These guidelines set out the principal requirements for the safe storage and distribution of time- and temperature-sensitive pharmaceutical products (TTSPPs). They are based upon existing regulations and best practice guidance from a wide range of international sources(see References), while accepting that local legislation and regulations will continue to take precedence. The target audience includes regulators, logisticians and pharmaceutical professionals in industry, government and the international agencies.
The document has been prepared in close consultation with the WHO Task Force on Regulatory Oversight on Pharmaceutical Cold Chain Management which has been central to the review process. A full list of members is given at the end of this annex.
The intention is that the guidance in this document should be directly applicable in less-developed countries as well as in the industrialized world. To this end, supplementary materials will be developed to show how the
requirements can practicably be achieved, particularly in resource constrained settings. Experience with vaccine supply chain assessments in many less-developed countries demonstrates that the mandatory standards set out in this document can be achieved, and that some countries are also capable of meeting many of the optional requirements.
The document is designed to give a balanced overview of the major aspects of good storage and distribution practice for TTSPPs. As such it deliberately includes references to requirements which can be found in general guides to good manufacturing practice (GMP), good storage practice (GSP) and good distribution practice (GDP). The purpose is not to supplant these source materials, but to
ensure that the reader is aware of the relevant GMP, GSP and GDP implications when seen from the particular and specialized perspective of TTSPP management...