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 reassure that the veterinary medicinal products are manufactured in compliance with their Marketing Authorization and they 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 GMP rules of EU (91/412/EEC).
The manufacturing facilities are periodically inspected by the Greek National Organization for Medicines (EOF), which issues a certificate that PROVET follows EU-GMP requirements.
safety and quality in products and services, protecting always health and 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 that concerns 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 National Organization of Pharmaceutical, which operates according to the principles of G.L.P.
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, which is a global quality management system that defines how an organization must operate in order to enhance customer’s satisfaction in terms of quality of the provided products and services.
By using 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.
The result of the implementation of the above quality standard, is that the company attains the defined quality targets, maintains and strengthens its reputation and reliability in the market.