Featured Pharma Online Editorial

  1. People: The Most Persistent Risk To Data Integrity 11/15/2019

    HR changes continually impact overall data integrity—from a single new hire to a corporate-level change with a merger or acquisition. It's a commonly overlooked weak link in the data integrity chain.

  2. SOP Remediation: When Reinventing The Wheel Is The Best Approach 11/12/2019

    When faced with scenarios that demand SOP remediation (outsourcing, mergers, acquisition), repurposing processes, written content, templates, etc., can be the worst possible and most expensive approach when you factor in time, human resources, and long-term outcomes.

  3. Debunking The Top 3 Myths About Quality By Design (QbD) 11/8/2019

    Pharmaceutical QbD and quality risk management principles have become mainstays, but prevalent myths stymie adoption of the concepts. Dismantling those myths enables more companies to capitalize on the benefits of QbD.

  4. Closing Quality Gaps: 7 Steps To Properly Resource A Remediation Project 11/4/2019

    Teams often rely on ad hoc resource allocation and a naively hopeful attitude about the qualifications and capabilities of project team members. These tips can help you avoid such mistakes and improve the chances of your project's success.

  5. Achieving Integrated Quality Through A Continued Process Verification Program 11/1/2019

    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. 

  6. Are Good Manufacturing Practices No Longer Good Enough? 10/28/2019

    Janet Woodcock’s recent comment on the state of pharmaceutical development,“It’s not working…,” should not surprise anyone. Her continuation, “and, it won’t work in the future," is the more surprising, and particularly troubling statement. What must we change?

  7. Can Regulatory And Pharmacopeial Compliance Practices Establish Quality? 10/25/2019

    The stated mandate of regulatory authorities (e.g. the FDA) and pharmacopeias (e.g. USP) is to establish and monitor safety, efficacy, and quality of manufactured drug products. This article examines the role of those authorities on quality during production processes.

  8. An Introduction To Sampling Plans 10/21/2019

    Sampling plans are used extensively throughout organizations regulated by the FDA. Most have a statistical procedure that specifies a certain acceptable quality level based on risk. (If not, they should!) However, most  follow the requirements of the procedure without fully comprehending how sampling plans actually work. This is why you should.

  9. ISO 22519: An Unnecessary, Faulty, And Confusing Standard 10/11/2019

    The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.

  10. FDA FY2018 Drug Inspection Observations And Trends 10/7/2019

    The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency's 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.