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:5/25/2016)... ... May 25, 2016 , ... The ... fracture-specific plating options designed to address fractures of the distal tibia and fibula. ... The Acumed Ankle Plating System 3 is composed of seven plate families that ...
(Date:5/25/2016)... ... ... Scientists at the University of Athens say they have evidence that the ... research that could lead to one good one. Surviving Mesothelioma has just posted an ... The team evaluated 98 mesothelioma patients who got a second kind of ...
(Date:5/25/2016)... ... May 25, 2016 , ... Biohaven Pharmaceutical Holding Company Ltd. ... the company’s orphan drug designation request covering BHV-4157 for the treatment of Spinocerebellar ... FDA. , Spinocerebellar ataxia is a rare, debilitating neurodegenerative disorder that is ...
(Date:5/24/2016)... (PRWEB) , ... May 24, 2016 , ... Last week, ... for corporate executives and entrepreneurs, held The Future of San Diego Life Science event ... San Diego life science community attended the event with speakers Dr. Rich Heyman, former ...
Breaking Biology Technology:
(Date:3/18/2016)... , March 18, 2016 ... Suppliers of Biometrics, ICT, Manned & Unmanned Vehicles, Physical infrastructure ... & security companies in the border security market and the ... and Europe has led visiongain ... companies improved success. --> defence & security ...
(Date:3/15/2016)... ALBANY, New York , March 15, 2016 ... a new market report published by Transparency Market Research "Digital ... Growth, Trends and Forecast 2015 - 2023," the global digital ... at US$ 731.9 Mn in 2014 and is forecast to ... to 2023. Growth of micro, small and medium enterprises (MSMEs) ...
(Date:3/14/2016)... MELBOURNE, Florida , March 14, 2016 ... on the growing mobile commerce market, announces the airing of ... York channels starting the week of March 21 st . ... and CNBC, including its popular Squawk on the Street show. ... company focused on the growing mobile commerce market, announces the ...
Breaking Biology News(10 mins):