GMP News - Packaging


USP <88> "Biological Reactivity Tests, In Vivo" is currently also undergoing Revision

In the course of the revision of the Chapter on biological reactivity the USP has also published a draft of chapter <88> on in vivo tests. This news presents a summary of the changes.



Biological Reactiviy - USP Chapter is undergoing Revision

The USP has recently published a revision of its Chapter <87> "Biological Reactivitiy Tests, In Vitro" for comments. One of the objectives is a better alignment with other relevant USP chapters.



New Definition of Pharmaceutical Grade Plastic Packaging Materials

The proposed USP General Chapter <1031> The Biocompatibility of Pharmaceutical Packaging Systems and their Materials of Construction has been published for comment in the current issue of Pharmacopeial Forum. It outlines a risk-based approach to biocompatibility evaluation.



USP Draft Chapters for Glass and Plastic Packaging Systems

The two proposed USP General Chapters <660> and <661.2> have been published for comment in the current issue of Pharmacopeial Forum. The deadline for comments is May 31, 2023.



USP: New General Chapter Supplier Qualification <1083>

On August 01, 2023, the new USP Chapter "<1083> Supplier Qualification" will officially enter into force. In the USP Forum, the draft chapter could be viewed and commented on until the end of November 2021.



USP is Announcing a Proposal to Modify the Glass General Chapter <660>

Due to the current shortages of glass vials the USP is announcing a proposal to modify General Chapter <660> Container— Glass. In particular, the revision is anticipated to remove the glass classifications based on composition.



The new ICH Q9 Revision on Quality Risk Management becomes Effective as of 23 July 2023: A Detailed Analysis

In January you could read about the publication of the revised ICH Q9 guideline. What is new with regard to quality risk management (QRM)?



USP Proposes to Add Flexibility in the Selection of Parenteral Packaging

To help address concerns about the supply of glass vials, the USP intends to revise the packaging and storage statements in several USP monographs for parenteral products which currently prescribe a specific type of glass.



Revision of USP General Chapter <661.1> Plastic Materials of Construction

The USP revised the general chapter <661.1> Plastic Materials of Construction. In particular the sections on Polycarbonate and PVC have been updated.



USP clarifies Requirements for Plastic Packaging Systems

The USP General Chapters—Packaging and Distribution Expert Committee is proposing a revision to the Scope section of chapter <661> Plastic Packaging Systems and Their Materials of Construction. The revision is published to clarify the testing expectations that are outlined in <661.1> and <661.2>.



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.


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