GMP News - Packaging


Rationale to the revision of USP Chapter <381> Elastomeric Closures for Injections

The USP has recently undertaken an in-depth review of chapter <381> which has resulted in significant revisions especially to the heavy metals and functionality tests. In a stimuli article the USP now provides the rationale for the proposed changes to USP general chapter Elastomeric Closures for Injections <381>.



Safety by Design: EMA Reflection Paper on Development of Medicines for Use in the older Population

The EMA recently published a draft Reflection Paper on the pharmaceutical development of medicines for use in the older population.



FDA Draft Guidance on Expiration Dating of Unit-Dose repackaged Solid Oral Dosage Forms

The FDA is proposing a more restrictive expiration dating for unit-dose repackaged solid oral dosage forms. Read more about FDA´s draft guidance Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.



Comment Period Extended for USP Packaging General Chapters Appearing in PF 43(3)

The comment period  for USP Packaging (and Materials) General Chapters appearing in PF 43(3) has been extended to September 30, 2017. Read more about new and revised USP Packaging Chapters.



USP Draft General Chapters on Plastic Components and Systems Used in the Manufacturing of Drug Products

The USP proposes two new general chapters <665> and <1665> to address the qualification of polymeric components used in the manufacture of pharmaceutical and biopharmaceutical APIs and drug products. Chapter <665> was previously published as Plastic Components and Systems Used in Pharmaceutical Manufacturing <661.3>. Read more about the proposals for Polymeric Components and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products and Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products.



USP Draft Chapters on Glass Containers <660> and <1660>

Revised USP general chapters <660> and <1660> have been published for comment in the Pharmacopeial Forum. Read more about the drafts for Containers-Glass and Evaluation of the Inner Surface Durability of Glass Containers.



USP Draft Chapters on Elastomeric Closures <381>, <382>, <1381> and <1382>

Four USP draft chapters on elastomeric closures have been published for comment in the Pharmacopeial Forum 43(3). Read more about the proposed USP general chapters <381>, <382>, <1381> and <1382>.



Now Official: Revised USP Plastic Packaging Chapters <661.1> and <661.2>

The revised USP General Chapters <659>, <661>, <661.1> and <661.2> are online available and have become official on May 1, 2017. Read more about the revisions of the four USP general chapters.



Packaging: Pharmeuropa Draft Chapters regarding PVC

In Pharmeuropa 29.2 several drafts of general chapters regarding packaging components and materials made of PVC have been published for comment. Read more about the drafts on materials and containers based on plasticised poly(vinyl chloride).



Three-year period for implementation of USP Plastic Packaging Chapters <661.1> and <661.2>

The USP Expert Committee Packaging and Distribution decided to provide a three-year period for implementation of the requirements specified in General Chapters <661.1> and <661.2>. Read more about the revison regarding USP General Chapters Plastic Materials of Construction and  Plastic Packaging Systems for Pharmaceutical Use.



Sterile plastic containers for human blood and blood components

A draft for Ph. Eur general chapter 3.2.3. Sterile plastic containers for human blood and blood components has recently been published for comments in Pharmeuropa. It is proposed to delete the abnormal toxicity test (2.6.9) (ATT) from the Tests section.



USP´s Intent to Revise and to Develop Elastomeric Packaging Chapters

The U.S. Pharmacopeial Convention (USP) proposes to revise its elastomeric packaging chapters. Find out more about these revisions of USP chapters <381>, <382>, <1381> and <1382>.



USP´s Intent to Revise Chapters on Biocompatibility of Packaging Systems and Medical Devices

The U.S. Pharmacopeial Convention (USP) proposes the revision of general chapters regarding the biocompatibility of materials used in pharmaceutical packaging systems, medical devices and implants. Read more about the suggested modernization of general chapters <87> Biological Reactivity, In Vitro, <88> Biological Reactivity, In Vivo, and <1031> The Biocompatibility of Materials used in Drug Containers, Medical Devices and Implants.



Draft USP Chapter <671> Containers - Performance Testing

A draft version of general chapter <671> Containers—Performance Testing has been recently published in the Pharmacopeial Forum - and is open for comments until end of March.



Ph. Eur. Draft Chapter 3.2.1 "Glass containers for pharmaceutical use"

A draft of a revised version of the European Phramacopoeia general chapter on glass containers has been published for comment. Read more about the Ph. Eur. draft general chapter 3.2.1 "Glass Containers for Pharmaceutical Use".


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