shivpharma2016

SOP on Planning and Handling of Exhibit batches and Placebo batches Objective : To lay down a procedure for Planning and Handling of Exhibit batches and Placebo Batches. Scope : This Standard Operating Procedure is applicable for formulation plant. Responsibility : Executive / Supervisor – Production and PDL personnel shall plan the manufacture of Exhibit batches and … Read more

SOP on Procedure for Procurement, Handling, Storage and Reconciliation of LDPE Poly Bags and Hand Gloves Objective :  To lay down a procedure for Procurement, Handling, Storage and Reconciliation of LDPE Poly Bags and Hand Gloves. Scope :  This SOP is applicable for Formulation Plant. Responsibility : Production Supervisor / Officer shall be responsible for the … Read more

SOP on Batch Numbering procedure for Optimization /Exhibit Batches of Drug Products and Intermediates Objective : To lay down a procedure on the batch numbering system for optimization/exhibit batches of drug products and intermediates. Scope : This standard operating procedure is applicable for assigning the batch number to optimization/exhibit batches and intermediate products to be manufactured. … Read more

SOP on Testing of Primary Packaging Materials Objective : To lay down a procedure for Testing of Primary Packaging Materials. Scope : This Standard Operating Procedure is applicable at formulation plants. Responsibility QC- officer / Executive : Shall be responsible for carrying out sampling and testing of Packaging Material. Head QC : Shall be responsible for compilation, … Read more

SOP on In-Process and Finished Goods Testing Objective : To lay down a procedure for In-Process and Finished Goods Testing. Scope : This standard operating procedure is applicable at formulation plant. Responsibility IPQA Officer shall be responsible for sampling of the in-process and finished products. QC Officer/Executives shall be responsible for testing in-process and finished products. … Read more

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 … Read more

SOP on Storage, Handling and Destruction of Control Samples of Finished Products Objective : To lay down a procedure for storage, handling, review and destruction of control samples of finished products. Scope : This Standard Operating Procedure is applicable to Baddi formulation plant. Responsibility Officer /Executive – IPQA shall be responsible for Storage, Handling, review and Destruction … Read more

SOP on Sampling of Wash Water Objective : To lay down a procedure for sampling of Wash Water of equipments. Scope : This Standard Operating Procedure is applicable for formulation plant. Responsibility Executive/ Officer – IPQA shall be responsible for the implementation of the procedure as per this SOP. Head- QA/ designee shall be responsible for compliance … Read more

SOP on Handling of Out-of-Specification and Out-of Trend Test Results Objective : To lay down a procedure for handling of Out-of-Specification and Out-of-Trend Test Results. Scope : This SOP shall be applicable for chemistry based testing of drug substances, excipients, components and drug products at formulation plant . The SOP is not applicable for the … Read more

SOP On Qualification procedure for External Calibrating Agency Objective : To lay down a procedure for qualification of external calibrating agency. Scope : This Standard Operating Procedure is applicable for qualification of external calibrating agency, for instruments /equipment for which in-house calibration facility is not available. Responsibility : Heads of Engineering, Quality Control and Quality Assurance departments or … Read more