GMP News - Packaging


FDA Warning Letter: Product Mix-Ups and Insanitary Conditions at US Repackager

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Missouri. The company failed to adequately investigate the presence of foreign tablets in the drug products. Furthermore, during an FDA inspection, one operator was observed to pick individual tablets up off of the floor and place them directly into the feed hopper.



Revised Ph. Eur. Chapter on Rubber Closures

The final version of Ph. Eur. 3.2.9. Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders has been published in the European Pharmacopoeia (Ph. Eur.) 11.1. The supplement is now available and will become applicable as of 1 April 2023.



FDA's recommended Font and Font Size for Instructions for Use Labeling

The FDA published now a guidance document on Instructions for Use (IFU) labeling. What is the recommended font and font size?



Ph. Eur. Survey for DEHP Plasticiser Alternatives

Due to a change in REACH, the Ph. Eur. is considering to replace the plasticiser DEHP and is therefore seeking information from manufacturers. The deadline for replies is 30 September 2022.



Elastomers for Pharmaceutical Packaging and Manufacturing

Following the recently adopted USP general chapter <665> for plastic materials used in manufacturing, the USP now published two draft chapters for elastomers for pharmaceutical packaging and manufacturing.



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.


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