Good Distribution Practices News

26.09.18

Version 10 of EU Q&As on Safety Features: Specific Questions on Bundle Packaging

The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission released version 10 of the questions and answers catalogue on safety features in July 2018. The specific question of bundle packaging has also been addressed. Get more information about bundle packaging in EU's Q&A document on the safety features.

more

26.09.18

"Ambient", "Room Temperature", "Cold " - what is what?

What are the regulatory requirements behind "ambient", "room temperature" and "cold chain"? The answer to the meaning of different storage conditions is not that easy.

more

25.09.18

New Q&As on Chapter 3 of the EU-GDP Practice Guide (Premises and Equipment)

The European GDP Association has published new Question & Answers on Chapter 3 of the EU-GDP Guide (Premises and Equipment).

more

25.09.18

Regulatory Expectations for Contract RPs

For some wholesalers, the concept of using an external Responsible Person might be useful. But there a few things which need to be considered.

more

19.09.18

CMDh Clarifications on the Implementation of the Falsified Medicines Directive

In April 2018, the CMDh published a document to clarify questions which arose from the original Q&A document dated March 2017 on the implementation of the Falsified Medicines Directive. Read more about the document "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".

more

15.08.18

EMA: More GMP/GDP Inspections performed

Almost 2.500 GMP inspections were performed last year by EU/EEA inspectors. And still many of them in the US.

more

02.08.18

What makes a good RP?

In its blog the Medicines and Healthcare products Regulatory Agency (MHRA) explains what the UK authority expects from a Responsible Person: knowledge, experience, training.

more

02.08.18

No Monitoring needed if there are no Storage Conditions on the Outer Packaging?

The question on monitoring requirements for packaging with no storage condition information was the first GDP-related question being published along with an answer in the Q&A Section of EMA's website.

more

02.08.18

PIC/S implements EU-GDP for APIs

PIC/S adopt EU GDP principles of GDP for active substances for PIC/S purposes.

more

01.08.18

Import vs. Manufacturing: Any Differences in the EU?

What does it mean that, in the European Union (EU), all of the requirements for and obligations of Manufacturing Authorisation holders (MIAHs) also apply to importers?

more

20.06.18

2D Matrix Codes: which countries are already connected to the European Hub?

There is not much time left until the safety features have to be implemented. These features are required to comply with the Falsified Medicines Directive, which will enter into force on 9 February, 2019. Meanwhile, a number of national data storage and retrieval systems have joined the EU Hub, as the European Medicines Verification Organisation (EMVO) reported.

more

20.06.18

Product tracing - new FDA requirements

The FDA has published a draft guidance which is to standardise the data traceability of products. Find out how long traceability data for products need to be stored according to the new FDA guideline "Standardization of Data and Documentation Practices for Product Tracing".

more

14.06.18

GDP: Are Inspectors looking for Data Integrity?

Data Integrity is still a hot topic in GMP inspections. And in the GDP area data integrity is also increasingly becoming a subject, as some examples from the MHRA show.

more

14.06.18

Fertility Drugs stolen in Italy

More than 16.000 packages of fertility drugs were stolen in Italy when a truck was hijacked.

more

14.06.18

IMPs: Applicability of the GDP-Guidelines

A new draft EMA Guideline requires that GDP-Guidelines for medicinal products should be taken into consideration for IMP shipments.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics