ABHAWhat side effects are you having from getting vaxed? Vaccine Common side effects can include: Pain on the leg or arm where the shot was given. Swollen lymph nodes. Irritability or crying. Sleepiness. Loss of appetite. Possible Side Effects After Getting a COVID-19 Vaccine Side effects after a COVID-19 vaccination tend to be mild, temporary, … Read more
Risk Assessment tools used by Pharmaceutical Industry Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards . Quality risk assessments begin with a well-defined problem description or risk question. When the risk in question is well defined, an appropriate risk management tool and … Read more
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 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