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Standard Operating Procedure (SOP) for Reduce Testing in pharmaceutical starting materials (Raw Material) procured from approved vender.

Reduce Testing Procedure

1.0   Objective

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

2.0   Scope

• • This SOP is applicable for Reduce Testing of raw materials procured from approved vender.

3.0   Procedure for Reduce Testing:

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

• • Non availability of testing facility.

• • Sufficient data is available for specific test.

• • Given below points shall be considered for reduced testing:

• • Procurement of materials from approved manufacturer / vendor, if materials receive from approved vendor or a supplier the original container, original label and original seal shall be verified, it should be from manufacturer 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 the Annexure-I (Proposal for reduce testing) and shall handover to Head QC for review.

• • After reviewed the Annexure-I Head Quality Control shall submit to Head QA for review.

• • After approval of Head QA and Authorization by Head 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.

• • Excipients:

  • 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 manufacturer COA.

• • Head QC or designee shall collect the list of last ten approved batches (In case of API) and five approved batches (in case of Excipients) in the form of spread sheet and attach the list to the proposal along with copies of Manufacturer COA, In-house 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 calendar year).

• • The data of 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 the 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.

• • 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 testing completely as per the specification. Subsequently reinitiate the reduce testing.

• • Before start the analysis, the analyst shall verify the test parameter performed under reduce testing as per Annexure-III. (Product list of reduced testing).

• • The product list of reduced testing parameters shall be updated on quarterly basis or as and when required. In case of any new materials added, the same shall be updated manually in to the list.

• • Material receive from other location of same group of company then, only limited parameters i.e. description, identification and assay shall be performed and remaining test shall transcript from the manufacturer COA.

4.0   Annexure – Reduce Testing

Annexure I      : Proposal for reduced testing

Annexure II     : Trend of Results

Annexure III    : Product list of reduced testing