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…
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…
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:…
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…
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…
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…
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…
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…
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),…
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.…
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