Success in developing a drug product, medical device, or drug substance requires navigating the tradeoffs and decisions of today's complex global regulatory realm. Some of the most common questions about compliance concern dealing with the FDA 483 list of inspection observations, warning letters, and consent decrees following FDA regulatory action. [Online name] posed some important questions about warning letter responses and remediation — and other important regulatory issues — to Richard Aleman, VP of regulatory compliance at Pharmatech Associates. Aleman has an insider’s view on these issues, having spent 28 years at the FDA in both the field and headquarters organizations, specializing in biopharmaceuticals, drugs, and medical devices.
While other industries have learned from the principles of quality and statistical control methodology, (bio)pharma has been slow on the uptake. This article proposes tactic designs that utilize collaboration tools to facilitate Kaizen/continuous improvement in quality management systems (QMSs).
Integrated delivery networks (IDNs) were among the earliest adopters of Medicare accountable care organization (ACO) programs. The Centers for Medicare and Medicaid Services (CMS) releases results specific to these programs on an annual basis, creating opportunities for new drug development.
Prepacked chromatography columns provide an economic advantage by freeing up end users valuable time and resources by eliminating manual packing and cleaning.
The European Union’s (EU) Falsified Medicines (FMD) Directive 2011/62/EU amends Directive 2001/83/EC to safeguard public health by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines. It also introduces new rules to more rigorously regulate the supply chain.
Address optimal configuration of a multi-column continuous chromatography (MCC) system, with insight into the impact antibody titer has on the number of chromatography columns required to optimize productivity of a MCC process.
Examine common regulatory challenges and areas of uncertainty in the implementation of continuous bioprocessing, and understand practical, total solutions.
Review simplified continuous filtration, particularly for UF/DF, with a look into our exclusive license to patents in the field of single-pass tangential flow filtration (SPTFF), which enables continuous filtration without recirculation at several stages of a continuous bioprocess.
It has never been clear whether visual inspection is reliable since it has never actually been validated. If it can be validated, then the use of this technique for release of equipment would be justified and might even be used in place of traditional swab methods, which take substantial amounts of time and resources to develop, validate, and perform.
Addressing the concerns regarding limiting the rapid adoption and implementation of single-use technology has centered on standardizing single-use component extractables data packages to be used for end user risk assessments.
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