1.

PURPOSE: To lay down an approved procedure for initiating retesting of raw materials.

2.0

SCOPE: Applicable to all the Raw materials.

3.0.

RESPONSIBILITY: R&D Personnel, Stores Officer and QC Personnel.

6.0

ACCOUNTABILITY: Head - R&D;QC incharge; Stores head

5.0

DEFINITIONS: Nil

6.0

PROCEDURE

6.1 At the time of approval of all raw materials, a retest date is assigned by QC, which is recorded in the Stores Ledgers. 6.2 All RMs are to be provided a retest date of six months and for solvents the retest date shall be 1 year and for APIs / Intermediates are retested basing on the holding study or the stability study being conducted, if there is no established study for APIs or intermediates 6months will be the resting period. The retest date shall not exceed the expiry period mentioned by the vendor, in that case the expiry period will be the final retest date in which the material cannot be utilised. The restesing shall be done not more than 5 times unless justified (Basing on R&D supporting data). 6.3 6.4 At the end of every month, Stores Officer prepares a monthly stock statement.

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