We offer services of our international and Armenian experts who can visit your factory and advise/consult you on the GMP issues which can help you to prepare for GMP audit or improve your compliance level. The consultancy touches the following:
- Company Quality Management (including establishment of the requirements for a quality management system and a quality manual, definition of management responsibilities, resource management etc.)
- Personnel (evaluation of personnel competence and qualification, measurement, analysis and improvement of training programs etc.),
- Premises (assessment of location, design, construction, personnel flow, partition systems, adaptation and maintenance of premises as well as HVAC and Water systems),
- Equipment (assessment of equipment design, location, installation and calibration),
- Documentation (assessment of Batch Documentation, Standard Operational Procedures, analytical records, maintenance and calibration records, training records etc),
- Production operations (sterile and non-sterile production, processes validation),
- Quality Control operations (evaluation of quality control department procedures, facilities and personnel, products sampling and testing procedures etc.),
- Inspection and Audit (development of Internal Audit system, control of nonconforming product, implementation of corrective and preventive actions, effectiveness monitoring etc).
To whom it is addressed:
Pharmaceutical companies targeting to comply with Good Manufacturing Practices and the companies already complying with that of requirements and willing to upgrade and/or improve their components.