Monday, January 1, 2018

Cleaning Validation Sampling Using Swabs and TOC Analysis

For years the pharmaceutical industry has dealt with challenges associated with swabs and swab sampling. This video from GE Analytical Instruments highlights some key elements that can improve your cleaning validation program and will help you re-think the approach when using swabs for TOC analysis. Learn more at http://ift.tt/2Cmpi7A.

Cleaning Validation SOPs

During a session at IVT's 17th Annual Validation Week, Dawn Tavalsky explained the proper execution of standard operating procedures (SOPs) for cleaning validation. Tavalsky discussed the training operators, visual inspection, and eye exams.

Pharmaceutical Qualification & Validation

The best easy way to describe the Pharmaceutical Qualification & Validation. You will clearly understand the Process Validation, cleaning validation with examples and calculation, Area Validation, water system validation, Personnel qualification, Equipment qualification with day in day out examples.

Qualification and Validation

The presentation gives details of qualification and Validation required as per GMP. It covers details on Validation Master Plan, DQ,IQ,OQ,PQ, Validation Protocols and what is expected in Validation Reports

Pharmaceutical Water: System Design, Operation, and Validation

This book is Good for professionals dealing with water treatment system.
This book covers the following aspects of water treatment system.
  1. Impurities in water
  2. PreTreatment techniques used
  3. Ion removal techniques such as reverse osmosis and ion-exchange
  4. It also describes further ion removal techniques
  5. Distillation system and pure steam generation
  6. Water storage system and accessories reqiured
  7. Ozone system and accosories
  8. Various polishing components used
  9. Design and installation of  Distillation system
  10. Materials uses in Distillation syetem
  11. Various controls and instrumentation
  12. Water specification guilines
  13. System installation procedure
  14. Specification guidelines
  15. Start up and commissioning procedure
  16. System Validation --the most Important one

A major new work on all aspects of water, the most used raw material ingredient in the pharmaceutical and biotechnology industries―used as an excipient in pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent.

Drawing on the author’s extensive field experience with more than 400 pharmaceutical and related water purification systems, the text’s numerous case studies illuminate the best and worst of water system design and operation.