• Version
• Download 7967
• File Size 3.52 MB
• File Count 1
• Create Date February 14, 2022
• Last Updated March 19, 2025

Guidelines for Good Distribution Practices for Medical Products and Health Technologies in Kenya

Pharmacy and Poisons Board (PPB) GDP Guidance Overview

The Good Distribution Practices (GDP) Guideline for Health Products and Technologies in Kenya, published by the Pharmacy and Poisons Board, ensures the quality, safety, and integrity of HPTs during their distribution. This guideline defines a robust framework to maintain product quality from the point of manufacture to the end user. It emphasizes quality management systems, personnel training, proper storage, handling, and compliance with legal and regulatory requirements.

Purpose and Scope

This guidance aims to:

1. • Maintain the quality, safety, and efficacy of health products throughout the supply chain.
   • Prevent the distribution of substandard, falsified, or adulterated medical products.
   • Provide stakeholders, such as wholesalers, retailers, hospital pharmacies, importers, and exporters, with the required standards for lawful and professional distribution.
   • Establish clear regulatory guidance for the handling, storage, and transportation of health products and technologies.

Key Features of the Guidance

1. Organizational Structure and Management:

1. • Defined roles and responsibilities for personnel.
   • Quality management system implementation.

1. Personnel and Training:

1. • Mandatory training for handling pharmaceutical products.
   • Compliance with hygiene and safety protocols.

1. Storage and Warehousing:

1. • Proper storage conditions, including cold-chain management.
   • Regular temperature and humidity monitoring.

1. Distribution and Transportation:

1. • Secure and efficient handling during importation, warehousing, and transportation.
   • Procedures to address damaged, returned, or expired goods.

1. Risk Management and Validation:

1. • Regular risk assessments to ensure compliance.
   • Validation of storage premises, equipment, and transportation systems.

1. Regulatory Compliance:

1. • Ensuring proper labeling, batch tracking, and compliance with the Pharmacy and Poisons Board's requirements.

Roles and Responsibilities

• Distributors and Wholesalers:

• • Ensure proper storage and timely transportation of products.
  • Maintain accurate records of stock, including batch tracking and customer details.
  • Conduct regular self-audits and corrective actions.

• Pharmacists and Pharmaceutical Technologists:

• • Oversee the quality of health products during distribution.
  • Perform routine quality checks and report adverse findings to regulatory authorities.

• Regulatory Authorities (Pharmacy and Poisons Board):

• • Inspect and certify compliance with GDP requirements.
  • Enforce the recall of substandard or falsified products.
  • Provide training and guidelines for stakeholders.

• Transporters:

• • Maintain product integrity during transit, including adherence to cold-chain requirements.

Attached Files