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When the U.S. Pharmacopeia set out to modernize Chapter Containers—Plastics, now known as Plastic Packaging Systems and Their Materials of Construction, users wondered how much the revised standard would impact their testing programs. Attendees...
If you are using a particular plastic packaging system for a drug already on the market, its use is most likely USP compliant under the recently finalized USP Chapter Containers-Plastics. But when will you need to subject that same plastic...
No national requirement for pharmaceutical track and trace has materialized to supersede California’s 2015 law, and Unique Device Identification has just been proposed in draft form.With U.S. mandates slowly emerging, pharmaceutical and medical...
ISPE, the International Society for Pharmaceutical Engineering, offers new guidance on the design, construction, and commissioning and qualification of packaging, labeling, and warehousing (PACLAW) facilities. The "ISPE Good Practice Guide...
Harmonizing ISO 11607 and EN 868-1 will benefit medical device manufacturers.Don't stop reading if you've heard this before: Efforts are under way again to harmonize ISO 11607, Packaging for Terminally Sterilized Medical Devices, and EN 868-1...
To help prevent counterfeiting and to minimize medical dispensing errors around the world, auto-ID standards need harmonizing.Automatic identification technologies involving bar codes and RFID are being looked at as powerful weapons in the fight...
In February 2008, PMP News hosted a Webcast on ISO 11607 featuring members of the Sterilization Packaging Manufacturers Council (SPMC). Guest moderator Marie Tkacik, chairperson, SPMC Technical Committee, led fellow members as they addressed some...