SOP on Intermediate and finished product Analysis, Approval and Rejection
Objective: To lay down the procedure for analysis, approval and rejection of Intermediate and finished product.
Scope: This procedure is applicable for analysis, approval and rejection of Intermediate sample, validation sample and finished product sample in QC Department.
Responsibility: Chemist or above /Executive / nominee
Accountability: Head – Quality Control
Procedure: Quality Assurance personnel shall collect Intermediate samples, validation samples and finished product samples and handover the sample along with sample intimation slip filled with all details to QC section in-charge or nominee. Finished product sample shall be given along with finished product intimation slip and intermediate product and validation sample with sample intimation slip.
QC section in-charge or nominee shall receive the sample and verified the all given details with that particular sample and after that record information of finish product in finish product control register , Intermediate product in intermediate product control register and validation sample in validation product control register.
A.R.No. of product shall be generated as per current version of SOP.
In case of allocated batch, QA shall provide batch packing allocation form , along with finished product intimation slip. From this allocation form, QC Executive / nominee shall ensure that first packed batch have to be analyzed and analytical results for subsequently packed batches shall be referred from that of first packed batch.
Incase of finished product sample (Tablets / Capsules) manufactured for Domestic, ROW markets, if difference between packing of first batch and subsequently packed batches is not more than 30 days then only results of first packed batch shall be taken for reference to subsequently packed batch, otherwise complete analysis of this subsequent batch shall be performed as per respective specification.
Incase of finished product sample (Dry powder Injection) manufactured for Domestic, ROW markets, results of filled vials (intermediate stages) shall be taken for reference for release of finished product.
Quality Control Executive / Nominee shall allocate the sample to chemist for analysis.
Quality Control Chemist shall perform the analysis as per specification and standard test procedure of respective product, and record the observation and calculation in respective work sheets.
After completion of analysis, QC chemist shall submit worksheet along with intimation slip to QC executive / Nominee for review.
QC executive / nominee shall review analytical data w.r.t. Specification & STP for adequacy and prepare Certificate of Analysis for Finished product.
If all the results of analysis found within specification product shall be passed than QC Executive or nominee shall prepared Certificate of Analysis for Finished product.
If results of any test found out of specification then SOP SOP on handling, investigation and reporting of out of specification results) shall be followed for necessary action.
Based on the conclusion of OOS investigation, product shall be rejected or passed.
After review, QC executive / nominee shall send the worksheet to QC Head or nominee.
Incase of intermediate & validation samples QC head or nominee shall give final approval.
Incase of finished product sample manufactured for Domestic, ROW and regulated markets QC Head or nominee shall approve worksheet and review the COA.
Finished product sample manufactured for Domestic, ROW and regulated markets Approval of COA shall be done by QA Head or nominee.
List of Annexure
- Finished Product Control Register
- Intermediate Product Control Register
- Validation Product Control Register