November 2014
Intermediate to advanced
206 pages
6h 12m
English
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Chapter 5
Cleaning Validation and Its Regulatory Aspects in the Pharmaceutical Industry
S. Lakshmana Prabu*; T.N.K. Suriya Prakash†; R. Thirumurugan‡ * Department of Pharmaceutical Technology, Bharathidasan Institute of Technology, Anna University, Tiruchirappalli, Tamil Nadu, India† Department of Pharmaceutics, Al Shifa College of Pharmacy, Malappuram, Kerala, India‡ Department of Pharmaceutical Chemistry, School of Pharmacy, International Medical University, Kuala Lumpur, Malaysia
Abstract
Pharmaceutical products and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms, or by other materials (e.g., airborne particles, dust, lubricants, raw materials, intermediates, ...
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