To lay down the procedure for storage of retention samples (control samples).
1.0 PURPOSE:
1.1 To lay down the procedure for storage of retention samples (control samples).
2.0 SCOPE:
2.1 This SOP is applicable for Quality control department.
3.0 RESPONSIBILITY:
3.1 Assistant - QC
4.0 ACCOUNTABILITY:
4.1 Executive - QC
5.0 PROCEDURE:
5.1 Retention samples shall be kept for all Active Pharmaceutical Ingredients, Intermediates and Non corrosive Critical Raw materials.
5.2 The retention samples quantity should be equivalent to two full analyses as per specification.
5.3 Active pharmaceutical ingredients retention samples shall be packed in similar packing system in which the API is packed or in one that is equivalent or more protective than the marketed packing system and labeled as per Annexure – I.
5.4 The retention samples for Intermediates, critical Raw materials (except solvents, gases, water, corrosive material) shall be packed in double LDPE bag and labeled as per Annexure – I.
5.5 Active pharmaceutical ingredient retention samples shall be retained for one year after the assigned expiry date of the batch or for three years after the complete distribution of the batch, whichever is longer.
5.6 The intermediate and critical raw material retention samples shall be retained for one year from the date of release. This period shall be shortened if their stability, as mentioned in the relevant specification, is shorter.
5.7 Retention sample shall be kept in the retention sample storage area. The sample details shall be entered in the retention sample inward register.
5.8 QC assistant shall record daily the Temperature and Humidity of the retention sample storage room.
5.9 Expired retention sample as per 5.5 and 5.6 shall be destroyed as per SOP –xxxxx.
5.10 Retention samples can be issued for any investigation purpose, provided, such issues are authorized by Manager – QC or his designee.
5.11 The date of issue, purpose and the Quantity used and the returned date shall be recorded in a register.
END OF DOCUMENT
Retention samples, quality control, pharmaceutical ingredients
