In Part 1 of this two-part article, FDA supervisory consumer safety officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 program director Art Czabaniuk, and OPQO Division 3 investigator Lindsey Schwierjohann presented #10 through #6 of the top drug GMP inspection citations for FY2018 and provide insight into the observations. This part counts down citations #5 through #1.
Any company with successful Phase 1 study data must ensure sufficient and consistent supply of drug product for possible Phase 2 and Phase 3 trials. For this reason, Phase 1 companies planning to outsource manufacturing of their clinical supply should take some essential steps early in the clinical manufacturing campaign to assure a timely and reliable supply of material throughout their clinical trials.
In accordance with the increasing emphasis on human factors as it applies to medical products and their associated written materials, the FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.
This article provides a road map for transport validation, which is used to qualify packaging for the entire product supply chain. When transport validation is done incompletely, poorly, or not at all, it can result in off-label drugs that are potentially harmful to patients.
In this two-part article, FDA supervisory consumer safety officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 program director Art Czabaniuk, and OPQO Division 3 investigator Lindsey Schwierjohann present the agency’s top 10 drug GMP inspection citations for FY2018 and provide insight into the observations. This part unveils citations #10 through #6, and Part 2 will cover citations #5 through #1.
Are the methods used for developing the current generation of biopharmaceuticals, monoclonal antibodies, hormone replacements, etc., applicable to the next generation of Cellular and gene therapies?
Project execution and project management are probably two of the topics that are most written about but least understood by the biopharmaceutical industry. This article is not about the theory of management, but it is a primer on approaches to project execution, some of which may assist the reader in understanding their path of least risk.
Every organization that is regulated by the FDA must consider sources of contamination and cross-contamination in their manufacturing operations. A robust personnel hygiene program is an important element for good manufacturing practices (GMPs) necessary to prevent contamination and cross-contamination, in order to ensure the safety of medicinal products.
Of the four critical documents that must be negotiated and executed by both sponsor and CDMO (NDA, quotation, MSA/SA, and QTA), the QTA is often the least-prioritized by the procurement team. Yet, in practice, the QTA will be the most useful for development- and clinical-stage companies, because it provides a framework for operations and a road map for building quality systems.
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.
This white paper highlights the fact that there are no limits to progress in the pharma industry and provides an insight into the improvement potential of all processes in the supply chain using aggregation.
This condensed version of the Industry 4.0 Guide provides an improved appreciation of Industry 4.0, guidance integrating product inspection equipment with Industry 4.0 practices and innovations.
For a host of reasons, auto-injectors are becoming biopharma companies’ delivery method of choice for commercial use and late-stage clinical trials. Auto-injectors ensure that the prescribed dose of medication is delivered fully and completely,making it easier to track compliance in clinical trials.
Organizations recognize the growing need for control of the entire cold chain as the changing global scenario requires highly efficient processes and flexibility.
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.
Free collection of articles exploring topics including the various types of risks associated with medicinal products, the role of risk management in pharmaceutical and biopharmaceutical regulation, QRM principles and practices, the role of QRM across the product life cycle, primary literature sources for QRM, and common challenges associated with QRM implementation.More Content Collections