Quality & Certificates at Pompey (Novasep Process)

Quality is a Key Word at Novasep.
This is particularly true since the quality requirements of our customers are increasing because of internal regulations or the regulations of authorities. This is why quality is a constant concern for everyone at Novasep. More than being a mere desire and a necessary requirement to comply with norms and regulations, Quality Management at Novasep is an essential tool for the growth of the company.

The very successful regulatory inspections of AFSSAPS (French Authority) and the FDA in 2005 also demonstrate the high level of implication of our Quality team and the Compliance of our Quality system to regulatory guidelines & laws.

The Quality system is based on ISO 9001 and cGMP requirements defined in ICH Q7A. The general organisation of the Quality Management System is shown in the diagram below.

 

Customer Satisfaction

Whatever the nature of the job to be done, Novasep personnel does everything it can to satisfy the customers' needs. This means, among other things, being flexible and creative. We particularly focus on making sure that delays are respected, documentation is properly done. Quality is at the expected levels, specific requirements are fulfilled, etc...

Continuous Improvement

Whatever the tools used (management meetings, internal and external audit results, corrective and preventive actions, etc...), continuous improvement is the main objective of our Quality Management System. The whole staff participates in the continuous improvement of products and services, as required by the customers. The responsibility of the Quality Assurance division is to organize, guide and supervise the actions to improve Quality and comply with the Quality Management System (internal and external regulations and procedures), and to provide the tools for this to be efficiently done.

Compliance

Complying with the norms and regulations of the pharmaceutical industry is a mandatory task for Novasep:

a. System compliance
The Qualification/Validation Unit qualifies and confirms with tangible proofs that the units produced will operate properly and will achieve the results expected by the customer. The "V" qualification methodology is applied:

For automated systems, particular attention is paid to specific norms and guidelines recognized as standards in the pharmaceutical industry such as GAMP 4 and regulatory expectations (for instance: FDA 21 CFR Part 11).

Compliance with current Good Manufacturing Practices (cGMP) for Custom Manufacturing
The manufacturing of active pharmaceutical ingredients and intermediates is performed according to cGMP rules. There is no alternative, except in rare cases (e.g.: production of material for technical studies) the level of documentation can be adapted to the customer's requirements.

The first FDA inspection of the site in Pompey took place in September 2005. This FDA PAI inspection was completed in 3 days. No FDA 483 forms were issued, confirming that Novasep Process is in compliance with the current GMP following ICH Q7A guidelines for the manufacturing of advanced intermediates and APIs.

Novasep has been also successfully inspected by AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé) in May 2005. The inspection checked all aspects related to the manufacturing of active pharmaceutical ingredients and intermediates. The conclusions of the inspection was: Novasep "is able to manufacture active and intermediate ingredients for the pharmaceutical industry according to the recommendations described in: - ICH, Q7A; 2001, "Good Manufacturing Practices for Active Pharmaceutical Ingredients" - in application of L-5313-1 (Code de la Santé Publique)".

 

Download Inspection certificate