Pharma GMP News of the Week: 28-August-2022

Period: August 21, 2022 to August 27, 2022

FDA issued draft guideline “Charging for Investigational Drugs Under an IND: Questions and Answers”

Date of news: August  23, 2022

This guidance provide information to industry,  physicians, researchers,institutional review boards (IRBs), and patients about the implementation of the FDA’s regulations on charging for investigational drugs under an investigational new drug application (IND) for either clinical trials or expanded access for treatment use (21 CFR 312.8), which went into effect on October 13, 2009. 

Since 2009, the FDA has received numerous inquiries on its implementation of the charging regulations. As a result, in June 2016, the FDA issued the final advice for industry Charging for Investigational Drugs Under an IND – Questions and Answers. Since the release of the final guidance, the FDA has received queries from stakeholders via the docket and discussions with review divisions.

Source: https://www.fda.gov/media/161079/download 

News from EDQM – EDQM seeks support from industry stakeholders to provide feedback on availability of alternative plasticisers to DEHP in containers for aqueous solutions for intravenous infusion in authorised medicinal products

Date of news: August  23, 2022

Because of a change in the REACH Regulation ((EC) N° 1907/2006) that will be implemented in November 2021, European Pharmacopoeia experts have been considering replacing the plasticiser DEHP (bis(2-ethylhexyl)phthalate), specified as plastic additive 01 in Ph. Eur. general chapter 3.1.14. Containers for aqueous solutions for intravenous infusion made of plasticized poly(vinyl chloride).

To aid in this reflection, the Ph. Eur. specialists would like to obtain information from manufacturers on the availability and use of containers for aqueous solutions for intravenous infusion that incorporate alternative plasticisers to DEHP in their composition for medicinal products.

Source: https://www.edqm.eu/en/-/ph.-eur.-survey-for-the-availability-of-alternative-plasticisers-to-dehp-in-containers-for-aqueous-solutions-for-intravenous-infusion-in-authorised-medicinal-products 

Blog published by MHRA “Innovation, Quality & Transparency – a Compliance Team 1 Perspective”

Date of news: August  23, 2022

Source: https://mhrainspectorate.blog.gov.uk/2022/08/23/innovation-quality-transparency-a-compliance-team-1-perspective/ 

European Commission published final version of EU Annex 1: Manufacture of Sterile Medicinal Products – The deadline for coming into operation of Annex 1 is 25 August 2023, except for point 8.123 which is postponed until 25 August 2024

Date of news: August  25, 2022

After 14 years of study, the EU’s widely awaited amendment of its GMP Annex 1 for sterile medicinal products was announced on Thursday. The amended standards, which are slated to go into effect on August 25, 2023, apply to both domestic and imported sterile pharmaceuticals.

The current Annex I has been in force since 2008, with various proposed amendments since then. The most recent proposed amendment to the Annex was made available for public comment in early 2020, and over 2,000 comments were received.

There is a new section on pharmaceutical quality systems that combines quality risk management (QRM) principles into sterile medication manufacturing. There are other references to QRM throughout the document. A new section addresses the concept of a contamination control strategy (CCS) in decreasing contamination, as well as new sections that incorporate recent improvements in sterile processing technology in manufacturing, such as limited access barrier systems (RABS) and isolators.

The modification aligns sterile drug manufacturing principles with World Health Organization (WHO) and Pharmaceutical Inspection Cooperation Scheme (PIC/S) standards, as well as with the US Food and Drug Administration’s (FDA) 2004 advice on sterile drug products created using aseptic processing.

Source: https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf 

FDA issued Questions and Answers on “E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential”

Date of news: August  26, 2022

The purpose of the question-and-answer (Q&A) document is to clarify important issues for industry on  Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (October 2005) and Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (October 2005). 

This advice updates ICH E14 Q&As Q12 (5.1) and Q13 (6.1), as well as adding new ICH S7B Q&As Q17 (1.1) to Q30 (4.2). This guidance is the final version of the draft guidance that was issued in September 2020.

Source: https://www.fda.gov/media/161198/download 

FDA published draft guidance “Q2(R2) Validation of Analytical Procedures” on its website

Date of news: August  26, 2022

This guideline discusses elements to be considered during the validation of analytical processes contained in registration applications submitted to ICH member regulatory authorities. Q2(R2) gives instructions and recommendations for developing and evaluating the numerous validation tests for each analytical technique. This guideline is a compilation of terminology and definitions. These words and meanings are intended to bridge the gaps that frequently exist between various compendia and papers produced by ICH member regulatory agencies.

Source: https://www.fda.gov/media/161201/download 

FDA published draft guidance “Q14 Analytical Procedure Development” on its website

Date of news: August  26, 2022

This guideline covers science-based and risk-based approaches to creating and maintaining analytical techniques appropriate for assessing the drug substances and drug products’ quality. The methodical approach proposed in ICH Q8 Pharmaceutical Development, together with the concepts of ICH Q9 QRM, can be applied to the development and management of analytical methods. A minimum (also known as conventional) approach or parts of an upgraded approach might be used while constructing an analytical technique. Furthermore, the guidance discusses factors to consider while developing multivariate analytical techniques and doing real-time release testing (RTRT). The objective of this guideline is to augment ICH Q2 Validation of Analytical Procedures.

Source: https://www.fda.gov/media/161202/download 

FDA published draft guidance “M12 Drug Interaction Studies” on its website

Date of news: August  26, 2022

During the development of a therapeutic product, this guideline provides recommendations to support a consistent approach in conducting, developing, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies. A unified strategy will eliminate uncertainty for the pharmaceutical business in meeting the requirements of numerous regulatory authorities and will result in more efficient resource usage.

Source: https://www.fda.gov/media/161199/download 

FDA published draft guidance “E11A Pediatric Extrapolation” on its website

Date of news: August  26, 2022

The purpose of the document is to make guidelines for, and to encourage worldwide harmonisation of, the use of paediatric extrapolation to aid in the development and approval of paediatric pharmaceuticals. Harmonization of paediatric extrapolation methodologies should lessen the chance of significant disparities between areas. Importantly, harmonisation could limit juvenile populations’ exposure to unneeded clinical trials while also facilitating more rapid access to paediatric medicines globally.

Source: https://www.fda.gov/media/161190/download

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