GMP
The pharmaceutical industry in the European Union maintains high standards of quality assurance in the development, manufacture and control of medicinal products, by following the EU rules to Good Manufacturing Practice, as amended by Directive 91/412/EEC.
These rules ensure that the veterinary medicinal products are manufactured in compliance with their Marketing Authorization and meet the requirements for safety, quality and efficacy.
PROVET has its own manufacturing facilities for the development, manufacturing and quality control of veterinary medicinal products, which operate according to EU GMP rules (91/412/EEC).
The manufacturing facilities are periodically inspected by the Greek National Organization for Medicines (EOF), which issues a certificate that PROVET adheres to EU-GMP requirements.
safety and quality in products and services, always protecting health and the environment
PROVET is licensed to produce the following:
- Sterile products (small volume injectables aseptically filled including penicillin products, large volume injectables terminally sterilized).
- Non sterile products (tablets, simple, antibiotic, hormone containing, pessaries – liquid for internal use – liquid for external use – sprays, antibiotic, ectoparacitisides – powders for internal use, simple, antibiotic, penicillin powders – creams).
- Pharmaceutical premixes and feedingstuffs.
GLP
Good Laboratory Practice (G.L.P.) is a quality system regulating the organizational processes and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported (ENV/MC/CHEM(98)17:section I).
PROVET has a Test Unit certified by the Greek National Organization for Medicines (EOF), and which operates according to the principles of G.L.P.
The G.L.P. Test Unit of PROVET can support and conduct the following studies:
- Determination of drugs in biological fluids, referred to in Pharmacokinetic, Bioavailability and Bioequivalence studies.
- Determination of residues in animal tissues and animal products.
ISO 9001:2008
PROVET applies to all its activities the international standard ISO 9001:2008 process: a global quality management system which defines how an organization must operate in order to enhance customer satisfaction and ensure quality of provided products and services.
By adhering to this standard, PROVET controls effectively all processes that concern research and development, purchasing, production, quality control, storing, logistics, provision of services to the customer etc.
At the same time, through this process, the company not only meets the defined quality targets, but also enhances its reliability and reputation in the market.