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Six Critical Areas to Ensure Regulatory Compliance in Aseptic Manufacturing are Outlined in New Management Brief
AGAWAM, MASS. — An unscheduled inspection of an aseptic
manufacturing process can hit a pharmaceutical company with the fury of a New
England nor’easter. But a new management brief explains how a best-practice
control and monitoring system can minimize the danger of FDA noncompliance. The
brief is available for download from http://www.microtestlabs.com/weathering-the-storm-brief.
In the aseptic manufacturing business, all processes must be best
practice to ensure the process will comply with the regulations. If any are
poorly designed, not utilized, or deviated from, then the entire aseptic
manufacturing system is considered out of compliance. This means that the
checks and balances of a quality system must ensure that the sterile
environments and surrounding support SOPs truly are working and show no signs
of trending towards failure.
• Training and professional development
• Environmental monitoring (EM) procedures
• Incorporation of single-use technology
(e.g. needle/tubing sets)
• Facility design and maintenance
• Process simulation
• Raw material control, preparation, and
sterilization
“The FDA has been very critical of aseptic fill/finish companies
whose manufacturing environments are out of trend or outside of
specifications,” noted management brief author Alexander (Alex) Mello, M.S., SM
(NRCM), the director of Project Management, Manufacturing at Microtest
Laboratories, Inc., in Agawam, MA.
“Rigorous production system control and
monitoring through data generation and analysis will pave the way for best-practice
pharmaceutical manufacturing,” he stated.
About Microtest Laboratories
Microtest Laboratories is a leader in testing services and
contract manufacturing for medical devices, pharmaceuticals, and biotechnology.
Founded in 1984, the company’s expertise and flexible processes enhance product
safety and security, speed time to market, and minimize supply chain
disruption. Microtest’s unique single-source capability to provide testing and
manufacturing solutions allows the company to support a full pharmaceutical or
medical device product release. Our facilities in Agawam, Massachusetts,
include state-of-the-art aseptic manufacturing areas; analytical chemistry, microbiological,
and virological laboratories; Class 100 clean rooms; onsite steam and ethylene
oxide sterilization, plus depyrogenation capabilities; purified water systems;
and voice/data systems. For more information, visit
http://www.microtestlabs.com or call 1-413-786-1680 or toll-free
1-800-631-1680.
# # #
Labels: Aseptic, Aseptic Fill/Finish Contract Manufacturer, Fill/Finish, Pharmaceutical Manufacturers, pharmaceutical manufacturing, pharmaceutical testing
Microtest Honored as Regional Example of Success; Receives Hampden Achievement Award, Induction into STCC Western Mass. Entrepreneurship Hall of Fame
Agawam, Mass., October 3, 2008 – In recognition of the company’s growth, success, and importance to the region, Microtest Laboratories of Agawam has received the Hampden County Achievement Award and has been inducted to Springfield Technical Community College’s Western Massachusetts Entrepreneurship Hall of Fame. “The achievements of Microtest Laboratories’ growth and success serve as a powerful model for the future of Massachusetts, and Microtest will serve as an inspiration to thousands of people who visit every year,” said Dr. Andrew M. Scibelli, President of Springfield Technical Community College (STCC). Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries and has made numerous multi-million capital investments and expansions of its facilities the past several years – along with growing its professional workforce to more than 100. The company works closely with Western Mass. economic and business organizations as well as the region’s educational institutions. Microtest President and Scientific Founder Steven Richter, Ph. D., is an ardent supporter of regional technical training programs as a means to ready both current and future workers to contribute to – and reap the benefits of – the area’s burgeoning life science industry. “It is an honor for all of us at Microtest to be recognized for our achievements,” said Richter. “If we can serve a role for others, then let it be as a example of the potential that’s available throughout Western Mass. when working partnerships among our entrepreneurs, education, residents, and government are permitted – and encouraged – for the benefit of all.” The Andrew Scibelli Enterprise Center is committed to furthering regional economic development, entrepreneurship education and workforce development. It is home to the Western Massachusetts Entrepreneurship Hall of Fame. Established in 2000, it honors innovative entrepreneurial individuals and businesses in Western Massachusetts, in hope to inspire the next generation of business leaders.
About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, 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. # # # Labels: Agawam, analytical laboratory, analytical services, Aseptic Fill/Finish Contract Manufacturer, Contract Manufacturing Organization, medical device, Microtest, release testing, sterility validation
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 MicrotestMicrotest 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. # # # Labels: analytical services, Aseptic Fill/Finish Contract Manufacturer, Contract Manufacturing Organization, release testing, sterility validation, white paper, whitepaper
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