ProPharma Quality & Compliance

  1. Improving Patient Health And Safety: SOPs And Process Mapping 10/21/2024

    In this study, a biotech company faced compliance challenges due to inadequate SOPs that lacked detailed process maps. Propharma stepped in to provide a strategy and project plan.

  2. ProPharma Supports A Contract Manufacturer's Form 483 Response 9/10/2024

    Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

  3. Demystifying CAPA Management: Overcoming Challenges In The Fast-Paced World Of GMP 9/10/2024

    Equip your team to navigate the complexities of Corrective Action / Preventive Action (CAPA) in the drug and medical device industries with expert insights and practical strategies.

  4. Understanding GxP Compliance In Drug, Medical Device Development Lifecycles 9/10/2024

    Deve into the nuances of GxP compliance, exploring why these standards are vital for safeguarding public health and upholding the integrity of products throughout their entire lifecycle.

  5. The Importance Of EU/UK QP Audits 9/10/2024

    This analysis highlights the significance of EU/UK QP audits, focusing on key aspects such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and Annex 16.

  6. The Financial Advantages Of Outsourcing Vendor Audits 9/10/2024

    Based on industry insights, we examine the financial impact of internal audits and the benefits of outsourcing, offering a clear perspective on how organizations can streamline their audit processes.

  7. A Guide to Solving Complex Life Sciences Challenges 9/10/2024

    Life sciences organizations are consistently inundated with decisions and challenges of varying scale. Learn a structured approach to navigate complex decisions and challenges across the value chain.

  8. Qualified Person (QP) Services 8/29/2024

    Providing around-the-clock support, enabled by at least two QPs per assignment, delivering full continuity, and reduced risk.

  9. Manufacturing And Import License (MIA) And Batch Certification 8/29/2024

    Navigating both the specific country and general European regulations and requirements to supply medicinal products to the European markets can be a complex challenge. This applies both to Marketing Authorisation Holders (MAH) of approved commercial medicinal products and Sponsors of clinical trials.

  10. Quality And Compliance 8/22/2024

    Compliance solutions for product development agility and audit readiness.