Senior Consultant Igor Gorsky has been published by Contract Pharma. Gorsky’s article, “Sterile Manufacturing Future Trends and Challenges” addresses the biotechnology market’s unprecedented growth and the need for contract manufacturers to update their facilities with new technologies that increase efficiency and compliance.
“Sterile product manufacturing facilities are aging,” Gorsky commented. “While some firms are keeping their facilities current so that new generations of products can be manufactured with fewer risks and interventions, many are not.” He continued, “While reviewing recently issued FDA Forms 483 and Warning Letters, we are finding many firms are not up to par and compliant with elementary aseptic practices. They need to be, and soon. By the middle of this century, biopharmaceuticals are set to overtake all other pharmaceutical sales and become a therapy of choice for new generations.”
Igor Gorsky is currently senior consultant at ConcordiaValsource, LLC. He has held multiple positions with increasing responsibility at several pharmaceutical companies, working in production, quality assurance, technical services and validation, as well as heading up global pharmaceutical technology validation. He can be reached at firstname.lastname@example.org.
Mike Long, Senior Director of Consulting Services, is a recent contributor to BioProcess Online. Long’s article, “A Line-Of-Sight Approach To Continued Process Verification Planning” addresses the importance of planning for continued process verification (CPV) at the onset of product development. This occurs only when one understands important product and process attributes that must be monitored during the product’s life span.
“Any discussion of CPV planning must begin at Stage 1, process design,” Long commented. “It does not matter if the planning is for a new product, a tech transfer, or a legacy product. The components of Stage 1, and identifying the relative severities of critical quality attributes (CQAs) and important material and process parameters, are critical. Without them, creation and execution of CPV plans is not possible.”
Mike Long, Ph.D., is a past member of the Parenteral Drug Association’s (PDA’s) Science Advisory Board and co-leader of the PDA’s Quality Risk Management interest group. He is the current lead of the PDA Applied Statistics interest group and co-leader of the PDA’s new CPV task force. Long is a frequent industry speaker/writer who has instructed courses in data analysis at Tufts University’s graduate engineering management program. He taught risk management and quality systems in Regis College’s graduate program in regulatory and clinical research management. Long earned a bachelor’s degree from Worcester Polytechnic Institute, a master’s degree from Tufts University, and a doctorate from Northeastern University.
Chief Operating Officer Hal Baseman is recently published by Pharmaceutical Online. Baseman’s article, “Five Keys to Aseptic Processing Improvement & Efficiency” explores, in the context of recent compliance trends, five guiding and linked principles for aseptic process improvement and efficiency in sterile health care products.
“Our objective should always be to modernize and improve aseptic processes,” Baseman commented. “Manufacturers of sterile products must engage in critical thinking, asking ‘Why?’ and ‘Why not?’ questions, challenging and pushing the industry towards more effective means of quality and process control. In this way, we can ensure that we are prepared to meet the challenges of providing sterile pharmaceutical products that are not only safe and effective, but also are available and affordable for the patients who depend on them.”
ValSource today announced the ValSource Rapid Response Team. The team is a fast action, fast response group for clients needing to promptly address regulatory and compliance citation matters. The team was developed and strategically staffed to quickly mobilize and respond within the short time frames required for regulatory matters.
The team is comprised of ValSource’s senior knowledge group that includes specialists in microbiology, contamination prevention, process control, validation, data integrity, training, quality risk management, regulatory expectations and overall quality system implementation. ValSource Chief Operating Officer Hal Baseman commented, “This team is exceptional for their expertise. That has always been the case. What is new is the speed at which they can execute.” Baseman continued, “This comes from strategic, purposeful forethought, planning and staging.” Baseman also pointed to ValSource’s local regional offices that are strategically positioned across the United States as another factor benefiting the team’s capability.
The Rapid Response Team reviews technical and regulatory materials, presenting findings and data via approved vehicles and platforms to address regulatory concerns, microbiological procedures, data management, acceptance criteria and responses to Health Authority questions.
The knowledge tools and solutions ValSource delivers simplify complex issues and foster knowledge transfer to increase client self-sufficiency. Where possible, ValSource works closely with all relevant technical personnel and managers. Contact the Rapid Response Team directly at RRT@valsource.com for more information.
Chief Operating Officer Hal Baseman and Director of Learning Solutions James Vesper are featured presenters at the 2017 Parenteral Drug Association Annex 1 Workshop. The workshop, being held October 2-3 at the Omni Shoreham Hotel in Washington, D.C., is designed to present the newly released draft revision to EU Annex 1, Manufacture of Sterile Medicinal Products of the European Union Guidelines to Good Manufacturing Practice of Medicinal Products for Human and Veterinary Use.
“Make no mistake. This critical revision will impact sterile manufacturing processes worldwide,” Baseman commented. “Understanding the content of expectations of global health authorities places those responsible for sterile product manufacturing in a much better position to navigate the challenges of modern aseptic processing.”
Baseman will deliver opening remarks and present the session: Industry Perspectives: Challenges and Opportunities. James Vesper’s session—What Scares Us About Risk? How Risk Tolerance Impacts our Thinking About Aseptic Processes—examines research on risk perception and how it can apply to producing sterile drug products. Vesper commented, “The presentation is designed to stimulate thinking on how factors—such as understanding the hazard and trust in the source of information—affect the amount of risk we are willing to accept. We need to know how our experiences and unintentional biases can affect the decisions we are making.”
The workshop brings together regulators, contributors, industry experts, and the actual personnel who must implement the new requirements, with the purpose of reviewing the content of the revised Annex, focusing on the most critical changes and regulatory expectations, and their impact on the daily operations of global manufacturers of sterile products.
Compounding Pharmacy Consultant Christopher (Chris) J. Smalley has been appointed to the American Pharmacists Association (APhA) House of Delegates (HOD) as a delegate for the Academy of Pharmaceutical Research and Science. “This role presents authentic opportunities to inform the Association’s policy development process around compounding pharmacy,” Smalley commented. “Through networking and policy-related activities leading up to the House of Delegates meeting, I hear firsthand the new and exciting developments our clients and industry face. I’m able to advocate solutions borne of ValSource’s tailored, risk-based approaches to hospital pharmacies and compounding centers.”
The HOD is the principal policy-making body of the APhA. This democratic forum represents the views and interests of a diverse group of members who meet once a year for two days during the APhA Annual Meeting and Exposition to establish broad policy on health care, medication use and professional and governance matters. In addition, delegates provide input throughout the year on policy topics under consideration by the Association.
Chris Smalley works with pharmacists to design, build and operate compliant compounding facilities. He recently retired from Merck, where he worked for five years on innovative implementation and validation, including Single Use Systems globally. Previously, he was Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and validation activities globally. His research experience includes responsibility for Quality in the U.S. operations of the Sanofi Research Division, and earlier as a plant manger for the Johnson & Johnson family of companies. Chris has been a member of the Parenteral Drug Association (“PDA”) Board of Directors, as well as a member of the PDA Science Advisory Board. Currently, he is a member of the ISPE Disposables CoP. His APhA delegate term runs June 2017 – May 2018.
Reach Chris at email@example.com.
ValSource Chief Operating Officer Hal Baseman, along with ValSource Consultants David Hussong, Mike Long and James Vesper, are contributors to the book, Aseptic and Sterile Processing: Control, Compliance and Future Trends. Through practical, sound science, the book reassesses current risks and technologies and considers new developments in the field.
“We’ve seen a rise in regulatory concerns about adequately determining the risk factors that challenge aseptic and sterile products processing,” Hal Baseman commented. “This book calls for a paradigm shift to the industry’s understanding of sterility. Renewed emphasis is placed upon assurance and controls, including leveraging the best available technologies and conducting thorough, science-based risk assessments of processes.”
Aseptic and Sterile Processing: Control, Compliance and Future Trends, edited by Tim Sandle and Edward C. Tidswell, is available here from the PDA Bookstore. Among the subjects covered are contamination risks, regulations, bioburden control, endotoxin control, water systems, depyrogenation, filtration, microbial contamination risks to cleanrooms, environmental monitoring, aseptic process simulations, single-use disposable technology, disinfection, sterility testing, cleanroom operator controls, risk assessment, human error and rapid methods.
Senior Consultant Marsha Steed is a featured speaker at the ECHO Consulting Group Educational Summit. The summit takes place Friday, August 18th at The Ritz Carlton in San Juan, Puerto Rico. Steed presents the session: “Microbial and Environmental Monitoring Risk Assessment.” Marsha’s presentation addresses microbial and Environmental Monitoring (“EM”) risk assessment tools and methods for all types of manufacturing processes: aseptic processing, terminal sterilization, low bioburden and non-sterile.
“Contamination control begins with good design coupled with risk assessment and risk mitigation,” Steed said. “Our strategies ensure microbial risk assessments evaluate all materials and equipment used in the manufacturing process so that risks can be understood and mitigated when possible. Likewise, we encourage EM risk assessments be performed to ensure that EM sample locations are selected based on risk.”
Steed is a recognized expert in risk based Environmental Monitoring and microbiological contamination control with over 20 years of experience in the pharmaceutical and medical device industries with extensive experience in Quality and Microbiology. Her leadership experience includes global experience with manufacturing locations in North and South America, Europe and Asia. Marsha has strong quality auditing experience for requirements to FDA, EMEA, ISO and other national regulatory requirements. Her experience includes being a notified body inspector for ISO/CE marking. Marsha is actively involved in the PDA and is a member of the Scientific Advisory Board (SAB), the Education Advisory Board (EAB) and the 2017 Microbiology Program Planning Committee.
Marsha can be reached at firstname.lastname@example.org.
Marc Glogovsky has joined ValSource as a Senior Consultant. Marc has 19 years’ industry experience, specializing in aseptic operations, quality control and environmental monitoring. His work at ValSource addresses common misunderstandings in the development and implementation of sound, globally accepted risk based environmental monitoring programs.
“Applying results and information obtained from various microbiology assays can be confusing,” Marc comments. “ValSource affords me myriad opportunities to alleviate customers’ misconceptions and misunderstandings, ultimately improving their overall quality and production methodologies.”
Prior to joining ValSource, Marc managed Veltek Associates, Inc.’s environmental monitoring division where he was responsible for global portfolio management, technical support and product distribution. He has written a number of publications related to rapid microbiology, environmental monitoring, Mycoplasma and MALDI-TOF microbial identification. A Parenteral Drug Association (“PDA”) member for more than fifteen years, Marc is on PDA’s Education Advisory Board, is a faculty advisor at PDA-TRI and has served on a number of PDA Technical Report committees. Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology from Rutgers University.
Marc can be reached at email@example.com.
Compounding Pharmacy Consultant Christopher J. Smalley is a contributor to the book, A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry. The book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients.
Chris Smalley’s chapter, Identification of Critical Knowledge: Demystifying Knowledge Mapping, provides examples of how companies can map their organizations’ knowledge and assess critical knowledge gaps in order to improve access, flow and reuse of critical knowledge by the people who need it, when they need it. Smalley commented, “Tacit knowledge—knowledge based on memory—contributes to making better pharmaceuticals and helps to explain why an operator trained in the procedures and following the batch record might not be successful in manufacturing a satisfactory batch.” He continued, “The challenge for organizations is to capture tacit knowledge and make it institutional knowledge by incorporating it into batch records updates and procedures.”
Chris Smalley works with pharmacists to design, build and operate compliant compounding facilities. He recently retired from Merck, where he worked for five years on innovative implementation and validation, including Single Use Systems globally. Previously, he was Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and validation activities globally. His research experience includes responsibility for Quality in the U.S. operations of the Sanofi Research Division, and earlier as a plant manger for the Johnson & Johnson family of companies.
Chris has been a member of the Parenteral Drug Association (“PDA”) Board of Directors, as well as a member of the PDA Science Advisory Board. Currently, he is a member of the ISPE Disposables CoP. His chapter for A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry is available at www.crcpress.com.
Chris can be reached at firstname.lastname@example.org.