1. What do you mean by "Quality Assurance"?
The sum total of the organized arrangements made with the objects of ensuring that all Products are of the quality required for their intended use and the quality systems are maintained.
2.What is the definition of SOP?
SOPs are detailed written instructions for the operations routinely performed in the course of any activities associated with pharmaceutical manufacturing.
A written authorized procedure which gives instructions for performing operations not necessarily specific to a given product / material, but of a more general nature the equipments preventive maintenance and cleaning; recall of products; purchasing; cleaning of premises and environmental control; sampling and inspection etc.
3.What are the contents of the SOP?
Objective/Purpose, Scope, Responsibility, Accountability, Procedure, List of formats/Annexure, Abbreviations, Reference, Revision History.
4.What is the clean room?
Clean rooms are defined as especially constructed, environmentally controlled enclosed spaces with respect to airborne particulates, temperature, humidity, air pressure, air flow patterns, air motion, vibration, noise, viable (living organisms) and lighting.
Particulate control includes:
Particulate & microbial contamination Particulate concentration & dispersion
5.What are the classifications of clean rooms?
Generally clean rooms are classified in to the following types as per different guidelines: Schedule M: Grade A, Grade B, Grade C, Grade D
USFDA (US 209E): Class 1, Class 10, Class 100, Class 1000, Class 10000, Class 100,000 WHO 2002: Grade A, Grade B, Grade C, Grade D EU GMP: Grade A, Grade B, Grade C, Grade D ISO 14644-1: ISO-3, ISO-4, ISO-5, ISO-6, ISO-7, ISO-8, ISO-9 Australia (AS 1386): 0.035, 0.35, 3.5, 35, 350, 3500 Germany (VDI 2083): 1, 2, 3, 4, 5, 6
6.What is the difference between GMP & cGMP?
GMP: GMP is the part of Quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
GMP are aimed primarily at diminishing the risks
inherent in any pharmaceutical production.
Such risk are essentially of two types:
Cross-contamination (in particular of unexpected
contamination)
Mix-ups (confusion)
CGMP: Current Good Manufacturing Practices. This means any procedure / system adopted by the manufacturer which proves to be necessary and important for identity, strength and purity of a product.
7.What is the difference between Qualification and Validation?
Qualification is equipment / instrument oriented but validation is process oriented
8. What is the definition of Validation?
Validation is the documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting predetermined acceptance criteria
9. What are the types of validation?
Process validation, Analytical method validation, cleaning validation, facility validation, Utility validation & software validation.
10.What is the definition of Qualification?
Qualification is the action of proving and documenting that any equipment or ancillary systems are properly installed, work correctly, actually show the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.
Page No 1 > Next Page