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STANDARD OPERATING PROCEDURE Title: Procedure For Quality Risk Management Department: Quality Assurance OBJECTIVE This SOP defines the approach to Quality Risk Management (QRM) of a GMP site which may be used to facilitate the process and to aid personnel performing the assessment. SCOPE Applicable to any process at a GMP site that requires a Risk … Read more
FACTORY ACCEPTANCE TEST OF INSPECTION CONVEYOR Contents Objective Scope Responsibility Verification of Technical Specification Verification of Material of Construction Verification of Instruments Verification of Operation Verification of InterLock Machine Trail Sheet Suggestions/ Modifications FAT Closed Out OBJECTIVE: To verify that the machine at the Manufacturer’s site is ready as per the Design Qualifications and in … Read more
CARBOPLATIN INJECTION 150MG/15ML CARBOPLATIN is a chemotherapy drug. It targets fast-dividing cells, like cancer cells, and causes these cells to die. This medicine is used to treat ovarian cancer and many other cancers. Carboplatin Injection is an anticancer medicine that is used in the treatment of ovarian cancer (cancer of the ovary, part of the female … Read more
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PERFORMANCE QUALIFICATION PROTOCOL PURIFIED WATER SYSTEM OBJECTIVE To describe the Performance Qualification procedure to be used during validation of purified water system in order to: a) ensure the system reproducibility over an appropriate time period as per user requirement specifications. b) ensure that the system is showing consistency in producing water of pre-established specifications. SCOPE … Read more
Entry & Exit in Microbiology Laboratory Objective To lay down a procedure for entry & exit in Microbiology Laboratory. Scope This SOP is applicable for entry & exit in the microbiology laboratory Responsibility A microbiologist is responsible to follow this SOP. Accountability Department Head & QA Head shall be accountable for the implementation of this … Read more
Cleaning of Dispensing and Sampling Tools Objective To lay down a procedure for Cleaning of Dispensing and Sampling Tools after dispensing and sampling activities respectively. Scope This standard operating procedure is applicable for Cleaning of Dispensing and Sampling Tools Responsibility Trained Worker shall be responsible for cleaning of Dispensing/Sampling Aids. Store & QC personnel shall … Read more
Issuance of Packing Materials and transfer of Issued materials from Packing Material Store to Production Objective To lay down a procedure for Issuance of Packing Materials and transfer of Issued materials from Packing Material Store to Production. Scope This Standard Operating Procedure is applicable in Packing Material Store for Issuance of Packing Materials and transfer … Read more
Cleaning of Raw Material Store, Packing Material Store and Finished Goods Store Objective To lay down a procedure for Cleaning of Raw Material Store, Packing Material Store and Finished Goods Store. Scope This Standard Operating Procedure is applicable for Cleaning of Raw Material Store, Packing Material Store and Finished Goods Store at formulation plant Responsibility … Read more
Objective To lay down a procedure for dispensing of raw materials and transfer of dispensed materials from RM stores to various sections of the Production Department. Scope This Standard Operating Procedure is applicable at Raw Material Store for dispensing of Raw Materials and their transfer to the various sections of the Production Department at formulation … Read more