EU GMP Annex 1 released

The EU Commission has published their long-awaited revision draft of Annex 1 "Manufacture of Sterile Medicinal Products".

About The Annex 1 Conference

European GMPs and the Role of the QP

Understand the European approach and the legal framework – and get familiar with the unique roles and responsibilities of the EU QP.

Learn more

Acknowledged GMP/GDP Certification

Highly qualified personnel is crucial in the pharmaceutical industry. The ECA Certification scheme with 14 continuous education programmes trains you adequately.

Read more

GMP/GDP Training Matrix

GMP/GDP Training Matrix

Are you looking for certain GMP/GDP Training Courses? The GMP/GDP Matrix will help you find your training course.

Find out more

ECA WebAPP – standing out, outstanding

The ECA WebApp lets you have all GMP/GDP information at hand – anytime, anywhere.

Read more

Latest GMP News

Jan 23

Five new Warning Letters - Four Batch Record Review Citations ...

Data integrity is for sure still a hot topic in inspections. But it seems inspectors are getting more back to the roots: document and batch record design and review.

More

Jan 23

FDA publishes Draft Guideline on Use of Nanotechnologies for Biological Medicina ...

The FDA expands their guidelines regarding the use of nanotechnologies with a draft on the topic "Drug Products, Including Biological Products, that Contain Nanomaterials".

More

Jan 23

Revision of USP chapter on NIR ...

Besides IR and Raman, NIR is frequently used in the inspection of incoming active ingredients and excipients. New suggestions for updating the two NIR chapters were issued in the USP's Pharmacopeial Forum. Please find more information on the changes to the USP chapters <856> and <1119> on near-infrared spectroscopy.

More

Jan 23

PSURs: EMA revises Post-Authorization Procedural Advice ...

The EMA recently revised its post-authorization procedural advice for users of the centralized procedure. Read more about new and revised Q&A´s concerning Periodic Safety Update Reports (PSURs).  

More

Jan 23

Bizarre Warning Letter to Chinese Drug Manufacturer ...

Over the past months, the ECA reported about the growing number of Warning Letters issued to Asian companies. A recent FDA Warning Letter resulted in a ban on imports for a Chinese manufacturer of pharmaceutical products.

More

Jan 17

New Annex 1: Consequences for the QP ...

The new  draft of Annex 1 (Manufacture of Sterile Medicinal Products) will be much more extensive and contain some new rules and additions. There are also some things in the Annex 1 draft QPs need to consider.

More

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK