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Extractables & leachables for pharmaceutical products 2010

Author: Smithers.
Publisher: Shrewsbury [England] : Smithers Rapra Technology Ltd., [2010] ©2010
Edition/Format:   eBook : Document : Conference publication : EnglishView all editions and formats
Summary:
Impurities originating from any part of the manufacturing or storage of drug products can potentially result in expensive product recalls and damage to a company's reputation - not to mention the serious threat posed to patient safety. Nowadays extractables and leachables assessment of all materials - and especially elastomeric and plastic components - forms an integral part of the submission for approval of a new  Read more...
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Genre/Form: Electronic books
Material Type: Conference publication, Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Smithers.
ISBN: 9781847356123 1847356125
OCLC Number: 874967691
Notes: "Maintaining the integrity of drug products through best practice extractables and leachables testing"--Cover.
Description: 1 online resource (198 pages) : illustrations
Contents: 9781847356123; 9781847356123_content; First four pages Extractable; Paper 01 --
ORIGINS OF EXTRACTABLES AND LEACHABLES FROMPOLYMER PRODUCTS; Paper 02 --
REGULATORY EXPECTATIONS FOR SAFETY QUALIFICATIONOF EXTRACTABLES AND LEACHABLES IN MEDICINALPRODUCTS; Paper 03 --
ACCEPTABLE VARIABILITY AND FOCUSED TESTING ONCONTAINER CLOSURE SYSTEM FOR REGULATORYFLEXIBILITY; Paper 04 --
LEACHABLES IN PARENTERAL DRUG PRODUCTS ANDRESPONSES TO THESE FROM HEALTH AUTHORITIES; Paper 05 --
THRESHOLDS AND BEST PRACTICES IN PARENTERAL ANDOPHTHALMIC DRUG PRODUCTS. Paper 06 -THRESHOLDS AND BEST PRACTICES IN PARENTERAL ANDOPHTHALMIC DRUG PRODUCTSPapers 7-11 --
THE EXTRACTABLES AND LEACHABLES SAFETYINFORMATION EXCHANGE (ELSIE): DEVELOPMENT OF ANEXTRACTABLES AND LEACHABLES DATABASE; Paper 12 -ADVANCING QUALITY OF MATERIALS THROUGHCOLLABORATION WITH THE SUPPLY CHAIN: THE WORK OFTHE IPAC-RS OINDP MATERIALS WORKING GROUP; Paper 13 -BPSA CONSENSUS RECOMMENDATIONS FOREXTRACTABLES TESTING OF SINGLE-USE.
Other Titles: Extractables and leachables for pharmaceutical products 2010
Responsibility: organised by Smithers.

Abstract:

Impurities originating from any part of the manufacturing or storage of drug products can potentially result in expensive product recalls and damage to a company's reputation - not to mention the serious threat posed to patient safety. Nowadays extractables and leachables assessment of all materials - and especially elastomeric and plastic components - forms an integral part of the submission for approval of a new drug system or medical device. With regulatory authorities such as the FDA and the MHRA demanding assurance that a product's integrity has been scrutinised - the pharmaceutical industry has formed a range of industry working groups such as the Product Quality Research Institute (PQRI), Parenteral and Ophthalmic Drug Products (PODP), Extractables and Leachables Safety Information Exchange (ELSIE) and Bio-Process Systems Alliance (BPSA) to work towards a common understanding of what extractables and leachables testing should be done and at what stage in the supply chain it is most appropriate. These proceedings cover all the presentations from the conference which provided a unique opportunity to learn about the latest developments from industry practitioners and working groups to meet regulatory requirements and ensure compatibility in drug-package combinations.

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