Author: Ginny Lee

  • The FDA’s New Draft Guidance

    More recently, the FDA has begun seeing data integrity as a major concern to the violations discovered during audits. As a result, the FDA published its new draft guidance, Data Integrity and Compliance with cGMP, in April 2016 with the purpose to provide organizations with recommendations to ensure reliable and precise data documentation; which will […]

  • Departmental Roles of Data Integrity

    Adherence to cGMPs is vital to all Life Sciences manufacturers and data integrity is one component that impacts cGMP. A corporation’s data integrity is influenced by everyone at an organization. As a result, it is essential that employees at all levels understand their roles and responsibilities with data integrity. Let’s take a look at a […]

  • What Is Data Integrity?

    Data integrity is vital to success in cGMP manufacturing. Companies can produce safer and higher quality products when they document reliable, accurate data. However, in order to ensure data integrity in your organization, you must first have a good understanding of what data integrity is. The FDA defines data integrity as “complete, consistent and accurate […]

  • The Difference Between Industry Standards: GAMP, ASTM, and ICH

    We often get questions from our customers about adherence to different industry standards.  “Which ONE do you follow?” The answer is not as simple as it appears. In fact, the question itself is much more complex. Theories and standards of GAMP, ASTM E2500, ICH Q8, ICH Q9, ICH Q10, and 21CFR part 11 work together […]

  • FDA’s Proposed Quality Metrics Guidance: Meeting FDA Requirements with Electronic Data

    To expand upon what we discussed in our first blog of this series, let’s take a look at the main focuses of the FDA’s proposed quality metrics guide. A few of their priorities include utilizing CAPA systems that enable continuous improvement, decreasing the number of unexpected and out-of-specification results, and gaining a deep understanding of […]

  • The Key to Improving Quality Culture

    Culture.  With regards to the FDA, this word typically refers to growing microorganisms or other living materials in a medium.  You will also find the word “culture” in The FDA’s Draft Guidance for the “Request for Quality Metrics.”  The word is used 10 times in fact.  In an effort to promote risk based inspections and […]

  • FDA’s Proposed Quality Metrics Guidance

    As we’ve heard since 2013, the FDA will soon require quality metrics to be submitted for certain product types. There is no better summary of what the FDA hopes to achieve, than a quote taken from an FDA PowerPoint: “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drug products without […]

  • GMP Asset Management in New Facilities: Compliance Drivers

    The productivity benefits of implementing an EAM system early when building a new facility provide immediate return on investment for an organization. Some of the benefits include paperless document routing and use of electronic signatures as well as automatic notifications that can speed the time it takes to process new equipment and approve documents. You […]

  • GMP Asset Management in New Facilities: Productivity Drivers

    Trend toward New Facilities In the previous blog in our series on GMP Asset Management in New Manufacturing Facilities, we discussed the trend that Biotech companies are increasingly building new facilities rather than outsourcing the manufacturing of their products. While this trend may not be the majority, it has been occurring more frequently in recent […]

  • GMP Asset Management in a New Facility: Booming Biotech Industry

    Booming Biotech Industry The overall market and drug development activity in the Biotech industry is explosive. There are several figures that point to this level of activity. Since the 2000s, there have been two major periods of record numbers of Biotech IPOs – (2004-2007) and (2013-present) – as seen in the Bloomberg graph. Over the […]