In House Training Course

Annex 13

Manufacture of Investigational Medicinal Products

(Product Specification File – PSF)

(~1 hour)

Annex 13, Section 9 defines the requirements for the Product Specification File. It lists the various documents which the file must contain or refer to.

• How can the requirements be realised?
• What do the authorities expect?
• What advantages can Pharmaceutical development take of the PSF?
• How one can successfully implement the PSF?

This training could be used in conjunction with other courses available, please contact us if you would like help in putting a programme together

Speaker

Dr David Inglis