Active Pharmaceutical Ingredients (API)
Active Pharmaceutical Ingredients
PCAS operates four industrial sites in accordance with good manufacturing practices for active pharmaceutical ingredients (ICHQ7): Aramon, Limay and Villeneuve-la-Garenne in France, as well as Turku in Finland.
These sites are audited and accredited by their respective national authorities, in accordance with European directive 2011/62/EU. They are also regularly inspected by foreign agencies, such as the American FDA (Food and Drug Administration).
|Sites||Agence nationale européenne*||FDA (États-Unis)||PMDA (Japon)|
|* ANSM (France), FIMEA (Finlande) | ** Off-site review of GMP | Last updated in June 2016*|
Pharmaceutical intermediates, performance products and advanced specialties
PCAS operates three sites in accordance with ISO 9001 standards: Bourgoin-Jallieu and Couterne in France, Saint-Jean in Canada. On the basis of this standard, the Group has developed an internal set of reinforced manufacturing standards for pharmaceutical starting materials, known as MPPS. These additional standards were specially developed for the production of RSMs (Regulatory Starting Materials).
Link to PCAS's ISO certificate: Certificat ISO - 16_PCAS_ISO_9001-2008_SGS_14_01_16_14_09_18_v05
Link to ISO Saint Jean certificate: Certificat ISO - 2013 - 2016
Basic standard for all products manufactured by the site
MPPS - Matière Première pour Produit de Santé (pharmaceutical starting material)
Additional requirements primarily related to reinforced supervision of quality assurance (review of batch and release forms), verification of cleaning and validation of analytical methods.
The specific requirements of customers can generally be taken into account by means of quality agreements incorporating GMP (ICHQ7): the Bourgoin-Jallieu and Couterne sites both manufacture certain GMP-compliant products in very specific conditions.