Certifications

Hygiene & organisational practices

Market launch authorisation

In response to a lack of confidence during the 90s, brought about by various health and food-related crises, certain representatives of the pharmaceutical industry introduced a certification process known as GMP. This process is managed by an international association.

The holder of a manufacturing authorisation must manufacture a product fit for use in line with the specifications defined in the market launch authorisation. He must not, under any circumstances, expose a patient to a risk which calls into question the safety, quality or efficiency of a product.

Risk limitation

With this in mind, the BPF are committed to limiting 2 risk categories:

  • risks of the cross contamination of products (by another product or an internal or external contaminator);
  • risks of confusion, particularly relating to the labelling and identification of components.

They focus on the hygiene and organisational practices which must be implemented on all levels.

Since April 15th,  2016, the ANSM has no longer issued paper copies, as the certificates issued feature in the public community database EudraGMDP in accordance with Article 111(6) of the amended directive 2001/83/EC (http://eudragmp.ema.europa.eu).

Our certifications for each site are listed below:

PHARMASTER

GMP certificate for human investigational medicinal products 
Manufacturing Authorization for human medicinal products
Manufacturing Authorization for veterinary medicinal products

BTT

BPF ANSES certificate
BPF ANSM certificate

SYNERLAB DÉVELOPPEMENT

BPF ANSES certificate
BPF ANSM certificate

 LYOFAL

ISO 9001 certificate
Human  medicinal products
Human investigational medicinal products
GMP certificate for drugs intended for use on humans
ANVISA certificate
FDA Korean certificate

ALCALA FARMA

GMP certificate, Spanish agency for drugs & health products Alcala de Henares site
GMP certificate, Spanish agency for drugs & health products Guadalajara site
Manufacturing authorisation certificate, Spanish agency for drugs & health products Alcala de Henares site
Manufacturing authorisation certificate, Spanish agency for drungs & health products, Guadalajara site