SOP on retesting of raw material
Objective: To lay down the procedure for retesting 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.
Accountability: Head – Quality Control.
Procedure: Material shall be transferred to Quarantine area by warehouse personnel as soon as retesting period is due.
Approved label shall be defaced and new Quarantine label shall be affixed alongside defaced approved label on each container of the material by warehouse personnel.
Intimation for re-sampling shall be sent to Quality control department by warehouse for the material to be retested.
QC personnel shall enter the material details in Retest raw material control register and sampling shall be done as per SOP.
A.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 retesting. For example, if intimation for retesting of raw material is received first time and its previous A. R. No. is RM/25/0051 then A. R. No. of material to be retested shall be RM/25/0051/R1.
Retesting period of active and inactive raw materials 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.
If Expiry date of material is coming before the in-house retest date then retest date shall not be applicable and material shall be considered expired as per expiry date given by vendor.
Raw material shall be retested five times, after that material shall be sent to FR & D for further investigation and decision shall be taken, based on the investigation done by FR & D.
Analysis and approval of retest 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.
Annexure – Retest raw material Control