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
SOP on Pharmacopeial updation of documents as per the Pharmacopeial changes Objective: To lay down a procedure for Pharmacopeial updation of documents as per the Pharmacopeial changes. Scope: This procedure is applicable to Pharmacopeial updation of documents as per the Pharmacopeial changes.. Responsibility: QC Chemist or above & QA officer or above Accountability: Head Quality Control & Head Quality Assurance Procedure: … Read more
SOP on retesting of raw material Objective: To lay down the procedure for re-testing of raw material for material lying in warehouse for longer period. Scope: This SOP is applicable for retesting of raw material for material lying in warehouse for longer period. Responsibility: Chemist or above of QC Department & Officer or above of warehouse Department. Accountability: Head – … Read more
SOP on Sampling of Raw Material Objective: To lay down the procedure for sampling of raw material. Scope: This procedure is applicable for sampling of raw material Responsibility: Chemist or above Accountability: Head – Quality Control Procedure: Sampling of Raw Materials: Raw material sampling shall be initiated after receiving the “GRN” from warehouse. Ensure that material is received from … Read more
SOP FOR INCIDENCE HANDLING PURPOSE: To lay down a procedure for reporting, investigation and disposition of Incidents. SCOPE: this procedure is applicable to the reporting of investigation and disposition of unplanned, uncontrolled incidents either directly or indirectly associated with Manufacturing/Packaging, or Analytical operations. RESPONSIBILITY: Observer / Concerned Department Officer shall report the Incident. Observer / … Read more