TRIGGERING OF INSPECTIONS

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

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

DQ OF TURN TABLE

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

IQ of AUTOMATIC AIRJET BOTTLE AIR AND VACUUM CLEANING MACHINE

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 … Read more

DQ OF INSPECTION CONVEYOR

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 1000 mg

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

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

AMOXYCILLIN CLAVULANATE FOR INJECTION

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 … Read more