In the first blog posts we have analysed the paradigm shift in GMP and listed a series of support guidelines as evidence of this shift. Last week, we also analysed the real impact of these changes on the pharmaceutical industry, and introduced the concept of indicators to evaluate the level of GMP compliance and the maturity of the organization. Now, it’s time to review these indicators.
AFA audits are focused on reviewing and understanding how companies are organized and the quality, management, manufacturing and control processes. Through this understanding, the compliance with the significant and applicable parts of cGMP is determined. We select some indicators that provide an objective and structured assessment output. These indicators are as follows:
•Staff training: The actual level of training in both technical and GMP concepts is observed in the staff of the audited sites.
•Facilities and Premises: Suitability of the facilities for the purpose.
•Quality Oversight: The Quality Department is provided with sufficient resources and is actively involved in the oversight of all direct or indirect product quality-related processes.
•Risk Management: Risk management is a transversal tool that allows effectively managing the risk of all the processes of the company; the selection of quality indicators, critical operations and parameters, the management of exceptions, the prioritization and validation exercises, among others.
•Exceptions management. CAPA system: Root cause is investigated for the exceptions timely. Assessment of the impact is expanded to other batches, facilities, equipment, processes or systems. CAPA system is in place, collecting the management of all the exceptions allowing controlling and relating them to gainknowledge and ease the establishment of effective improvement actions.
•Quality Monitoring: Quality indicators are well established in the company for the processes and products. A system is in place to monitor the quality indicators and to assess the trends and excursions (OOT). Product Quality Review report is prepared periodically, collecting all the relevant information about the product and demonstrating the state of control of the process to finally propose and implement possible improvement actions.
•Data Integrity & Traceability: The data governance system is integral to the quality system and Data integrity requirements apply equally to manual (paper) and electronic data.
Data is compliant with the ALCOA Plus concept:
A attributable to the person generating the data.
L legible and permanent.
O original record (or ‘true copy’).
Plus complete, consistent, enduring and available.
The evaluation of these indicators allows having a good overview of the level of compliance and identifies the strengths and weaknesses. Our auditors’ courses allow acquiring the necessary knowledge to carry out this evaluation as well as to review practical cases that illustrate the current state of the companies in the sector. Next opportunity to attend to AFA Auditors Training Course will be next November 20th and 21st 2018 in Frankfurt.