Article archive

Personal overview of FDA Commissioner Margaret A. Hamburg about visit in India

05/03/2014 21:59
In her monthly blog, FDA Commissioner Margaret A. Hamburg gives a personal overview about her recent visit in India. The Federation of Indian Chambers of Commerce and Industries organised roundtable meetings where challenges of Indian pharmaceutical and food exporting companies were discussed. More...

New Guidance on Validation of Analytical Methods by USFDA

28/02/2014 22:11
A new FDA Guidance for Industry entitled "Analytical Procedures and Methods Validation for Drugs and Biologics" was published a few days ago. This Guideline replaces the Guidance for Industry "Analytical Procedures and Methods Validation" from 2000 (this document has never been finalised and has...

My new Mobile Application "SRK GCP World"

27/02/2014 00:20
  Hi Friends! Welcome to SRK GCP World. One of my friends suggested me to create a mobile application on Good Clinical Practices (GCP) as this topic is useful now to Pharma Professionals. With his idea, I created this application. This application contains information related to GCP such...

Draft EU GMP Annex 15 for Qualification and Validation published

12/02/2014 06:43
        The European Commission has published the draft of the Annex 15.   Compared to the original 11 pages of Annex 15 the draft has now 17 pages. The above-mentioned concept paper is mentioned as a reason for the revision, i.e. adjustments to changes partially to part...

EudraGMDP Database- GDP Certificates

09/02/2014 19:08
   The volume of the EudraGMDP database keeps on growing. While the former database - known as EudraGMP - contained only GMP certificates, the new extended one already contains 677 GDP certificates. Thanks to a search function, you can scan entries according to various criteria. At...

GMP Inspections: Enhanced International Collaboration

09/02/2014 19:02
   The international exchange of information between authorities is intensifying - which is certainly - against the background of increasing globalisation - a meaningful development. For example in January, the US American Health Agency FDA informed the Swiss Authority Swissmedic about...

White paper on "Raising Quality Results on Supplier Audits Using EQMS for Pharmaceutical Companies"

09/02/2014 18:48
    Supply chain integrity is necessary to a pharmaceutical company’s success. Formal contracts, quality agreements, and product and chemical purchase specifications alone never guarantee supply chain integrity. Astute pharmaceutical companies implement audit processes as an integral...

My new Mobile Application "SRK GMP Videos"

08/02/2014 01:14
    Hi Friends! Welcome to SRK GMP Videos. Many times we feel to watch GMP related Videos but we don't know where to get those. Even if we get some times, we must have thought to have readymade and topic wise. If we get those in our mobile or tablet, it will be a great use. So this...

MHRA: Good pharmacovigilance practice compliance report template now available

05/02/2014 00:15
The risk-based inspection compliance report 2013 for good pharmacovigilance practice is now available. The compliance report template can be found in the good phramacovigilance practice section of the website. Good pharmacovigilance practice: risk-based inspections

New EMA Guidance Qualification of novel Methodologies for Drug Development

05/02/2014 00:08
The European Medicines Agency EMA has published the revised Guidance to Applicants "Qualification of novel methodologies for drug development" (EMA/CHMP/SAWP/72894/2008). This guidance has already been finally agreed by CHMP in early 2009 and has now been revised for the second time. What's new is...
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