Angie Drakulich was editorial director of Pharmaceutical Technology.

Angie Drakulich

	Here at ExcipientFest 2012, in connection with IPEC, rooms are full of attendees listening for ways to better follow GMPs, for best testing practices, for ways to manage user-supplier relationships and more. Below are a few key points made thus far.

	-Relying on a Certificate of Analysis may not always guarantee what you are getting, Catherine Sheehan, USP

	-The Chinese Pharmacopeia is adding 150 new monographs by 2015; some of these are being developed in coordination with USP

	-Do excipient GMPs really exist? For starters, an excipient is a drug under the US Statute, and defined as a drug component. IPEC has the new ANSI NSF standard 363 on Excipient GMP.  And looking ahead, FDA is developing a proposed rule to amend regulations on the control over components used in the manufacture of finished products to increase assurance of shipments via quality specs, facility qualification, and controlled distribution. These sound like additional GMPs on the way…. Maridalia Torres, San Juan District Director, FDA

	-There is a paradigm shift in industry to be proactive versus reactive, Maridalia Torres, San Juan District Director, FDA

	-Where does FDA stand on third-party audits and auditors? The agency is still thinking this issue through but encourages and supports the industry efforts in this area. The agency may never put an official okay for third-party auditors on paper, so to speak, but the bottom line is that if a company uses a third-party auditor and can demonstrate that the organization and auditing process meet the end product’s quality specs and help in the process, then that is what FDA will be looking for. The responsibility is on the manufacturer to show that their choice and process in this area is quality and risk based.

	-The upcoming PDUFA revision includes language about third-party auditors; it also addresses excipient manufacturer registration. Although individual excipient manufacturers do not have to register just yet, the final product manufacturer will need to list the names and addresses of its excipient manfuacturer suppliers/sources as part of their annual Section 510 registrations.

Articles

Here at ExcipientFest 2012, in connection with IPEC, rooms are full of attendees listening for ways to better follow GMPs, for best testing practices.

Live from ExcipientFest: Roundup of What’s Been Said

	Here at ExcipientFest 2012 in San Juan, excipient manufacturers and users are debating how to move foward surrounding the issue of atypical visible particles found in excipients. A speakers panel was held yesterday afternoon featuring Dale Carter, chair IPEC Americas; Cindy Buhse with FDA; Dave Schoneker of Colorcon and IPEC; and Ann Van Meter with Dow Wolff and IPEC.

	This issue is deemed a hot topic and will be discussed in the coming months as IPEC works to develop a guideline on how visible particles should be assessed (is more screening needed on the manufacturer side, more risk assessment?) and how user decisions about acceptance criteria should be made. At the end of the day, these  atypical visible particles, often caused by the manufacturing process as a result of compression (i.e., charring), are not considered harmful to the user. In most cases, the particles are extremely small in size (some only visible under a microscope) and there may be only 1 or 2 particles in an entire 20,000 pound container of excipient. In cases where excipient raw material is full of atypical particles–think about the look of salt and pepper together–that’s a different case and not what this dialogue is about.

	There are no current regulations in this area and IPEC argues that zero particles is an impossible task–these particles have always been there and always will be there, and now the industry needs to decide what to do about them. The alternative–or status quo–is that entire shipments of raw material may be rejected by the user for a few harmless particles, costing thousands of dollars not to mention affecting the supply chain and leading to potential drug shortages. At the same time, users need to feel 100% assured that their product is safe and that it won’t be rejected by regulators–also a valid argument.

	There is no easy answer to this discussion but it’s clear that users and makers of excipients need to be involved to talk about how they’re going to sort this out and what the next steps are. IPEC’s goal is to share the final guideline with FDA.

Here at ExcipientFest 2012 in San Juan, excipient manufacturers and users are debating how to move foward surrounding the issue of atypical visible particles found in excipients.

Live from ExcipientFest: The Maker-User Dialogue over Visible Particles

	Today in San Juan, at ExcipientFest 2012 in partnership with IPEC, Michael Beatrice of Abbott spoke about the seven deadly sins of quality management. Beatrice heads Quality at Abbott and used to serve as deputy director of CBER at FDA. The seven items to avoid, he notes are: bureacracy, tradition (just because you’ve always done something a certain way doesn’t make it right), excess (too many priorities), isolation (lack of communication among groups and with public), deafness (not listening to employees at all levels), and complacency.

	Beatrice offered three key tools for managing quality and dealing with challenges such as globalization and economically motivated adulteration: quality management reviews, certification, and knowledge management. Quality intelligence, he noted, is key. Companies need acquire, analyze, and share information across all divisions, sites, and groups.

	Beatrice also described how Abbott took 221 corporate policies and got them down to 17 such policies that were able to meet global GMP standards for the 130 plus markets that the company works in. GMPs are not a menu–you can’t pick and choose which ones to follow, he said. There is a way to group GMPs and find tools and procedures that can enable compliance across the board. The model that Abbott used involved starting with the policy or regulation, interpreting that policy, setting an application/procedure for carrying it out, and aligning a toolbox with it.

	When talking about the various GMPs companies must follow today, Beatrice highlighted the World Health Organization. WHO is becoming a regulatory agency, he said. Companies need to pay attention to what the organization is doing because WHO is working with regulators and organizations worldwide.

	More to come from ExcipientFest this week….

Today in San Juan, at ExcipientFest 2012 in partnership with IPEC, Michael Beatrice of Abbott spoke about the seven deadly sins of quality management.

Live from ExcipientFest: Deadly Sins of Quality Management

FDA’s Center for Drug Evaluation and Research (CDER) has been running an educational, regulatory-based forum since 2005 to engage its international regulatory counterparts. This forum includes online learning courses on how the Center organizes its drug-review process in the US.
 

This month, CDER added a new program in drug safety to its “CDER World” platform for training and education. The new program includes information about the agency’s Office of Surveillance and Epidemiology. The forum meetings, held twice a year, are held through CDER World in a “live” format via the Internet in order to reach as many people as possible. 


“The interest in these ‘live’ meetings has grown exponentially with FDA working in harmonization with countries around the world,” states the CDER World 

. “Many more people than can be accommodated at these small meetings want to learn about the science, technology, regulations and processes CDER uses to accomplish its complex and challenging work.”
 

Other eLearning programs focus on compliance, generic drugs, and new drugs. Each educational session includes a list of Frequently Asked Questions from international forums. These questions are updated by CDER periodically.

This month, CDER added a new program in drug safety to its "CDER World" platform for regulatory training and education.

CDER Adds to Online Regulatory Learning Program

	FDA’s Center for Drug Evaluation and Research (CDER) has been running an educational regulatory-based forum since 2005 to engage its international regulatory counterparts. This forum includes online learning and continuing education courses on how the Center organizes its drug-review process in the US.
	This month, CDER added a new program in drug safety to its “CDER World” platform for training and education. The new program includes information about the agency’s Office of Surveillance and Epidemiology. Other eLearning programs focus on compliance, generic drugs, and new drugs. Each educational session includes a list of Frequently Asked Questions from international forums, which CDER updates periodically.
	The forum meetings, held twice a year, are held through CDER World in a “live” format via the Internet in order to reach as many people as possible. The online sessions can be viewed at any time through the 

	It’s nice to see that FDA, and CDER in particular, are putting this basic information out there so that industry and other regulatory bodies can have a deeper understanding of its processes. Many organizations on the regulatory and industry side are increasing their level of transparency and sharing of information-a feat that has been hard to accomplish in this patent-driven environment. Harmonization of regulatory reviews and marketing authorizations will go a long way towards streamlining the global pharmaceutical development and manufacturing marketplace. This online learning program is one of many forward steps in that direction.

FDA’s Center for Drug Evaluation and Research (CDER) has been running an educational regulatory-based forum since 2005 to engage its international regulatory counterparts.

FDA Expands Online Learning

  Johnson & Johnson announced this week that Sheri S. McCoy, vice-chairman of the Executive Committee, has resigned from the company. She was considered to be in line for the CEO position, being filled by Alex Gorsky. 

McCoy, who joined J&J in 1982, is reportedly moving on to head Avon, a smaller company in comparison to J&J but with similar healthcare products in the cosmetic and skincare area.

 “Sheri has made important contributions across Johnson & Johnson throughout her career.  During these last several years, she was instrumental in helping to bring stronger strategic focus to our Pharmaceutical business as it builds a robust pipeline and launches important new medicines; and to our Consumer business as it leverages the success of its iconic brands and worked to resolve some recent challenges,”  said J&J CEO and Chairman William C. Weldon, in a company 

 earlier this year that Gorsky would be succeeding Weldon, effective with the April 2012 annual shareholders’ meeting. Weldon served as Chairman and CEO since 2002. Gorsky is currently vice-chairman of the company’s Executive Committee with responsibility for the Medical Devices & Diagnostics Group, Global Supply Chain, Health Care Compliance & Privacy, and Government Affairs & Policy. Weldon will remain chairman of the company’s board of directors.


Comment from Reader J. Coupal, Lexington, KY:

"'..and to our Consumer business as it leverages the success of its iconic brands and worked to resolve some recent challenges.' '..[R]esolve some recent challenges' is the understatement of the year. A wide variety of seemingly unsolvable quality problems with McNeil Consumer products reflects performance of senior management responsible for quality oversight.It will take years for the public to regain enough confidence to buy and take those iconic products." 

Johnson & Johnson announced this week that Sheri S. McCoy, vice-chairman of the Executive Committee, has resigned from the company. She was considered to be in line for the CEO position.