Views: 355 Author: Site Editor Publish Time: 2023-03-28 Origin: Site Inquire
Defects identified in the quality system that would result in regulatory authorities determining that the system has collapsed, is not in a "controlled state," and/or would result in a high risk of products on the market or released to the market.
System crashes can result in regulatory actions. Severe defects may constitute a direct violation of production permits, or involve data deception, misguidance, or forgery, which, together with major defects, can lead to serious system failures. For instance, uncontrolled production management, non-conforming quality, product mix-up or deviation can directly affect the characteristics, strength, purity or quality of drug products or materials, resulting in recall and/or regulatory actions. Commercially distributed products may fail to meet specifications or regulatory requirements. Commercially distributed product labels may be incorrect (mislabelled).
Failure to effectively implement corrective preventive measures for deficient items from external inspection agencies. Supplier quality management with asterisked items from pharmacovigilance organs, warning letters, etc.; problems with sterility assurance of sterile products (e.g. microbial contamination), etc.
The deficiencies identified in the quality system may result in potential system breakdowns that are deemed by regulatory authorities. Failure to comply with specific regulatory requirements, standards, or corporate policies may affect the quality of the product. Multiple significant findings indicate that the quality system may be in an uncontrolled state, and products with potential defects may be released into the market. Major deficiency items may result in potential regulatory action.
For example, situations that lead to non-compliance of products; significant corrective and preventive system deficiencies; significant supplier control/purchasing control subsystem deficiencies; lack of change control for critical systems and related validation; changes executed prior to QA approval; use of uncalibrated instruments; ineffective training systems; inability to effectively implement corrective and preventive measures for previous supplier audits or external inspections.
Defects that have been identified, although not meeting the requirements of procedures and/or regulations to a significant degree, are in a "controlled state" and have relatively low potential impact on product quality or availability. For example, deviations from approved written procedures and/or policies of the company that do not affect product quality. Minor errors (such as minor errors in documentation) may indicate a trend. Contradictions between SOPs, etc.
A general quality audit can be designed to include basic information about suppliers (manufacturers, agents), personnel and organizations, factory facilities, equipment, quality assurance, quality control, production management, material management, handling of quality complaints, communication regarding quality issues and usage (additional items may be added as per actual circumstances).