GMP NEWS 2023

First Electronic Product Information (ePI) for Human Medicines

The EMA recently announced that the Heads of Medicines Agencies (HMA), the European Commission (EC) and the EMA have published for the first time electronic product information (ePI) for selected human medicines harmonized across the European Union (EU). Does this mean the end of the printed package leaflet?

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Falsification of Ozempic Confirmed

Following the recent concerns that falsified batches of Ozempic® may have entered the market, the Official Medicines Control Laboratory (OMCL) Chemisches und Veterinäruntersuchungsamt (CVUA, Karlsruhe, Germany)  has determined that suspected batches of Ozempic® pre-filled pens contained insulin glulisine instead of the claimed active substance, semaglutide.

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Clinical Trials Regulation - Version 6.6 of the Q&As

The European Commission (EC) published an updated Version 6.6 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). Amongst others, a new question on radiopharmaceuticals has been added.

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FDA issues draft Guidance on Confirmatory Evidence of Clinical Trials

The Confirmatory Evidence guidance supplements and expands the recommendations in the 2019 Substantial Evidence of Effectiveness draft guidance by providing further detail on the use of data drawn from one or more sources (e.g., clinical data, mechanistic data, real-world data).

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Further Warning Letters after Remote Evaluations by FDA

Two pharmaceutical companies had received a Warning Letter from FDA without ever having been inspected on site. This was purely on the basis of a remote evaluation.

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China tightens Counterespionage Law - Risk for Audits and Inspections?

China has passed a revised counter-espionage law that extends the powers to combat espionage. This increases the legal uncertainty for GMP inspections and audits.

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FDA Warning Letter: Inadequate Testing of BZK and Many General GMP Violations

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. Beside a whole series of general GMP violations, the authority in particular blames the company for failing to test the incoming component benzalkonium chloride (BZK).

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Swissmedic Clarifies GMP Requirements for Formula Drugs

The Swissmedic recently clarified some requirements for the manufacture and marketing of formula drugs (e.g. "Formula magistralis" medicinal products) by issuing an updated version of their corresponding guidance document. The guideline is the basis for "GMP inspections for formula drugs" carried out by the cantonal inspectorates and Swissmedic.

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New Ph. Eur. Cannabis Reagents

Following the previously pre-published Ph. Eur. Cannabis Flower Monograph and the announced Ph. Eur. CBD Monograph, four new Ph. Eur. cannabis reagents are needed for quality control purposes. The description of these Cannabis reagents will be published in the European Pharmacopoeia (Ph. Eur.) Supplement 11.5.

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Medical Cannabis - FDA's Perspective on Research and Drug Development

In addition to the recently published FDA guideline on Quality Considerations for Clinical Research with Cannabis the FDA now published an article to assist researchers with developing cannabis-derived product (CCDP) clinical research programs.

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FDA Delays Requirements for Cosmetic Facility Registration and Product Listing

The U.S. FDA issued a guidance on the delay of enforcement of the requirements for cosmetic product facility registration and cosmetic product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information.

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Cloud Computing: Relevance of SOC / SOC2 reports

Financial and organizational advantages 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 13: A cloud service providers refers to SOC reports when assessed, especially to the SOC2 report. Would this report be sufficient as concerns the requirements of the assessment and could it be used?

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EMA: Q&A documents on the topic of "Centralised procedures" revised

In September and November 2023, the "Questions & Answers (Q&A)" documents relating to centralised authorisation procedures were revised once again and published on the website of the European Medicines Agency (EMA). The Q&A catalogues, which can be used by marketing authorisation holders and applicants for centralised procedures, provide answers to possible questions at different stages of the centralised marketing authorisation application.

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FDA Warning Letter: Lack of Identity Testing and Stability Program

The U.S. Food and Drug Administration (FDA) has sent a Warning Letter to a manufacturer of over-the-counter (OTC) drug products. Based on a review of record, the authority found several CGMP violations. These concern inadequate identity testing of incoming components and finished drug products. Furthermore, an adequate stability testing program was not implemented.

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New Version of Quick Guide for Sponsors

The European Commission has published a new Version 3 of the Quick Guide for Sponsors. The revised guide provides clarifications on the submission of the IMPD-Q (Investigational Medicinal Product Dossier - Quality) for the IMP manufacture.

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EMA launches Website for accelerating EU Clinical Trials

The EMA has launched a dedicated website for the Accelerating clinical trials in the European Union (ACT EU) initiative.

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EMA releases Youtube Videos of Workshop on Real World Data

The European Medicines Agency (EMA) held a workshop in June on the quality of Real World Data (RWD) and its use to demonstrate Real World Evidence (RWE). In the meantime, Youtube video recordings of both days have been published.

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Interpretation of Annex 1 - Swissmedic publishes Q&A Document

Even three months after its entry into force, Annex 1 still raises many questions. Swissmedic has now published a document with technical interpretations of existing questions under the title "Interpretation of GMP Annex 1 2022 (Rev. 1)".

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FDA Warning Letter: Inadequate Quality Systems

The U.S. FDA issued a Warning Letter to the US American company "ALI Pharmaceutical Manufacturing, LLC" after having inspected its site in September/October 2022.

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Severe GMP Violations in the Aseptic Area

Due to numerous and serious GMP violations in the aseptic area, the FDA issued a Warning Letter to an Indian sterile manufacturer in October. The areas affected include media fills, employee behaviour in the aseptic area, cleanroom & equipment design, environmental monitoring and CAPA.

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