SOP for testing and release of Packing Material in pharmaceutical

1.0 Purpose:

To lay down a procedure for testing and release of Packing material.

2.0 Scope:

This procedure is applicable for testing and release of Packing material.

3.0 Responsibility:

QC Officer/Executive/Designee :

•To read the relevant specification for the Packing material.

•To request for respective protocol issuance to QA.

•To analyse the Packing material as per standard test procedure.

•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 and GRN.

QA Head/Designee:

•To approve, implement and ensure compliance of SOP.

4.0 Procedure :

4.1 After sampling of the Packing material keep them in designated place in Quality Control department.

4.2 QC Head/designee shall allocate the work to QC Officer/designee for analysis as per the production priority.

4.3 QC Officer/designee shall read the relevant specification/STP before starting the testing of any packing material and organize the work to finish in the allotted time period.

4.4 QC Officer/designee shall fill up the request form for respective protocol issuance to QA.

4.5 After receiving the protocol, QC Officer/designee shall start analysis of sample.

4.6 If non availability of testing facility, sample shall be analyse in an outside laboratory.

4.7 After completion of each test, QC officer/designee shall record directly on the respective Packing material protocol and make entry in relevant instrument usage log book.

4.8 QC Officer/designee shall attached all supporting data ( one number of printed packing material, excluding bottles, caps, rubber bungs and shippers, outside testing report, manufacturer COA etc.) with protocol.

4.9 If any results shall be out of specification, inform to QC Head/designee.

4.10 After complete analysis, QC Officer/designee shall prepare COA.

4.11 QC Officer/designee shall submit the completed report along with all raw data, sampling check list and GRN to the QC Executive/designee for review.

4.12 QC Executive/designee shall check the entire test thoroughly against the individual specification and hand over to QC Head/designee for final approval.

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

4.14 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.

4.15 QC Officer/designee shall Affix duly filled and signed APPROVED/REJECTED labels on all over Under test labels.
4.16 Retain the original copy of GRN along with the entire report and other two duplicate copies of GRN shall be given to store department.

4.17 Enter the status of packing material (release or reject) in packing material inward register.

4.18 QC officer/designee shall dispose the left over sample as per the SOP.