GMP News - Packaging


Ph. Eur. Packaging Chapters adopted

Several revised Ph. Eur. packaging chapters have been recently adopted by the Ph. Eur. Commission. These general chapters will appear in Ph. Eur. 9.6. Read more about the revised chapters on plasticized PVC materials and glass containers.



New EU Regulation lowers BPA Limit

The European Commission published its final Bisphenol A (BPA) Regulation. The Regulation lowers the BPA limit from currently 0.6 mg/kg to 0.05 mg/kg. This limit also applies for varnishes and coatings. Read more about the final Commission Regulation (EU) 2018/213.



Drafts of USP Packaging Chapters to be redeveloped

The USP recently posted the announcement of its intent to cancel and redevelop the drafts of packaging chapters previously published in the Pharmacopeial Forum. Read more about USP´s chapters on glass containers and elastomeric closures.



Revised Ph. Eur. monographs: Plastic Syringes and Blood Transfusion Sets

The revised versions of two Ph. Eur. general packaging chapters have been published for comment in Pharmeuropa. Read more about 3.2.8. Sterile single-use plastic syringes and 3.2.6. Sets for the transfusion of blood and blood components.



Revised USP Chapter <671> Containers - Performance Testing adopted

With USP 41 - NF 36 the revised general chapter <671>  Containers - Performance Testing will become official on May 1, 2018.



Revised USP Chapter for Elastomeric Closures now official

End of December the USP published its revised chapter <381> Elastomeric Closures for Injections which became official on January 1, 2018.



Ph. Eur. Monograph on Rubber Closures revised

The revised Ph. Eur. Monograph 3.2.9. on rubber closures will become official on July 1, 2018 (Supplement 9.5). Read more about Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders.



Draft EU Regulation on BPA in Varnishes and Coatings

Following the notified draft regulation published in 2016 the European Commission (EC) recently published a revised draft regulation on BPA. Read more about Bisphenol A in varnishes and coatings and plastics intended to come into contact with food.



USP <381> Elastomeric Closure for Injections

The USP General Chapters Packaging and Distribution Expert Committee recently posted the intent to revise General Chapter <381>. The Chapter currently includes a reference to <231> Heavy Metals, which will be omitted on January 1, 2018. Read more about the revision of Chapter <381> Elastomeric Closure for Injections.



Draft DIN EN ISO Injection Vials made of Tubular Glass

The DIN EN ISO committee published a draft for DIN EN ISO 8362-1 Injection vials made of glass tubing for comment.



Become an active part of the Conference "Particles in Parenterals"

The ECA Foundation's Visual Inspection Interest Group has been conducting the annual conference "Particles in Parenterals" for several years now. For the planning of the 2018 event you can become involved as an active part.



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.


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