Science and Technology News

Figure 4

Tue, 30 Mar 2010 15:04:52 GMT

N/A

Figure 3

Tue, 30 Mar 2010 15:04:14 GMT

N/A

Figure 2

Tue, 30 Mar 2010 15:03:35 GMT

N/A

Figure 1

Tue, 30 Mar 2010 15:02:39 GMT

N/A

Read the Journal Online in "Full Text" View and Make PowerPoint Slides

Fri, 26 Mar 2010 11:16:24 GMT

April 2010 You might already be taking advantage of the extensive search functions at the PDA Journal's new electronic home, but did you know you can create PowerPoint slides from the figures with just a touch of a button?

In Print: Perspective on Cleaning Validation and Revalidation

Fri, 26 Mar 2010 10:03:32 GMT

April 2010
The following are excerpts from the PDA/DHI book, Cleaning Validation Practical Compliance Solutions for Pharmaceutical Manufacturing, Vol. 2, by Destin LeBlanc. References have been removed from this excerpt but can be found in the book.

Journal Preview: Sign Up for Journal Alerts Online

Fri, 26 Mar 2010 09:57:22 GMT

April 2010
Did you know you can receive the PDA Journal's Table of Contents by email and through RSS? Just go to journal.pda.org to sign up for these features and never miss an issue.

In Print: QbD for Cleaning Validation

Tue, 23 Feb 2010 10:55:11 GMT

March 2010 We have all heard dreadful stories about delays to submissions, new product introductions and product releases because of failed cleaning validation. These types of costly delays can be prevented if we enter into validation after we are confident that the cleaning cycle is robust and validatable. However, far more than we would like to admit, we have witnessed or heard of events that demonstrate that this has not been the mindset or culture. Many firms have adopted an overkill approach, where they have developed extreme cycles to assure success. These cycles consume excess energy, cleaning agents, and water; increase equipment turnaround times; and produce more waste.

Technical Report Watch

Tue, 23 Feb 2010 08:25:37 GMT

March 2010 See where certain technical reports are within the publishing process.

The Challenges of Success - Looking forward to 2010 PDA SciTech Activities

Tue, 23 Feb 2010 08:18:21 GMT

March 2010 Each successive year, I have had the pleasure to report to you that PDA's SciTech program has been on an upward trend, as measured by the number of approved Task Forces and participants. In 2010, I expect more teams than ever before in my tenure to complete their goals and publish their deliverables. At the end of February, we will have already published two technical reports, Last Mile: Gidance for Good Distribtution Practices for Pharmaceutical Products to the End User (TR-46) and Preparation of Virus Spikes Used for Virus Clearance Studies (TR 47).

Journal Preview: Bio's CEO writes on Biotech Public Policy

Tue, 26 Jan 2010 13:00:39 GMT

February 2010 Volume 64, No. 1 (January/February) of the PDA Journal of Pharmaceutical Science and Technology is now available online. This issue has a guest editorial from James Greenwood, President and CEO, Biotechnology Industry Organization, on the public policy that is needed to advance biotechnology innovation. In addition, results from an FDA-sponsored study on the risks of changing sterile drug manufacturing sites are published.

Technical Report Watch

Tue, 26 Jan 2010 12:54:49 GMT

February 2010 Over the years, PDA expert task forces have developed several technical reports on various aspects of filtration. Now you can own all five of them in one easy-to-use hardbound volume.

IG Briefing: 13 PDA Interest Group Sessions

Tue, 26 Jan 2010 12:50:18 GMT

February 2010 The following is the schedule for the 13 interest group sessions that will occur on Monday, March 15 and Tuesday, March 16 at PDA's Annual Meeting.

Task Force Corner: Size, Workload Distinguishes PDA's Mycoplasma TF

Mon, 04 Jan 2010 13:48:02 GMT

January 2010 PDA's Mycoplasma Task Force boasts an ambitious agenda of nine articles, three technical reports and a training workshop. Task Force leader Barbara Potts outlined the group's work at PDA's 4th Annual Global Microbiology Meeting in October.

Advisory Board Watch: An Update on PDA's Three Scientific Advisory Boards

Mon, 04 Jan 2010 12:21:23 GMT

January 2010 The following article is a report on three of PDA's Advisory Boards.

2009 Archives

Mon, 04 Jan 2010 12:08:37 GMT

N/A

In Print: New Inspection Techniques for Aseptic Processing

Sun, 04 Oct 2009 20:53:19 GMT

October 2009
Aseptic manufacturing processes have evolved over a long period of time and are capable of producing high quality parenteral products. Continued innovation in aseptic processing techniques will ensure that the quality and production yields of sterile products continue to improve over time.

Journal Preview: New Editor Govind Rao Introduces Himself to PDA

Sun, 04 Oct 2009 12:31:39 GMT

October 2009 Volume 63, No. 5 (September/October) of the PDA Journal of Pharmaceutical Science and Technology is now available online.

Technical Report/White Paper Watch

Sun, 04 Oct 2009 12:29:03 GMT

October 2009Coming soon! PDA is preparing to publish a regulatory white paper.

ABs Look at Managing PDA Professional & Volunteer Resources at September Joint Strategy Meeting

Sun, 04 Oct 2009 12:23:52 GMT

October 2009We live in challenging times, yet PDA's community of scientists, technicians, regulatory experts and regulators are busier than ever, as are the professional staff at PDA.

Journal Editorial Team Now in Place

Mon, 17 Aug 2009 14:45:22 GMT

September 2009
Without doubt, the most exciting developments in PDA's Science and Technology program in 2009 have been the changes to the PDA Journal of Pharmaceutical Science and Technology.

Journal Preview: A Look at Extractables and Leachables

Mon, 17 Aug 2009 14:36:34 GMT

September 2009
The July/August issue of the PDA Journal is a special one focused on extractables and leachables, a very important issue for biologics and other kinds of sterile products, particularly with the increasing use of disposable manufacturing components and the number of novel delivery systems in use. Articles in the issue look at various packaging types.

In Print: Aseptic Processing Innovations

Mon, 17 Aug 2009 14:08:16 GMT

September 2009
The following is excerpted from the chapter, "Innovation In Aseptic Processing-Case Study Through the Development of a New Technology," by Benoit Verjans and Jacques Thilly, Aseptic Technologies. The chapter appears in the recently published PDA/DHI book, Practical Aseptic Processing: Fill and Finish, Volume II, edited by Jack Lysfjord. References have been removed for this excerpt, but can be found in the book.

PDA Survey Results: Cleaning Validation Sampling Recovery Practices

Tue, 07 Jul 2009 10:37:28 GMT

July/August 2009
The PDA conducted an online survey on the topic "Cleaning Validation Sampling Recovery Practices" during the fall of 2008. This is the fourth in a series of surveys the PDA has conducted on cleaning validation practices. The survey was designed by a team comprised of Destin LeBlanc, Cleaning Validation Technologies, Liz Dallison, Pfizer, Jennifer Carlson, Genentech, and Paul Pluta, Institute of Validation Technology.

Introducing PDA's PCMO Initiative

Tue, 07 Jul 2009 10:02:10 GMT

July/August 2009
DA is well known for the quality and usefulness of our technical reports, technical books and the PDA Journal of Pharmaceutical Science and Technology, and for the value and timeliness of our various training courses and events. In order to ensure that these offerings continue to meet the needs of our global members and industry during a time of decreasing resources and dramatic changes to the foundations of quality control/ quality assurance and GMPs, we-members of our Board of Directors and our Advisory Boards, along with staff-have developed a new initiative called the "Paradigm Change in Manufacturing Operations," or PCMO for short.

Advisory Board Watch: Working Together, Better and Harder for Members

Tue, 16 Jun 2009 10:49:32 GMT

June2009
At the PDA Annual Conference in Las Vegas in April, the leaders of PDA's volunteer, technical advisory boards met to accomplish two important strategic goals:
1) To review a new, major PDA initiative, called "Paradigm Change in Manufacturing Operations" (PCMO)
2) To discuss areas of common, overlapping scientific interest

Technology Trend: Going Green Can Save the Green Stuff

Tue, 16 Jun 2009 10:56:15 GMT

June2009
There was a time in the recent past when pharmaceutical companies were not concerned with "going green." According to Thomas Pagliuco, Director, Energy, Schering-Plough, that time is over.

Journal Preview: Evaluation of Optical Spectroscopy Technology for Real-Time Monitoring in May/June Journal

Tue, 16 Jun 2009 11:13:16 GMT

June2009
The May/June PDA Journal includes an evaluation of BioVigilant's IMD-A, which utilizes optical spectroscopy technology for continuous, real-time environmental monitoring.

IG Briefiing: Micro/EM IG Discusses Investigation Trends

Tue, 16 Jun 2009 11:05:56 GMT

June2009
The PDA Microbiology/Environmental Monitoring Interest Group met at the Annual Meeting in Las Vegas on April 20. We were very privileged at this meeting to have three great speakers, Jim Akers, PhD, President, Akers, Kennedy & Associates, Ken Muhvich, PhD, Principal Consultant, MicroReliance, and Karen Ginsbury, CEO, PCI Pharmaceutical Consulting. They all provided different perspectives on current trends in investigations. Akers talked predominantly about environmental trends. Muhvich gave some great information on trends with P. acnes. Ginsbury spoke about the whole process of performing an appropriate investigation. This was followed by a period for questions and group discussion.

Leadership Opportunity: Combo Products Experts Needed

Fri, 09 Jan 2009 14:54:45 GMT

January 2009
PDA's Scientific Advisory Board recently authorized the formation of the Combination Products Task Force. The task force is organized as a committee of the Combination Products Interest Group which was originally established in 1998. The task force is co-chaired by Michael Gross, PhD, Principal Consultant, Chimera Consulting, and Leader of PDA's Combination Product Interest Group; and Lisa Hornback, Principal Consultant, Hornback Consulting and member of PDA's Scientific Advisory Board.

In Print: Thermal Death Time Verification

Mon, 05 Jan 2009 16:17:56 GMT

In the past few years, there has been a exchange in emphasis by regulatory and compendial requirements to require that pharmaceutical manufacturers verify the accuracy of the thermal death time (D-value) and organism control counts for biological indicators used. Although the requirements were presented in draft form through compendial documents, only when the documents were officially issued did many pharmaceutical manufacturers first initiate verification procedures.

Technology Trend: Rapid Micro Methods Slowly Gain Ground

Mon, 13 Apr 2009 10:13:31 GMT

April 2009Rapid microbiological methods (RMMs) are steadily gaining acceptance in the pharmaceutical industry as a viable alternative to traditional methods, although their uptake has been confined mostly to new products. Regulatory acceptance of the alternative methods and the challenge of comparing them to historic methods is one barrier to widespread use for legacy products.

USP Unveils Chapter on EM for Nonsterile Drugs

Wed, 18 Nov 2009 07:00:04 GMT

November/December 2009 The United States Pharmacopeia (USP) used the 4th Annual PDA Global Conference on Pharmaceutical Microbiology to generate discussion about its draft chapter on environmental monitoring and control in nonsterile drug product manufacturing areas among the approximately 200 microbiologists and sterile product experts gathered at the 2-1/2 day event.

Interim Journal Website Facilitates Online Access

Mon, 13 Apr 2009 10:05:14 GMT

April 2009The interim website for the PDA Journal at www.pda.org/journal went live in March with the January/February issue, and the new page has been accessed more than 6,000 times in the two weeks following posting. While this launch can be considered successful, PDA wants to make it clear that we are earnestly working on a new, dynamic website with HighWire Press, scheduled to launch in mid-July. That website will be built from a HighWire Press template, which have a solid track record with a number of other HighWire Press journal partners.

Vol. 63, No. 1 Commentary

Mon, 06 Apr 2009 14:02:32 GMT

Reverse Osmosis as a Means of Water for Injection Production: A Response to the Position of the European Medicines Agency

Annual Meeting Preview: 15 IG's, 5 Task Forces, BioAB to Meet

Thu, 26 Feb 2009 10:56:27 GMT

March 2009
PDA members and volunteers will dedicate some of their time at the 2009 Annual Meeting conducting the business of the Association.

Technology Trend: Pfizer's Green Chemistry Cuts Waste, Saves Money

Thu, 26 Feb 2009 09:02:55 GMT

March 2009
Many industries and governments around the world are "going green," as as the world focuses more and more on the environment and the potentially negative effects of human activity.

Advisory Board Powwow to Plot PDA's Strategic Course

Thu, 26 Feb 2009 08:50:48 GMT

March 2009
To help advance the Association's mission, PDA is holding a joint Advisory Board meeting at its 2009 Annual Meeting. Participating will be PDA's all-volunteer advisory boards for science, regulatory affairs and biologics. The Program Advisory Board also might participate.

Journal Preview: Moist Heat "Myth Busting"

Mon, 13 Apr 2009 10:36:46 GMT

April 2009There's a popular television show in the United States called "MythBusters" that puts to the test popular beliefs and misconceptions, proving them right or wrong. Well, in the March/April issue of the PDA Journal, PDA's James Agalloco, James Akers and Russell Madsen do some mythbusting of their own with respect to moist heat sterilization in their commentary article, "Revisiting the Moist Heat Sterilization Myths." Who knows, maybe the article will inspire an episode of the television show!

Science and Technology Has Banner Year, Looks Ahead

Fri, 09 Jan 2009 14:09:55 GMT

January 2009
As we close 2008, I would like to take the opportunity to thank all of our volunteers and PDA members who have contributed to our efforts in Science and Technology. This was a banner year on multiple fronts, and I would like to take a brief opportunity to update all of you on our achievements.

2008 Archives

Fri, 09 Jan 2009 14:39:59 GMT

N/A

Journal Preview: Last Journal of the Year!

Mon, 01 Dec 2008 13:55:43 GMT

November/December 2008
Those considering investing in rapid sterility tests or not sure of the rapid methods' value should read the article by Gary Gresset, Erwin Vanhaecke and Jeanne Moldenhauer, a "technology/application" article appearing in the last Issue of PDA Journal Volume 62.

Sterilizing and Viral Filters Best Practices Updated with TR-26 & 41 Revisions

Mon, 01 Dec 2008 13:45:09 GMT

November/December 2008
PDA members who work with sterilizing and viral filters will benefit from updated best practices with the 2008 revisions of PDA Technical Report No. 26, Sterilizing Filtration of Liquids and Technical Report No. 41, Virus Filtration. TR-41 already mailed with the September/October edition of the PDA Journal, and TR-26 will mail with the November/December edition.

Annual Meeting Features 14 IG Sessions

Wed, 19 Nov 2008 08:51:03 GMT

March 2008
I am excited to tell you that thePDA 2008 Annual Meeting will feature fourteen Interest Group sessions. This is the largest number of Interest Groups to ever meet at a PDA Annual Meeting!

Interest Group Briefing: New QRM IG Holds 1st Meeting at PDA/FDA

Mon, 13 Oct 2008 16:30:37 GMT

October 2008
The PDA Quality Risk Management Interest Group met for the first time at the 2008 PDA/FDA Joint Regulatory Conference. The lively session drew over 50 participants who came not only because of their interest in Risk Management, but also because the co-chairs lined up four expert presentations on the topic.

Journal Preview

Mon, 13 Oct 2008 17:08:17 GMT

October 2008
Volume 62, Issue 5 of the PDA Journal contains several notable articles.

In Print: Contract Sterilization

Fri, 14 Nov 2008 14:54:33 GMT

February 2008
The medical device industry is using contract sterilization at an increasing rate. An effective contractual relationship must exist between the manufacturer and the sterilization contractor to guarantee a well-controlled sterilization process that is capable of producing a sterile, safe and effective product. A direct impact of this trend is the downsizing of sterilization support and a reduction in technical knowledge within the medical device manfacturer's personnel. Therefore, proper communication and understanding of the activities of the sterilization contractor is essential. It is critical that the responsibility for sterility is shared and that the division of responsibilities is clearly defined and understood by both parties.

Investing in the Industry's Future: PDA Graduate Student Symposium

Fri, 14 Nov 2008 14:42:09 GMT

February 2008
In the last several years, PDA has put together a Graduate Student Symposium at the PDA Annual Meeting. The topics presented at these symposia tend to offer the meeting attendees insight into what the future may hold in terms of cutting-edge thinking in science and technologies pertinent to the pharmaceutical and biopharmaceutical industry.

Building a Better Journal Online

Mon, 13 Oct 2008 17:03:16 GMT

October 2008
Ever wanted to look up an article from the PDA Journal of Pharmaceutical Science and Technology away from your hardcopies? Ever wished the Journal archives were available in a format more convenient than CD-ROM? Do you think you should be able to link from a current Journal article to its references? Ever submitted an article to the Journal and wished it was published faster? Well, PDA is working to bring you these features and more with our new online version of the PDA Journal.

Journal Programs: Predoctoral Fellowship Grants Awarded

Mon, 08 Sep 2008 16:14:15 GMT

September 2008
PDA and theJournal of Pharmaceutical Science and Technology is pleased to announce the recipients of its third annual Predoctoral Fellowships. The recipients each will receive a $10k grant from PDA to help them conclude their doctoral research. PDA congratulates each winner, their sponsoring professor and the institutions at which they attend.

Journal Preview: Risk Management Survey Supports PDA Technical Report

Fri, 14 Nov 2008 14:47:41 GMT

February 2008
The first article in the first issue of the Journal for 2008 presents the results of a survey conducted by PDA's Risk Management for Aseptic Processes Task Force and served as impetus for the development of the upcoming technical report on the same subject.

Your Technology Trends Article Can Contribute to the Advancement of Our Industry

Thu, 13 Nov 2008 16:15:40 GMT

January 2008
As part of the Science & Technology Snapshot, we want to present information on the latest technology trends relevant to the PDA community.

Journal Preview: Japanese Regulators Contribute Two Articles

Mon, 08 Sep 2008 16:14:07 GMT

September 2008
The July/August edition of the PDA Journal of Pharmaceutical Science and Research features two research papers by a team of researchers including members of Japan's health authority. Both papers examine different aspects of aseptic processing.

Task Force Corner: Single-Use Tools: A Focus of the Disposables Task Force

Mon, 08 Sep 2008 16:14:31 GMT

September 2008
Rob Repetto, Director Manufacturing Sciences & Technology, Wyeth, the Disposables Task Force leader, has unveiled some of the Task Force's recent and upcoming plans to the PDA Letter.

Journal Preview: November/December 2007 Journal

Thu, 13 Nov 2008 16:07:24 GMT

January 2008
The last issue ofPDA Journal of Pharmaceutical Science and Technology for 2007 is loaded with excellent research articles.

Task Force Update: A Peek at the "Sneak Peek"

Thu, 13 Nov 2008 15:59:12 GMT

January 2008
The Task Forces presented their work at the "Sneak Peek" on Nov. 5, hosted by Amgen at its Thousand Oaks, Calif., headquarters.

PQRI Update: Parenteral and Ophthalmic Drug Products (PODP) Leachables and Extractables Working Group

Mon, 08 Sep 2008 16:14:23 GMT

September 2008
On June 24, 2008, The Product Quality Research Institute's (PQRI) as Parenteral and Ophthalmic Drug Products (PODP) Working Group (a follow-on to the PQRI Leachables and Extractables Working Group) met at PDA's headquarters to initiate the process for development of Thresholds and Best Practices.

Task Forces: Connecting Members and Nonmembers to Solve Everyday Challenges

Mon, 17 Nov 2008 10:51:00 GMT

April 2008
Another benefit of belonging to PDA is the opportunity to share ideas, debate and establish documented industry best practices. To enable that end, specific task forces are sanctioned by PDA Advisory Boards. Each task force is composed of PDA members and nonmembers devoted to transforming the group's scope statement into a PDA technical report-what PDA calls a best practices guide. Each technical report, if approved by the relevant Advisory Board and the PDA Board of Directors, will be published as part of our PDA Journal of Pharmaceutical Science and Technology. While most task forces address new topics of interest, other teams come together to address needs for revision in content which arise over the course of a technical report's life cycle.

Interest Group Briefing: Prefilled Syringes IG Considers E-Beam

Tue, 18 Nov 2008 14:31:42 GMT

July/August 2008
On May 27, the European branch of the PDA Prefilled Syringes Interest Group met in Berlin to discuss a number of pressing matters.

PDA Collaboration: Managing Retest Dates on IMPs an Issue for PDA/ISPE Task Team

Tue, 18 Nov 2008 14:55:52 GMT

July/August 2008
In September 2007, a Task Team was formed by PDA and ISPE to look at alternative methods for managing retest dates for Investigational Medicinal Products (IMPs) utilized in the EU. Made up of eleven members collectively from PDA and ISPE; the core objective of the Task Team is to ensure an efficient process is in place that will help ensure that any IMP dispensed to the patient/volunteer will always be within the authorized shelf-life.

Revised EMEA Guideline on Monoclonal Antibody Manufacturing

Thu, 09 Oct 2008 15:29:34 GMT

On 18 June a delegation of PDA experts met with the EMEA's Biologics Working Party (BWP) for a scientific discussion to support revision of the "Guideline on Production and Quality Control of Monoclonal Antibodies and Related Substances, draft, (EMEA/ CHMP/ BWP/ 157653/ 2007, 5 April 2007).

PDA Call for Volunteers to Participate in Developing and Reviewing Technical Reports

Fri, 11 Jul 2008 09:43:02 GMT

N/A

Task Force Corner: Task Force Invites TR Review

Tue, 18 Nov 2008 15:01:33 GMT

July/August 2008
Microbiological Data Deviations (MDD) Task Force is pleased to announce that its technical report has reached the global review stage. The report outlines the current best practices for investigating MDDs and explaining why they are different from Out of Specifications investigations.

A Philosophical Discussion about Media Fills

Wed, 19 Nov 2008 08:26:07 GMT

July/August 2008
In January I had the pleasure of attending a meeting of the PDA Irish Chapter in Dublin. The title and focus of the meeting wasTrends in Aseptic Processing - A Risk Management Approach. The meeting was well organized and hosted by the PDA Ireland Chapter, led by Chapter President,Frank Hallinan,PhD, Director, Wyeth, and Secretary, Paul Logue, Vice President and General Manager, Elan, and their very capable staff.

Technical Report Watch

Mon, 08 Sep 2008 16:00:34 GMT

N/A

Technical Report Watch

Mon, 08 Sep 2008 16:14:38 GMT

N/A

Advisory Board Update: SABs Meeting in Colorado

Mon, 17 Nov 2008 14:15:12 GMT

June 2008
The PDA Science Advisory Board (SAB) met at the 2008 Annual Meeting in Colorado Springs, Colo., for a status check on a number of current projects.

In Print: Troubleshooting Microbiological Failures

Mon, 17 Nov 2008 14:00:04 GMT

June 2008
Dose audit failures can be costly and result in delays in product distribution and sale. Any investigation to determine a probable cause depends on the data available and a thorough knowledge of both the manufacturing process and the test methods used. The following checklist can be used during an investigation to invalidate a failure and allow a reaudit.

September 2007

Thu, 28 Aug 2008 13:04:04 GMT

from PDA Letter

Technology Trend: A Look into the Future: Nanocarriers, Nanomachines and Micropharmacies

Mon, 17 Nov 2008 13:50:01 GMT

June 2008
Nanotechnology already is having an impact on drug delivery, but the industry is just on the cusp of maximizing the full potential of this technology.

Six Regulatory Documents and a Trip Make For an Unusually Busy Week

Mon, 17 Nov 2008 11:31:47 GMT

April 2008
Welcome to another edition of the Quality and Regulatory Snapshot. As I write this, I'm at 35,000 feet somewhere over the Atlantic Ocean on my way home after a very successful PDA/EMEA Conference in Budapest, Hungary. This Conference was attended by over 400 people, and over 50 regulators from all across Europe were present, either as attendees or presenters. Congratulations to the Program Committee, chaired bySteve Bellis, David Cockburn and Lothar Hartman for assembling such an outstanding program. Thanks also to all the speakers who took time out from their day jobs to prepare their presentations and share their knowledge and perspectives with the attendees. In next month's issue of the PDA Letter you will be able to read more details on the Conference. We hope to be able to bring you the third PDA/EMEA Conference sometime in the future-stay tuned for news on this.

November/December 2007

Thu, 28 Aug 2008 12:59:48 GMT

N/A

January 2008

Thu, 28 Aug 2008 11:51:00 GMT

N/A

In Print: Risk Analysis in Aseptic Processing

Mon, 17 Nov 2008 11:04:24 GMT

April 2008
Certainly it is possible to use a form of HACCP-like risk analysis in aseptic processing. However, the processes and facilities currently used for aseptic processing are so uniform in design and performance that other methods may actually be more suitable.

February 2008

Thu, 28 Aug 2008 11:47:25 GMT

from the PDA Letter

PDA Survey Results: Cleaning Validation Sampling Practices

Mon, 01 Dec 2008 14:02:45 GMT

November/December 2008
PDA conducted an online survey on the topic “Cleaning Validation Sampling Practices” during the summer of 2008. This is the third of a series of surveys the PDA has conducted on cleaning validation practices. The survey was designed by a team comprised of Destin LeBlanc, Consultant, Cleaning Validation Technologies; Liz Dallison, Principal Scientist, Analytical Control, Pfizer; Jennifer Carlson, Technical Manager, Corporate Quality Systems and Support, Genentech and Paul Pluta, Editor- In-Chief, Journal of Validation Technology and Journal of GXP Compliance, Institute of Validation Technology.

March 2008

Thu, 28 Aug 2008 11:41:59 GMT

from PDA Letter

In Print: To Rotate or What to Rotate-Now that is a Question!

Fri, 14 Nov 2008 11:08:19 GMT

March 2008
We have seen few topics that polarize microbiologists quite as much as this one! It has become a regulatory expectation that disinfectant programs in manufacturing facilities will include a rotation of different types of disinfectants.The logic behind this is that use of a single type of disinfectant could lead to a build up of resistant organisms and thereby render the microbial control program ineffective. Unfortunately there appears to be little, if any, empirical evidence that this occurs in actual pharmaceutical practice.