| Re-sampling and Retesting of Packing Material |
1.0 OBJECTIVE 1.1 To lay down the procedure for Re-sampling and retesting of packing material. 2.0 SCOPE 2.1 This SOP is applicable for Re-sampling and retesting of packing material in quality control department. 3.0 RESPONSIBILITY 3.1 QC-officer/QC–Executive/Section Head 3.2 Head QA shall be responsible for: Approval/rejection of packing material. 4.0 ACCOUNTABILITY 4.1 Head-QC 4.2 Head-QA 5.0 PROCEDURE 5.1 Retesting 5.1.1 Retest period for packing material shall be classified as follows: 12 months: Carton, catch cover, PVC/ PVDC film, labels, inserts, corrugated box, corrugated partition Center plate / carton, Tape, Alu. foil (Plain/Printed) G.P. /Alu. Blister foil. 5.1.2 Retest date for a material shall be given at the time of its release and it shall be mentioned on the approved label. 5.1.3 Samples for retesting shall be tested for specified critical parameters specified on the packing material specification of the sample. 5.1.4 Microbiological analysis may be done for the primary packaging material or whenever required. 5.2 Re-sampling 5.2.1 Re sampling of a material will be done as and when the retest period is due. 5.2.2 An intimation (Retest note) for re-sampling shall be sent to Quality control department by warehouse as per Format No.XXX. 5.2.3 Material shall be transferred to Quarantine area as soon as retesting period in due and affixed with ‘Quarantine’ label. 5.2.4 QC Officer shall make the entry of re-test material in Re-testing register (Format No. XXX). 5.2.5 QC officer shall samples the material as per SOP No. XXX. 5.2.6 After approval/rejection of retest sample, approved/rejected Label shall be affixed to the containers and material shall be transferred to approved/rejected quarantine area. 5.2.7 In case of material fails to meet the acceptance criteria, investigation of analytical result shall be carried out according to Out of specification SOP No. XXX. |