Compliance Management Featured Articles

  1. Viral Safety Approaches For Advanced Therapy Medicinal Products 7/11/2017

    Manufacturers safeguard biologic materials during the development process through a set of measures commonly referred to as the “Safety Tripod.”

  2. Managing GxP Environmental Systems To Ensure Data Integrity 3/9/2017

    In the life science industries — pharma research, manufacturing, medical devices and biotech — guidance and regulatory enforcement strategies are being re-evaluated with a focus on data integrity.

  3. Pharma's Quest For Consistent Quality 5/19/2015

    The preliminary findings from the International Society of Pharmaceutical Engineering’s (ISPE’s) Quality Metrics Pilot Program were revealed at the association’s recent Quality Metrics Summit. How will this data help the pharma industry create a universally accepted set of manufacturing quality standards and what challenges did the pilot uncover?

  4. Shifting Pharma's Mindset: Viewing Quality As Value Creator, Not Cost 5/14/2015

    The pharma industry is quickly, and fortunately, realizing that the value that quality creates can far outweigh the cost savings associated with not investing in it.

  5. Impact Of Strategic Outsourcing On QA Oversight By Sponsor Companies 3/5/2014

    Recently, we have been observing a change in the approach to outsourcing — more midsize and large biopharmaceutical companies are shifting to a strategic outsourcing model. Strategic outsourcing generally means assigning work to one or a maximum of two preferred (strategic) partners.

  6. Supplier Audits Or Bust: Six Keys To Pharma Audit Success 1/6/2014

    Supply chain integrity is necessary to a pharmaceutical company’s success. When dealing with a multitude of suppliers spanning several geographies, manufacturing issues can arise if proper protocols are not in place. Specific challenges include product purity, regulatory compliance, safety, cost containment and quality assurance.

    Audit processes are an integral component of supply chain management. Conducting an effective audit empowers pharmaceutical companies and their suppliers to raise performance levels and strengthen relationships while improving patient-care quality. The mutual benefits of a successful audit include:

    • Supply chain continuity and reliability;
    • Cost reductions;
    • Improved risk management;
    • Global visibility; and,
    • Enhanced customer satisfaction.
  7. GDUFA Sheds New Light On Industry's Common Ground 7/1/2013

    FDA user-fee programs will now apply to all the competing pharma sectors — and in many ways highlight the interests they share.

  8. Quality Management: How Much Are Vendors To Blame?

    Biopharmaceutical manufacturing is one of the most demanding industries on its suppliers: demanding that its vendors be prequalified as primary or secondary, requiring confirmations of product provenance, certificates of analysis, and other sometimes onerous documentation. All of this is done for drug product quality and consistency.

  9. The Falsified Medicines Directive – What Does It Really Mean?

    The trade in falsified medicines — medicines that look real but really aren’t what they seem — is a huge and growing one, and it is putting patients’ health and even their lives at risk. Along with regulatory authorities around the world, the European Union is putting directives into place that could begin to slow this deadly trade.

  10. Solving The OOS Problem With Continuous Manufacturing

    With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.