Continuous improvement in data integrity can advance a firm on the journey toward a mature culture of quality, particularly through the implementation of QA on the shop floor. Batch record review (BRR) and product disposition are often complicated by data integrity issues and poor data quality.
Writing and enforcing standard operating procedures (SOPs) is a challenge. Poorly written SOPs are a common cause of deficiencies and observations cited in 483s and warning letters from the FDA.
Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. Risk-based thinking can and should be applied to the organization’s strategic and tactical planning processes.
Discovered in 1961, liposomes have been around for several decades as a drug delivery platform that has achieved varying levels of applications and popularity. With their biocompatibility and well-understood chemistry of encapsulation of a wide variety of APIs (active pharmaceutical ingredients), liposomes make it through the screening process for many potential products.
Packaging is an important component in the development of various drugs, as it can greatly affect drug stability and safety. Packaging material is chosen on the basis of its efficacy and other characteristics that enable it to preserve the quality, potency, and safety of the pharmaceutical products. As the industry evolves, packaging is becoming more important both to the successful marketing of products and to the health and safety of patients. As a consequence, there are more reasons than ever to include packaging considerations early in the drug development process.
This article looks at in-process bioburden testing and the importance of establishing accurate data and routinely monitoring the data for adverse trends.
This two-part series of articles looks at how the application of new technologies around data analytics has proven beneficial for the biopharmaceutical industry and regulators alike. The first article explored how technological advancements such as use of real-time data, predictive modeling, and artificial intelligence are gaining regulators’ acceptance and enabling the more efficient development of effective drugs and treatment solutions. This article examines the current environment of collaboration in the industry, along with technologies that will open opportunities to utilize data across life science sectors, including cross sector intelligence (CSI), the convergence of information across multiple sectors, enabling intelligent data-driven decision making.
Members of the BioPhorum Fill Finish group discuss the specific needs that led to the development of the recently released user requirement specification document for small, flexible filler technology; important requirements the document specifies; how the document will benefit industry stakeholders; and next steps for the initiative.
Following the publication of ICH Q9, industry eagerly embraced the opportunity to share ideas and best practices related to QRM. This article focuses on selected publications addressing general, rather than specific, applications of QRM.
As the divorce date approaches for the U.K. and the EU, one would be forgiven for thinking there would be a plan in place to deal with an event that will have such a profound global impact on the pharma industry. However, manufacturers have to prepare for any possibly scenario, while continuing to wait for clarity.
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