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GMP PUBLISHING PEITHER INC.

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We provide expertise and know-how for all GMP topics and facilitate the implementation of GMP for all partners in industry and regulatory authorities. Our publications close the gap between GMP regulations on the one hand and the fulfilment of requirements in practice on the other. Good Manufacturing Practice (GMP) should be better and easier to realise for the readers. 

Customer needs are in the center of our efforts, resulting in sustainable and successful relationships with our clients. GMP-Verlag Peither AG serves as a platform for GMP knowledge and has become a trusted partner for all GMP related questions and publications. 

In 2006, we first released the knowledge portal GMP Compliance Adviser, which is updated 8-10 times a year. With this online tool - now being sold in over 70 countries, we serve customers in the pharmaceutical industry worldwide. 

In collaboration with over 80 authors from Europe and the US, GMP-Verlag Peither AG enables the achievement of GMP requirements around the world.

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MHRA: Risk-Based Resumption of On-Site Inspections in September
After the US FDA already announced the gradual resumption of on-site surveillance inspections in May (we reported), the MHRA is now also...

WHO: Three New Draft Guidelines Published
The World Health Organisation (WHO) has published three new draft guidelines, which are currently available for comments. In September 2020, all...

EMA: New Guideline on the Quality of Water for Pharmaceutical Use
On 20 July 2020, EMA published the final 10-page Guideline on the quality of water for pharmaceutical use. The date of entry into force will be...

EMA: New Q&A on Nitrosamine Impurities for Marketing Authorisation Holders
Shortly after the publication of the EMA's final assessment report on nitrosamine impurities in medicinal products (we reported), a 15-page Q&A...

EMA: MRA Partners May Participate in JAP Audits As Co-Auditors
As of July 2020 the EMA (European Medicines Agency) has amended the European "Joint Audit Programme, JAP". These adaptations enable regulatory...

Nitrosamines: Lessons Learnt From Sartan Medicines
On 23 June 2020, the European medicines regulatory network published the outcome of a lessons learned exercise on the presence of nitrosamines...

WHO: Three New Draft Guidelines for Commentary
In May 2020, the WHO published the following three drafts for commentary: Objective: The document aims to promote a more efficient approach to...

WHO Publishes Technical Report Series No. 1025, 2020
The WHO Expert Committee on Specifications for Pharmaceutical Preparations meets annually and their reports (Technical Report Series) include...

EMA: Update of Q&A on Flexible Regulatory GMP/GDP Requirements During COVID-19
A second revised version of the Q&A document was published on May 26, 2020. A new block of questions (sub-point 6) with six questions and...

US FDA: Gradual Restart of Surveillance Inspections
The US FDA is planning a gradual re-start of on-site surveillance inspections in cooperation with the Centers for Disease Control and Prevention...

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King of Prussia, PA, 19406
United States
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