Carrying out the training for the personnel of the production plant in order to contribute to a successful GMP inspection. Carrying out the specific training on current issues of the manufacturer in the field of good manufacturing practices (for all sections of GMP: pharmaceutical quality system, personnel, premises and equipment, documentation, production, quality control, subcontracted activities, complaints, quality defects and product recalls, self-inspection, qualification and validation, confirmation of the conformity of the batch and its release by the qualified person, manufacturing particulars of pharmaceutical substances, sterile medicines, biological and immunobiological medicines, medicines for veterinary use and others). The recommended standards of behavior of the personnel during the inspections: communication with the inspector, preparation and presentation of the documents, behavior during the inspection tour. Some recommendations that can help answer the similar questions during inspections for various departments of the production plant: quality assurance, quality control laboratories, production, engineering systems and maintenance, warehouse, validation and qualification and others.
