Pharma Knowledge Park
Think Think...The whole of Science is a refinement of everyday thinking...
 
 
 

PHARMA KNOWLEDGE PARK

Pharma Knowledge Park is exclusively designed for the pharmaceutical professionals.

This site provides links to various pharmaceutical regulatory sites, Technical articles, news on updated regulatory guidelines, In addition to this, management ebooks, Pharmaceutical technical ebook links and presentations are part of this site.

WHO issues Update of Pharmaceutical Water Guideline

New EMA Q&As on Genotoxic Impurities

WHO publishes revised Draft Guideline on Quality Risk Management.

FDA requires Registration of Manufacturing Facilities until December 2, 2012.

Actual GMP Deficiencies concerning Validation/Qualification/Calibration as seen by the MHRA

Additional Guidance Document on Active Substance Master File (ASMF) published by EMA

US Government Report on Innovation in Pharmaceutical Development

The new EU GMP Chapter 1 in Pharmaceutical Development

FDA Requirements on Bioequivalence Data for Generic Drug Products

New EU GMP Chapter 7 on Outsourced Activities

New Guide for Manufacturers of Stand Alone Software

Questions and Answers of the Japanese Regulatory Authorities regarding Computerized Systems

Interesting Topics...

Pharmaceutical Gallery...

do-it-online

News

New releases

Newsletter

man-and-women-sitting-at-table

PKP- Newsletter - March - 2012

REGULATORY AGENCIES

EDQM

EP

CEP

EMA

USFDA Drug News


Federal Register

FAQ

                                             Search in site

OMCL Guidelines

Qualification of Equipment - Core document*

Qualification of Equipment Annex 1: Qualification of HPLC Equipment*

Qualification of Equipment Annex 5: Qualification of Automatic Titrators*

Qualification of Equipment Annex 7: Qualification of mass spectrometers

Visit OMCL guideline page : Click here

PRESENTATION GALLERY

Reference Standards

Analytical Method Validation

Stability