SOP for Reduce Testing for Raw Material

Objective

To lay down a procedure for reducing the testing of raw materials.

Scope

This SOP is applicable for Reduce the Testing of raw materials procured from an approved vendor.

Responsibility

It is the responsibility of QC Executive.

Accountability

Manager – Quality Control

Manager - Quality Assurance

Procedure

Reduced Testing shall be done in raw materials in the following cases:

• Non-availability of the testing facility.
• Sufficient data is available for the specific tests.

Given below points shall be considered for reduced testing:

• Procurement of materials from approved manufacturer/vendor, if materials receive from an approved vendor or a supplier the original container, original label and original seal shall be verified, it should be from the manufacturer's end.
• Sufficient trend data for the specified tests is available.
• Scientific justification shall be implemented for test which is not critical to assess the product quality considered for Reduce Testing.
• QC chemist shall raise and summarize the details on Annexure-I and shall hand over to Manager QC for review.
• After reviewing Annexure-I Manager Quality Control shall submit to Manager QA for review.
• After approval of Manager QA and Authorization by Manager QA the reduced testing shall be implemented.

Active Pharmaceutical Ingredient:

• Minimum ten consecutive batches from a qualified vendor shall be tested completely as per the specifications and for existing materials prepare the trend data for last ten batches for results.
• During reduced testing, the following tests shall be performed but not limited to and other values shall be adopted from manufacturer / Vendor COA.

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1. Description
2. At least one identification
3. LOD / Water content
4. Assay
5. Microbial testing (Wherever applicable)

Excipients:

• A minimum of five consecutive batches from a qualified vendor shall be tested completely as per the specifications and for existing materials prepare the trend data for last five batches for results.
• During reduced testing, the critical tests shall be identified as per requirement and other values will be adopted from the manufacturer COA.

1. Description
2. At least one identification
3. LOD / Water content
4. Assay
5. Microbial testing (Wherever applicable)

• Manager QC or designee shall collect the list of the last ten approved batches (In case of API) and five approved batches (in case of Excipients) in the form of spreadsheet and attach the list to the proposal along with copies of Manufacturer COA, Inhouse COA of last ten consecutive batches (in case of API) and five consecutive batches (in case of Excipients) and a “Trend of Results” – Annexure-II.
• QC shall follow the reduced testing procedure for consignments received after approval of the proposal for reduced testing.
• Complete testing shall be done on one batch (for both API and Excipients) in a year (Starting from the calendar year).
• The data of the reduced test shall be transcripted in COA from vendor COA.
• If API / Excipients manufacturer changes the process then again the first three batches supplied by the API / Excipients manufacturer by the following new process shall be tested completely as per the specification. Subsequently, the reduced testing shall be performed as described above.
• If any OOS /incident are encountered then complete testing of 5 consecutive batches shall be performed and the Quality Assurance performs the risk assessment.

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• Upon addition of new tests in the specification and/or major revision of standard test procedure then again the first three batches of API / Excipients shall be tested completely as per the specification. Subsequently, reinitiate the reduced testing.
• Before start the analysis, the analyst shall verify the test parameter performed under reduced testing as per Annexure-III. (Product list of reduced testing).
• The product list of reduced testing parameters shall be updated every quarter or as and when required. In case of any new materials are added, the same shall be updated manually into the list.
• Material received from other locations of the same group of the company then, only limited parameters i.e. description, identification, and assay shall be performed and the remaining test shall be transcript from the manufacturer COA.

Annexure

Abbreviation

QC: Quality Control

SOP: Standard Operating Procedure

Revision History

Nil

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