GMP News - APIs and Excipients

09.03.22

Herbal Drugs: Concept Paper on GACP Revision Published

EMA´s HMPC published the concept paper on the revision of the guideline on good agricultural and collection practice for starting materials of herbal origin. Amongst others, the revision will address the need for clarification regarding GMP vs GACP.

more

09.03.22

Information Duties and Responsibilities of CEP Holders - the new EDQM Public Document

The EDQM has published a new public document on the relationship between marketing authorisation holders/applicants and CEP holders. Here you can find out which duties and responsibilities a CEP holder has to fulfil towards his clients.

more

02.03.22

FDA Warning Letter: Key Aspects of the ICH Q7 Guideline disregarded

In February 2022, the U.S. FDA issued a Warning Letter (WL) to an Indian drug manufacturing site called "Indiana Chem-Port" due to significant violations of cGMP regulations for active pharmaceutical ingredients (APIs).

more

24.02.22

ANVISA: Version 2 of the CADIFA Manual for APIs available

The second version of the "CADIFA Manual for Administrative Procedures" of the Brazilian Health Regulatory Agency (Anvisa) was published in June 2021 and needs to be followed for API dossiers.

more

23.02.22

How to keep up to date with GMP

How can you stay up to date with the ongoing changes in the GMP world? This question is frequently addressed during ECA courses and conferences. ECA´s weekly GMP Newsletter informs you about all relevant updates in the GxP arena.

more

16.02.22

EMA updates Questions and Answers Document

Do active substances for veterinary medicinal products have to fulfil the same GMP requirements for active substances for human medicinal products? This is just one of the new questions in the EMA Q&A document.

more

16.02.22

Herbal Drugs: Ph. Eur. Cannabis Monographs and other relevant Topics

EMA´s Herbal Medicinal Products Committee (HMPC) released the minutes for the HMPC meeting held in November 2021. Amongst others, the HMPC noted three new Ph. Eur. Cannabis Monographs for flowers and extracts in the pipeline. Other relevant topics were nitrosamines, GACP revision and elemental impurities in herbal medicinal products.

more

09.02.22

CMDh/HMA: Update of the Q&A List on Variations

A new version of the "Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008" was created in December 2021 and published on the HMA (Heads of Medicines Agencies) website.

more

09.02.22

Warning Letter: API Testing still in the Focus of the U.S. FDA

In January 2022, the U.S. FDA issued a Warning Letter to an Indian drug manufacturing site called "Aurobindo Pharmaceutical Limited" due to significant violations of cGMP regulations for active pharmaceutical ingredients (APIs).

more

09.02.22

Nitrosamine Drug Substance-related Impurities: FDA Recommendations for Minimising Risks through Formulation Design Changes

To prevent the formation of nitrosamines and establish an effective control strategy, it is necessary to consider all possible risks as comprehensively as possible. A communication from the FDA provides information on the risks that can arise from the formulation of the medicinal product and what needs to be considered when formulating a product. 

more

26.01.22

Inadequate OOS Investigations lead to FDA Warning Letter

Recently the U.S. Food and Drug Administration (FDA) issued a warning letter due to inadequate investigations into out-of-specification (OOS) test results.

more

26.01.22

USP: Analytical Instrument Qualification Stimuli published for Comments

Since the beginning of 2022, the stimuli document "Analytical Instrument and System (AIS) Qualification, to support Analytical Procedure Validation over the Life Cycle- PF 48(1)" has been published for comment on the USP Pharmacopeial Forum website.

more

25.01.22

Proposal for New General USP Chapter on Quality Attributes of Starting Materials for the Chemical Synthesis of Therapeutic Peptides

In the Pharmacopeial Forum, PF 48(1), a proposal for a new general chapter <1504> was published. According to the Expert Committee, the aim of the new chapter is to provide an overview of the minimum quality attributes required for starting materials used in the manufacture of synthetic therapeutic peptides.

more

25.01.22

Safety Assessment of Clinical Trials

To ensure effective and efficient safety assessment of clinical trials, the EU Commission published rules and procedures for the cooperation of the Member States. The new Regulation will become applicable on 31 January 2022 - together with the Clinical Trials Regulation (EU) No 536/2014.

more

19.01.22

USP Proposal for Contaminant Pyrrolizidine Alkaloids

A new USP chapter <1567> on pyrrolizidine alkaloids (PAs) is being proposed. It discusses some analytical methods and existing challenges to measure PA contaminants in herbal medicinal products.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics