CONSULTANCY ON THE GMP AND GDP REQUIREMENTS 1.1. Independent auditing of quality systems for their compliance with the GMP and GDP requirements. 1.2. Preparation of an enterprise or a site for its certification / licensing under the GMP and GDP requirements. 1.3. Design and implementation of quality systems: 1.3.1. Composition / assessment of the quality system documents: - quality manual (QM), - site master file (SMF), - standard operation procedures (SOP), - validation master plan (VMP), - annual quality survey, etc. 1.3.2. Information back-up of an enterprise until obtainment of a certificate / license 1.4. Development and implementation of a risk management system 1.5. Consultancy and an information support of a company at the stage design, refurbishment or reconstruction of pharmaceutical plants 1.6. Any other assistance provided to pharmaceutical enterprises in the context of implementation and maintenance of the GMP and GDP requirements.