GMP News - Quality Assurance

07.10.20

Free Access to FDA 483s

FDA's Office of Regulatory Affaires (ORA) is publishing electronic copies of various inspection and related records on their websites.

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07.10.20

How Extensive is GMP and GDP Training in the Pharmaceutical Industry: Survey Results

In the course of a survey in the GMP/GDP environment, about 200 questionnaires were filled out. The aim of the survey was to record the current status of the implementation of GMP/GDP training measures in the pharmaceutical industry. Read more here about the results of the survey on GMP/GDP training.

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30.09.20

FDA clarifies "Intended Use"

The U.S. FDA revised the text of their "intended use regulation" to provide additional examples and explanation. In particular clarity is provided by describing examples of types of evidence the agency would consider relevant to determining the intended use of a product. 

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30.09.20

2-Step Process for Implementation of Pharmacopoeial Procedures

A new Ph. Eur. draft chapter 5.26 proposes a two step implementation process for the use of pharmacopoeial procedures.

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30.09.20

Drug Shortages: a European Solution at Last?

The European Parliament wants the European Union to become more independent with regard to pharmaceuticals and medical devices. A report on this has now been developed and adopted.

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30.09.20

What happens when Product is delivered before Release?

A Warning Letter was sent to a company who shipped product without a release.

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23.09.20

Nitrosamine Impurities in Medicinal Products and APIs - the New FDA Guidance

The new FDA Guidance for industry reflects the current state of knowledge regarding nitrosamine impurities. Read more here about what measures the FDA expects from medicinal products and API manufacturers to take to mitigate the risk of nitrosamine contamination.

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23.09.20

Inspection Report: What Inspectors are looking for

Roughly 10% of deficiencies raised by MHRA inspectors were directly attributable to poor investigations. So what do inspectors observe?

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23.09.20

What are FDA's Requirements for Pharmaceutical Quality - YouTube Videos give Answers

The FDA presented its requirements for pharmaceutical quality, including quality assurance aspects in a webinar. This webinar focused on stakeholders in the pharmaceutical supply chain worldwide. The presentations are available as YouTube videos.

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23.09.20

Herbal Medicinal Products: HMPC's Statement on Pyrrolizidine Alkaloids

The Herbal Medicinal Products Committee (HMPC) of the EMA has published the draft of the updated public statement of the HMPC on pyrrolizidine alkaloids (PAs). The document contains, among other things, the limits for the maximum daily intake of PAs.

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16.09.20

FDA Feedback on Combination Products

There is a draft guideline on combination products describing the ways in which a sponsor can communicate with the FDA during the development of a combination product. What does it say?

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14.09.20

Eurasian Pharmacopoeia Available

The Eurasian Economic Commission published Volume 1 of the EAEU Pharmacopoeia. This Volume contains 157 general texts and general monographs.

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14.09.20

Corona: What measures have Governments taken in the Life Sciences Sector?

Governments have been implementing different emergency measures in the fight against the current pandemic. Now an overview of the various measures in the EMEA region has been published.

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14.09.20

Warning Letter: FDA criticises Missing Re-Validation

The FDA has recently issued a Warning Letter to criticize, among other things, the lack of revalidation at a pharmaceutical manufacturer. At first sight, this seems surprising, as it replaces stage 3 of the process validation lifecycle, the Continued Process Verification, the periodic re-validation that was common in the past (exceptions are made in the sterile area). What are the reasons for FDA's request?

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14.09.20

Inspection Observations on Supplier Qualification because of Inspection at Supplier

A US company received an FDA Warning Letter because of problems at their CMO that were not detected in time.

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