“Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” QUALIFICATION The premises, the supporting utilities, the equipment and the processes have been designed in accordance with the requirements of GMP. This normally constitutes Design Qualification or DQ. Design qualification […]
1. What is 21 CFR part ? Title 21 CFR Part of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) 2. Different between Qualification and Validation? “Qualification” refers to the activities performed on facility, utility and equipmentThe “Validation” refers to the activities performed on processes, practices and methods. 3. Critical […]
Step 1: Measure the length, width and height of the room using a good old fashioned tape measure 🙂 This will determine the size of the room or in other words its volume. Length x Width x Height = Step 2: Using a device called a ‘balometer’ measure the air supply coming out of the […]
A cleanroom or clean room is an environment, typically used in manufacturing or scientific research that has a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors. More accurately, a clean-room has a controlledlevel of contamination that is specified by the number of particles per cubic meter at a […]
Interview questions for Technician (engineer) in parenteral injectable plant 1. Which test should to be perform for detect the leakage & penetration of steam in Steam sterilizer/ Autoclave? Answer: The identification for any leakage & penetration of steam can be tested by the following methods: Chamber Leak Test, Bowie Dick […]
CFR – Code of Federal Regulations Title 21
Interview Questions for Quality Assurance (QA- Validation) in pharmaceutical industry Final round of Interview questions in technical round (Sun Pharmaceutical Industries Ltd.) 1. What is the recommended bio burden limits of purified water & WFI? Purified water has a recommended bioburden limit of 100 CFU/mL, and Water for injection (WFI) has a recommended bio burden […]
Interview Questions for Production (Injectable preparation) in pharmaceutical industry Final round of Interview questions in technical round in Production (SPV) : 1. Principle of Autoclave operation. 2. Basics of cleaning validation during change over of different product in filling. 3. How to take swab from filling needle in filling machine ? 4. Handling of filters […]
Interview Questions for Production (Injectable preparation) in pharmaceutical industry (Cipla) Final round of Interview questions in technical round in Parenteral Production (SPV) : 1. Viable and non viable limits for classified area. 2. Acceptable Lux value as per guidelines for visual inspection of filled vials or ampoule. 3. Endotoxin, Bioburden, TOC Limits of WFI comparison […]
