Good Manufacturing Practices consultancy

About:

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.

Consultants:

Aram Ghazaryan