SOP for retesting of raw materials in pharmaceutical

1.0 Purpose:

To lay down a procedure for retesting of raw material.

2.0 Scope:

This procedure is applicable for Retesting of Raw material in Quality Control department.

SOP for retesting of raw materials in pharmaceuticals

3.0 Responsibility:

QC Officer/Executive/Designee :

•To enter details in retesting inward register.

• To plan sampling and testing of retest material.

• To request for respective protocol issuance to QA.

• To maintain record of instruments usage log book.

• To issuance the approved/rejected labels.

• To prepare COA.

• To check all the test results against the individual specification.

QC Head/ Designee :

• To review, implement and ensure compliance of SOP.

• To approve the COA.

Warehouse Head/Designee :

• To prepare list of retest materials as per schedule.

• To inform QC department.

QA Head/ Designee :

• To approve, implement and to ensure compliance of SOP.

4.0 Procedure:

4.1 The retest date shall be allotted as follow:

MATERIAL PERIOD

Active Material - 1 Year

Inactive Solid Material - 2 Year

Inactive Liquid Material - 1 Year

Colors/Flavors - 1 Year

Empty Hard gelatin Capsule - 1 Year

4.2 Note: If the microbial limit test is applicable for any raw materials, the retest period shall be 1 year.

4.3 Note: If the retest date is exceed from the expiry date of the material then expiry date to be considered as retest date.

4.4 QC Officer/designee shall followed above retest period and mention the retesting date on the “Approved” label.

4.5 Warehouse Head/designee shall prepare the list of raw materials for retesting at starting of every month shall raise a "Test request form" and send it to QC department.

4.6 QC Officer/designee shall enter details of test request form in Inward register for retest of Raw material and allocate the A.R. No. as per the SOP.

4.7 QC Head/designee shall allocate the work to QC Officer/Executive/designee for reanalysis as per the production priority.

4.8 The QC officer/designee shall sample the raw material as per the Raw material sampling SOP.

4.9 QC Officer/designee shall test the Raw material as per SOP and perform only those tests as mentioned in individual specification using respective standard test procedure.

4.10 After completion of analysis, QC Officer/designee shall prepare the COA as per the SOP and attach with protocol. Officer will also attach all the raw data, COA of previous approved material, manufacturer COA and copy of test request form and hand over to QC Executive/designee for review.

4.11 QC Executive/designee shall check all the record thoroughly against the individual specification and hand over to QC Head/designee for final approval.

4.12 QC Head/designee shall randomly check the data and approve the COA.

4.13 After final approval, QC Executive /designee shall issue the “APPROVED/REJECTED” labels as per the number of packs in the consignment and take in the entry in label issuance record.

4.14 QC Officer shall deface the previously approved label by cross(X) mark ,affix duly filled and signed “APPROVED/REJECTED” labels on below of previously approved label of all packs/containers with revised retest period.

4.15 Enter the status of Raw material (release or reject) in Inward register for retest of Raw material

4.16 QC Officer/designee shall dispose the left over sample as per the SOP.