Last week’s round -up;
12-16 July 2021

published 19 Jul 2021

Pharmeuropa 33.3

Pharmeuropa 33.3 has just been released for public consultation and the deadline for comments is the 30th September 2021. 47 draft texts have been published in Pharmeuropa 33.3 including the following finished dosage form monographs:

· Fulvestrant injection

· Golimumab concentrated solution

· Influenza vaccine (live, nasal)

· Raltegravir potassium chewable tablets

· Raltegravir potassium tablets

· Yellow fever vaccine (live)

Ph. Eur. Commission 170th Session Outcome

The Ph. Eur. Commission has published the outcome of its 170th session which was held in June 2021. The Commission has adopted 69 texts that will be published in Ph. Eur. Supplement 10.8 and will be effective as of 1st July 2022. During the session, the Commission has also taken several decisions related to animal welfare including the replacement of the rabbit pyrogen test with suitable in vitro alternatives, within about 5 years. The test for specific toxicity in guinea pigs was deleted from 17 monographs for vaccines for human use containing the diphtheria component and 3 monographs on clostridial vaccines for veterinary use were revised to replace or encourage manufacturers to replace several animal tests with in vitro methods and delete the residual toxicity test on the final product. Work on two major new general chapters was announced including a chapter on phage therapy active substances and medicinal products for human and veterinary use and a general chapter on high throughput sequencing. A third PaedForm monograph, Phosphate 60 mg/mL Oral Solution was approved and a new text, Midazolam nasal spray, was added to the work programme.

EDQM “RTEMIS” pilot project

Travel restrictions brought on by the COVID-19 pandemic have caused interruptions in the EDQM’s inspection programmes and the directorate has had to find new ways to continue GMP evaluations of manufacturing sites. In view of this, the EDQM has developed a pilot system of Real-Time Remote Inspections (RTEMIS) which combines a live video feed, linking inspectors and API manufacturing sites, and the review of documentary sources, with the objective of monitoring compliance with both GMP and applications for CEPs in manufacturing sites. The approach is not meant to replace on-site inspections in terms of value and effectiveness, however, it allows inspectors to assess GMP compliance in companies that have already been inspected by the EDQM.

EMA Guide to CTIS Training material

EMA has published a detailed Guide to CTIS Training Material Catalogue.  It comprises 23 modules ranging from an overview of the system, user management, practicalities of using the system, methods of supervision on the system, data protection and considerations for different user groups.  A link to the guide and to the individual modules cited therein can be found here:

PIC/S finalizes GMP data integrity guidance

The Pharmaceutical Inspection Co-operation Scheme’s (PIC/S) new guidance on good practices for data management and integrity for pharmaceutical manufacturers and distributors has come into effect. The document serves as a guide to inspectorates in the planning of risk-based inspections relating to good data management practices, without imposing an additional regulatory burden and helps regulators clarify how current GMP/GDP requirements relate to “current industry data management practices”. The guidance covers all activities related to the handling of data including data policy, documentation, quality and security. Both on-site and remote, or desktop, inspections are included within the scope of the guidance.

Further information on the topics covered in the final guidance document may be found at the following link:

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