From Batch to Continuous Processing

How can a continuous process be kept in a controlled state and how is it validated? How should deviations in a continuous process be handled? The conference "Continuous Manufacturing", in Berlin from 4-5 December 2019 will answer those questions and cover OSD and Biotech manufacturing.

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Weekly GMP Newsletter

NEW SERVICE: the weekly Newsletter is now available here.

Read the GMP Newsletter dated 13.11.2019

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.

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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.

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ECA – Your GMP/GDP Information Source

With news, trainings and conferences, a comprehensive guidelines database, publications and more the ECA is the leading European training and information services provider in the GMP and GDP environment.

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Latest GMP News

Nov 13

Batch Release without Determination of Identity and Strength and other GMP viola ...

FDA's Warning Letters provide a valuable source of detailed information and can be helpful in preparing for an inspection, making a more detailed analysis worthwhile. Read more here about what FDA inspectors have discovered in recent months regarding frequent weaknesses at GMP-liable pharmaceutical manufacturers.

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Nov 13

Data Integrity for Analytical Instruments connected to a LIMS via a Middleware ...

The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 6: How can I handle analysis devices that are connected to a LIMS via a middleware? The manufacturer does not allow access to the original data in the automated analyser though.

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Nov 13

FDA works on regulatory pathways for CBD products ...

Cannabidiol (CBD) is currently marketed in a variety of product types, such as oil drops, infused pouches, capsules, syrups, teas and topical lotions and creams. Therefore, the FDA is working on the evaluation of regulatory policies related to cannabis and cannabis-derived ingredients.

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Nov 06

Another FDA Warning Letter for inadequate CAPAs ...

Deviations and CAPAs are still hotly debated topics in GMP inspections. This is shown once again by a recent FDA Warning Letter.

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Nov 06

General requirements for Plastics in Pharmaceutical Engineering ...

The main material used in plant engineering is stainless steel. The variant 316L is regarded as standard; material incompatibilities of steel with the product play almost no role. This is different for plastics. Beside the leach-out, ageing and surface finishing, other quality features are often specified. Now, what are the general requirements for plastics in pharmaceutical plant engineering?

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Oct 30

Data Integrity Violations detected by the FDA at US Company ...

Besides several Quality Unit related failures, a Warning Letter of the U.S. FDA mentions an enormous number of Data Integrity violations. Here you can read the remedations expected by the FDA.

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