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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

 

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News about GMP/cGMP

2013-10-09

The FDA is announcing the availability of a draft guidance for industry entitled ANDA Submissions—Refuse-to-Receive Standards.” This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) The guidance describes what should be included in these submissions and highlights serious deficiencies that may cause FDA to refuse to receive an ANDA.

 
2013-10-09

With the beginning of this month, the FDA has published the following two updated lists of GMP guidelines:

 
2013-10-01

After more than a year delay, IPEC India is expected to be created by the end of the year. IPEC-Americas’ vice chair confirmed that the registration process is moving forward. Due to difficulties concerning the naming of the organization the formation could not be realized in 2012.

 
2013-10-01

On 24 September 2013, the European Commission adopted two measures to improve the safety of medical devices. The new rules are:

  • A Commission Implementation Regulation clarifying the criteria to be met by notified bodies, which are responsible for inspecting manufacturers of medical devices, and
  • A Recommendation clarifying the tasks these bodies have to undertake when they perform audits and assessments in the medical devices sector.
 
2013-09-16

The European Commission has published the final version of the revised Chapter 2 on Personnel. Changes have been made in order to integrate the principles of “Pharmaceutical Quality System” as described in the ICH Q10 tripartite guideline. Furthermore, a section on consultants has been added.

 
2013-09-16

The number of PIC/S members is constantly growing. According to PIC/S, Hong Kong SAR’s Pharmacy and Poison Board has applied for PIC/S membership. Rapporteurs for this accession will be appointed at the next PIC/S Committee Meeting in Ottawa in October.

 
2013-08-23

The Falsified Medicines Directive (FMD) has now been transposed into UK legislation and came into force on August 20, 2013. The FMD (Directive 2011/62/EU) introduces a series of measures to prevent the entry of falsified medicines and substandard raw materials into the legal supply chain, including stricter rules on the controls and inspections of producers of active pharmaceutical ingredients (APIs), intensified record-keeping requirements for wholesale distributors, and a common EU-wide logo to identify legal online pharmacies.

 
2013-08-23

FDA is announcing the start of the Secure Supply Chain Pilot Program (SSCPP) in order to assist the Agency in its effort to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the FDA to focus its resources on imported drugs that fall outside the program and may pose risks.

 
 
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