Abstract:
The object of the GMP and associated rules is the assurance of the quality of the products for the safety, well being and protection of the patient. In achieving this aim it is impossible to over-emphasise the importance of people, at all levels, in the assurance of the quality of medicinal products. The great majority of reported defective medicinal products has resulted from human error or carelessness and not from failure in technology. All the people involved with the production, quality control or distribution of medicinal products, whether key personnel, production or quality control staff, inspectors or other involved in the many activities which lead to a patient taking a medicine, should bear this constantly in mind when performing their duties.
