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Newsletter - March 2012

 

Pharma Knowledge Park formerly known as Noor's Pharmaceutical Home. This site is exclusively designed for the Pharmaceutical professionals.

 



 

 

This Site provides links to various pharmaceutical regulatory sites. Technical

 Pharma Business News

 

articles, Pharmaceutical news on updated of regulatory guidelines. In-addition to this, Management ebooks, Pharmaceutical Technical ebooks links are the part of this site. One can find Presentations on technical topics from competent professionals from pharmaceutical industry.

  

 

 

 

 

 


 

 

LAB COMPLIANCE

 

Pharmaceutical Gallery 
 

 

Excellent compilation of FDA Warning Letters, Form 483 Observations, Establishment Inspection Reports by


PHARMA DISCUSSION FORUM

 

 

 

FREE DOCUMENT OF THE MONTH 

Handling Security Patches

 

 

 

 

 

 

 

 

LATEST REGULATORY NEWS /GUIDELINES

NEW  PRESENTATION

 

    

New Questions and Answers about the Centralised Procedure - EMA publishes an Updated Q&A Document 

FDA: QbD becomes mandatory for Generics. Quality by Design for ANDAs: An Example for Modified Release Dosage Forms.

Significant Administrative Changes in the New Revision of the Guideline on the ASMF Procedure.

Draft guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations.

Drug Master Files (DMF) - Recorded Webinar Presentation - Dr Arthur B. Shaw - USFDA 

Regulatory Classification of Pharmaceutical Co-Crystals - USFDA 

Q8, Q9, and Q10 - Questions and Answers(R4)- USFDA 


European Pharmaceutical Industry presents its Expectations to the EU Note for Guidance on Process Validation. 

Guidance Document Alternate Sample Retention Site Guidelines - Health Canada 

Enhancing GMP inspection cooperation between the EMA and FDA

"Final report on the International API inspection Pilot Programme - TGA 

Presentations about manufacturing Therapeutic Goods - TGA

 

 

 

Excellent Presentation by Mr. Saravanaraja

Subramanian on TSE /BSE Risk and Regulations in

Pharmaceuticals.

 

 

 

 

 

Download

Presentation

 

 

 

            

      

 

 

 

PHARMA NEWS BOX

MANAGEMENT MANTRA

PHARMA EBOOKS

 

 

 

 

 

 

Lab compliance News

The latest uploads are

The latest uploads are

European compliance Acadamy News

Heart Intelligence

The Seven Challenges - A Workbook and Reader About Communicating More Cooperatively

Analysis of Drug Impurities

Microbial Contamination Control in the Pharmaceutical Industry

 

Europe - EDQM EP CEP

USFDA - Drugs - News

Federal Register

Read more 

Read more

 

 

 

INTERNATIONAL REGULATORY SITES

 

 

US Food and Drug Administration

World Health Organization

European Department for the Quality of Medicines

International Conference on Harmonisation 

Medicines and Healthcare products Regulatory Agency

European Agency for the Evaluation of Medicinal Products

Therapeutic Goods Administration

PDMA, Japan

 

 

PRESENTATION GALLERY

 

 

 

Reference Standards 

  Analytical Method Validation

Stability

 

NEW UPDATION

 

 

 

 

 

 

 

 

       HPLC in FDA Warning Letter - A Summary Report by European Compliance Academy   





      Japanese Pharmacopoeia - Sixteenth Edition     

      New and Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2012






            
 

 NEW ARRIVALS  

 
   
Summary:-

In a new Recommendation for Risk-Based Inspection Planning in the GMP Environment, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) asks Inspectors to have a look at job cuts.

The PIC/S Expert Circle on Quality Risk Management has developed a 'Recommended Model for Risk-Based Planning in the GMP Environment' (PI 037-1). This Recommendation contains Quality Risk Management tools that may be used by inspectorates when planning frequency and scope of GMP-inspections.