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A basic design approach to Clean Room
“British Standard 5295” defines a clean room as a room with control of particulate contamination, constructed and used in such a way as to minimize the introduction, generation and retention of particles inside the room and in which the temperature, humidity, airflow patterns, air motion and pressure are controlled.
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Autoclaves Qualification & Validation
gmpua.com3 of 39 Autoclaves: Qualification & Validation Holger Fabritz - Expertentreff 14. September 2007 in Baden • Steam Autoclaves • Sterilisation with • Steam / Air Mixture • Saturated Steam • with possible initial vacuum sequence(s) • Cooling with • Air cooled down by heat exchanger • Hot Water Spray Autoclaves • Sterilisation with • Spraying of Water • (Flooding with water)
Pharmaceutical Process Scale-Up
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PHARMACEUTICAL MANUFACTURING HANDBOOK
gmpua.comAnalytical Method Validation and Quality Assurance. Erik Van Bockstaele, Institute for Agricultural and Fisheries Research (ILVO), Scientifi c Institute for the Flemish Community, Merelbeke, Belgium, Analytical Method Validation and Quality Assurance. T. Vasconcelos, Laboratory of Pharmaceutical Development, BIAL, Mamede do
Batch Control Part 1: Models and Terminology
gmpua.commetric units in all new and revised standards to the greatest extent possible. The Metric Practice Guide, which has been published by the Institute of Electrical and Electronics Engineers as ANSI/IEEE Std. 268-1992, and future revisions, will be the reference guide for definitions, symbols, abbreviations, and conversion factors.
Pharmaceutical Cleanroom Commissioning, Certification, …
gmpua.comPurpose of the Pharmaceutical Cleanroom Thai Ministry of Public Health Food and Drug Administration: Pharmaceutical products should be manufactured under the requirements of good manufacturing practices by licensed manufacturers with the object of ensuring that users will receive efficacious, safe and good quality products.
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