New USP 797 Regulations May Create New Hazards for Compounding Pharmacy Directors

AGAWAM, MASS. – September 23, 2008 – Though the new USP 797 regulations, which become effective June 1st, ease testing requirements, the impact of following the new minimums has the potential of creating new hazards for compounding pharmacy directors, warns Steven Wieczorek, Supervisor, Environmental Sciences, Microtest, Inc.

Issued by the U.S. Pharmacopoeia, the new version of USP 797 establishes bi-annual environmental sampling and testing as a minimum requirement, in place of the former monthly frequency. The regulations continue to require that pharmacies preparing compounded sterile preparations must have an effective plan and program that incorporate best practices and provide a clean, sterile working environment free of contamination.

Potential Hazards from Hidden Impacts

But Wieczorek says that adopting a bi-annual environmental testing program may impact a facility’s capability to maintain compliance. “Compounding pharmacy directors need to recognize the series of potential hazards lurking for them within the ‘hidden impacts’ of the new regulations.” Those hazards, he said, include:

• Bi-annual testing will not capture seasonal blooms of yeast, fungi, and bacteria.
• Problem tracking, diagnosis, and resolution will be difficult if environmental testing is conducted at six month intervals.
• The development of trend data that shows important seasonal fluctuations will be impossible when conducting bi-annual environmental testing.
• If a failure occurs during a bi-annual testing program, investigating up to 6 months of compounding activities and justifying what may or may not have been affected will be nearly impossible and extremely time consuming.
• With a monthly testing program, a failure will require investigation of only 3 to 4 weeks of data and will be significantly easier -- saving large amounts of time and money. It will also help insure that the compounds prepared in your facility are sterile and will provide a safer final product for patients.
• Testing at a higher frequency will provide peace of mind. You will know that your controlled compounding environment(s), policies, and technicians are under control and in compliance. This will help reduce infections and save lives.

Wieczorek and Microtest (Agawam, Mass., www.microtestlabs.com/usp797) will continue to recommend a monthly testing regimen for all pharmacies compounding sterile preparations.

“A monthly testing regimen will continue to provide critical environmental and trend data of a pharmacy as the seasons change. Monthly testing will better reflect continued control of the compounding environment. It also will enable rapid problem resolution at a time when facilities are most vulnerable to non-compliance issues,” Wieczorek said.

“Under the regulations, the pharmacy director holds quality control responsibility and is accountable for the facility’s compliance performance. We believe that embracing best practices to create a plan that meets the pharmacy’s specific environment will achieve the greatest success,” he said.

Pharmacies failing to comply with USP 797 risk exposure to patient lawsuits as well as the potential loss of The Joint Commission’s (JCAHO) accreditation.

Free Facility-Gap-Analysis Audit

To help pharmacy directors set a benchmark, Microtest offers a free facility-gap-analysis audit to help compounding pharmacies determine their USP 797 compliance level and corresponding preparation. The audit includes an examination of the compounding pharmacy service’s physical facility footprint, drug compounding procedures, operational policies and training programs. Microtest experts will determine the level of compliance achieved, existing level of risk exposure, and recommendations to achieve compliance to USP 797.

“The audit will recommend the designated sterile compounding risk level of the pharmacy service as well as establish an accurate baseline for compliance program next-action development,” Wieczorek said “With the audit in-hand, pharmacy directors can then create a service plan.”

Microtest offers compounding pharmacy directors a single, one-stop resource of complete USP 797 compliance solutions – as advice, assistance, or complete implementation – available in an incremental approach or as a comprehensive, turnkey solution. Services include: program implementation, onsite training, custom SOP documentation, clean room design, environmental monitoring, and CSP product testing. To learn more, on the Web, visit http://www.microtestlabs.com/usp797 or call toll-free 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/services/public-relations/

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White Paper Advises Pharma Manufacturers on How to Select an Aseptic Fill/Finish Contractor, Avoid the Most Common Mistakes

AGAWAM, MASS. – September 22, 2008 – For pharmaceutical manufacturers, the process of choosing a Contract Manufacturing Organization (CMO) can be a challenging task. The ramifications of making a poor decision can result in schedule delays, regulatory approval issues, and lost revenue.

The informative white paper, “Selecting An Aseptic Fill/Finish Contract Manufacturer: Avoiding the Most Common Mistakes,” focuses specifically on the unique steps involved in selecting and working with an aseptic processing CMO to produce injectable Final Drug Product (FDP). Download it at: http://www.microtestlabs.com/asepticpaper.

In addition to providing guidance on the selection process, the white paper also discusses common mistakes made by potential clients. These oversights – and their remedies – are sourced from a collective experience base that covers contract aseptic Fill/Finish (F/F) manufacturing, contract bulk drug manufacturing, and aseptic F/F outsourcing of bulk drug product.

The white paper is authored by John Dobiecki, Vice President of Manufacturing Operations for Microtest Laboratories. Dobiecki’s experience, which spans 25 years in the manufacturing and quality control of pharmaceuticals, medical devices, and biologic products, includes the preparation of INDs, NDA/ANDAs, CMC sections, and Pre-Approval Inspections (PAI), as well as multiple U.S. and European Regulatory Inspections.

In the white paper, Dobiecki:

• Details the nine key components of the RFP – The First Step (in the selection process)
• Discusses the finer points of Evaluating the Contractor’s Proposal
• Explains the two types of Site Visits and what should be included on the agenda
• Provides cautionary tips for making The Selection itself
• Warns of stumbling into making The Biggest Mistake which can derail a successful selection at any step of the process.
  

To download the white paper, free of charge, visit: http://www.microtestlabs.com/asepticpaper.

About Microtest
Microtest is a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/

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White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product

AGAWAM, MASS. – September 15, 2008 – Biopharmaceutical manufacturers, responsible for an extensive repertoire of products – including recombinant proteins, monoclonal antibodies, and vaccines – are faced with many aspects of testing specific to the type of product being assessed. A new whitepaper from Microtest Laboratories discusses the typical routine sampling and testing requirements associated with the aseptic processing of a biopharmaceutical from the perspective of a contract aseptic manufacturer and provider of contract manufacturing testing services.

The white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product” focuses what many consider the most critical part of a biological drug product’s manufacturing life cycle: going from the purified bulk drug substance (“PBDS”) to the sterile final drug product (“FDP”). It is available for download at: http://www.microtestlabs.com/control-environment.

Specifically, the white paper discusses establishing the testing “where and when” (and in some instances the “why”) for manufacturing formulation and fill/finish activities and how the approach is also applicable, for the most part, to small molecule drug products formulation and fill/finish.

In the white paper, the authors:

• Warn to test only when necessary to reduce interventions.
• Explain to test using methods that give data as quick as fittingly possible to condense processing times.
• Discuss how to utilize a client’s knowledge of the product, the contractor’s knowledge of formulation and aseptic manufacturing to develop the most appropriate formulation and F/F process.
  

The white paper is authored by John Dobiecki, Vice President of Manufacturing Operations, and Alex Mello, Director of Project Management, Manufacturing, both of Microtest Laboratories (www.microtestlabs.com), a contract manufacturer and provider of contract manufacturing testing services.

To download the white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product,” visit: http://www.microtestlabs.com/control-environment.

About Microtest
Microtest is a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/

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Technorati tags: Microtest, MicroSeq, medical device, analytical laboratory, sterility validation, release testing, analytical services