WHO guidelines for Technology Transfer(TT)

• 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

1. Project Planning: Define objectives, timelines, and responsibilities.

2. Data Collection: Gather process descriptions, analytical methods, and quality specifications.

3. Gap Analysis: Identify and address differences between SU and RU processes.

4. Transfer Activities:

   • Process and Analytical Method Transfer.

   • Validation and Verification.

   • Regulatory Submission and Approval.

Phases of Technology Transfer

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.