GMP News - Packaging


Classification of Packaging Changes

Recently, the CMDh has added a recommendation for the classification of a proposed packaging change to the list of unforeseen variations ("Article 5 Recommendations"). What is the recommended category for a change of the “total thickness” for a blister foil?



Revised Technical Guide for Metals and Alloys

Currently there are no compendial standards available for metal packaging systems for pharmaceutical use. Thus any other guidance providing information on metal components like the revised EDQM technical guide “Metals and alloys used in food contact materials and articles” can be useful.



Requirements for Styrene Block Copolymers

Following the previously published Ph. Eur drafts for COC / COP, a new Ph. Eur. chapter 3.1.18. Styrene block copolymers for containers and closures for parenteral preparations and ophthalmic preparations has been proposed in Pharmeuropa.



US Track & Trace Requirements

The FDA has issued a questions and answers document to assist industry and State and local governments in understanding the effects of the Uniform National Policy on drug product tracing.



ECA comments on FDA Guideline on Visual Inspection

In December 2021, the FDA published its long-awaited Draft Guideline on 100% Visual Inspection of Parenterals. Comments were accepted until mid-February 2022. Members of the Advisory Board of the ECA Visual Inspection Group took advantage of this opportunity and submitted numerous comments.



Version 19 of the Q&As on Safety Features

The European Commission published a new version of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Do the UIs of reference and retention samples taken from stock have to be decommissioned?



U.S. Pharmaceutical Distribution Supply Chain: Revised Draft Guidance on Verification Systems

The U.S. Food and Drug Administration (FDA) has issued a revised draft guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs. This document addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place.



Plastic Components Used in Manufacturing: USP extends Official Date for <665>

To address inquires and to give USP more time to engage with stakeholders regarding the suitability of making <665> an applicable general chapter, the USP intends to extend the official date for <665> to May 1, 2026.



Approved USP Chapters on Plastic Components used in Manufacturing

The new USP general chapters <665> and <1665> have now finally been approved. Chapter <665> establishes a baseline for the qualification of plastic components used in the manufacturing of pharmaceutical and / or biopharmaceutical drugs.



New Ph. Eur. Draft for COC

A revised draft for the new Ph. Eur. chapter 3.1.17. Cyclo-Olefin Copolymers (COC) has been published for comment in Pharmeuropa.



Requirements for Plastics in Pharmaceutical Equipment Engineering

Stainless steel is predominantly used in pharmaceutical equipment engineering. The 316L variant is basically regarded as standard; material incompatibilities of the steel with the product are more or less neglected. This is different with plastics. In addition to leach-out, aging and surface finish, other quality characteristics are often specified. But are there generally applicable requirements for plastics in pharmaceutical equipment engineering?



Questions and Answers on Labelling Flexibilities for COVID-19 Vaccines

The EMA published an updated version of the Q&A document relating to labelling flexibilities for COVID-19 vaccines. Can a QR code replace the printed expiry date?



FDA publishes Draft Guidance on Visual Inspection of Parenterals

It has been known for some time that the US FDA is working on its own guide on the visual inspection of parenterals. Now the draft has been published as a 15-page document.



Particles lead to Warning Letter for Japanese Sterile Manufacturer

The frequent occurrence of particles in sterile injection solutions and the inadequate investigation of the cause led to a Warning Letter to a sterile manufacturer in Japan. In addition, data integrity breaks and falsifications had occurred in the environmental monitoring.



CDER published Q&A Catalogue for Generic Drug Authorisations

In September 2021, the CDER (Center for Drug Evaluation and Research) of the U.S. FDA published a so-called "Draft Guidance for Industry" for generic medicinal product authorisations in the form of a question and answer catalogue.


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