GMP News - APIs and Excipients

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.

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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).

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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. 

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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.

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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.

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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.

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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.

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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.

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19.01.22

USP Draft Monograph for CBD

Because there is no existing USP monograph for this drug substance, a new monograph for Cannabidiol (CBD) is being proposed. It defines that CBD is obtained from Cannabis sativa.

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05.01.22

Q&As: China GMP and Registration of APIs

In December 2021, the ECA offered the Live Online Training "China GMP and Registration of APIs". During the Q&A sessions, many interesting questions were posed to the speakers' team.

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21.12.21

APIC: Update of the ICH Q7 "How to do" Document

The latest version (version 15) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for APIs was finalised and published on the APIC website in July 2021. It is also intended to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how to interpret it.

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21.12.21

Revised IPEC GDP Audit Guide for Pharmaceutical Excipients Available to the General Public

In September 2021, the International Pharmaceutical Excipients Council Federation (IPEC Federation) announced the availability of the revised IPEC Good Distribution Practices Audit Guide for Pharmaceutical Excipients (Version 3, 2021). After the guide was initially only accessible exclusively to IPEC members for three months, the document was now made available to the general public.

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21.12.21

GDP for Veterinary Medicinal Products: Implementing Regulation (EU) 2021/1248 of 29 July 2021

In August 2021, the new Commission Implementing Regulation (EU) 2021/1248 on measures on good distribution practice for veterinary medicinal products entered into force. Read more in the summary of the most important aspects of the new document.

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15.12.21

CEPs: New IT Application of the EDQM

In October 2021, the EDQM established a new IT application for handling and managing CEP applications. This resulted in some innovations and changes, especially in the communication between the applicant and the EDQM. This in turn led to updates in the related documents and guidelines.

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23.11.21

GDP for APIs used as Starting Materials in Veterinary Medicinal Products: Implementing Regulation (EU) 2021/1280 of 2 August 2021

The Commission Implementing Regulation (EU) 2021/1280 lays down the good distribution practices for active substances used as starting materials in veterinary medicinal products. It applies to importers, distributors, and manufacturers. The Regulation has been binding since August 2021 and is directly applicable in all Member States. We have summarised the most important requirements of the new Regulation.

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