PHARMA ONLINE WHITE PAPERS

• Selecting The Best Deterministic Method For Your CCIT Project

  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.

• The 5 Ws Of A Human Factors Strategy

  3/31/2025

  A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

• Best Practices For Internal Quality Audits In Life Sciences

  3/14/2025

  Discover why internal quality audits are vital in the life sciences sector to ensure regulatory compliance, mitigate risks, and maintain high standards of product quality and patient safety amidst evolving challenges.

• Validation And Qualification Approach In New Annex 1 Revision

  2/21/2025

  The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.

• Developing Effective Procedures

  10/21/2024

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

• Outsourcing Stability Storage: A Cost-Effective And Quality-Driven Approach

  8/22/2024

  Partnering with a leader in outsourced stability storage is revolutionizing the pharmaceutical and medical device industry to ensure product quality and compliance.