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Guidelines for Establishing Manufacturing Facilities for Health Products & Technologies In Kenya

Guidance on the Construction and Standardization of HPT Manufacturing Premises

Manufacturing premises for Health Products and Technologies (HPTs) play a critical role in ensuring the quality, safety, and efficacy of products supplied to the Kenyan market and beyond. Recognizing the substantial resources required for the construction and maintenance of these facilities, this guidance serves as a comprehensive reference to support the planning, development, and upgrading of HPT manufacturing facilities in Kenya.

Purpose

The purpose of this guidance is to:

• Provide a framework for designing and constructing HPT manufacturing facilities in compliance with national and international standards.
• Ensure facilities meet Good Manufacturing Practices (GMP) and other regulatory requirements to protect public health.
• Promote standardization across the sector, improving efficiency and ensuring equitable access to high-quality health products.

Scope

This guidance applies to:

• New construction of HPT manufacturing premises.
• Upgrading and modernization of existing facilities.
• Maintenance and compliance audits for operational premises.
• The document is intended for use by manufacturers, facility designers, contractors, regulators, and other stakeholders involved in the establishment and management of HPT manufacturing facilities.

Key Components of the Guidance

• Structural Requirements: Standards for layout, materials, and design to ensure durability and compliance.
• Environmental Controls: Specifications for air handling, water quality, waste management, and cleanroom classifications.
• Equipment Standards: Guidelines for the installation, validation, and maintenance of manufacturing equipment.
• Regulatory Compliance: Alignment with the Pharmacy and Poisons Board (PPB) regulations, WHO GMP standards, and other international best practices.
• Sustainability: Recommendations for energy-efficient and environmentally friendly construction practices. 

In conclusion

We hope this guidance serves as a valuable resource for all stakeholders committed to advancing healthcare through the establishment of high-standard manufacturing facilities. Stakeholders are encouraged to review this document thoroughly and integrate its recommendations into their projects.

By working together to uphold these standards and embrace innovation, we can collectively enhance public health outcomes in Kenya and the region. For further inquiries or support, please contact the Pharmacy and Poisons Board (PPB).

Attached: Full Guidance Document on ‘Establishing Manufacturing Facilities for Health Products & Technologies in Kenya’

Attached Files