The objective of in Sampling and Testing of In process and Finished Products is to verify that all applicable specifications and requirements pertaining to product are fulfilled and to prepare corresponding documents so as to check that testing parameters met the intended specifications and requirements through out the production run.
Purpose:-
This SOP is established to provide the guidelines for the sampling & testing of in process and finished products so as to get the representative sample of the whole batch for analysis.
Sampling and Testing of In process and Finished Products Additionally, the objective of the in process & final testing is to provide objective evidence of product conformance to specification and continued effectiveness of the quality management system.
Scope of Sampling and Testing of In process and
Finished Products:-
This procedure covers the Sampling and Testing of In process and Finished Products and this is applicable to Quality Control Department.
Responsibilities:-
- Officer QC
- Quality Control Manager
- Microbiologist
- Sr. Officer QC
Definitions:-
In process & Finished Products: A good purchased as a “raw material” goes into the manufacture of a product. A good only partially completed during the manufacturing process is called “work in process”. When the good is completed the complete manufacturing process but not yet sold or distributed to the end-user, it is called a “finished good”.
Sampling and Testing of In process and Finished Products, Sampling: It is a part of a large bulk/product which represents the whole bulk/product and the characteristics possessed by this part are the same as that of the bulk/product.
Flow Chart:
Process Flow Chart
- Sampling request by Production/FGS to IPQA
- IPQA conduct sampling and sent it QC for testing.
- Complete testing by QC and submission of final decision of QC to IPQA for line clearance.
- Submission of Release for Marketing by QA Department to FGS after the submission of FP COA by QC.
Description/Procedure:
Sampling & Testing of In-process Products:
- Production department sends the in process product sampling request to IPQA section on the floor. IPQA conduct the sampling as per sampling plan QP-SMP-03, affixes the “Sampled” label on container which are sampled and send it QC along with production request for testing and takes receiving on the register from officer QC.
- After receiving and verifying the sample & sampling request from IPQA section, Officer QC enters its information in the Product Sample Receiving Log Book and assigns it a QC number and initiate testing against the approved specifications.
- Samples for Sterility & LAL testing shall be conducted by microbiology section against the request of production.
- QC officer & microbiologist will conduct the testing of in process samples against the approved specifications and enter the raw data in the laboratory work book.
- After the completion of the analysis, Officer QC will submit analytical report to the Manager QC for approval.
- After verification of the analytical report QC Manager takes decision against that particular product either to release or reject.
- After the decision of the QC Manager, Officer Quality Control sends the release or rejects status to the in process IPQA along with the request submitted for testing.
- On the basis of results provided by QC, IPQA inform production and give line clearance accordingly.
Sampling & Testing of Finished Products:
- Finished Goods Store sends the in Finished Product sampling request to IPQA section on the floor. IPQA conduct the sampling as per sampling plan QP-SMP-03, affixes the “Sampled” label on the boxes which are sampled and send it QC for testing and takes receiving on the register from officer QC.
- After receiving and verifying the samples from IPQA section, Officer QC enters its information in the Product Sample Receiving Log Book and assigns it a QC number and initiate testing against the approved finished product specifications.
- QC officer & microbiologist will conduct the testing of the product samples against the approved specifications and enter the raw data in the laboratory work book.
- After the completion of the analysis, Officer QC will submit Certificate of Analysis to the Manager QC for approval.
- After verification of the Certificate of Analysis & Raw Data QC Manager takes decision against that particular product either to release or reject.
- After the decision of the QC Manager, Officer Quality Control sends the release or rejects status to Officer QA along with the copy of Certificate of Analysis.
- On the basis of results provided by QC, Officer QA & Manager QA takes decision to send the release for marketing to FGS.
Record:-
- Analytical Report (In process Control)
- Certificate of Analysis n (FP)
- In process Product Sample Receiving Record
- Finished Product Sample Receiving Record