SOP ON CAPA (CORRECTIVE ACTION AND PREVENTIVE ACTION) PURPOSE: To lay down the standard operating procedure for Corrective Action and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of nonconforming product, processes, and other quality problems. SCOPE: This SOP is applicable … Read more
SOP OF PRODUCT RECALL PURPOSE: This procedure covers transmission of information by means of a Rapid Alert between the different parties related to the recall of medicinal products, which have quality defects, including counterfeit or tampered products, when urgent action is required to protect public health. The procedure may be used also for transmission of … Read more
(DQ)DESIGN QUALIFICATION FOR PURE STEAM GENERATION SYSTEM DQ- The Author signature indicates that this document has been prepared in accordance with existing cGMP standards and adequately reflects the tasks and deliverables necessary for qualification of the equipment. REVIEWED BY: The reviewer’s signature indicates that, this document has been reviewed, and it accurately and completely reflects the … Read more
Design Qualification (DQ) Protocol Form Fill Seal Blow-Fill-Seal (BFS) technology is a manufacturing technique used to produce small, (0.1mL) and large volume, (500mL +) liquid-filled containers. The basic concept of BFS is that a container is formed, filled, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine. … Read more
SOP Preparation of User Requirement Specification (URS) Objective: To lay down a procedure for preparation, review and approval of user requirement specification. Scope: This procedure outlines the requirements, which shall be followed when creating a User Requirement Specification (URS), which is referred to as system or equipment design documentation. This procedure applies to all systems or … Read more
URS (USER REQUIREMENT SPECIFICATION) PROTOCOL FOR DYNAMIC PASS BOX This is a specific document prepared for the sterile facility. Hence, this document before being effective shall be approved and authorized by Unit Head and accepted by Vendor/Supplier. List of Content Front Page Index Approval Objective Responsibility Equipment description & Identification User Requirement Complementary aspects Safety … Read more
URS (USER REQUIREMENT SPECIFICATION) PROTOCOL FOR WASHING MACHINE This is a specific document prepared for the sterile facility. Hence, this document before being effective shall be approved and authorized by Unit Head and accepted by Vendor/Supplier. List of Content Front Page Index Approval Objective Responsibility Equipment description & Identification User Requirement Complementary aspects Safety and … Read more
URS (USER REQUIREMENT SPECIFICATION) PROTOCOL FOR HPHV STEAM STERILIZER This is a specific document prepared for the sterile facility. Hence, this document before being effective shall be approved and authorized by Unit Head and accepted by Vendor/Supplier. List of Content Front Page Index Approval List of general components Glossary Technical General Salient features Operational requirements … Read more
SOP on Cleaning, Maintenance and Calibration of Stability Chamber Objective: To lay down a procedure for cleaning, maintenance and calibration of stability chamber. Scope: This SOP is applicable for the cleaning, maintenance and calibration of stability chamber. Responsibility: QC Chemist or above AND Electrician or above Accountability: Head – Quality Control & Head – Engineering Procedure: Cleaning: Chamber shall be cleaned … Read more
SOP on receipt and handling of stability samples Objective: To lay down a procedure for receipt and handling of stability samples. Scope: This SOP is applicable for receipt and handling of stability samples in Quality Control Laboratory. Responsibility: QC Chemist or above Accountability: Head – Quality Control Procedure: Receipt of stability samples : Samples for stability studies shall be … Read more
