Webinar content

APIs used for parenteral dosage forms, or more widely for sterile medicines, should comply with certain requirements, but these will largely depend on the subsequent use of the API and how it is involved in the manufacturing operations of the final dosage forms.

There is a huge difference between Sterile API, which should adhere to regulations and guidelines beyond ICH Q7, and non-sterile API formulated later in sterile dosage forms: parenteral, ophtalmic,…

Risk Assessment plays, once more, a key role in the identification of what our expectations should be when auditing a specific manufacturer for a specific use of the API.

In case of non-sterile API used for parenteral FDF, the main risks and therefore, the expectation to prevent them requires that the API should be pyrogen-free. In case that the FDF manufacturing process does not include a filtration step, then the API must be also free from foreign particles.

This webinar will discuss:

Different uses if API in sterile dosage forms
Formulation processes involved and related risks
Practical measures manufacturers implement to prevent risks
Our responsibilities as auditors when auditing these type of API

Target group

Auditors of API suppliers, Technical staff of API manufacturers, and Quality Assurance personnel.

Speaker’s background

Dr. Octavi Colomina


PhD in Chemical Engineering and BS Sci. In Organic Chemistry. With 38 years of professional experience in R&D, Chemical and pharmaceutical Industry, Computer Sciences and Pharmaceutical Consultant and Auditor for 25 years.

Founder adn Technical Manager of TDV Compliance Technology and President of Asociacion Forum Auditorias (AFA).