Tower Mains Weekly Newsletter
Check out our latest ‘Meet the Team’ blog post on our Head of Clinical & Quality Management, Marina Freiberga. Marina tells us what initially attracted her to QA, her career highlights, and what makes her tick outside of work. Click here.
EU Commission: Manufacture of Sterile Medicinal Products
Covering the current regulatory and technological developments in the manufacture of sterile medicinal products, the EU Commission revised the EU GMP Annex 1 “Manufacture of Sterile Medicinal Products”. In particular, the integration of ICH Guidelines Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System) as well as the inclusion of new technological developments made the revision imperative. Long-awaited, the final version of Annex 1 was published on the 25th of August 2022.
- The new Annex 1 will come into force on 25 August 2023, i.e. exactly one year after publication in EudraLex Volume 4.
- Only with regard to Chapter 8.123 “Product transfer/loading/unloading areas for lyophilizers” the deadline is two years, i.e. 25 August 2024.
FDA approves single dose vial presentation of Comirnaty COVID-19 vaccine
On 25th August, the US Food and Drug Administration (FDA) approved a single dose vial presentation of the Comirnaty COVID-19 vaccine. The single-dose vials have grey caps and labels with grey borders, the vaccine must not be diluted before use, and each vial contains 1 dose of 0.3 mL. This presentation is approved for use in individuals 12 years of age and older.
FDA Guidance: Q14 Analytical Procedure Development
On 26th August, the FDA published guidelines describing science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug products. The systematic approach suggested in ICH Q8 Pharmaceutical Development together with principles of ICH Q9 Quality Risk Management can also be applied to the development and lifecycle management of analytical procedures. This guideline is intended to complement the ICH Q2 Validation of Analytical Procedures.
MHRA approves Novavax COVID-19 vaccine for 12- to 17-year-olds
On 26th August, the Medicines and Healthcare products Regulatory Agency (MHRA) announced it has granted Nuvaxovid, the COVID-19 vaccine developed by Novavax, an extension to its existing UK approval, for 12- to 17-year-olds.
FDA provides guidance to help prescribers evaluate potential drug interactions when using Paxlovid
On 26th August, the FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid for COVID-19. Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet or checklist.
Q&A: E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential
On 26th August, the FDA published a Q&A document intended to clarify key issues to facilitate implementing the ICH guidances for industry E14 Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (October 2005) and S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarisation (QT Interval Prolongation) by Human Pharmaceuticals (October 2005). This guidance revises ICH E14 Q&As Q12 (5.1) and Q13 (6.1) and adds new ICH S7B Q&As Q17 (1.1) to Q30 (4.2). This guidance finalises the draft guidance issued in September 2020.
FDA Safety Communication: Philips Respironics BiPAP machines recalled due to a plastic issue
On 29th August, the FDA issued a safety communication to alert patients, caregivers, and health care providers that Philips Respironics recalled certain bi-level positive airway pressure machines that may contain plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). The plastic may also cause the machine to fail and stop working suddenly during use.
Accelerating Clinical Trials in the EU: 2022-2026 workplan published
On 30th August, the European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) published the 2022-2026 workplan of the Accelerating Clinical Trials in the EU (ACT EU) initiative. The initiative, launched in January 2022, seeks to transform how clinical trials are initiated, designed, and run. The aim is to further develop the EU as a focal point for clinical research, promote the development of high-quality, safe, and effective medicines, and to better integrate clinical research into the European health system.
Issue Number: WN00076
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