PRECAUTIONS & GENERAL INSTRUCTIONS IN MFG AREA Ensure area and equipment cleanliness before starting the manufacturing operations. Check and ensure that all manufacturing equipment and other required accessories are clean and ready for use. Wear Gloves and Nose masks during all manufacturing processes. Counter-check the weights of all ingredients before using them in the batch. … Read more
Checklist for Precautions during working on Analytical Weight Balance (Before weighing) Checklist for Do’s Check calibration of balance before weighing Always ensure that the spirit level of the analytical balance is proper. Check silica gel for activation (dark blue) if not then dry it in the Oven till the color changes to dark blue. Use a … Read more
Checklist for sample preparation Checklist for Do’s Use a heating mantel or burner with glass beads to avoid bumping. Specific gravity – check the temperature during the analysis Weight/ml – avoid air bubbles in the tube. Polarimeter – Avoid air bubbles in the cell. For melting point, powder the substance to fine particles & fill in … Read more
Checklist for sample preparation by U.V. analysis Checklist for Do’s for U.V. analysis Cells used for the analysis should be identical and transparent. The solution whose U.V. reading is to be taken should be clear and transparent, it should not contain any foreign particles or fibres. For analysis solvents used should be spectroscopic grade. Where … Read more
What happens if you take expired Medicines? Expiration dates on medicines don’t mean your medication will go bad on that date, it just means that the medicine is less potent and may not work effectively. Aside from a handful of medicines that are rarely on the market, most common medicines do not become toxic after their … Read more
What 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