Last week’s round -up;
03-07 January 2022

published 10 Jan 2022

All you ever wanted to know about Ph. Eur. procedure 4 but never dared to ask

The EDQM has released a new document, ‘Procedure 4 (P4) – Everything you always wanted to know’, intended to help stakeholders understand the advantages of applying for monograph elaboration via this route. Procedure 4 monograph elaboration applies to active substances (and corresponding medicinal products) or excipients present in medicinal products that are still under patent or single source, provided that the medicinal product has been approved in at least one member state of the pharmacopoeial convention. It also applies to monographs on biotherapeutics as elaborated by the P4bio Working Party Advantages of P4 elaboration are: 1. Direct contact with the EDQM. 2. Regular updates during the elaboration process / full transparency. 3. Specifications as approved by the licensing authorities are unchanged. 4. A CEP can be requested immediately after adoption of the new monograph.

More clarity on ICH continuous manufacturing guideline requested

Several industry trade associations have requested more clarity on the ICH Q13 guideline on continuous manufacturing (CM), which covers CM of drug substances and drug products, including chemical entities and therapeutic proteins. Stakeholders have asked for clarity on what constitutes a state of control for a CM process, the scope of the guideline, and the definition of a batch size. More clarity on whether the principles in the guideline also apply to ATMPs has been requested. A stakeholder has also suggested that an example of a CM process being in a “state of control” should be provided as this would help in demonstrating when a state of control has been achieved. It has also been suggested that the definition of a batch should be expanded to include additional examples. Another stakeholder has suggested that the section of the guideline on non-conforming material or waste in CM should be revised, as manufacturing waste has not been a significant issue in CM. It has also been suggested that the guideline should make a clearer distinction between CM of small molecule drugs and biologics, since regulatory review, inspection, and management of post-launch process changes can differ significantly.

New FDA Guidance on the Inspection of Injectable Products for Visible Particulates

The FDA has released a new draft guidance on the Inspection of Injectable Products for Visible Particulates – Guidance for Industry. The draft guidance focusses on the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination. The guidance also clarifies that compliance with an applicable USP compendial standard alone is not generally sufficient for meeting the current GMP requirements for the manufacture of injectable products. However, the guidance does not cover subvisible particulates or physical defects that products are typically inspected for along with inspection for visible particulates such as container integrity flaws, fill volume, appearance of lyophilized cake/suspension solids.


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