You are on your weekly project conference call with your CMO, discussing a product-filling project which is on track. The CMO’s project manager says, “Oh, I am going to go off agenda and ask for your signature by today to go forward with a machine-testing plan. If we don’t do it tomorrow, we might need to push your production run by a couple of weeks.” This is the first you have heard of it, so you are reacting on several levels.
A recent U.S. FDA publication entitled The Future of Pharmaceutical Quality and the Path to Get There suggested that the future of pharmaceutical quality is Six Sigma, meaning that no more than 3.4 defects occur per million opportunities (at every manufacturing facility). The way to achieve this goal is to move from the current management standards to performance standards. The need for an additional incentive — the economic driver — was also recognized in the publication. The proposed path forward aims to achieve the long-standing vision of the FDA’s Center for Drug Evaluation and Research (CDER): “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive regulatory oversight.”
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.
New York City has long aspired to become a life sciences hub, but while the city seems to have all the elements necessary to foster such industry growth, it has continually fallen short of this goal. New York currently ranks a distant third behind both Greater Boston and the San Francisco Bay Area, and there’s some work to do if it hopes to catch up.
Adopting a life cycle management approach will assist in identifying risk factors and constraints and provide structure and control, with a clearly defined methodology to identify and mitigate risk.
Our discussion continues with the physical application of GMP design practices as influenced by the CDC and NIH regulations. The first part of our design discussion covers various processes and their applicable BSL levels, to understand the risk levels and what types of processes must be contained.
Serialization in the pharmaceutical sector is a direct response to the problems of counterfeit, stolen, and gray-market drugs. There’s been a huge incentive for counterfeiters to duplicate high-profit-margin products. According to the 2016 Brand Protection and Product Traceability Market Research Report from PMMI, the black market for counterfeit drugs is about $75 billion annually.
In today’s world of ever-increasing regulatory scrutiny on pharmaceutical quality we have all witnessed first-hand the public relations nightmare of adverse events, drug recalls, and even company closures. In response, pharma companies have set stricter rules and regulations for their employees to follow, to ensure they remain in compliance with regulators and avoid negative inspection results.
There have been considerable updates in the Brexit situation since April 2017, including, the surprising result of the U.K. general election. If anything, news regarding Brexit and the biopharma industry has started to heat up in recent months, and there have been a number of relevant developments that manufacturers must keep their eye on.
“Patent dance” refers to the elaborate exchange of patent information between a biosimilar applicant and a biologics sponsor under the Biologics Price Competition and Innovation Act (BPCIA) of 2009. It is intended to have the parties resolve any patent disputes expeditiously, preferably before the launch of the biosimilar product. Under the Act, within 20 days of FDA’s acceptation of an abbreviated biologics license application (aBLA), the biosimilar applicant “shall provide to the reference product sponsor a copy of the application … and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.” This starts the dance.