GUEST COLUMNISTS

  • 7 Speed Bumps To Avoid When Outsourcing Clinical Supply Manufacturing
    7 Speed Bumps To Avoid When Outsourcing Clinical Supply Manufacturing

    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.

  • Examining FDA’s New Patient Labeling Draft Guidance
    Examining FDA’s New Patient Labeling Draft Guidance

    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human factors as it applies to medical products and their associated written materials, the FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products –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.

  • Pharmaceutical Transport Validation — Where To Begin?
    Pharmaceutical Transport Validation — Where To Begin?

    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.

  • FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018
    FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018

    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.

  • Developing And Manufacturing Cell & Gene Therapies: Do Biopharma Methods Apply?
    Developing And Manufacturing Cell & Gene Therapies: Do Biopharma Methods Apply?

    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 Models For Biopharmaceutical Facilities
    Project Execution Models For Biopharmaceutical Facilities

    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.

  • Is Your Personnel Hygiene Plan Up To Date?
    Is Your Personnel Hygiene Plan Up To Date?

    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.

  • Negotiating Quality Technical Agreements: Strategies for Non-Quality Professionals
    Negotiating Quality Technical Agreements: Strategies for Non-Quality Professionals

    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.

More From Our Expert Columnists

PHARMA ONLINE WHITE PAPERS

  • Comparison Of Credo Carbon Footprint To Similar Performance Single-Use Shippers
    Comparison Of Credo Carbon Footprint To Similar Performance Single-Use Shippers

    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.

More Pharma Onine White Papers

PHARMACEUTICAL ONLINE CONTENT COLLECTIONS

PO_QualityManagementEbook_300x200

 

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

TRAINING COURSES

Root Cause Analysis & CAPA Identification: A Step-by-Step Guide for Manufacturers September 24 - 24, 2019
1pm-2:30pm EDT, Online Training
Stability Programs – Key Factors in Meeting FDA/ICH Expectations September 26 - 26, 2019
1pm-2:30pm EDT, Online Training
Sterility Failure Investigations – A Step-by-Step Process for Success September 30 - 30, 2019
1pm-2:30pm EDT, Online Training
Clinical Research Project Management - 7 Breakthrough Behaviors For Success October 3 - 3, 2019
1pm-2:30pm EDT, Online Training
More Upcoming Courses