Good Manufacturing Practices Division
GMP Division exists to ensure that personnel, premises and practices employed in the manufacturing of Health Products and Technologies comply with the defined codes of practice and other prescribed requirements through inspection of manufacturing facilities (both local and international)
As per CAP 244 of the Laws of Kenya, every person who is granted a manufacturing license is mandated to comply with good manufacturing practices. Additionally, marketing authorisation is granted upon confirming that the site of manufacture complies with Good Manufacturing Practices.
Services offered by the Division include
- Conducting inspections to manufacturing sites (both local and foreign) for purposes of marketing authorization
2. Regulatory oversight to local manufacturers by conducting Risk Based Inspection (RBI)
3. Advising and guiding clients interested in setting up HPT manufacturing sites in Kenya.
4. Certification of sites for GMP compliance or non compliance.
Commitment to Best Practices
The PPB is committed to aligning its GMP oversight framework with internationally recognized standards. WHO guidelines will serve as a primary reference in the development, updating, and implementation of this document, ensuring its relevance and effectiveness in promoting public health.
By working together, regulators, manufacturers, and other stakeholders can uphold the highest quality standards for HPTs in Kenya, fostering trust and ensuring the safety and efficacy of all health products in the market.