SOP for Reduced Testing : Pharmaceutical Guidelines

SOP for Reduced Testing

Standard operating procedure to reduce the testing of raw materials to increase the speed of testing and productivity of quality control department.

1.0 PURPOSE

To define the procedure for releasing the materials after reduce testing.

2.0 SCOPE

This procedure is applicable to raw material testing carried out in quality cControl.

3.0  RESPONSIBILITIES

3.1 Analyst
3.1.1 To check the integrity of the consignment at the time of sampling.
3.1.2 To ensure approved COA of manufacturer should available.
3.1.3 To carry out reduce testing as per SOP.

4.0 ACCOUNTABILITY

4.1 Head QC or Designee
4.1.1 To ensure the documentation as per SOP.
4.1.2 To ensure that analysis carried out as per SOP while apply the reduce testing.

5.0 PROCEDURE

7.1 Same Batch

7.1.1 If the material of the same batch no. received within two months from the same manufacturer, analyst shall check the integrity of the container, approved COA of the manufacturer, and other details as per the GIM against the “QUARANTINE” label.
7.1.2 If all above parameter found satisfactory, analyst shall sample the material as per the general sampling procedure for raw material.
7.1.3 Material shall be analysed for critical tests which are specified as “(**)” in respective specification.
7.1.4 If material comply with critical tests, the material shall be released on the basis of previous analysis.

7.2 OVI and Residual Solvent

7.2.1 If manufacturer’s COA comply with the specification for OVI/ residual solvents tests than material can be released on the basis of manufacturer’s COA.

7.3 Reduce Testing based on Trending

7.3.1 Reduce testing shall be allowed after the satisfactory analysis / trending in the following cases.
7.3.1.1 Raw materials which have completely analyzed and approved for consecutive five times of the same vendor.
7.3.1.2 In case of vendor is approved from regulated agency than raw materials, which have completely analyzed and approved for consecutive three times of same vendor.
7.3.2 After generation of above data raw material shall be analysed for critical tests which are specified as “(**)” in respective specification.
7.3.3 If material complies with critical tests, the material shall be released.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 COA: Certificate of Analysis
6.3 OVI: Organic Volatile Impurities
6.4 QC: Quality Control





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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