June 30, 2020
A Brief History Of Parenteral Process Validation — How We Got Here
August 30, 2019
According to a team of pharmaceutical water experts, including ValSource Consultant Igor Gorsky, the ISO 22519 standard does not reflect current accepted, or even future, best practices and is deeply flawed and biased against proven water treatment unit operations in favor of a trademarked technology.
November 14, 2017
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….
November 9, 2017
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….
October 26, 2017
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….
July 11, 2017
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….
June 29, 2017
Senior Validation and Risk Consultant Christopher M. Hanff has been published by Pharmaceutical Online. Pharmaceutical Online provides the pharmaceutical manufacturing and packaging industry with exclusive and actionable information to help industry members tackle the challenge of bringing life-saving and life-improving therapies to market. Hanff’s article, “Pinpointing Supply Chain Risk Through Line-Of-Sight Shipping Validation” addresses how shipping validation can act as a vehicle, delivering improvement throughout the entire pharmaceutical quality system.
April 21, 2017
ValSource Senior Validation and Risk Consultant Christopher M. Hanff has been published by The PDA Letter. The Letter is the Parenteral Drug Administration’s membership magazine covering the science, technology, and regulation behind the manufacturing of sterile injectables. Hanff’s article, “Translate Your Knowledge into Reliability,” sets a foundational understanding of knowledge management and focuses on opportunities for meaningful, practical knowledge transfer.
“Whatever we know individually, it’s not valuable to others if it’s not available to others,” Hanff says in the article….
June 6, 2016
ValSource today announced Fred Hammonds has joined as a Senior Director. Hammonds brings more than 30 years experience in the safety field. He now leads ValSource’s Construction and Site Safety Services department. Under Hammonds’ leadership, ValSource’s Safety Solutions Group acts proactively to secure worksites, schedule field audits and train and resource qualified safety professionals at its clients’ facilities worldwide. Hammonds also leads safety training for ValSource’s more than 200 employees.
ValSource Founder David Calvaresi commented, “ValSource has always been committed to safety….
Survival and susceptibility of Burkholderia cepacia complex in chlorhexidine gluconate and benzalkonium chloride.
April 2, 2015
Kim, Ahn, LiPuma, Hussong, and Cerniglia. 2015. Survival and susceptibility of Burkholderia cepacia complex in chlorhexidine gluconate and benzalkonium chloride. Journal of Industrial Microbiology & Biotechnology. Date: 21 Mar 2015 (online) http://link.springer.com/article/10.1007/s10295-015-1605-x
The Burkholderia cepacia complex (BCC) includes opportunistic pathogenic bacteria that have occasionally been recovered from various pharmaceutical products, including antiseptics and disinfectants. Plausible reasons for the contamination include intrinsic sources, such as inadequate process controls, especially for water or equipment used during product manufacture, or extrinsic sources, such as improper handling and dilution or distribution in contaminated containers….