In pharmaceutical industry, process validation performs this task, ensuring that the process does what it purport to do. Validation is one of the important steps in achieving and maintaining the quality of the final product. If each steps of production process is validated we can assure that the...
An Overview: The Role of Process Validation in Pharmaceutical Industry. International Research Journal of Pharmacy, 2012; 3(1): 25-27.Bala R, Kaur G, Rana AC, Seth N. The role of process validation in pharmaceutical industry. Int Res J Pharm 2012;3: 25-27....
The utilities in typical facilities include Gases—compressed air, nitrogen, oxygen, carbon dioxide; Liquids—process water, solvents; Steam—process, clean; House Vacuum; Electrical; Drains—process and waste. There may be other utilities encountered within the facility and the same or simi- lar ...
Microorganisms are ubiquitous in nature and as such they will be present everywhere — in the air, on floors, ceilings, personnel, raw materials, excipients, water, instruments, and equipment, i.e., virtually everything involved with the pharmaceutical manufacturing process. Microorganisms are an es...
PROCESS VALIDATION IN PHARMACEUTICAL INDUSTRY: A REVIEW. Validation is a tool of quality assurance which provides confirmation of the quality in equipment system, manufacturing processes, software and testing met... Sharma,Ajay,Saini,... - 《Pharma Science Monitor》 被引量: 3发表: 2013年 Process...
Pawar, "Current Perspectives on Cleaning Validation in Pharmaceutical Industry : A Scientific and Risk Based Approach," Int. J. Pharm. Phytopharm. Reasearch, vol. 1, no. 1, pp. 8-16, 2011.PAWAR, H.A.; BANERJEE, N.D.; PAWAR, S.; PAWAR, P. Current perspectives on cleaning ...
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters ad...
摘要: The article reviews the book "Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies," edited by A. S. Rathore and G. Sofer.关键词: PHARMACEUTICAL industry BOOKS -- Reviews NONFICTION ...
and microfiltration. It also provides practical methods to test raw materials and in-process samples...
Because of more complex stage-wise acceptance criteria, traditional process capability measures are inadequate for general application in the pharmaceutical industry. The probability of acceptance concept provides a clear measure, derived from specific acceptance criteria for each quality attribute. In line ...