SOP for Preparation, Approval, Issue and Control of Work Sheets for Record of Analysis

OBJECTIVE

To lay down the procedure for preparation, approval, issue, and Control of worksheets for Record of Analysis /Analysis Report.

SCOPE

This procedure applies to the pharmaceutical Manufacturing facilities of PharmaInfo Limited.

RESPONSIBILITY

• Chemist-QC for preparation of worksheets and analysis report for Record of Analysis.
• Manager-QC or his designee for checking of worksheets for Record of Analysis and analysis reports.
• Manager-QA shall approve the worksheets and analysis report.
• Executive-QA Documentation for the custody, issue and control of worksheet for record of analysis.
• Manager -QA or his designee to ensure compliance.

PROCEDURE

• Worksheets for record of analysis shall be prepared as per the respective STP for all Raw materials, Packaging materials, In-process products, Finished products, Stability samples, and Water.
• Worksheets for analysis record shall be prepared by the QC-Chemist as per the STPs, checked by the Manager-QC or his designee, and approved by the Pharmacist In-Charge.

Preparation of worksheet for record of analysis and analysis reports

1. The first page of the worksheet for the record of analysis of all the material except water shall be prepared in the format as shown in Annexure-1. The continuation page for all materials including water shall be prepared in the format as per Annexure-2. For water, the first page of the worksheet shall be prepared in the format specified in Annexure-3.
2. Analysis Reports shall be prepared as per

2.1 Annexure-4 (For Raw materials & Packing Materials)

2.2 Annexure-5 (For In process & Finished Products)

2.3 Annexure-6 (For Water)

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• The record of analysis shall contain the provision for recording all the data that is required to establish that the analysis has been performed as per the relevant STP and the standard operating procedure as applicable. In general, the COA shall contain the provision to record the following details (not limited to).

1. Name of the test:
2. Provision to write the instrument details like the instrument model, identification numbers, and system condition/parameters as specified in the respective STP.
3. Record of chemicals/Standards/reagents being used and their manufacturing lot numbers, the grade used, use before details, and any drying details of reference standard as required.
4. For volumetric and test solutions the internal tracking/lot no. strength as applicable, any dilution done, use before date.
5. Record of any weighing/ dilution done
6. Record of time/duration/dates.
7. Any system suitability requirement as mentioned in the respective test procedure.
8. The procedure is in sequential order as mentioned in STP.
9. Any limits/values as specified in the specification are a test procedure.
10. Record of any observation.
11. Any formula to be used and calculation
12. Bracketing standard calculation
13. Pass / Fail status.
14. Signature of analyst with date and signature of the person and checking with date.

• If any STP or specifications need to be revised, the respective worksheet and/or analysis report shall be revised simultaneously by the QA documentation Executive. The superseded worksheet shall be stamped as "SUPERSEDED COPY" and filed for reference.

1. Any minor corrections like typographical errors etc., required for immediate use shall be made by the user manually in the user copy along with sign and date. The same shall be authorized by the Manager-QC or his designee.
2. Corrections are to be made as per SOP “Correction of Documentation errors and Ratification of Master Documents”. In case there is a significant impact of the change in the document, the Manager QA shall specify the need for reanalysis/corrective actions as appropriate.
3. The corrections made manually shall be incorporated in a subsequent revision.

Issue of worksheets for record of analysis shall be followed as described below for water samples.

• As per the requirement of the worksheets, Chemist - QC shall fill the request "Request for Issue of Record of Analysis” (Annexure-7) countersigned by the Manager-QC or his designee and forward the request to the Quality Assurance department.
• Executive-QA Documentation shall enter the details of the worksheet to be issued in the register for "Issue and Control of worksheets for Record of analysis" (Annexure-8).
• Executive-QA Documentation shall issue the worksheets to Chemist-QC. Chemist-QC shall receive the same after signing in the register for "Issue and Control of Worksheets for record of analysis".

The issue of worksheets for Raw materials and Packaging materials

• Upon receipt of intimation from Warehouse, Chemist-QC shall inform the material name, B. No. to Executive-Q.A Documentation.
• Executive-QA Documentation shall enter the details of the worksheet to be issued in the register for "Issue and Control of worksheets for Record of analysis" (Annexure-8).
• Executive-QA Documentation shall issue the worksheets to Chemist-QC. Chemist-QC shall receive the same after signing in the register for "Issue and Control of Worksheets for record of analysis".

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Issue of worksheets for record of analysis for stability samples

• Before sampling, Chemist-QC shall inform the Product name, Batch No. details to Executive-Quality Assurance.
• Executive-QA Documentation shall enter the issue details in the register for “Issue and control of worksheets for record of analysis (Annexure-8).
• Executive-QA Documentation shall issue the worksheets to Chemist-QC. Chemist-QC shall receive the same after signing in the register for "Issue and Control of Worksheets for record of analysis".

Issue of worksheets for Record of Analysis for production batches

• Executive-Production shall fill in the details in the 'Request for Issue of Record of Analysis' (Annexure-7) and forward the request to Quality Assurance.
• Executive-QA shall enter the issue details in the register “Issue and control of worksheet for record of analysis"
• Executive-QA shall enter the 'No. of pages issued' column in the Register and issue the requested worksheet(s) to Chemist-QC. Chemist QC shall receive the same after signing in the register for "Issue and Control of Worksheets for record of Analysis"(Annexure-8).
• In case partial worksheets are required, Chemist-QC shall fill the "Request for issue of a partial record of analysis" (Annexure-9) and get authorization from Manager-QC or his designee and Manager-QA or his designee. Manager - QA or his designee will arrange the issue of the worksheet through Executive-QA Documentation.
• In case of retest, QA shall issue the required worksheet and the reason shall be included under the remarks column in the register. Note: A deviations/Incident summary sheet shall be issued along with the issue of all worksheets.
• On receipt of the request, Executive-QA Documentation shall arrange the request page(s) of the worksheet/analysis report, enter in the column for ''Additional Issue details' in the register for Issue and Control of Worksheets for record of analysis" and get the signature of Chemist-QC in the column for ''Received by/Date' while issuing.
• The requested page(s) shall be issued, by stamping User copy by: ___________ Date: ________ on the first page of the worksheet and signed by Executive-QA Documentation, and all the pages shall be written as "PARTIAL ISSUE".
• Completed analytical documents shall be handed over to Executive-QA through "Document Handover Tag" (Annexure-11) by counting the total no. of pages (including the record of analysis, hard copies, and others) duly writing A.R. No., Total no. of pages, submitted by the date and taking the signature of QA Executive as a receipt in the register "Document handover Details" (Annexure-10).
• On receipt of completed documents along with 'The Documents Handover Tag and document handover details register, Executive-QA shall sign in the received by column on the Tag in the register which shall be maintained by QC.
• Executive-QA shall review the documents and if all the documents are found satisfactory, he/she shall sign in the "Reviewed by/Date" column on the tag and hand over the documents to Executive-QA Documentation.
• On receipt of reviewed documents, Executive-QA Documentation shall enter the 'Returned Details' in the register "Issue and Control of worksheets for record of analysis".
• Executive – QA Documentation shall reconcile the number of pages of the worksheet received against the number of pages issued. In case any discrepancy is observed, he shall inform Manager-QA. The completed worksheets shall be stored in Quality Assurance.
• Photocopying of the issued worksheets for record of analysis/analysis reports is strictly prohibited.

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ABBREVIATION

Q.C: Quality Control

Q.A: Quality assurance

ANNEXURE

Annexure No.-1 - Formats for “Record of Analysis”

Annexure No.- 2 - Format for “Record of Analysis”

Annexure No.-3 - Format for “Record of Analysis”-water

Annexure No.-4 - Formats of “Analysis Reports” of Material

Annexure No.-5 - Formats of “Analysis Reports” of Product

Annexure No.-6 - Formats of “Analysis Reports” of water

Annexure No.-7 - Formats of “Request for issue of Record of analysis”

Annexure No.-8 - Formats of “Issue and Control of Worksheets”

Annexure No.-9 - Formats of “Request for issue of Partial Record of Analysis”

Annexure No.-10 - Format of “Documents Handover Details”

Annexure No.-11 - Format of “Documents Handover Tag”

REVISION HISTORY

Nil

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