Featured Pharma Online Editorial

  1. 4 Ways To Prevent Manufacture And Distribution Of Substandard Medications
    12/12/2018

    If a legitimate product is not manufactured according to quality standards or becomes degraded as it travels through its supply chain, it can be ineffective at best or deadly at worst. 

  2. Is Your Document Control System Out Of Control?
    5/13/2013

    Document control is always an interesting topic for discussion.  It seems like a simple topic and area for compliance, but I often run into companies with document control systems that are overly complicated and difficult to manage. By Christine Park, Quality Architech

  3. Does Your Quality System Assure Products Are Safe And Effective?
    3/26/2013

    The Food and Drug Administration (FDA) guidance document (Quality Systems Approach to Pharmaceutical CGMP Regulations) references this clause as the basis for management review activities. The Q10 Guideline, published by International Conference for Harmonization (ICH) provides greater prescription and detail regarding the expectations of management review for the pharmaceutical quality system. Regardless of which reference document you use, a systemic review of the quality system activities is key to assuring continued suitability and effectiveness.

  4. 7 Keys To Establishing A Quality Culture Your Senior Management Will Love
    2/5/2013

    Executive Management participation and support is key to the successful development, implementation, and management of pharmaceutical quality systems. The FDA guidance document (Quality Systems Approach to Pharmaceutical CGMP Regulations) defines the expectations for management with executive responsibility (MWER). These expectations for MWER are aligned with the Q10 Guideline, published by International Conference for Harmonization (ICH). By Christine Park, Quality Architech

  5. Implementing A Systemic Approach To Pharmaceutical Quality Systems
    1/3/2013

    In 2002, the Food and Drug Administration (FDA) announced an initiative to integrate quality systems and risk management approaches into existing regulations for pharmaceutical manufacturing. While the FDA hasn’t changed the 21 Code of Federal Regulations (CFR) Parts 210 and/or 211 regulations, they have published industry guidance, Quality Systems Approach to Pharmaceutical CGMP Regulations. By Christine Park, Quality Architech

  6. 4 Steps To “Right Sizing” Your Personnel Resources To Support Quality

    We all have them and we all need them. The real question is do you have the right resources?  And, do you have enough to support your quality system? By Christine Park, Quality Architech