received.

5.26 Pre-purchased Raw Material :

  • Material Name 
  • Material Code
  • Manufacturer
  • Batch No.   
  • Manufacturing Date
  • Retest / Expiry Date
  • A.R. No.

5.27 Below the Material / Product / Sample details, a table with four columns, shall be provided. i.e. Sr. No., Test, Result and Limit.

5.28 Below the Innovator details, a table with three columns, shall be provided. i.e. Sr. No., Test and Result.

5.29 Test column shall have sequential Tests, which are given in the respective Specification.

5.30 Result column shall have sequential Results of respective Tests.

5.31 Limit column shall have sequential Limits (against the test), which are given in the respective Specification.

5.32 Below the Table, the “Remarks” shall be provided indicating Material / Product / Sample Complies / Does Not Comply with the above mentioned Specification.

5.33 After recording all results QC Person shall print the CoA.

5.34 He / She shall check the CoA for accuracy of entries and make his / her signature with date.

5.35 Manager QA / Designee shall approve the CoA for Semi-Finished Product, Finished Product, Innovator samples Water samples, Stability Study sample, Nitrogen Gas and Exhibit batches.

5.36 Manager QC / Designee shall approve the CoA for Raw Material, Packaging Material and Pre-purchased Raw Material samples.

5.37 QA Person shall attach the COA with respective Batch Record.

6.0 Acceptance Criteria:

Not Applicable

7.0 Frequency:

As and when Required

8.0 Format for recording:

8.1 Blank CoA Format.

Details mentioned in SOP              
Sr. No.TestResultLimit
            

Remarks:

Prepared By (Quality Control):                                       

Checked By (Quality Control):                                  

Approved By (Quality Control/ Quality Assurance):

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