The World Health Organization (WHO) provides guidelines to ensure that pharmaceutical products are consistently produced and controlled according to quality standards during technology transfer.
Purpose and Scope
Purpose: To offer a structured framework for effective transfer of manufacturing processes, analytical methods, and related information.
Scope: Applies to the transfer of technology for APIs, pharmaceutical products, and analytical methods.
Key Principles
Quality Assurance: Maintain product quality throughout the transfer.
Documentation: Ensure transparency and traceability.
Communication: Facilitate knowledge transfer between sending and receiving units.
Regulatory Compliance: Adhere to all regulatory requirements.
Roles and Responsibilities
Sending Unit (SU): Provides complete, accurate information.
Receiving Unit (RU): Assimilates and implements the technology effectively.
Phases of Technology Transfer
Project Planning: Define objectives, timelines, and responsibilities.
Data Collection: Gather process descriptions, analytical methods, and quality specifications.
Gap Analysis: Identify and address differences between SU and RU processes.
Transfer Activities:
Process and Analytical Method Transfer.
Validation and Verification.
Regulatory Submission and Approval.
Documentation Requirements
Transfer Protocols: Outline transfer activities.
SOPs: Specific procedures for processes.
Reports: Document all transfer activities, validations, and deviations.
Regulatory Compliance
GMP Compliance: Maintain quality standards.
Regulatory Submissions: Update authorities on changes.