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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

 

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News about GMP/cGMP

2015-05-08

Following a three years period since publishing the “Biologics Price Competition and Innovation Act” and therein the “Approval Pathway for Biosimilar Biological Products”, the FDA has now finalized the following three guidance documents on Biosimilars:

Guidance for Industry - Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

Guidance for Industry - Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

Guidance for Industry - Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.

 
2015-04-27

For many years now, discussions have been ongoing as to whether it is possible to include non-distillation technologies as a method for the production of Water for Injections (WFI). Following a number of consultations with its stakeholders, the Ph. Eur. is proposing a revision of the monograph for Water for Injections (0169) to take into account current manufacturing practices which use methods other than distillation to produce water of injectable quality. The draft of the monograph foresees production of WFI also by reverse osmosis, which may be single-pass or double-pass, coupled with other suitable techniques such as deionisation and/or ultrafiltration.

 
2015-04-21

As announced on the website of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the PIC/S Committee, by written procedure, has adopted the revision of Annex 15 of the PIC/S GMP Guide. The document will enter into force on 1 October 2015, simultaneously to the EU revision of Annex 15.

 
2015-04-08

The currently valid version of the EU GMP Guide  Annex 15 “Qualification and Validation” from 2001 will finally be replaced by 1 October 2015. This is when the now published revised Version of Annex 15 will enter into force. An update was more than necessary. Not only the new principles of ICH Q8, Q9, Q10 and Q11 constituted a new regulatory environment but also a continuous updating of Chapters of Part I of the EU GMP Guide or Annex 11 (computerised systems). Another important document to be mentioned in connection with the new Annex 15 is the EMA guidance on process validation. The changes now reflect the changed regulatory requirements and the latest state of technology in the pharmaceutical industry.

 
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.

 
2015-01-30

New versions of Chapter 3 (Premises and Equipment) and Chapter 5 (Production) have been published providing transitional arrangements for toxicological evaluation. The chapters are otherwise unchanged – apart from an editorial correction of footnote 2 in Chapter 5 – and become operational on 1 March 2015 for all other aspects.

 
2015-01-23

China’s Food and Drug Administration (CFDA) has issued the country’s first Good Supply Practices (GSP) regulations that apply to all Class 1, 2 and 3 medical device distributors, as well as third-party logistics service providers for medical devices.

 
2015-01-23

China’s Food and Drug Administration (CFDA) has revised the Good Manufacturing Practice for Medicinal Devices in accordance to the newly revised Regulations for the Supervision and Administration of Medical Devices and Administrative Measures for the Supervision of Medical Device Manufacturing.

 
 
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