Contributing Editors

  1. Are You Asking Too Much From Your Filler?

    The core mission of the pharmaceutical industry is to manufacture products for patients to cure them, vaccinate them, or alleviate a symptom, often by manufacturing a liquid injectable or an oral solid, among other therapies. In this article, we will focus on the aseptic injectable, from a general standpoint, to see what we are doing with our aseptic filling systems and why.

  2. When To Use A Fishbone Diagram … And Why You Should Do It More Often Than You Think

    The previous article in our "Identifying And Resolving Errors, Defects, And Problems Within Your Organization" series focused on identifying manufacturing trends so you can know when to act and when to let your processes run without interference. This one discusses what needs to happen when a defect or nonconformance is detected and needs to be investigated, explaining one of the most broadly applicable and durable root cause analysis tools: the fishbone diagram.

  3. 5 Strategies To Combat Counterfeit Drugs And Pharma Supply Chain Threats

    Pharma companies ignore the issue of counterfeiting and drug diversion at their own peril. This article discusses noteworthy examples of how drug manufacturers of various sizes are tackling this problem.

  4. A Standard Approach To Classify Visible Particles In Parenteral Products

    The presence of visible particles in parenteral biopharmaceuticals remains a hot topic in the industry. Despite regulatory bodies targeting a goal of no visible particles, and despite industry’s focus on further improving the efficacy of inspection processes, particles will continue to be found during production and in the marketplace.

  5. Batch Testing And Brexit: 4 Things You Need To Know

    The U.K. has until March 29, 2019 to negotiate a deal with the EU to remain a member of the EMA. If no agreement is reached, MHRA has set forth the principles that will be in place on March 30 in case of a “no deal” scenario,including recently introduced new guidelines for the batch testing of medicines entering or leaving the U.K.

  6. Continuous Manufacturing: Why Isn’t It Ubiquitous Yet? (When It Should Be)

    The question is no longer, “Will continuous manufacturing work?”, but “When will everyone be doing it?” But surprisingly, there are still many objections to continuous manufacturing within the biopharma industry.

  7. Auditor Evaluations: A GMP Auditing Best Practice

    Auditing programs perhaps implicitly provide feedback at the reporting stage of an audit. Most companies and third-party auditing programs conduct a technical review of completed audit reports. 

  8. Risk Mitigation Strategies For Compounding Pharmacy Operations

    With the 2018 Compounding Policy Priorities Plan, the FDA has established a clear pathway for advancement of policies for traditional compounding pharmacies and associated outsourcing facilities. The agency intends to implement the strategies while ensuring access to medications for the critical patient population. It is acting under the belief that a growing number of organizations are trying to get into the large drug manufacturers’ domain while operating under pharmacy licenses.

  9. How FDA, Industry, And Academia Are Guiding AI Development In Biopharma

    Continuously learning systems (CLS) are artificial intelligence (AI) algorithms that constantly and automatically update themselves as they recognize patterns and behaviors from real-world data — enabling companies to become predictive, rather than reactive, with quality assurance. 

  10. What Risk Factors Does The FDA Consider In Scheduling Drug GMP Inspections?

    The FDA’s latest effort at transparency in the drug GMP inspection planning process can be found in the new Manual of Policies and Procedures (MAPP) 5014.1, “Understanding CDER’s Risk-Based Site Selection Model,” used to prioritize sites for routine surveillance GMP inspections.