Pharma GMP News of the Week: 15-January-2023
Period: January 8, 2023 to January 14, 2023
The Medical Device Coordination Group (MDCG) has published guidance on the application of the medtech legislation to devices and diagnostics produced and used by healthcare organisations in the European Union.
Month of news: January 2023
The majority of the article is devoted to determining what constitutes a suitable quality management system (QMD) for in-house devices. Under an acceptable QMS, health institutions must produce and use in-house devices. The MDCG guidance includes examples of topics covered by a suitable QMS, such as risk management and traceability, as well as details on what is necessary in each area.
The EMA has amended its good distribution practises (GDPs) advice to explain how the rules apply to brokers operating outside of the European Economic Area (EEA).
Month of news: January 2023
Two new questions about GDP needs are included in the paper. The new issues cover whether a broker can broker operations between parties outside the EEA, as well as whether a broker can broker activities for medicinal products without an EEA marketing license but with an EEA marketing authorization.
The answer is no to both queries. In clarifying the answers, the EMA referred to its GDP recommendations from 2013. Both suppliers and clients must be based in the EEA, according to the standards. Brokering operations between suppliers and clients outside the EEA are not covered by EU law. Similarly, for the requirements to apply, a pharmaceutical product must obtain a marketing authorisation in at least one EEA nation.
News from EDQM “Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of new paragraph on control of N-nitrosamines”
Date of news: January 6, 2023
The European Pharmacopoeia (Ph. Eur.) Commission adopted the updated general monographs Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619) at its 174th session in November 2022. These monographs now include a section outlining the Ph. Eur. approach to N-nitrosamine impurities. This strategy was developed based on responses from the most recent round of public engagement in Pharmeuropa as well as recent statements from the heads of the European Medicines Agency and the Medicines Agency.
The updated monographs will appear in Ph. Eur. Supplement 11.3 and go into effect on January 1st, 2024. Now that the topic of nitrosamine control in individual monographs has been raised, the Ph. Eur. Commission will begin considering solutions.
The EMA has adopted the ICH guideline on continuous manufacturing
Date of news: January 6, 2023
The European Medicines Agency (EMA) has approved final international guidance on the continuous manufacture of drug substances and drug products, which will take effect in July.
Continuous production entails continuously feeding input materials into a system and continuously removing output materials from the manufacturing process. The strategy differs from the more often used stop-start batch production process, prompting the International Council for Harmonisation (ICH) to produce the Q13 continuous manufacturing standard.
Source: ICH guideline Q13 on continuous manufacturing of drug substances and drug products – Step 5
News from EDQM “Ph. Eur. Commission welcomes Ethiopian FDA as observer”
Date of news: January 9, 2023
The Ethiopian Food and Drug Administration (EFDA) received observer status from the European Pharmacopoeia (Ph. Eur.) Commission during its 174th session (November 2022). This choice shows the dynamism of the European Pharmacopoeia, which today comprises 40 members and 31 observers from around the globe (39 European states and the European Union).
This status entitles EFDA representatives to take part in the scientific work of the European Pharmacopoeia Commission and other EDQM activities, benefit from the EDQM’s experience in the field of medicinal products for human and veterinary use, engage in discussions with experts from European and international licencing authorities and inspectorates, and work on the creation of global quality controls for medicines and the analytical techniques used.
EDQM published “Outcome of the 174th session of the European Pharmacopoeia Commission, November 2022”
Date of news: January 9, 2023
On November 22 and 23, 2022, the European Pharmacopoeia Commission (EPC) conducted its 174th session. The European Pharmacopoeia (Ph. Eur.) Supplement 11.3 (July 2023) will publish the 85 documents that the Commission approved during this session, with an implementation date of 1 January 2024.
These 85 texts contained one new general chapter and 13 new monographs:
Monographs:
Dabigatran etexilate mesilate (3095); Levocetirizine dihydrochloride (3115); Bupivacaine (2761); Gallium (68Ga) oxodotreotide injection (3050); Gallium (68Ga) DOTA-NOC injection (3051); Eclipta prostrata (2852); Helichrysi flos (3089); Horse-chestnut bark (2945); Burdock root (2943); Adhatoda vasica leaf (2738); Lonicera japonica flower (3159); Chrysanthemum flower (3162);
General chapter:
Particle size analysis by image analysis (2.9.48).
It also adopted revised versions of 72 texts covering:
The general chapter Friability of uncoated tablets (2.9.7) and The general chapter Osmolality (2.2.35).
Source: Outcome of the 174th session of the European Pharmacopoeia Commission, November 2022
FDA Published guideline “Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals”
Date of news: January 10, 2023
This document serves as industry guidance on the requirements for a foreign supplier verification programme (FSVP) in 21 CFR part 1, subpart L, that importers of human or animal food must establish and follow to make sure that each food they import into the United States complies with applicable U.S. requirements and is not adulterated or (for human food) misbranded with regard to allergen labelling.
FDA Published draft guideline “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format”
Date of news: January 12, 2023
The Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format” draft guideline for industry is now available, according to the FDA.
The purpose of this advice is to help applicants create the DOSAGE AND ADMINISTRATION portion of labelling. This guideline is intended to help applicants make sure that the DOSAGE AND ADMINISTRATION section contains the dosage- and administration-related information required for a drug’s safe and effective use and that the information is presented in a way that is pertinent to and understandable to healthcare professionals. The industry guidance titled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format,” which was released on March 29, 2010, is being withdrawn.
EMA has published “Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)” that has been held from 9 to 12 January 2023
Date of news: January 13, 2023
Following are Key Points:
- Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors
- New safety information for healthcare professionals
- Zolgensma: fatal cases of acute liver failure
