Custom Search

Wednesday, April 20, 2011

Analytical Methodology Process validation aspects

Validation and approach towards analytical Methodology

Pharmaceutical manufacturing process knowledge depends on accurate and precise measuring techniques used to test and examine the quality of drug components, in-process materials, and finished drug products. Validated analytical methods are not necessarily required during product- and process-development activities or when used in characterization studies and during process validation. Nevertheless, analytical methods should be scientifically sound (e.g., specific, sensitive, and accurate) and provide results that are reliable. There should be assurance of proper equipment function for laboratory experiments. Procedures for analytical method and equipment maintenance, documentation practices, and calibration practices supporting process-development efforts should be documented or described. New analytical technology and modifications to existing technology are continually being developed and can be used to characterize the process or the product. Use of these methods is particularly appropriate when they reduce risk by providing greater understanding or control of product quality and for process validation. However, analytical methods supporting commercial batch release must follow CGMPs in parts 210 and Part 211. Clinical supply production should follow the CGMPs appropriate for the particular phase of clinical studies.

Also see
Aspects of Validation of Aseptic Process and Sterilisation , Sterilization of Equipment, Containers, and Closures

What is pharmaceutical product information manual (Pharmaceutical product dossier) for registration of  pharmaceutical prodct to foreign contries
--------------------------------------------------------------------------------------------------------

Process Validation Series    

Process Validation Stage 3 The Continued Process Verification.

Process Validation : Process Qualification and Process Performance Qualification (PPQ)

Process Design and Process Validation Recommendations

Process validation and its regulatory, statutory requirements.

Process Validation and Drug Quality Approach to Process Validation.

General Considerations for Process Validation and Recommendations

==========================================================================================
Do you know now this website is now a most popular and most referred website in pharmaceutical industry all over the world and in pharmaceutical companies by pharmaceutical manufacturers for almost all topics related to FDA guildelines, Pharmaceutical Process Validations, and for GMP guidelines for Pharmaceutical Manufacturing (Current Good Manufacturing Practice for Pharmaceutical Manufacturing , c GMP guidelines ),and technical aspects of pharma manufacturing research and development , Pharma Regulatory Affairs  and latest news and new drugs developments.
==========================================================================================


Details on pharmaguideline. are here at who guideline blogspot com(whoguideline.blogspot.com)

No comments:

Posted by: Martin

How to sucessfuly activate and receive our articles on pharmaceuticals by E-Mail

Dear readers if you wish to receive our articles on pharmaceutical automatically into your email Inbox , as and when we write a new article over this website, then follow these 3 simple steps.


1.You should write your Email ID in the box provided and push the subscribe butten


2.Enter the text code that we show you in a small new browser window after you enter your email ID.

3.Log in to your email and Cheke our verification email sent by "FEEDBURNER" , there you should verify the link we send you by email.




Enter your email address get our articles by email whenever this website is updated





Delivered by FeedBurner



Join the list of our readers from Universities ,Research and Development centers Pharmaceutical Companies from all over the world.











Pharma Research Regulatory Guidelines Website
Texas Dallas, TX 75211 US
Email: editor@pharmacistspharmajournal.org Website: http://pharmacistspharmajournal.org/
Copyright © 2008-2015 all rights reserve www.pharmacistspharmajournal.org