PROVET

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.

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.

ISO 14001:2004

PROVET, has established and applied an environmental management system according to the Standard EN ISO 14001:2004.

Every activity, such as production, storage, analysis, transportation and distribution is based on the protection of the environment.

This is accomplished by identifying, encountering and reducing the Environmental Impacts that result from PROVET’s activities and by establishing environmental programs and procedures that are designed to improve Company’s environmental performance.

OHSAS 18001:2007

PROVET’s Management, according to STANDARD OHSAS 18001:2007, takes all necessary actions for the improvement of health and safety conditions and ensures the protection of Company’s personnel, cooperators and visitors life and safety within Company’s facilities, as it is defined from current Greek and European legislation.

Company’s Policy is based on:

• The evaluation of hazards and the necessary actions for their control.
• The issue of appropriate programs that aim to prevent danger and improve occupational conditions.
• The maintenance and monitoring of equipment, utilities and facilities safety operation.
• The respect of legislative and other requirements, standards and internal procedures.
• The open and transparent communication along with the continuing education to all matters concerning health and safety.