OBJECTIVE To review the Quality Management System implementation status and to plan for resolving any outstanding issue and for closing the gaps. SCOPE This SOP is applicable for holding Quality Management Review meeting system in (Company Name). RESPONSIBILITY 1. Team members of concerned departments ...

1.0 OBJECTIVE : To establish a procedure to determine holding time limits of intermediate materials/products, equipments, chemicals/reagents. 2.0 SCOPE : This procedure is applicable for all products to be manufactured at (Company Name). 3.0 RESPONSIBILITY 3.1 Production/Engineering department shall ...

1. Purpose: This defines the procedure for secondary gowning in sampling area. 2. Scope: This procedure is applicable for Secondary gowning and de-gowning in the sampling area. 3. References and Attachments: 3.1. References: None 3.2. Attachments: None 4. Responsibilities: 4.1. Personnel Department: 4.1.1. To ...

1.0 OBJECTIVE: To lay down the procedure for facility qualification. 2.0 SCOPE: All manufacturing, packaging, storage and other relevant area in (Company Name). 3.0 RESPONSIBILITY 3.1 Engineering Manager or his/her designee will be responsible for initiating facility qualification. 3.2 Validation manager ...

1. Objective: To ensure continuous consistent product quality, the quality of raw and packaging material from reliable vendors is essential. The purpose of this procedure is to describe the various activities and system for the approval of vendors for the active / inactive ingredients and packaging ...

Objective: To lay down procedure for codification of material and issuance. Scope: This SOP shall applicable to Quality Assurance Department of (Company Name). Responsibility: Officer/Manager of Quality Assurance Department. Procedure: =>> All the material such as raw material (Active and Excipients), ...