Insights On Regulatory Compliance

  1. Effective Contamination Control 6/16/2025

    Discover key strategies for contamination control in cleanrooms, as well as explore contaminant sources, behaviors, and best practices for cleaning and removal to ensure high standards of product and process quality.

  2. How Particle Counting Efficiency Affects Distribution Data 6/24/2025

    Examine how counting efficiency and resolution impact data interpretation in critical environments like cleanrooms and pharmaceuticals.

  3. How Digital Cleaning Validation Can Simplify Audit Readiness And Improve Compliance 9/26/2025

    Discover how to enhance audit readiness and improve compliance by shifting to a digital cleaning validation program. Learn to determine worst-case products and maximum safe carryover limits.

  4. ICH Guidelines: Challenges And Solutions For Pharma Manufacturers 10/8/2024

    Take the next step in enhancing your pharmaceutical manufacturing processes by investing in a robust quality management system (QMS) designed for ICH compliance and operational excellence.

  5. Selecting The Best Deterministic Method For Your CCIT Project 3/31/2025

    Container Closure Integrity Testing (CCIT) ensures drug sterility, evolving with regulatory updates like USP <1207>. Deterministic methods are preferred over probabilistic ones to maintain product integrity.

  6. Achieve Pharma 4.0 With Next Generation Software-Defined Manufacturing 11/5/2025

    Explore how software-defined manufacturing is helping companies overcome legacy system challenges, improve OEE by up to 25%, and accelerate batch release cycles while maintaining compliance.

  7. Guide To Pharmaceutical CAPA And Quality Management 3/14/2025

    CAPA management is vital for quality systems, especially in pharmaceuticals. Examine how issues are identified, corrected, and prevented to safeguard health and uphold regulatory compliance.

  8. Test Kit Management: The Hidden Weak Point In Your Visual Inspection Program 9/17/2025

    A proper test kit management program is no longer a “nice-to-have”—it’s a compliance necessity. Without a structured system, you risk inspector drift, failed audits, and errors in batch release.

  9. De-Risking The Transition From Vial To Drug-Device Combination Product 7/25/2025

    When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.

  10. Compliance Audits: 4 Solutions To Avoid Failure 9/20/2024

    Although inspection and audit processes have evolved, you can still effectively navigate and manage them within your organization. Explore four solutions to address audit and inspection pain points.