At Azierta, we are experts in supporting the obtaining and maintenance of the GMP / GDP certification.
The need to maintain and control the state of the manufacturing plants of starting materials, active principles, excipients and conditioning materials make it essential to implement and maintain a Quality System according to the most updated GMP regulations.
In addition, the current guidelines on Rules for the Correct Distribution of Medicines for Human Use (2013/C 343/01) have also conditioned TAC laboratories and local representatives to obtain a GDP certificate for their facilities.
At Azierta, we make it possible for our clients to obtain GMP/GDP certification in accordance with current regulations:
- Implementation and revision of Quality Systems.
- Risk Analysis.
- GAP analysis.
- PNTs procedures.
Advice and implementation of quality systems