GMP News - Quality Assurance

20.04.16

Position Paper on QP Qualification published

The German Qualified Person Association (GQPA) has developed a position paper with own proposals to help shape the requirements on the qualification of Qualified Persons.

06.04.16

The new Annex 16 is coming into Force

The new Annex 16 "Certification by a Qualified Person and Batch Release" will become effective as of 15 April 2016. The contents will reflect the coming state of expectations regarding the batch release.

31.03.16

QP Education and Qualification - What is needed?

We are frequently asked about the educational requirements in order to become a Qualified Person in Europe. Comprehensive educational modules are offered, especially in the UK. These training courses contain different topics like pharmaceutical law, Microbiology, Quality Management etc and require the trainee to take part in multiple courses over an extended period. But is this needed to become a QP in Europe?Read more about QP education and qualification.

17.02.16

Should Equipment Status Identification Labels be retained with the Batch Record?

Keeping equipment status identification labels with the batch record provides additional confirmation during the review process. But is it required?

10.02.16

Outlook: What will bring the GMP Year 2016?

The past year was a quite eventful year - with new GMP developments as well as with announced changes. This year won't be less exciting, also because now many of the new requirements must be implemented; and also novelties have to be expected. In this news, we have compiled an outlook.

03.02.16

The GMP year 2015 - what was new in the EU?

The previous year 2015 was another eventful year. Again there were new developments in the GMP environment as well as announcements of changes that preoccupied the pharmaceutical industry. Read more in our overview about GMP regulations in 2015.

20.01.16

Best Practice Guide for Quality Agreements published

The Rx-360 Supplier-Led Working released a Best Practices for Quality Agreements Guide aiming to identify best practices as well as common sense solutions to the quality agreement process.

23.12.15

What are FDA's 2016 Priorities?

FDA's Center for Drug Evaluation and Research (CDER) has published an overview on the forthcoming priorities.

09.12.15

Identification of Medicinal Products Standards will apply in six Months

The pharma sector must comply with IDMP standards in the EU region starting July 2016. This provides regulators with the means of easily comparing product data across regions and with different manufacturers.

02.12.15

The QP Declaration: some Questions remain open

More than one year after the final guidance on the QP Declaration was published, some questions remain open or are frequently asked by the stakeholders. The most important ones have been summarised in a CMDh document.

14.10.15

Finally published: new Annex 16 on QP Certification and Batch Release

The European Commission finally has published the new EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release".

16.09.15

EDQM Clarification for Products outside the Scope of ICH Q3D

The requirements described in the ICH Q3D Guideline on testing for metal impurities do not apply to all pharmaceutical products. In its latest press release for products outside the scope of ICH Q3D, the EDQM clarified what manufacturers of these preparations, e.g. manufacturers of veterinary medicinal products, still need to be aware of.

16.09.15

Lack of Supplier Qualification leads to Recall

An antibiotic had to be recalled in Germany as a supplier was not originally qualified. This was announced by the manufacturer in a press release.

09.09.15

EU: New GMP Implementing Act published

The EU Commission has published a new public consultation on an Implementing Act on GMP principles and guidelines for medicinal products for human use.

02.09.15

What is new with regard to Warning Letters for Medical Device Manufacturers?

The ECA regularly evaluates the FDA Warning Letters. What is new in the first half of the 2015 fiscal year (1 October 2014 to 31 March 2015)? The answer is actually nothing. Actually? Find out more about the current specifically medical devices related developments in the top 5 list.

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