Cleaning of Lifter Machine Objective : To lay down a procedure for the cleaning of Lifter Machine. Scope :This SOP is applicable for cleaning of Lifter Machine to warehouse of formulation plant Responsibility Operator / Technician – For cleaning of Lifter Machine. Warehouse personnel– For checking the cleanliness of the Lifter Machine. Accountability Department Head/In-charge … Read more
Operation of Vacuum Cleaner Objective :To lay down a procedure for the Operation of Vacuum Cleaner. Scope : This SOP is applicable for Operation of Vacuum Cleaner to warehouse of formulation plant. Responsibility Operator / Technician – For Operation of Vacuum Cleaner. Warehouse personnel– To maintain proper functioning of the equipment & procedure as per … Read more
Testing and approval/rejection of packaging material Objective: To lay down a procedure for testing and approval/rejection of packaging materials. Scope: This sop is applicable for testing and approval/rejection packaging materials Responsibility: QC –Chemist or above shall be responsible for testing of packaging materials QC-Executive / Nominee shall be responsible for reviewing of worksheet. Accountability: Head … 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 OBJECTIVE: Installation Qualification protocol for Automatic Air … 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