As a consequence from the extensive globalization, the relevancy of good distribution practice (GDP) of APIs for use in the manufacture of medicinal products is growing rapidly. With the recent draft guidance for APIs, the European Commission has suggested detailed demands on API-GDP, including GTP. The growing quality impact due to transportation is reflected in more detailed requirements for the defined quality assurance system. Moreover, wholesale trading with APIs is addressed more specifically and with more detail.
We encourage You to benefit from our experience, acquired during several years of company-specific consulting and employee training in the area of GDP and GTP.
- Set-up and establishment of GDP and GTP concepts
- Risk-based identification of qualification and validation activities needed
- Qualification, validation, and setup of monitoring for storage facilities according EU GMP and US CFR
- Transport validation
- Cold chain validation including holding times
- Audit support in controlling the distribution chain
- Preparation of cost-efficient plans for monitoring of storage facilities and product transport