SOP for testing and release of Raw materials in pharmaceutical

Standard operating procedure for testing and release of Raw materials in pharmaceutical.

1.0 Purpose:
To lay down a procedure for testing and release of Raw material.

2.0 Scope:
This SOP is applicable for testing and release of Raw material in Quality Control Department.
Sop for testing and release of raw materials in pharmaceutical

3.0 Responsibility:

QC Officer/Executive/Designee:
•To read the relevant specification for the Raw material.
•To request for respective protocol issuance to QA.
•To analyse the Raw material as per standard test procedure.
To maintain record of instruments usage log book.
•To issuance the approved/rejected labels.
•To prepare the 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 Raw material, keep it in designated place in Quality Control department.

4.2 QC Head/designee shall allocate the work to QC Officer/Executive/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 Raw 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 / non availability of reference standards, impurity standards   for testing, sample shall be tested in an outside laboratory.

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

4.8 QC Officer/designee shall follow the good document practices.

4.9 QC Officer/designee shall attached all supporting data (IR graph, UV print, HPLC chromatograms, outside testing report, manufacturer COA etc.) with protocol.

4.10 If any result shall be out of specification, inform to QC Head/designee and follow the procedure.

4.11 After complete analysis, QC officer/designee shall prepare COA for Raw material.

4.12 QC Officer/designee shall submit the COA with filled protocol, raw data, sampling check list and GRN to the QC executive/designee for review.

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

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

4.15 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.

4.16 QC Officer/designee shall Affix duly filled and signed APPROVED/REJECTED labels  on all over  Under test  labels.

4.17 Retain the original copy of GRN along with the entire report and other two duplicate copies of GRN will be given to warehouse department.

4.18 Enter the status of Raw material (release or reject) in Raw material inward register.

4.19 QC Officer/designee shall dispose the left over sample.


Write comments
May 10, 2018 at 10:10 AM delete

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