Free Download: MHRA (Europe) Releases New Guidance Document for Pharmaceuticals
_______________________________________________________
The Medicines and Healthcare Products Regulatory Agency of Europe (MHRA) has recently released a new guidance for manufacturers and distributors of pharmaceutical products. This paper sets out key legal and ethical implications on manufacturers, wholesalers, distributors, NHS trusts, registered pharmacies and dispensing doctors.
Download guidance. |
Drug Recalls More than Double Since 2008
________________________________________________________
A 50 percent increase in drug recalls in the past year is raising fears over the quality of drug manufacturing in the US.
According to a report on CNN Money, the federal Food and Drug Administration (FDA) reported more than 1,742 recalls in 2009, compared to 426 in 2009, a massive jump by any standard. One company was involved in more than 1000 of the recalls, and has subsequently shut down. Furthermore, 165 recalls in 2009 were of products made, or believed to be made, abroad, which is a 58 percent increase from 2008. Read complete article. |
Study: FDA product recalls shows that more clinical testing wouldn't prevent most problems __________________________________________
With critics questioning whether regulators give medical devices enough scrutiny before approving them for patients, University of Minnesota law Prof. Ralph Hall pored over seemingly obscure regulatory data to determine whether the allegations are true.
Hall studied Food and Drug Administration (FDA) recalls of medical devices between 2005 and 2009, focusing on the most-serious kind of pullback -- products that could cause serious injury or death in patients if they malfunctioned. There were 112 recalls in that category.
Of those, roughly 55 percent were recalled because of "post-market" issues, mostly manufacturing problems, and 45 percent were traced to "pre-market" issues -- mostly design and software design problems.
|
CAPA investigations and documentation vary between countries, markets and/or cultures? ________________________________________________________
CAPA is directly related to quality in manufacturing. The more we understand about where most manufacturing takes place, the better quality system improvement providers can prepare to assist these manufacturers with respect to language, cultural differences, regulations etc.
Based on your experience, does the quality of CAPA investigations and documentation vary between countries, markets, and/or cultures- and if so, how?
|
Last Month's Poll Results: Most Life Science Products Manufactured in US
_________________________________________________________
Last month, we issued a poll asking "Where does your organization manufacture its products?"
Here are the results from the life science manufacturers worldwide:
#1 United States
#2 India
#3 Japan
|
PathWise to Speak at Upcoming PDA/FDA Joint Regulatory Conference
_________________________________________________________
The PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues. Each year, FDA speakers provide updates on the current state of efforts impacting the development of global regulatory strategies; while industry professionals from some of today's leading pharmaceutical companies present case studies on how they employ global strategies in their daily processes.
|
|
|
|
|
|
|
|
Monthly Newsletter
PathWise, Inc.
August 2010 |
CAPA Workshops for Life Sciences
This 2-day course, taught by former FDA Investigators, PathWise, and MasterControl industry experts, is designed to meet the requirements mandated by regulatory agencies to effectively investigate and locate causes and correct them.
September 15-16, 2010
Newport Beach, CA
PathWise Webinars
Integrating ISO 14971 and ICH Q9 into the Quality System
This webinar provides insight into the necessary industry standards and offers meaningful techniques that risk management professionals can use to implement ISO 14971 and ICH Q9 into their quality system.
For more information or to purchase.
_________________
Integrating FDA and Trending Requirements into your CAPA System
This session offers attendees a "how-to" approach to effectively integrate the FDA's CAPA and Trending requirements, providing them with the skills necessary to develop a strong, sustainable and compliant CAPA system.
For more information or to purchase.
Conducting OOS and Non-Conformance Investigations
This webinar provides a process to effectively expedite and document OOS and non-conformance investigations to increase compliance in your organization.
|
|
