• Version
• Download 3628
• File Size 578.01 KB
• File Count 1
• Create Date November 20, 2023
• Last Updated March 19, 2025

Kenya Good Manufacturing Practices Guidelines

Pharmacy and Poisons Board (PPB) GMP Guidance Overview

The Pharmacy and Poisons Board (PPB) has adopted and published this comprehensive guidance document based on multiple technical Good Manufacturing Practice (GMP) guidelines issued by the World Health Organization (WHO). In line with WHO recommendations, the document also includes Kenya-specific adaptations to address unique national circumstances and regulatory requirements.

Purpose and Scope

This guidance aims to:

• Provide a framework for ensuring that Health Products and Technologies (HPTs) manufactured in, imported into, or exported from Kenya are consistently produced and controlled to meet quality standards appropriate to their intended use.
• Support manufacturers in maintaining compliance with marketing authorizations or product specifications.
• Enhance regulatory oversight of GMP inspections by aligning PPB practices with internationally recognized standards while addressing local regulatory needs.

Key Features of the Guidance

• Adoption of WHO Guidelines:
  • Incorporates core WHO GMP principles for manufacturing, quality control, and storage.
  • Includes additional country-specific provisions to address Kenya’s unique industry and public health priorities.
• Non-Technical GMP Guidelines:
  • Simplified guidelines tailored for the local manufacturing industry and PPB inspectors (we need to develop some like for PQR, deviation handling).
  • Developed in alignment with international best practices to enhance accessibility and usability.
• Updates and Implementation:
  • Regular updates to incorporate emerging regulatory trends and WHO-recommended changes.
  • Focus on continuous improvement in oversight processes to safeguard public health.

Roles and Responsibilities

• Manufacturers:
  • Ensure strict adherence to GMP guidelines in all production and quality control processes.
  • Maintain accurate and updated documentation for inspection and compliance purposes.
• PPB GMP Inspectors:
  • Conduct routine, for-cause and follow-up inspections to assess compliance with the guidelines.
  • Provide technical support and training to industry stakeholders on GMP requirements.
• Marketing Authorization Holders (MAHs):
  • Collaborate with PPB to address quality concerns and implement corrective actions promptly.

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.

Attached Files