GMP News - Regulatory Affairs

11.05.22

Classification of Packaging Changes

Recently, the CMDh has added a recommendation for the classification of a proposed packaging change to the list of unforeseen variations ("Article 5 Recommendations"). What is the recommended category for a change of the “total thickness” for a blister foil?

11.05.22

How to Demonstrate Comparability of Analytical Procedures

A new Ph. Eur. Chapter 5.27. Comparability of alternative analytical procedures has been proposed in Pharmeuropa 34.2. The comment deadline is 30 June 2022.

10.05.22

What is a Pregnancy Prevention Programme?

The EMA has published the "Guideline GVP Module XVI Addendum III - Pregnancy prevention programme and other pregnancy-specific risk minimisation measures" for public consultation.

05.05.22

Update of the EMA Q&As on parallel Distribution of Medicinal Products

The so-called "Frequently asked questions about parallel distribution" for centrally authorised medicinal products were updated in April 2022 and published on the EMA website.

05.05.22

EDQM updates List of available Reference Standards

Also in March, the list of available reference standards, which comprises more than 3.000 substances, was revised - and the resulting changes, innovations and updates were listed in the newsroom of the EDQM website.

05.05.22

FDA publishes updated PQ/CMC Document for Comments

In March, the U.S. FDA published the draft of the "Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange document" for comments.

04.05.22

EMA´s Cannabis Glossary

The glossary summarizes existing scientific and legislative terminology relevant for medicinal products containing Cannabis-derived active substances. What is CBD oil and what is Cannabis oil?

27.04.22

Requirements for Styrene Block Copolymers

Following the previously published Ph. Eur drafts for COC / COP, a new Ph. Eur. chapter 3.1.18. Styrene block copolymers for containers and closures for parenteral preparations and ophthalmic preparations has been proposed in Pharmeuropa.

26.04.22

EDQM Survey: TOC to replace Test for oxidisable Substances in Sterile WFI

The EDQM has launched a survey on whether the test for oxidisable substances for sterilised water for injection (Sterile WFI) in the European Pharmacopoeia should be changed to a test for total organic carbon (TOC). Read more.

26.04.22

Product Transfer: Is a Transfer Plan a required GMP Document?

A frequently asked question in courses on product / technology transfer is: Is a transfer plan a required GMP document?

13.04.22

Still Issues with CBD Products

The FDA issued again Warning Letters to several companies for selling Cannabidiol (CBD) products with misleading product claims.

05.04.22

EDQM: Availability of Reference Standards

The EDQM (European Directorate for the Quality of Medicines & HealthCare) regularly updates the list of available reference standards on its website.

05.04.22

EDQM implements "Real-Time Remote Inspections"

Due to the Corona pandemic and the resulting changes in working conditions, a new type of inspection was needed in addition to classical on site inspections of API manufacturing facilities and paper-based GMP assessments. For this purpose, the pilot project for so-called "Real-Time Remote Inspections (RTEMIS)" was created.

05.04.22

MHRA GCP Inspector´s Experience during the COVID-19 Pandemic

The MHRA GCP Inspectors provided insight in their experience during the COVID-19 Pandemic. Although they have their limitations, remote GCP inspections have proven to be very effective and critical findings have been identified.

05.04.22

Recent Findings in GCP Inspections

The EMA published the Annual report of the Good Clinical Practice Inspectors’ Working Group (GCP IWG) containing examples of findings observed during recent GCP inspections. In addition, the 3-year work plan for the GCP IWG has been released.

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GMP News - Regulatory Affairs

Classification of Packaging Changes

How to Demonstrate Comparability of Analytical Procedures

What is a Pregnancy Prevention Programme?

Update of the EMA Q&As on parallel Distribution of Medicinal Products

EDQM updates List of available Reference Standards

FDA publishes updated PQ/CMC Document for Comments

EMA´s Cannabis Glossary

Requirements for Styrene Block Copolymers

EDQM Survey: TOC to replace Test for oxidisable Substances in Sterile WFI

Product Transfer: Is a Transfer Plan a required GMP Document?

Still Issues with CBD Products

EDQM: Availability of Reference Standards

EDQM implements "Real-Time Remote Inspections"

MHRA GCP Inspector´s Experience during the COVID-19 Pandemic

Recent Findings in GCP Inspections

Recommended Event

Setting Specifications and Acceptance Criteria - Live Online Training How to Achieve Regulatory Compliance for APIs, Biological Substances and Drug Products

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