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.
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.
Faced with competing priorities, teams often rush to turn their plans into projects while missing the important steps in between. Resource planning is chief among these oversights.
Continued process verification (CPV) is not only required for companies but also is a good investment in product quality and setting the foundation for continuous improvement.
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.
This white paper explores eight considerations in detail and could be helpful to EHS managers and supervisors looking to select a Powered Air-Purifying Respirator system for their particular application.
Containment will always be needed to protect payloads during transportation. While it is important to the protection of the value of the payload, it has no environmental benefit. It is important for organizations to carefully consider the impact of their containment, packaging, and shipping decisions, especially when high volumes of transactions are involved. Read more about how a reusable logistical approach as opposed to a single-use shipper can considerably reduce the environmental impacts of transporting thermally protected payloads.
The principal concern for any scientist or technician working in the laboratory is that glassware, instruments, and equipment be free of interfering residues.
This paper provides an introduction to particle sizing comparing six widely used techniques, explaining how they work and what this means in terms of strengths and limitations.
Biopharma R&D teams everywhere face the same dilemma in the development of biologics and vaccines: Increase productivity to meet strict budgets and deadlines, while maintaining or improving data accuracy.
How single-use bioreactors address some of the key challenges the industry faces by decreasing time-to-market, reducing validation efforts, increasing flexibility, reducing investment costs and optimizing cost of goods.
This free collection of articles is from the Data Integrity In The Life Sciences series, the purpose of which is to highlight contemporary insights and relationships to key quality systems in order to elevate the most important topics and advance improvements in the collective quality culture.More Content Collections