GMP News

A proposed monograph for Cannabis Species Inflorescence has been published in the USP Herbal Medicines Compendium (HMC). It is open for public comments for 90 days.

In September 2022, the documents "IRIS guide for applicants" and "IRIS guide to registration and RPIs" were updated again - now containing some innovations and revisions.

Following the recently introduced new Ph. Eur. chapter 5.26 Implementation of pharmacopoeial procedures, the EDQM published some examples to provide users with practical guidance. How can the critical factors potentially affecting the analytical procedure performance be identified?

A revised general chapter 2.2.46. Chromatographic separation techniques has been published in Ph. Eur. 11.0. The implementation date is 01 January 2023. Due to numerous queries received through the EDQM HelpDesk, selected questions and answers have now been published. These complement the series of existing FAQs dealing with the European Pharmacopoeia and international harmonization.

As of early September 2022, the Stimuli Document "Analytical Instrument and System (AIS) Qualification: The Qualification Life Cycle Process" has been posted for comments on the USP Pharmacopeial Forum website.

To facilitate FDA’s internal tracking of submissions that include real-world data (RWD), the agency published a guidance on how to identify the use of RWD in submission cover letters.

The FDA addresses inquiries from stakeholders related to Good Clinical Practice on an ongoing basis and has now published responses to questions received from 2017 to 2021. One of the interesting questions asks: Is it possible to have a Remote Location ("satellite site")?

A proposal for USP chapter <1079.4> Temperature Mapping for the Qualification of Storage Areas has been published for comments in the Pharmacopeial Forum, PF 48(5). It will apply to every link in the supply chain, such as manufacturers, wholesale distributors and third-party logistics providers. The new chapter should be viewed in the context of the United States Pharmacopeia's (USP) efforts to build out the <1079> series of chapters on Good Storage and Distribution Practices.

The competent authority of Germany (Thuringian State Authority for Consumer Protection) has entered a new GPD Non-Compliance Report dated 21 July 2022 into the EudraGMDP database. The wholesale distribution authorisation (WDA) of the company concerned was suspended. Among other things, the authority criticized the lack of a GDP-compliant quality system.

Bracketing approaches are certainly allowed in the context of cleaning validation. First, for the products themselves, so that a "worst case" substance can be used for validation, second, for devices of the same design, the effort can be reduced by bracketing. In this way, a device can be selected. So how to define these "worst cases"? Read more here about FDA's view on this.

The Brazilian Health Regulatory Agency, ANVISA, published answers to questions received during a webinar on clinical research with medicinal Cannabis held in May this year. One of the important questions addressed is: How can batch reproducibility be demonstrated?

The FDA published now a guidance document on Instructions for Use (IFU) labeling. What is the recommended font and font size?