On-line Advance Training Session

In this on-line course, the GMP auditing criteria for the APIs and the final product used in Clinical Trials will be reviewed, from the API production to the final labelling and distribution of the CTS.

The following topics will be covered:

Clinical trials perspective
Development stages of the drug substance and drug product
GMP requirements for the batches to be used in clinical trials
Approach of the audits to manufacturers

The APIs and Final Dosage Forms that are to be used in Clinical Trials are of paramount importance to ensure the safety and quality of the final commercial product. Furthermore, the protection of voluntaries and patients involved in the Clinical Trials is also a primary objective.

The manufacturing and control of these products are subject to Good Manufacturing Practice (GMP) to ascertain the quality and safety of the Clinical Trial Supplies (CTS) and to obtain reliable and integer data to support the filing of the product. Due the products nature and depending on the different development stages, the GMP principles applicable have different approach.

Examples of most common observations will be shown during the course, and it will be enabled a space for questions and answers.

Target group

Professionals opearting in the Pharmceutical business wishing to improve their resources and knwoledge on performing effective supplier audits.

Speaker’s background

Ms. Gràcia Rovira

TDV Consultant

Industrial Engineer, Chemical specialisation (ETSEIB). Since 1999, she has developed her professional activity in the pharmaceutical industry, in the Quality Assurance area for new pharmaceutical products development projects and as a technical and quality consultant in different fields of the GXP regulated sector. Within the Quality Assurance activities, she has carried out quality system internal audits and clinical trials supplies release audits in the Pharmaceutical Development area, as well as audits of related suppliers. Since 2016 she is a qualified AFA auditor, carrying out audits of manufacturers of commercial finished product and investigational drugs, excipients, APIs and analytical laboratories.