SOP for testing and release of In-process and Finished product in pharmaceuticals

1.0 Purpose:
To lay down a procedure for testing and release of In-process and Finished product.

2.0 Scope:
This procedure is applicable for testing and release of In-process and Finished product in Quality Control department.

3.0 Responsibility:

QC Officer/Executive/Designee :
• To enter the details in In-ward register and allocate A.R. No.

• To read the relevant specification.

• To request for respective protocol issuance to QA.

• To analyse the sample as per standard test procedure.

• To maintain record of instruments usage log book.

• 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 intimation slip.

QA Officer/Designee :
• To plan sampling of In-process and Finished product sample.

• TO hand over the sample to QC.

QA Head/Designee:
• To approve, implement and to ensure compliance of SOP.

4.0 Procedure:

4.1 QA Officer/designee shall handover the collected sample along with the sample intimation slip to QC department.

4.2 QC Officer/designee shall enter the details in inward register for In-process and Finished product and allocate the A.R. No.

4.3 QC Head/designee shall Keep the sample at designated place in Quality Control department.

4.4 QC Head/designee shall allocate the work to QC Officer/designee for analysis.

4.5 QC Officer/designee shall read the relevant specification/STP before starting the testing of any In -process material/ Finished product and organize the work to finish in the allotted time period.

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

4.7 After receiving the protocol, QC officer/designee shall start analysis of sample.

4.8 If non availability of testing facility / non availability of reference standards, impurity standards for testing, sample shall be tested in an outside laboratory.

4.9 After completion of each test, QC officer/designee shall record directly on the respective In- process/
Finished product protocol and make entry in relevant instrument usage log book.

4.10 QC officer/designee shall follow the good document practices.

4.11 QC officer/designee shall attach all supporting data (IR graph, UV print, HPLC chromatograms, Karl Fischer reports, auto titration reports, outside testing report etc.) with protocol.

4.12 If observed results shall be out of specification, inform to QC Head/designee.

4.13 After complete analysis of In-process samples, QC officer/designee shall attached all raw data with protocol, sampling intimation slip and hand over to QC Executive or designee for review.

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

4.15 QC Head/designee shall randomly check the data and approve the sample intimation slip.

4.16 After approval, QC Executive/designee records the date of release in the inward register for in-Process. Hand over one copy of sample intimation slip to QA department for further process and keep one duplicate copy along with the report.

4.17 After complete analysis of Finished products, QC Officer/designee shall prepare COA as per the SOP and submit the completed report with raw data, sample intimation slip and outside testing report to the QC executive/designee for review.

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

4.19 QC Head/designee shall randomly check the data, approve the COA and sample intimation slip.

4.20 After approval, QC Executive/designee records the date of release in the inward register for Finished product. Hand over one copy of sample intimation slip to QA department and keep one duplicate copy along with the report.

4.21 QC officer/designee shall submit the complete finished product report to QA department.

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