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
TRIGGERING OF INSPECTIONS There are two types of events that trigger inspection: categories that will regularly prompt an inspection request, and categories in which the district office may elect to perform an inspection at their discretion for elements of applications — filed or otherwise. The following categories will regularly prompt a pre-approval or cGMP: 1. … Read more
Electronic Signatures Controls for identification codes/password Persons who use electronic signatures based upon the use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include: (a) Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination … Read more
TURN TABLE DESIGN QUALIFICATION Stainless steel Scrambler & Unscrambler, which is familiar as turn table. This is built on MS Square frame, solid guide rail & reduction gear box for jerk less & noiseless performance. Turntable is useful to ensure total synchronization, uniform flow of container and to take a turn at 90 degree to suit … Read more
INSTALLATION QUALIFICATION of AUTOMATIC AIRJET BOTTLE AIR AND VACUUM CLEANING MACHINE Contents Pre Execution Approval Objective Equipment Description Participants Log Installation Qualification Checklist Sub-Component CheckList Component Location List MOC Verification List Test / Inspection Reports Utility Verification List Attachment Log Summary, Conclusion, and Recommendation Abbreviations Post Execution Approval PRE-EXECUTION APPROVAL Prepared by By signing, the … Read more
DESIGN QUALIFICATION OF INSPECTION CONVEYOR 3.1/2” X 5 FT Inspection table is equipment consisting of a three-track conveyor with a hood with lighting arrangement and visual inspection background of alternate black & white color. Inspection table have stainless steel structure with moving SS slat chain. Structure made out of SS square pipe & supported on … Read more
Cefazolin Sodium for Injection 1000mg GENERAL INSTRUCTIONS: Good manufacturing practices should be followed during the entire process of manufacturing including sampling and dispensing. All the containers and equipment used for manufacturing shall be properly cleaned as per the relevant SOP of the current version. All the equipment and containers should have a proper status label … Read more
CEFEPIME AND AMIKACIN FOR INJECTION 1.25GM PRODUCT PROFILE Generic Name: CEFEPIME & AMIKACIN FOR INJECTION Strength :.25 GM Lot size: 70500 units Average Filled Weight: 2.15 gm/vial Label Claim: Each vial contains: Cefepime Hydrochloride USP equivalent to Cefepime ___________ 1000 mg Amikacin Sulphate IP equivalent to Amikacin _____________250 mg Shelf Life: 2 Years Dosage Form: … 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