Navigation Links
ISPE Releases New Guidance for Designing and Constructing Packaging, Labeling and Warehousing Facilities
Date:7/3/2012

Tampa, Fla. USA (PRWEB) July 03, 2012

ISPE announced today that it has released new guidance relating to the design, construction and commissioning and qualification of packaging, labeling and warehousing (PACLAW) facilities. The Guide helps companies meet CGMP requirements for these types of facilities while avoiding product adulteration, product mix-up, label mix-up and misbranding. The Guide contains FDA input and is the industry’s only guidance of this type for PACLAW facilities.

“PACLAW facilities are very different from other types of pharmaceutical facilities, and up until this point, there has been no consistent guidance available to help companies ensure compliance,” said Guide Author Nick Davies. “With this ISPE Good Practice Guide, the industry finally has tools to ensure their PACLAW processes are efficient, compare their processes to established best practices and demonstrate compliance to regulatory agencies.”

The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities presents an approach to satisfying CGMPs while providing realistic solutions to business and operational concerns. It addresses Quality by Design principles and establishes consistent guidelines that can be incorporated into the design and/or reconfiguration of PACLAW facilities. It covers facility design issues for most primary packaging operations, such as filling of the dosage form in the immediate container/closure system, and other packaging, labeling and warehousing processes. The Guide also provides direction on how to comply with the FDA’s systems-based approach with a risk-based inspectional model as it relates to PACLAW facilities.

The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities is available for purchase from ISPE at http://www.ISPE.org/PACLAWFacilitiesGuide.

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is a not-for-profit Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. ISPE will soon be recognized globally as the leading technical organization for professionals engaged in producing quality medicines and pharmaceutical devices across the entire product lifecycle. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit http://www.ISPE.org for additional Society news and information.

Read the full story at http://www.prweb.com/releases/2012/7/prweb9666951.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. ILVO-T&V Belgium Releases Validation Report of the Charm Sciences Beta-lactam and Tetracycline 2-minute Test for Raw Commingled Milk
2. Atlanta LASIK Surgeon Dr. Ashraf Releases YouTube Videos Featuring Patient Testimonials and Discussion of Common Eye Treatments
3. AtheroNova Releases 2011 Financial Results
4. eCareSoft Releases eCS Cirrus™
5. HCCS Releases ICD-10 Countdown Clock With Integrated CMS Twitter Tweets
6. HealthCare Institute of New Jersey Releases 2011 Biopharmaceutical and Medical Technology Economic Impact Data
7. International Probiotics Association Excited To Learn The FDA Has Decided To Issue A New, Revised NDI Draft Guidance
8. West Wireless Health Institute Applauds House Passage of Bill to Streamline FDA Medical Device Approval Process, Expedite Mobile Medical App Guidance
9. Quest Diagnostics Reports Fourth Quarter 2011 Financial Results; Provides Guidance for 2012
10. diaDexus, Inc. Pre-Announces 2011 Q4, YE Revenue and 2012 Guidance
11. Butamax Early Adopters Group surpasses capacity targets with addition of Big River; Membership represents 11 production facilities and nearly 900 million gallons of ethanol capacity
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... ... innovative medical technologies, services and solutions to the healthcare market. The company's primary ... various distribution, manufacturing, sales and marketing strategies that are necessary to help companies ...
(Date:6/24/2016)... 24, 2016  Regular discussions on a range of subjects ... the two entities said Poloz. Speaking at a ... , he pointed to the country,s inflation target, which ... "In certain areas ... have common economic goals, why not sit down and address ...
(Date:6/23/2016)... ... June 23, 2016 , ... ... its second eBook, “Clinical Trials Patient Recruitment and Retention Tips.” Partnering with experienced ... this eBook by providing practical tips, tools, and strategies for clinical researchers. , ...
(Date:6/23/2016)... June 23, 2016 A person commits a crime, ... scene to track the criminal down. An outbreak ... and Drug Administration (FDA) uses DNA evidence to track down ... Sound far-fetched? It,s not. The FDA has increasingly used ... investigations of foodborne illnesses. Put as simply as possible, whole ...
Breaking Biology Technology:
(Date:4/19/2016)... , UAE, April 20, 2016 ... implemented as a compact web-based "all-in-one" system solution for ... biometric fingerprint reader or the door interface with integration ... modern access control systems. The minimal dimensions of the ... readers into the building installations offer considerable freedom of ...
(Date:4/13/2016)... physicians supporting Medicaid patients in Central Florida ... telehealth thanks to a new partnership with higi.   ... can routinely track key health measurements, such as blood ... they opt in, share them with IMPOWER clinicians through ... location at no cost. By leveraging this data, IMPOWER ...
(Date:3/23/2016)... 23, 2016 ... Gesichts- und Stimmerkennung mit Passwörtern     ... MESG ), ein führender Anbieter digitaler ... mit SpeechPro zusammenarbeitet, um erstmals dessen Biometrietechnologie ... die Möglichkeit angeboten, im Rahmen mobiler Apps ...
Breaking Biology News(10 mins):