SOP on In-Process and Finished Goods Testing

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1.0 Objective

To lay down a procedure for In-Process and Finished Goods Testing.

2.0 Scope

This standard operating procedure is applicable at pharmaceutical formulation plant..

3.0 Responsibility

3.1 IPQA Officer shall be responsible for sampling of the in-process and finished products.

3.2 QC Officer/Executives shall be responsible for testing in-process and finished products.

3.3 Analyst-QC shall be responsible for preparing the trend analysis report for the products.

3.4 Head-QA/QC or designee shall be responsible for review of trends of the products, implementation and compliance of this SOP.

4.0 Abbreviations and Definitions

IPQA                       :  In-Process Quality Assurance

GTPs                       :  General testing procedure

Spec/STPs               :  Specifications/Standard testing procedures

COA                       :  Certificate of Analysis

SOP                         :   Standard operating procedure

5.0 Procedure

5.1 The sampling shall be done as per SOP titledSampling of In-process Materials and Finished Products’.

5.2 Testing shall be done as per approved Specifications/ STPs/ GTPs.

5.3 Testing of In-process materials shall be undertaken with following concept.

5.3.1 In-process materials shall be tested as per the specifications/STPs as applicable stage wise i.e. S1 stage (granules/ bulk solution/medicament), S2 stage (uncoated tablets/ ready-to pack stage in case of uncoated tablets/ capsules /or any other formulation), S3 stage (coated tablets/ ready-to-pack stage of coated tablets /or any other formulation)

5.3.2 For Solid dosage forms first ten (10) batches shall be tested for complete testing as indicated in respective spec. /STPs/GTPs at different stages (all in-process stages and minimum five batches in case of finished product stage), as applicable marketwise and trend analysis data shall be prepared for in-process stages by QC personnel.

5.3.3 For Liquid/Semi solid dosage forms first twenty (20) batches shall be tested for complete testing as indicated in their respective spec./STPs at different stages (all in-process stages and minimum ten batches for finished product stage) and trend analysis data shall be prepared for in-process stages by QC personnel

Note: For Liquids/Semi solids all batches shall be subjected to microbiological testing as per approved GTPs. Batches shall be released as per approved specifications.

5.3.4 QC personnel shall send the request (Annexure-1) to QA detailing of summary of trend analysis of the product along with the trend analysis data.

5.3.5 QA shall make comparative evaluations on different stages. Subsequent testing shall be planned in following manner afterwards.

5.3.5.1 QA personnel shall evaluate the trend. If not satisfied with the trend on critical test parameter(s), the investigation on out-of-trend data shall be undertaken involving representatives from different departments like QC, Production and Stores, by QA. In such condition, subsequent testing on the critical test parameter(s) shall be continued at finished good testing stage unless the outcome is satisfactory.

5.3.5.2 If the trend is satisfactory,

5.3.5.2.1 The product in subsequent batches shall not be tested at S1, S2 and / or Ready to pack stage.

5.3.5.2.2 The test report / COA of finished product for release shall be prepared taking the analytical findings on similar tests from the test reports/ work sheets of ready-to-pack stage testing.

5.3.5.2.3 QA personnel shall prepare/modify the list as per the submissions of trends for different products by QC personnel’s and intimate IPQA personnel’s for the revised sampling plan on “Annexure-2”.

5.3.5.3 Thereafter, every tenth (10th) batch shall be subjected to complete testing at all stages for physico-chemical as well as for microbiological testing. For example, if in financial year April 2006 to March 2007, 114 batches of Nimulid tablets have been manufactured, then following batches shall be taken for complete testing: 0386501 to 10, 20, 30…………, 90, 0386600.

5.3.5.3.1 First Batch/Lot of the product in every financial year shall be subjected to complete testing afterwards the same procedure of point no. 5.3.5.3 shall be followed for testing.

5.3.5.4 In case of process deviation or any other deviation and/ or in view of any out-of-specification investigation undertaken during the manufacture of the product, the testing at finished stage shall be in the discretion of quality assurance department using good scientific logics, for those batches which have been planned not to be tested at finished stage.

Note: At any stage Head-QA/Designee shall send any particular batch for complete testing.

5.4 In case, where packaging is being done for different pack styles e.g. sales pack or physician pack and/or for different markets, the testing shall be done once i.e. only on one pack size unless the relevant spec/STP applicable for that pack type has different test parameter. The philosophy of testing (as mentioned at point no. 5.3) shall be batch-wise not pack-type-wise, at finished testing stage.

5.5 In case of liquid products, Deliverable volume determination shall be done by IPQA, and a copy of results shall be forwarded to QC department for incorporating the same results in the final release COA of that particular product.

6.0 Forms and Records

6.1 Trend Analysis Report                        :           Annexure-1

6.2 Trend analysis data summary record  :           Annexure-2

7.0 Distribution

7.1   Master Copy                                     : Documentation Cell (Quality Assurance)

7.2   Controlled Copies                             : Production, Quality Assurance and Quality Control

8.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

Annexure-I

Trend Analysis Report

                                                                                                                                              Dated:-

To:       Quality Assurance Department                                               From:   Quality Control Department

Subject: – Trend Analysis Data Submission

Product Name:

Generic Name:

S.No. Batch Number Batch Size Mfg. date Exp. date
         
         

 

Summary:-

Prepared by: –                                                  Checked by: –                                      Approved by:-

(QC Analyst)                                                    (Manager-QC)                                         (Head-QC)

Disposition by QA:-

 

Sign/Date

(Head-QA)

  Annexure-II

            Trend Analysis Data Summary Record

Product Name Product Code Batch Number Stage
From To S1 S2 S3 S4 Finished Product
                 
                 

Write ‘N.A.’ wherever not applicable, ‘OK’ ‘Not OK’ wherever applicable

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