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….
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…
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…
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 OBJECTIVE: Installation Qualification protocol for Automatic Air…
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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…
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…
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:…
AMOXYCILLIN CLAVULANATE FOR INJECTION PRODUCT INTRODUCTION AMOXYCILLIN- CLAVULANATE FOR INJECTION is a penicillin-type of antibiotic that helps your body fight infections caused by bacteria. It is used to treat infections of the lungs (e.g., pneumonia), ear, nasal sinus, urinary tract, skin, and soft tissue. It will not work for viral infections such as the common…
SOP for Operating Procedure for Gelatin Storage Vessel Check the ‘CLEANED’ status label duly filled and signed on the Gelatin Storage Vessel, then unwrap the cling film. Ensure the cleanliness of the Gelatin Storage Vessel. Affix ‘BATCH IN-PROCESS’ status label on Gelatin Storage Vessel duly filled and signed. Record all observations in line clearance record….
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OPERATION OF REVERSE OSMOSIS SYSTEM To provide the operating procedure for the Reverse Osmosis system. This procedure covers the operating procedure for the Reverse Osmosis system. PROCEDURE The Reverse Osmosis system is fed with softened water stored in a tank with a capacity of 5000 Liter. The feed pump pumps water from the tank to…
