GMP News

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.

More

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.

More

Bioburden - Question and Answers on Biopharmaceutical Manufacturing

Questions - and answers about Bioburden. A first excerpt of the most important questions during the ECA Bioburden Workshop.

More

Comments on the new ICH Q9 Guideline Q9 (Quality Risk Management) published

The comment period for the draft revised ICH Q9 Guideline Q9 (Quality Risk Management) published in December ended in March. Now the feedback has been published.

More

Brexit: Legal Proposals adopted on the Supply of Medicines in Northern Ireland, Cyprus, Ireland and Malta

The European Parliament and Council agree to proposals from the EU Commission to ensure the continued supply of medicines to Northern Ireland, Cyprus, Ireland and Malta. Both a directive and a regulation are now in place.

More

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?

More

Numerous GMP Deficiencies at OTC Manufacturer in Puerto Rico

The USA FDA has issued a Warning Letter to a pharmaceutical manufacturer for failing to adequately address numerous deficiencies identified during an inspection.

More

Revised Technical Guide for Metals and Alloys

Currently there are no compendial standards available for metal packaging systems for pharmaceutical use. Thus any other guidance providing information on metal components like the revised EDQM technical guide “Metals and alloys used in food contact materials and articles” can be useful.

More

News on the various Mutual Recognition Agreements (MRAs)

The new annual report of the GMP/GDP Inspectors Working Group has been published and gives a brief but good overview of what is new in 2021. There has also been movement on the MRA with the USA.

More

FDA Warning Letter: Testing into Compliance using Unvalidated Test Methods

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to an American drug manufacturer. The company retested failing lots with unvalidated test methods until passing results were obtained. Other deficiencies concern the cleaning validation, the stability program and HPLC data integrity.

More

FDA sends Warning Letter to EU Company after Remote Evaluation

A pharmaceutical company in Poland received a Warning Letter from FDA without ever having been inspected on site. It was issued purely on the basis of a remote evaluation.

More

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.

More

What are the GMP Requirements for Airlocks?

Without airlocks between cleanroom areas of different cleanroom classes, no flow of material or personnel would be possible. But what are the GMP or purity requirements for airlocks?

More

Revision of Chapter 2.6.7 of the European Pharmacopoeia published for Comment

After about 10 years, the EDQM has now published a draft revision of Chapter 2.6.7 on mycoplasma testing, which will be available for comment until the end of June.

More

FDA Warning Letter due to GMP Violations when handling OOS Results

During an inspection, FDA inspectors look closely at how quality control handles analytical data that deviates from the specification. Find out what is important to consider when handling OOS results, verifying test methods and checking electronic data.

More

FDA Warning Letter: No Quality Unit, No Thorough Investigations and No Stability Program

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a Californian firm that utilizes Contract Manufacturing Organizations (CMOs) to manufacture nasal spray products. The FDA criticises the lack of a quality unit (QU), an insufficient investigation into microbial contamination and an inadequate stability program.

More

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.

More

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?

More

Overview of the Incoterms Rules

The Incoterms rules are frequently used in international and domestic contracts. In this article, you will get an overview of the Incoterms 2020 and their meaning.

More

MHRA Releases New Version of the Green Guide

The 2022 edition of the Rules and Guidance for Pharmaceutical Distributors (the "Green Guide"), compiled by the Medicines and Healthcare products Regulatory Agency (MHRA), was published. It provides an authoritative source of European good distribution practices and UK guidance, information and UK legislation on these activities.

More

MHRA Releases Recording of the Medicines Supply to Northern Ireland Webinar

On either 02 or 03 February 2022, interested parties could take part in a live webinar of the Medicines and Healthcare products Regulatory Agency (MHRA) on Medicines Supply to Northern Ireland. A recording of the webinar, excluding the Q&A sessions, was now published.

More

FDA Guidance for Chimeric Antigen Receptor (CAR) T Cell Products

With a draft guidance for the development, manufacture and control of chimeric antigen receptor (CAR) T cell products, the FDA is expanding its recommendations for advanced biological products and providing further guidance to developers and manufacturers.

More

FDA revises Recommendations on Investigational COVID-19 Covalescent Plasma

The FDA has already updated its recommendations on handling plasma donations from COVID-19 diseased donors several times. Recently, a new update of the Guidance for Industry Investigational COVID-19 Convalescent Plasma was published.

More

Genome Editing in Gene Therapy - FDA Draft Guidance for IND

Gene therapies are becoming increasingly important. One method is the so-called genome editing. The FDA has published a draft guidance for Investigational New Drugs (IND) for these Gene therapy products.

More

FDA updates Information on Bacterial Contamination of Platelets for Transfusion

In December, the FDA updated its important information for blood establishments and transfusion services on bacterial contamination of platelets for transfusion, which has been published since 2016.

More

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics