Navigation Links
Reshaping pharmaceutical quality
Date:6/2/2008

The first scientific papers outlining the progress made on the Product Quality Lifecycle Implementation (PQLI) initiative are being published in the June 2008 issue of the Journal of Pharmaceutical Innovation (JPI). Written by experts representing the global pharmaceutical manufacturing industry, these papers present practical scientific and technological approaches to implementing ICH* documents that address pharmaceutical development, quality risk management and pharmaceutical quality systems. The June issue will be published in print and is available free of charge on Springer's electronic information platform SpringerLink at http://www.springerlink.com/content/1939-8042 with the possibility to comment.

The PQLI initiative was launched by the International Society for Pharmaceutical Engineering (ISPE) in June 2007 to help industry find practical technical solutions to the challenges of implementing guidelines put forth by the ICH. The first three task teams formed focused on criticality, design space and control strategy, and how these areas are linked; a Legacy Products Task Team has also been formed as the fourth topical area. PQLI is projected to be at least a five-year initiative that has started with interactive fact-gathering sessions held in the USA and Europe. For background information on the PQLI papers, please see http://springer.com/12247.

The criticality study describes a mechanism for categorizing and delineating criticality for quality attributes, variables, material attributes and process parameters in accordance with a risk-based approach reflective of quality by design (QbD) principles. Design space discussions considered the linkage of the patient experience with product quality. The Control Strategy Team has proposed a model process to enable a clear logic to be used on how a control strategy differentiates between patient and business requirements, as well as showing the linkage from critical quality attributes. The Legacy Products Team has started work and will produce a paper later in 2008 in JPI.

"The task teams are to be congratulated for their technical publications in the Journal of Pharmaceutical Innovation which embrace input from interactive global workshops that included participation from both industry and regulators," said Moheb M. Nasr, Ph.D., Director, Office of New Drug Quality Assessment (CDER, FDA). "These papers, and the PQLI initiative, are important 'next steps' to facilitate the implementation of QbD and to answer the tangible challenges."

Jacques Morenas (AFSSAPS) and current chairman of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) said, "EU regulators are ready to work with ISPE on the future role of the EU Qualified Person, taking into account how critical it is. Work is already in progress as we can see from efforts made in conjunction with the Processed Analytical Technology (PAT) Team at the European Medicines Agency (EMEA) level and we will be happy to continue."


'/>"/>

Contact: Joan Robinson
joan.robinson@springer.com
49-622-148-78130
Springer
Source:Eurekalert

Related medicine news :

1. Amira Pharmaceuticals Achieves Milestones in FLAP Inhibitor Program With GlaxoSmithKline
2. Vion Pharmaceuticals Announces Presentation of Data from Phase III Trial of Cloretazine(R) (VNP40101M) and Cytarabine in Relapsed Acute Myelogenous Leukemia at the ASCO(R) Annual Meeting
3. Managing Cross-Functional Teams for Pharmaceutical Product Commercialization Excellence
4. Lotus Pharmaceuticals, Inc. Reaffirms its Confidence in Meeting its Make Good Target for Fiscal Year 2008
5. KV Pharmaceutical Company Updates Timing of Fiscal 2008 Securities and Exchange Commission Filings
6. Anthony Clarke, PhD Joins Alexza Pharmaceuticals as Vice President, International Development Operations
7. Alseres Pharmaceuticals, Inc. Announces 2008 Annual Stockholders Meeting
8. Caraco Pharmaceutical Laboratories, Ltd. Reports Record Results for the Fourth Quarter and Fiscal Year 2008
9. FDLI Publishes Comprehensive Handbook on Pharmaceutical Risk Management
10. Research Study Shows That Pharmaceutical Field Sales Reps Productivity Inhibited by Unnecessary Internal Communication
11. Lotus Pharmaceuticals, Inc. Announces Conference Call to Discuss First Quarter 2008 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2017)... ... January 22, 2017 , ... "Photo Cloud allows FCPX users to ... 3D slideshow with complete ease," said Christina Austin - CEO of Pixel Film Studios. ... the FCPX timeline. Presets include scenes with one, three, four or five ...
(Date:1/21/2017)... ... January 21, 2017 , ... Caronlab Australia, an Australian ... January ECRM Trade Show in Hilton Head, SC, where it benefited from outstanding meetings ... quality of its beauty and wellness products. At this trade show, the company had ...
(Date:1/21/2017)... ... ... "ProDOF is the perfect set of tools for video editors that want to create the ... Austin - CEO of Pixel Film Studios. , Video editors using ProDOF can add ... DSLR racking focus from one area into the next. ProDOF comes with 0.5 second, ...
(Date:1/21/2017)... ... January 21, 2017 , ... Phytocéane invites you to take an ... of the world with ZANZIBAR SHOWER GEL. Inspired by the beauty of Zanzibar, a ... Oil and moisturizing vegetal coral to create this gentle, crystal-clear shower gel to cleanse ...
(Date:1/21/2017)... ... January 21, 2017 , ... Northern California Medical Associates ... joined their multi-specialty medical group. The dermatology practice provides general dermatologic treatment, outpatient ... to add this excellent dermatology practice to our group’s medical services,” explains NCMA ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... , Jan. 19, 2017 This report ... current and future scenario of the global market. Large ... opioid consumption. Severe chronic constipation is a major side ... traditional laxatives. Hence, novel targeted therapy has been prescribed ... sufferers, launch of targeted medicines, and growing awareness about ...
(Date:1/19/2017)... Accuray Incorporated (Nasdaq: ARAY ) ... to set the bar for excellence in customer satisfaction. ... satisfaction rating among radiation treatment delivery systems in the ... Intelligence Briefing™. The most recent ratings trend also shows ... peers for 11 of the past 12 quarters. ...
(Date:1/19/2017)... January 19, 2017 Shire plc ... the U.S. Food and Drug Administration (FDA) has acknowledged ... Drug Application (NDA) for SHP465, a long-acting, triple-bead, mixed ... potential once-daily treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). The FDA ... June 20, 2017, the designated Prescription Drug User Fee ...
Breaking Medicine Technology: