SOP on retesting of raw material
Objective: To lay down the procedure for re-testing of raw material for material lying in warehouse for longer period.
Scope: This SOP is applicable for retesting of raw material for material lying in warehouse for longer period.
Responsibility: Chemist or above of QC Department & Officer or above of warehouse Department.
Accountability: Head – Quality Control.
Procedure:
Material shall be transferred to Quarantine area by warehouse personnel as soon as re-test period is due as per SOP.
Approved label shall be defaced and new Quarantine label shall be affixed alongside the defaced approved label on each container of the material by warehouse personnel.
Warehouse shall send the GRN for re-sampling of Raw Material due for re-testing to Quality control department.
After receiving re-test request from warehouse, QC personnel shall enter the material details in Re-test raw material control register.
R. No. shall be allotted by adding suffix ‘/ Rn’ where ‘/’ is for separation, R is for retesting and n is the no. of times of re-testing. For example, if request for re-testing of raw material receives first time and the initial A. R. No. is RM/25/0051 then A. R. No. of re-test material shall be RM/25/0051/R1 and Raw Material sampling shall be done as per SOP.
Re-testing period of active raw material and that of inactive material having microbiological analysis shall be six months. Inactive raw material not having microbiological analysis shall have retest period of one year.
Retesting can also be carried as per any directive from Quality assurance department.
Incase of active raw material, if expiry date / re-test date assigned by vendor is coming before the in-house retest date , then re-test date shall not be applicable and material shall be considered expired.
Incase of Inactive materials, if expiry date assigned by vendor is coming before the in- house retest date, then retest date shall not be applicable and material shall be considered expired.
Incase of Inactive materials, if retest or re-evaluation date assigned by vendor is coming before the in-house retest date, then retest date shall be inline with that of vendor. However, if the material is not used before its retest period then the material shall be analysed before use. The validity of repeat testing shall be for one month i.e. material should be used within 30 days. Incase period of 30 days is over after the repeat analysis, the material shall be analysed again before use.
Analysis and approval of re-test raw material shall be done as per SOP.
Expired or rejected raw material shall be destroyed by ware-house as per SOP.
Retesting parameters of raw material has been mentioned in respective raw material specification.