The Aseptic Processing Survey

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October 2006 PDA Letter

In this issue, PDA takes a critical look at the U.S. FDA Critical Path Initiative and considers what impact, if any, this program will have on the long-term health of the pharmaceutical industry. In “PAT: Déjà vu All Over Again?,” Lynn Torbeck questions whether expectations laid out for process validation since in the U.S. FDA guidance on process analytical technologies are in reality old expectations. Lothar Hartmann highlights the problems caused by and posits a solution to the recent and troubling trend of increasing foreign inspections in the article “Solving the Over-Inspection Problem.” PDA’s Gail Sherman shares the plans for the new TRI facility in Bethesda, expertly provided by Vectech Pharmaceutical Consultants’ staff. The issue also includes photos from the TR-1 “summer feedback tour” and important recent visits to the old headquarters at 3 Metro Center, and much more!

FDA Announces Final Guidance, Biological product Deviation Reporting for Licensed Manufacturers of Biological products Other Than Blood and Blood Components

In the October 19 Federal Register, the U.S. FDA announced the availability of a final guidance for the industry entitled Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components. The guidance is intended to provide assistance to licensed manufacturers of biological products other than blood and blood components in the reporting of any event associated with the manufacturing, to include testing, processing, packing, labeling or storage, or with the holding or distribution of a licensed biological product which may affect the safety, purity or potency of a distributed licensed product. The guidance document will assist these licensed manufacturers in determining when a report is required, who submits the report, what information to submit in the report, the timeframe for reporting, and how to submit the report.

PDA Technical Report No. 28, Revised 2006: Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals mails with the September/October PDA Journal. All members should receive their copy of the technical report, which was produced in cooperation with PhRMA when they receive their Journal. For more information on the TR, please go to the PDA Bookstore.

PDA CALL FOR VOLUNTEERS
TO PARTICIPATE IN DEVELOPING AND REVIEWING TECHNICAL REPORTS

Call for Authors: 

PDA is seeking content experts globally to participate in developing technical reports on the following subjects: 

Please contact the person listed along with that title. 

Call for Reviewers: 

PDA is seeking content experts globally to participate in reviewing and providing comment/feedback on the following Technical Reports drafts:

If you have not already participated on a PDA Technical Report, please be prepared to offer a short biographical sketch outlining your areas of expertise and interest pertinent to the development of this project.

We encourage you to offer your time, skills, and expertise to any of these projects! 

Facilities and Engineering Interest Group Scope and Mission, Fall 2006

Interest Group

The Facilities and Engineering Interest Group (FEIG) is a forum for discussing issues in the Pharmaceutical and Biotechnology industry of particular interest to engineering and maintenance professionals, and to other groups that have an interest in topics including HVAC system, calibration preventive maintenance, facility design, engineers change control and energy.

The FEIG is also a forum for influencing the programs of the PDA, and a source for topics and papers to share at PDA conferences and in Technical Reports.  We host meetings at the PDA Annual Meeting and the PDA/FDA Joint Regulatory Conference.  Come join us.

Chris Smalley indicated that he would ask the Science Advisory Board to approve a scope statement for a task force to prepare a technical report on quality systems in facilities and engineering.  Any PDA members who are interested in participating in this task force is invited to submit their name to Chris at smallec2@wyeth.com.  You do not need to be a member of the Facilities and Engineering Interest Group to join this Task Force.

The September meeting was held in conjunction with the PDA/FDA Joint Regulatory Conference in Washington, D.C. on September 13th.

We had a great breakfast meeting on Wednesday morning, discussing the Quality Systems in Facilities and Engineering.  Procedures and programs, such as Trackwise® were mentioned as elements of such a Quality System, but by themselves were not complete.  It is important that quality, and Quality Systems not be seen as being owned by or the responsibility of the Quality Unit.  Rather, they should be owned by the facilities and engineering function.

Issues such as roles and responsibilities, whether of the facilities and engineering group, the training group, or the quality unit were mentioned as important contributors to a Quality System, as was the culture of the organization.  For instance, at times the relationship between the groups may be antagonistic, with the Quality Unit perceived as a “Policeman”, or at other times whether there was trust and collaboration occurring between groups.

The impact of the Quality Systems on procedures, training, the management of deviations, the change control process, and preventive maintenance were also discussed.

Please consider joining us at our next meeting, which will be held in conjunction with the PDA Annual Meeting at the Red Rock Casino, Resort and Spa in Las Vegas, NV on March 19-23, 2007!

PDA Global Headquarters
Bethesda Towers
4350 East-West Highway, Suite 200
Bethesda, MD 20814 USA
Tel: +1 (301) 656-5900
Fax: +1 (301) 986-0296

NEWS RELEASE

PDA Contact: Matthew Clark
Tel: +1 (301) 656-5900, ext. 125
E-mail: clark@pda.org

ISPE Contact: Marsha Strickhouser
Tel: +1 (813) 960-2105
E-mail: mstrickhouser@ispe.org

ISPE/PDA Conferences to Examine Guidances for Pharmaceutical Industry with ICH Experts

Bethesda, Maryland, USA (September 26, 2006) - The International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA), will co-host the first in a series of scientific conferences addressing the International Conference on Harmonisation’s (ICH) Q8 and Q9 Pharmaceutical Development and Quality Risk Management Guidance.

Challenges of Implementing Q8 and Q9 – Practical Applications, will be held 6-7 December 2006 in Washington, D.C., USA. The conference will be presented again 12-13 February 2007 in Brussels, Belgium.

Members of the International Conference on Harmonisation (ICH) Expert Working Groups who wrote “Q8 Pharmaceutical Development” and “Q9 Quality Risk Management” have been enlisted to develop content and give presentations for the upcoming joint ISPE/PDA conferences.

Regulators from the US Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA), and Japan’s Ministry of Health, Labor and Welfare (MHLW) will participate in the conferences. Co-hosts ISPE and PDA are two leading associations in the pharmaceutical manufacturing industry that have joined forces to further explore the recently published Guidances for Industry, ICH Q8 and Q9.

The FDA issued Q8 on 22 May 2006, and just two weeks later, issued Q9. The Guidances for Industry are expected to have a major impact on how the industry and those who regulate it will do business.

“I am pleased we are able to join forces with PDA to produce these important events,” said Bob Best, President and CEO of ISPE. “By combining our expertise on these subjects we will be able to better serve the industry. I would also like to thank the members of the ICH negotiating team represented by regulators and industry for their participation in developing this program.”

“We are excited about the opportunity to work with ISPE on this initiative,” said Robert Myers, PDA President. “These conferences will enable both organizations to leverage our strengths to provide high-level scientific forums that will be mutually beneficial to our members and the pharmaceutical and biopharmaceutical community.”

Conference developers explain that the event is designed to take attendees on a “back-stage tour” of the ICH negotiating table, looking at not only what is in the Guidances for Industry, but also at what wasn’t included and why. Nearly fifteen representatives of the ICH Expert Working Groups are involved in the conference planning and presentations.

Regulators from the US, Europe, and Japan will discuss how to:
• Conduct science and risk-based assessment of submissions
• Balance expectations for a quality by design-based submission and approval of a product without raising the bar
• Provide regulatory flexibility while still assuring product quality
• Handle legacy products

Industry representatives from each region will provide their perspectives of the challenges associated with the implementation of the Guidances, including a review of the potential benefits, such as enhanced process capability and robustness, better integration of review and inspection systems, achieving greater flexibility in specification setting, and the management of post approval changes.

In addition, through case studies, attendees will learn from regulators and industry representatives about experiences with the FDA’s CMC Pilot Program, and the implementations of strategies for quality risk management.

Representatives from both ISPE and PDA will provide updates on their respective associations’ work relative to Q8 and Q9. Panel discussions will provide opportunities for interaction between speakers and attendees. The conferences will be structured so that all attendees have the benefit of attending all sessions and hearing all presentations.

To register for the upcoming conference in Washington D.C., visit www.ispe-pda.org/Q8Q9.

About PDA
The Parenteral Drug Association (PDA), Connecting People, Science and RegulationSM, is a nonprofit international organization and a leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 10,000 members worldwide. More information about PDA is available at www.pda.org.

About ISPE
ISPE is the Society of choice for more than 23,000 pharmaceutical manufacturing professionals from 81 countries. ISPE aims to be the catalyst for “Engineering Pharmaceutical Innovation” by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA; a European office in Brussels, Belgium; and an office in Singapore to serve Asia-Pacific. Visit www.ispe.org for Society news and more information.

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PDA Call For Volunteers To Participate In Upcoming Technical Report

The PDA Technical Report #13 Task Force, chaired by Jeanne Moldenhauer of Vectech Pharmaceuticals is seeking technical volunteers to actively participate in revision of the upcoming Technical Report Fundamentals of an Environmental Monitoring Program.We encourage you to offer your time, skills, and expertise to this project.

If you are interested in integrating your skills with this project, please contact Iris D. Rice, Coordinator, Scientific and Regulatory Affairs (rice@pda.org) and express your interest in volunteering. Please be prepared to offer a short biographical sketch outlining your areas of expertise and interest pertinent to the development of this project.

PDA FILTRATION INTEREST GROUP MEETING, SEPTEMBER 12, 2006

During this year's Graduate Student fellowship competition, the PDA received a series of three applications from the University of the Witwatersrand in Johannesburg, South Africa, that the review committee recommended for special consideration. The applicants included two students from the Democratic Republic of Congo and a Nigerian national all of whom have demonstrated an extraordinary drive and determination to make a meaningful contribution to medical sciences. The PDA decided to award each of these students a two thousand dollar grant in support their efforts toward graduate training in pharmaceutical technology. Therefore, a special award for global pharmaceutical science education will be made in the name of the following three students of Eberhard W. Neuse, Professor of Macromolecular Chemistry, to the University of Witwatersrand:

• Diakanua Nkazi
• Hembe E. Mukaya
• Blessing A. Aderibigbe

Please plan to attend. If you have any suggestions for topics, wish to propose questions, or initiatives; or otherwise wish to contact us, please email Hal Baseman at hbaseman@valsource.com or call at 561.676.3940; or contact Tim Ramjit at timothy.ramjit@spcorp.com , 908.709.4865.

PDA 2005 Annual Report

From the European Medicines Agency (EMEA): Questions and Answers on GMP Issues
http://www.emea.eu.int/Inspections/GMPQaA.html

PDA seeks volunteers for the newly created TRI Education Advisory Committee

1. Advise TRI on the design, development and implementation of a full training curriculum for the industry, academia and regulatory health authorities in both hands-on laboratory training, and lecture series;

2. Develop for TRI use, courses related to the hot topics in the industry;

3. Align with PDA’s Interest Groups, Committees, Advisory Boards and Chapters world-wide to assure a common understanding of content for courses delivered by TRI faculty;

4. Assist in cross promotion of TRI educational offerings with other PDA programs and events.

PDA Mycoplasma Task Force Seeks Technical Volunteers

The PDA Mycoplasma Task Force, co-chaired by Barbara Potts (Genentech) and John Geigert (BioPharmaceutical Quality Solutions) is seeking technical volunteers to participate in four important subgroups:.

(1) Standardization of mycoplasma removing filters
(2) Inactivation/removal of mycoplasma from pharmaceutical processes
(3) Emerging mycoplasma issues from insects and plants
(4) Standardization of mycoplasma test methods

We encourage you to make a difference for our membership and our industry. Please contact Iris Rice to volunteer. Please provide a short bio and indicate which subgroup you would be interested in serving on.

New PDA Facility to Offer Enhanced Pharmaceutical and Biotechnology Training and Education

Bethesda, Md. (June 7, 2006): The Parenteral Drug Association (http://www.pda.org) today announced it will consolidate operations, including the Baltimore-based PDA Training and Research Institute (PDA TRI), to offer enhanced pharmaceutical and biotechnology training and education from a centralized facility.

The new headquarters will occupy the first and second floors of the Bethesda Towers in the heart of Bethesda, Maryland. This places PDA TRI close to Maryland's I-270 technology corridor, putting PDA within close proximity to many of the state's pharmaceutical and biotechnology companies, as well as regulatory groups with which PDA regularly interacts.

Click here for News Release.

The Pyrogens Working Group (PWG) of the Interagency Coordinating Committee on the Validation of Alternative Methods committee seeks knowledgeable persons to serve on a peer review committee that will evaluate available (and limited) data and make a recommendation related to implementing IVPT in the U.S., including regulated industry.

The committee desires candidates who are knowledgeable and experienced with pyrogens and endotoxins testing, with a broad geographical and demographic representation from academia and industry, especially from within the U.S. CVs for candidates are needed by Friday, May 26. 

Click here to view the Federal Register Notice.

Interested candidates may contact David Hussong PhD, or David G. Allen, PhD.

Survey: Implementation of Risk Management Programs in Aseptic Processing

Bethesda, Md. (May 08, 2006): In April 2005, PDA chartered a Risk Management Task Force to compile and provide information on the implementation of risk management programs in aseptic processing facilities, with specific focus on sterility and endotoxin. Your input is requested to help us understand the current utilization of risk management practices in our industry, the extent to which they are institutionalized and the industry’s perspective on risk factors associated with aseptic processing.

Participate in this survey

Your feedback will provide the Task Force and PDA membership with valuable information that reflects membership needs and perspectives in this area. We appreciate your cooperation and participation.

2006 BOARD REPRESENTS DIVERSE BASE OF GLOBAL LEADERSHIP

Bethesda, Md. (December 13, 2005): The Parenteral Drug Association (PDA) today announced its 2006 Board of Directors and Officers.

The newly elected Officers for 2006-2007 are: Chair, Vincent Anicetti, Genentech, Inc.; Chair-Elect, John Shabushnig, PhD, Pfizer Inc; and Secretary, Lisa Skeens, PhD, Baxter Healthcare Corporation. Maik Jornitz, Sartorius Corporation, has been appointed Treasurer. The 2004-2005 Chair, Nikki Mehringer, Eli Lilly and Company assumes the office of Immediate Past Chair.

Yoshihito Hashimoto, Chiyoda Corporation, was reelected as Director. Three newly elected Directors will join the PDA Board in 2006: Steven Mendivil, Amgen; Amy Scott-Billman, GlaxoSmithKline; and Gail Sofer, GE Healthcare. In addition, Anders Vinther, PhD, CMC Pharmaceuticals A/S, and Stephen Bellis, IVAX Pharmaceuticals UK, have been appointed Directors.

"We are extremely pleased and honored that these outstanding and accomplished individuals have joined the PDA Board of Directors," said Robert Myers, PDA President. "Each brings a proven record of leadership that will complement the capabilities of our current Board members. The scientific and geographic diversity of the new Officers and Directors reflects PDA's growth over the last decade and strengthens our position as a global association for pharmaceutical and biopharmaceutical professionals."

Outgoing members include Immediate Past Chair, Floyd Benjamin, Keystone Pharmaceuticals, Inc. and Secretary, Stephanie Gray, Pharmaceutical Strategies.

"On behalf of PDA, I would like to recognize the leadership and insight provided our Board members over the last two years," said Mehringer. "The 2006 PDA Officers and Directors will continue to provide strong strategic guidance to ensure PDA remains dedicated to promoting scientifically sound and practical technical information and education for industry and regulatory agencies worldwide."

PDA Names Georg Roessling, PhD, Senior Vice President of PDA Europe

Bethesda, Md. (December 7, 2005): The Parenteral Drug Association (PDA) today announced that Georg Roessling, PhD, will join the Association as Senior Vice President of PDA Europe, effective January 1, 2006.

"Under Dr. Roessling's leadership, PDA's European office will operate more independently of the Association's U.S. headquarters," said Robert Myers, PDA President. "This will bring superior service to our European membership and increased value to all of PDA."

Dr. Roessling is respected throughout the global pharmaceutical community and has a long history with PDA. He recently served as Treasurer of the Association's Board of Directors. He has a strong background in pharmaceutical science and manufacturing technology, gained through 21 years of product development experience. His managerial skills will strengthen PDA's overall operation in Europe.

Prior to joining PDA, Dr. Roessling worked at Schering AG, Berlin, Germany, where he most recently served as Head of the CMC Technology Office/Drug Delivery Systems. He formerly held positions in Pharmaceutical Development at Schering, including 13 years as Head of Parenteral Development. He has more than 50 patents and patent applications and is the author or coauthor of over 40 publications.

"I am very excited to join the PDA staff under Bob Myers' leadership," said Roessling. "I look forward to connecting with the Association's European community and the global membership to accomplish PDA's mission of bringing practical technical information to the pharmaceutical and biopharmaceutical industries. We have much opportunity to be of service to the members residing in Europe. "

Roessling is based in Berlin, Germany and will report directly to Robert Myers.

Bethesda, Md. (November 10, 2005): The Parenteral Drug Association (PDA) is training representatives from the Republic of Kazakhstan to develop a stronger, more informed regulatory agency by exposing professionals from that country to a broad range of pharmaceutical technologies and U.S. and European regulatory functions.

PDA has teamed with Eli Lilly and Co. and Purdue University on the project, and will train approximately 200 delegates from Kazakhstan over the next three years.

"Building on the successful training PDA provided for the Italian inspectorate in 2002 and 2003 and for Taiwanese officials in 2005, the Association is well-positioned to offer comprehensive and practical GMP training to members of the Kazakhstan Ministry of Health and National Center for Assessment of Drugs, Items for Medical Purposes and Medical Equipment," said Robert Myers, PDA President. "This is the largest single training project PDA has undertaken to date."

The program began October 31, 2005 with a two-week training of 44 delegates at PDA's Training and Research Institute at the University of Maryland Technology Center in Baltimore, Maryland. Those 44 students will then begin a two-week series of courses November 13 at Purdue University's main campus in West Lafayette, Ind., and at Eli Lilly's headquarters in Indianapolis.

"PDA's training is designed to be synergistic with the work being done by Purdue and Eli Lilly," said Gail Sherman, Vice President of Education, Director of PDA Training and Research Institute. "The trainees have been excited about meeting and learning from our many experts who have conducted the training"

As a nonprofit scientific organization, PDA has brought together a unique panel of volunteer experts from the Association's membership, academia, U.S. FDA, U.S. Pharmacopeia and in-house senior leadership.

The training includes sessions examining the regulatory systems and requirements necessary for the review and approval of drugs and biologic products, with an emphasis on U.S. and European regulations. Sessions also cover the science and technologies of the pharmaceutical practice, clinical trials, manufacturing issues, labeling and advertising.

"There is a huge shortage of prescription drugs for diseases that are devastating the populations of developing countries," said Charles Rutledge, Vice President for Research at Purdue and Professor of Pharmacology, who is principal investigator of the program. "If developing nations are self sufficient in pharmaceutical manufacturing, there will be no need for the U.S. government or U.S. pharmaceutical companies to provide these medications at a great financial loss."

Publicly-Supported Clinic Operating in Bayou La Batre, Alabama, to Receive $7,700 for Pharmaceuticals

In mid-October, the Katrina Relief Fund established by Novatek International and EMD Chemicals, with support from PDA and its Foundation for Pharmaceutical Education, Training and Research, was awarded to Bayouclinic, Inc., a not-for-profit clinic in Bayou La Batre, Alabama. The sparsely populated shrimping village was hit by a 25-foot storm surge which left 2000 of the town's 2300 residents homeless. Seafood processing plants, the lifeblood of the community, were permanently destroyed.

Bayouclinic has worked for 15 years in this poor community of hardworking, independent fishermen and factory workers. Prior to hurricane Katrina, the community suffered from a 50% unemployment rate and a 40% rate of residents without any medical insurance. Bayouclinic, along with other health care and social service providers, has worked to address those needs. The clinic serviced 4200 patients from Bayou La Batre and the surrounding areas.

The clinic did not make it through the hurricane unscathed. Despite a foundation built on stilts, the clinic received five feet of water and everything inside was virtually destroyed. A local Red Cross Shelter and a U.S. Federal Emergency Management Administration (FEMA) trailer are serving as temporary homes for the clinic.

The Katrina Relief Funds will be used to provide patients at the clinic with prescription medicines.

PDA is pleased to have participated in raising money for and awarding the proceeds of the Novatek International-EMD Chemicals Katrina Relief fund. We thank all of the PDA members and staff who contributed funds.

September 2006 PDA Letter -- The September issue includes a forward thinking look at the role of the Qualified Person in Europe by Joyce Ramsbotham, with her article: "Times are Changing: The Role of the Qualified Person in the 21st Century." Also, PDA highlights two distinguished past leaders--Ed Fry and Fred Carleton--with the continuation of the Past Leader Spotlight series. PDA's Science and Regulatory Department provides an update on the status of the revision of PDA Technical Report No. 1, which is undergoing an extensive stakeholder comment period. In the Quality and Regulatory Affairs section, we include recently posted Questions and Answers from the EMEA website.

Click here for the September 2006 PDA Letter