Regulations and Compliance

In Kenya, local manufacturing of healthcare products must comply with various regulatory guidelines, national laws, and international standards to ensure the safety, quality, and efficacy of medicines. The PPB is the primary regulatory body overseeing the pharmaceutical sector in Kenya. Manufacturers must adhere to the Kenya Good Manufacturing Practices (GMP) Guidelines, which are periodically updated in line with the World Health Organization (WHO) standards. These guidelines cover various aspects of production, including quality control, documentation, and facility requirements. Compliance with national laws such as the Pharmacy and Poisons Act, the Public Health Act, and the Industrial Property Act is mandatory. These laws regulate the registration, manufacturing, and distribution of pharmaceutical products to ensure public health safety.

International Standards ISO Standards: Local manufacturers should adhere to ISO standards pertinent to the pharmaceutical industry. Key standards include:

  1. ISO 9001: Quality Management Systems, ensuring that products consistently meet customer and regulatory requirements.
  2. ISO 13485: Specific to medical devices, focusing on the quality management systems required for regulatory compliance.
  3. ISO 14001: Environmental Management Systems, to ensure sustainable and environmentally responsible manufacturing practices.

Others Include: WHO Pre-qualification WHO pre-qualification has become a trusted and reputed symbol for safety, quality, and efficacy across stakeholders and hence adds value.


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