The new article addresses the matters related to the technical competence and training requirements for inspectors, as well as to their responsibilities.
Table of Contents
The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the Good Manufacturing Practices in the sphere of site inspection management. The document is intended to provide additional clarifications regarding the existing regulatory framework. The guidance is non-binding and could be subject to changes, should such changes be necessary to reflect the amendments to the underlying legislation.
Technical Competencies and Training Requirements
The document describes the technical competencies necessary for the inspectors to be able to perform their functions. According to the guidance, they should have extensive knowledge in the following spheres:
- Regulatory requirements set forth by existing laws and regulations that cover such aspects as:
- Achieving conformity with regulatory requirements;
- Implementing and maintaining risk management system requirements;
- Ensuring the relevant requirements for products and services have determined by the manufacturer;
- Ensuring that the interfaces of the manufacturer with its suppliers are effectively documented and controlled.
- Medical devices and manufacturing environment, including the types of medical devices, applicable risk-based classification, intended use, risks associated with medical devices, technologies used to manufacture medical devices, and other related aspects.
- Inspection or auditing standards and techniques, including the applicable international standards, respective fundamental concepts, key terms and definitions, risk assessment methods, as well as quality management tools.
- Statistical Analysis (basic concepts).
- Other aspects, including, inter alia, are the ones related to the quality control and safety evaluation.
The document also outlines the scope of requirements in the sphere of training the inspectors (auditors) should undertake. According to the guidance, the training should cover:
- Medical device basic GMP Inspection training (which is currently similar to Medicine basic GMP Inspection training);
- Medical device advanced GMP Inspection training.
Roles and Responsibilities
The document further describes in detail the roles and responsibilities of all the parties involved in audits and on-site inspections. As described by the authority, the auditors should:
- Meet any applicable requirements they are subject to be allowed to undertake the activities;
- Assist medical device manufacturers in interpreting the provisions of the applicable legislation;
- Ensure the high effectiveness of the inspecting activities undertaken;
- Collect evidence during the inspection to be able to analyze it;
- Protect the confidentiality of any information obtained in the context of an audit;
- Verify the way the corrective actions are undertaken to ensure their effectiveness;
- Follow the applicable safety-related requirements.
Apart from the above, the document describes separately the obligations of an auditor and lead auditor.
The scope of the guidance also covers the aspects related to the administration of the inspections and programs associated thereto. In particular, the document describes how additional experts could be involved, should it be reasonably necessary to assess the matter in question. For instance, it is stated that the number of manufacturing facilities assigned for a single inspection should not exceed five, and they should be located in no more than 3 countries. Furthermore, when planning an inspection, one should consider the maximum complexity to have sufficient time to complete the assessment.
The GMP certificate to be issued upon the results of an inspection conducted as described herein should remain valid for 5 years. At the same time, additional inspections could take place at any time. Moreover, an incompliance identified could be tolerated for a limited period, provided that the issue in question has been duly investigated by the respective laboratory.
According to the guidance, before commencing the inspection, a lead auditor should develop a site inspection plan addressing all the important aspects to be addressed in the course of an inspection. As further explained by the authority, such a plan should include:
- The audit scope and purpose;
- Identification of the manufacturer’s management team having significant direct responsibilities regarding the audit scope and purpose, if available;
- Identification of reference documents (such as the applicable quality system standard and, if available, the manufacturer’s quality manual);
- Identification of audit team members;
- The language of the audit;
- The date and place where the site visit is to be conducted;
- Identification, where possible, of the manufacturer’s relevant organizational units and, where appropriate, other auditees to be audited who are operating the critical phases of the subsystem;
- The expected time and duration for each major audit activity;
- The schedule of meetings, including any necessary daily briefings, to be held with the manufacturer’s management;
- The audit report distribution and the exited date of issue.
It is also stated that in case the inspection planned is important in the context of a regulatory decision-making process, such an inspection could have a higher priority.
The document also provides clarifications regarding the way the observations made during the inspection should be treated. For instance, it is stated that in case of fraud or misrepresentation, the authority may decide to reject the application. Each time identifying non-compliances, an auditor should assign the appropriate class based on the significance of such issues (e.g., major or minor deficiency). It is stated that the said classification would be further reviewed by the inspection quality assurance task force.
According to the guidance, critical deficiency is a deficiency that has produced or leads to a significant risk of producing either a product that is harmful to the human patient or a product that could result in a harmful residue. It is important to mention that the same classification should be applied in case of fraud or misrepresentation committed by the manufacturer. A major deficiency results in non-compliance with the applicable regulatory requirements. It could be a single deficiency or a group of several less critical deficiencies. All other deficiencies are the “minor” ones. Should the information be insufficient to classify the deficiency as “critical” or “major”, it should be treated as “other”. Under the applicable legislation, even one critical deficiency identified in the course of inspection results in a negative decision to be taken by the authority, meaning that the request to issue a GMP compliance certificate will be rejected.
In summary, the present guidance describes in detail the applicable qualifications and responsibilities of the auditors (inspectors). The document also provides additional clarifications regarding the approach to be applied when conducting an inspection, including the way the deficiencies should be classified.
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