Selecting an Off-Site cGMP Storage Provider

In this whitepaper you will learn:

• Critical Factors for Selection: Understanding the importance of materials management, physical site security, facility integrity, precise temperature monitoring, product safety, and compliance procedures when choosing an off-site cGMP storage provider.
• Materials Management: The need for proficient handling and expert management of pharmaceutical products, including services like aliquoting, validated transportation, cycle counting, and reference standards management.
• Physical Site Security & Accessibility: The necessity of multi-level access controls, video surveillance, and fire suppression systems to ensure the security and safety of stored products.
• Facility and Equipment Integrity: The importance of redundant power systems, backup chambers, and dual refrigeration systems to maintain continuous operation and proper storage conditions.
• Compliance and Quality Management: Ensuring the storage provider has a robust Quality Management System (QMS) and validation processes in place to meet regulatory and quality compliance requirements.