In modern times, the business operating model is commonly referred to by the three resources of “people, process, and technology.” Business intelligence (BI) activities also frequently refer to the triangulation of “people, process, and technology.” And the triad of “people, process, and technology” is touted by organization change management (CM) pundits and business process management (BPM) experts alike.
There are many ways to tackle pharmaceutical facility design, engineering, building, and production, and each plant has its own methods and culture. However, there are situations we have come across where we really scratch our heads and say, “What did they just do, and what were they thinking?” This article describes a series of events or activities that we have seen and, while they are amusing or baffling, they reveal the flaws in our industry.
There is a growing industry focus on standard operating procedure (SOP) remediation. Although outsourcing, mergers, and acquisitions have been in play for the last 20 years, these activities seem to be skyrocketing, which is creating quite a few scenarios that drive the need for SOP remediation.
Qualified Persons (QPs) are responsible for the certification of clinical trial materials in the EU and therefore are an essential link in U.S. sponsors’ supply chains. Indeed, engaging QPs well before the clinical trial material needs to be certified not only assures a smooth release process and trial start-up but mitigates pitfalls associated with unanticipated technical, quality, and regulatory challenges.
Pharmaceutical quality by design (QbD) and quality risk management (QRM) principles have become mainstays in pharmaceutical development. However, several myths are prevalent that prevent wider acceptance of the concepts by smaller firms. The lack of understanding of pertinent quality by design methods prevents smaller firms from benefiting from the majority of what QbD offers.
The EMA recently issued two new publications containing information on nitrosamines for marketing authorization holders (MAHs). Every MAH and manufacturer of chemically synthesized APIs and resulting drug products should carefully read the new EMA expectations on potential nitrosamine contamination.
The FDA's new pharmaceutical quality assessment system is intended to capture and manage information about inherent risk and control approaches for product design, manufacturing, and facilities, in a structured format with the intent to facilitate a concise and consistent quality assessment, and largely replace freestyle text.
For U.S. sponsors planning to conduct clinical trials in the EU, Qualified Persons (QPs) may at times be perceived as a challenge to overcome, because their role and responsibilities are not fully understood. Conversely, part of the QP’s role is to support clinical trials in the EU by certifying compliant clinical trial materials while protecting public health.
Janet Woodcock’s recent quote on the state of pharmaceutical development — “It’s not working…” — should not be a surprise to anyone. The industry has been struggling for years with long development times, high product failure rates, and frequent quality problems. But, Ms. Woodcock’s further statement — “and, it won’t work in the future” — is an especially troubling call for changes.
Sampling plans are used extensively throughout organizations regulated by the FDA. Most have a statistical procedure that specifies a certain acceptable quality level based on risk. (If not, they should!) However, most follow the requirements of the procedure without fully comprehending how sampling plans actually work. This is why you should.
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