SOP on Release of Clinical Trial batch(s) for further Repacking and Testing
Objective : To lay down a procedure for the release of Clinical Trial batch(s) for further Repacking and Testing by the consignee.
Scope : This standard operating procedure is applicable for the release of finished goods for clinical trials batches manufactured at formulation plants.
Responsibility :
Head, Quality Assurance or his/her designee in his absence shall be responsible for the release of Clinical Trial batches for further repacking & testing.
Abbreviations & Definitions
BMR : Batch Manufacturing Record; filled / unfilled regulated photocopy of Technical Directions along with other requisite forms/records, which reveals all the information of a batch of a product.
Batch : A defined quantity of starting material, packaging material of product processed in one process or series of processes so that it could be expected to be homogeneous
IPQA :In-process Quality Assurance
Procedure :
Once the batch of product is packed and FINISHED GOODS TRANSFER SLIP is signed by IPQA, the same shall be transferred to quarantine Finished Goods Stores by Production personnel.
After the QC release of the batch, Officer/ Executive, Quality Assurance shall review the BMR as per SOP.
QA, head/ designee shall finally generate Authorization Note for release of batch for repacking & testing to concerned consignee, upon his/ her satisfaction. Based on customer requirements an additional statement claiming that ‘The Batch has been produced in conformance with a practical cGMP requirements’ can be incorporated
If required, QA-Personnel shall send a copy of Authorization Note for release of pharmaceutical product for further repacking and testing to concerned consignee.
Only QA released Clinical Trial batches shall be transferred from Quarantine Finished Goods Stores to Approved Finished Goods Stores / Finished Goods warehouse from where further it can be send for repacking and testing to the concerned consignee.