GMP News

Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 3: What are the reasons for choosing the particular cloud model (private cloud, community cloud, public cloud)?

There is currently an ongoing discussion about the microbiological quality requirements for medical Cannabis depending on the route of administration. To move forward authors from the FDA recently published an article about a microbiological study of bulk Cannabis.

The Chemical Analysis Expert Committee intends to revise the USP General Chapter <621> Chromatography. Changes to the subsection on the signal-to-noise ratio are planned.

The USP chapter "<1467> RESIDUAL SOLVENTS-VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES" refers to the information provided in chapter <467 RESIDUAL SOLVENTS> and has thus now also been updated. The new draft has already been published on the website of the Pharmacopeial Forum of the USP and can be commented on until 31 March 2023.

The U.S. FDA published a draft guidance on the dosage and administration labeling section for certain medicinal products. The guidance is one of several FDA guidance documents addressing labeling for human prescription drugs.

In a 3.5 pages position paper, Notified Bodies have presented their views on hybrid audits of medical device and IVD manufacturers. What does it say?

Is it acceptable that storage conditions are not monitored for medicinal products which do not have any predefined storage conditions on the outer packaging? This is one of three new questions answered by the European Medicines Agency (EMA) on its website. The other two questions relate to the activities of brokers with parties outside the EEA.

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a drug repackaging and relabeling facility located in Pennsylvania. The document summarizes significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). It also addresses Good Distribution Practice (GDP) aspects.

If the outcome of an inspection is that the wholesale distributor does not comply with Good Distribution Practice (GDP), a statement of non-compliance may be entered into EudraGMDP. We have prepared an overview of the GDP Non-Compliance Reports published in 2022 and the respective reasons for issuing these reports.

Already in 2018, the ICH had started working on a Guideline entitled "CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS - Q13". A draft was published in mid-2021. Now ICH has approved the final version.

The EMA published an updated Q&A document regarding the new ICH M10 guideline on Bioanalytical Method Validation and Study Sample Analysis. The document became effective on 21 January 2023.