ESTABLISHMENT OF A NATIONAL MEDICAL LABORATORY ACCREDITATION SYSTEM INITIATED SINCE OCTOBER 2007 BY COMPILATION AND DISTRIBUTION OF NATIONAL MEDICAL LABORATORY STANDARDS IN ACCORDANCEWITH INTERNATIONAL REFERENCE STANDARDS AND FOLLOWED BY ORGANIZING SEVERAL TRAINING WORKSHOPSON QUALITY MANAGEMENT TARGETING ADMINISTRATIVE AND TECHNICAL DIRECTORS ADDRESSING. GIVENTHE IMPORTANT ROLE OF AUDIT IN ACCREDITATION PROCESS AND NECESSITY OF CONDUCTING THE ASSESSMENT BY TRAINED AND QUALIFIED PROFESSIONALS, TRAINING OF STAFF OF MEDICAL LABORATORY AFFAIRSDEPARTMENT, AT EACH MEDICAL UNIVERSITY, PLANNED SIMULTANEOUSLY. ...

The main responsibilities of Quality assurance consist of performing planned and systematic actions to ensure that the company products meet the quality required for their intended use. Thus Quality assurance principles are to ensure that GMP, GLP and other regulatory codes are respected. Responsibilities are clearly specified, all testing, controls, calibrations, validations, etc. are performed as specified. Products are not sold before the correct authorizations have been obtained Products are appropriately handled throughout their shelf-life. To establish the policy and general procedures for the documents management through its life cycle. To organize and perform quality audits, to determine conformity with Quality System requirements.To establish the general procedures for performing the validation actions. To analyse the performance and consistency of the production processes, through trend analysis of the critical points, coordinating the participation of the related areas. To organize and manage the calibration and verification of the measuring instruments, according to a program and using the adequate standards and reference materials, for ensuring the measurements' traceability. These procedures help assure biopharmaceutical efficacy, safety and quality before to sale.

ADRENOCORTICOTROPIC HORMONE (ACTH), A POLYPEPTIDE HORMONE, PRODUCED IN THE ANTERIOR PITUITARY AND SERVES TO STIMULATE STEROID PRODUCTION AND SECRETION BY THE ADRENAL CORTEX. ACTH DETERMINATION IS USED CLINICALLY IN THE DIFFERENTIAL DIAGNOSIS OF ADRENAL DISORDERS. IN ADDISON‘S DISEASE (PRIMARY ADRENAL INSUFFICIENCY), ELEVATED LEVELS ARE CHARACTERISTIC, WHEREAS IN ADRENAL INSUFFICIENCY LOW/NORMAL LEVELS OF ACTH ARE SECONDARY TO PITUITARY DYSFUNCTION...