• 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

 

>>> REGISTER for our free GMP Newsletter LOGFILE

Image

TOP 5 GMP Downloads

1. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.

 

2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.

 

3. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.

 

4. Technical Agreement
and Delimination of Pharmaceutical Responsibilities.

 

5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance

 

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

2015-04-01
 
2015-03-26

On 20 March 2015 the WHO has published a report on substandard/spurious/falsely-labelled/falsified/counterfeit medicinal products (SSFFCs). The report was developed during a Member State Meeting on SSFFC in October 2014 in Geneva, Switzerland. It includes recommendations for health authorities to detect and deal with actions, activities and behaviours that result in SSFFCs.

 
2015-03-13

In November 2014 the ICH Steering Committee endorsed an Implementation Working Group (IWG) tasked to develop a Questions and Answers document on ICH Q11 – Development and Manufacture of Drug Substances.

 
2015-03-06

The U.S. Food and Drug Administration (FDA) has published their yearly list of new and revised draft guidances CDER is planning to publish in 2015. The guidances are categorized in 14 different themes - from A (Advertising) to P (Procedural).

 
2015-03-06

EMA has published the work plan of the GMP/GDP Inspectors Working Group for 2015. The plan covers the different tasks of the group, e.g. harmonisation of inspections, mutual recognition agreements (MRAs) (maintenance, extension of scope) and GMP/GDP topics.
The list of GMP documents for revision contains the usual suspects – like Annex 15, but also the totally new Annex 21 on importation of medicinal products.

 
2015-02-25

The U.S. Food and Drug Administration (FDA) issued five draft documents related to drug compounding and repackaging to help entities in complying with important health provisions. The draft documents apply to outsourcing facilities, federal facilities, pharmacies and physicians. The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013.

 
2015-02-11

The European Medicines Agency (EMA) has released a Concept Paper on the Revision of Annex 1 of the Guidelines on Good Manufacturing Practice – Manufacture of Sterile Medicinal Products which addresses the need to update Annex 1 of the European GMP Guide. Annex 1 is common to the Member States of the European Union/European Economic Area as well as to the participating authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

 
2015-01-30

FDA has released a draft of the Guidance on cGMP requirements for combination products. The document is far more comprehensive than the actual version of 21 CFR 4 and consists of 46 pages.

 
 
Page 1/53    1   2   3   4   5   6   7   8   9   10