• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Stay informed!

If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices

 

>>> simply register for our free GMP newsletter LOGFILE

Image

TOP 5 GMP Downloads

1. GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals

 

2. Quality Agreement
Standard draft to adapt and extend

 

3. Premises
Official requirements | material flow | room classes | and much more...

 

4. GMP Audit Checklist
for Pharmaceutical and API Manufacturers

 

5. Documenting Process Validation
A Drugmaker‘s Guide – step-by-step manual based on real-world examination experience

 

Your benefits:

> no shipping costs
> no waiting period: if you choose payment by credit card you will receive an email with the download information immediately after payment.

 

>>> Click here to find more Downloads!

News about GMP/cGMP

2010-02-18

When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter.

 
2010-02-18

On Feburary 17, 2010 the german APV (Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V.) published an interesting Classification of  Inhaler Systems, contributed by  Carsten Kremer PhD.

 
2010-02-17

USP has recalled USP 33–NF 28 because of text errors that were introduced during conversion to a new format. The USP intends to reissue the publication in March 2010. Further information about the recall is available in two public notices released on January 8, 2010 and January 12, 2010.

 
2010-02-17

On Feburary 16, 2010 the FDA published a Warning Letter concerning cGMP-Violations caused by lack of Hygiene during the manufacturing process and inaccurate personal hygiene.

 
2010-02-15

The Committee for Medicinal Products for Veterinary Use (CVMP) adopted a “Concept paper on the need for revision of the guideline on stability testing for applications for variations to a marketing authorisation” (EMA/63033/2010-CONSULTATION) for a 2-month period of public consultation. Revision is required because of recent changes to the underlying variations legislation.

 
2010-02-11

The European Medicines Agency has launched a three-month public consultation on its Road Map to 2015, coinciding with its 15th anniversary on 26 January 2010.

 
2010-02-10

On January 14, 2010, the US Food and Drug Administration published a guidance that is intended to ensure the availability of medically necessary drug products (MNPs) during emergencies such as an influenza pandemic. The guidance cites the Center for Drug Evaluation and Research’s (CDER’s) definition of a medically necessary drug product as any drug used to treat or prevent a serious disease for which no appropriate substitute is adequately available.

 
2010-02-09

ICH's "Quality Implementation Working Group" offers in 2010 several Integrated Implementation Training Workshops for ICH Q8, Q9 and Q10.

 
 
Page 39/50    35   36   37   38   39   40   41   42   43   44