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Guidance for Adoption of Internationally Recognised Guidance Documents

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  • Create Date February 28, 2022
  • Last Updated February 28, 2022

Guidance for Adoption of Internationally Recognised Guidance Documents

GMP applies to the life-cycle stages from the manufacture of investigational medicinal products, technology transfer, and commercial manufacturing, through to product discontinuation. PQS can extend to the pharmaceutical development life-cycle stage and should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities. All parts of the PQS should be adequately resourced and maintained, including being provided with sufficient competent personnel, suitable premises, equipment and facilities. GMP inspection is carried out to assess the PQS put in place by the manufacturer. A PQS ensure that the Pharmaceutical products are fit for their intended use, comply with the requirements of the marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment of staff in many different departments and at all levels within the company, the company’s suppliers and the distributors. To achieve this quality objective reliably there must be a comprehensively designed and correctly implemented pharmaceutical quality system (PQS) incorporating GMP and QRM. GMP inspection is carried out by qualified, experienced and appointed by the regulator. Under certain circumstances, the regulator may face challenges in carrying out the regulatory function in which case adoption of international best practices is applied. The decision on whether to adopt an international guideline rest with appropriate technical committee (TC). PPB should establish TCs charged with the responsibility of adopting international guidelines. The PPB closely aligns its regulatory approaches to those of comparable international regulatory counterparts wherever possible. Prior to adopting any Guideline, the PPB undertakes an extensive process of internal and external consultations to ensure the Guideline is consistent with prevailing requirements in Kenya. PPB should publish a searchable list of International Guidelines adopted in Kenya.

Reasons for adoption

  1. a)  Adoption of international best practices to avoid duplication. International guidelines generally reflect the best practices of regulators worldwide and advances in a variety of countries.
  2. b)  Resource constraint especially inadequate and experienced human resource.
  3. c)  Participation in international certification schemes is facilitated.
  4. d)  Leads to regulatory efficiency thereby assuring quality, safety and

    efficacy of HPT.

  5. e)  Lack of requisite expertise in the NRA (e.g. GMP inspection and MA of

    vaccines) among others.

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