The new article covers the matters related to the preparation of the reports, GMP quality assurance, administrative measures, and complaint handling procedures.
Table of Contents
The Ethiopian Food and Drug Administration (EFDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the medical device manufacturer’s Good Manufacturing Practices (GMP) site inspection management. The document describes the aspects related to the way the on-site inspection should be conducted and highlights the key points to be considered in this respect. In particular, the guidance provides non-binding recommendations and clarifications regarding the applicable regulatory requirements set forth under existing legislation. At the same time, the authority reserves the right to make changes to the guidance and recommendations provided therein, should it be reasonably necessary to reflect the respective changes in the underlying legislation.
Inspection Report Writing
The scope of the guidance covers, inter alia, the aspects related to the report writing, reviewing, and approval process. Under the general rule, all observations and findings made in the course of an inspection should be duly documented daily upon completion of the daily inspections. The final report should be submitted within 15 calendar days from the date the inspection has been completed; and should contain all the details necessary for an independent assessment and making a regulatory decision. Once received by the authority, the report will be forwarded to the GMP quality assurance task force which will review the report and provide its response within 10 business days. The final report will be provided to the medical device manufacturer undergoing the inspection within 45 calendar days from the last day of the inspection.
GMP Quality Assurance
The document further describes the role of the GMP Quality Assurance task force to be formed by the Medicine Facility Inspection Directorate (MFID). According to the guidance, the said body is responsible for evaluating the final inspection report, as in case requested by the Directorate, and advising on a final decision for MFID before distributing it to the manufacturer. The scope of the aspects the GMP quality assurance task force may address include, inter alia, the ones related to the evaluation of inspectors or strategies for GMP inspection.
Administrative Measures
According to the applicable legislation, different administrative measures could be taken concerning both inspectors and medical device manufacturers in case of violations committed.
The measures that could be taken about inspectors are the following:
- Corrective Notification, which will be issued by the Directorate in case the violation is significant enough, and the inspector should take the appropriate steps to correct it. Such notification will be provided in writing.
- Warning Letter, which can be issued within 10 business days from the day when one of the following violations has been committed:
- The report hasn’t been submitted in time;
- The report writing procedure has not been followed;
- The roles and responsibilities are not followed;
- The requirements related to the conflict of interest and/or confidentiality are not followed.
- Rigorous Disciplinary Measures could be taken in response to a severe violation of the applicable legislation based on the decision to be taken by the Authority’s Disciplinary Committee.
The guidance further describes the administrative measures that could be taken concerning a medical device manufacturer. The main violations subject to special sanctions include, inter alia, the following ones:
Violation committed
Potential measures
An attempt to corrupt or deceive the inspectors
Rejection of inspection for at least five years
Providing false information as evidence of compliance
Rejection and blacklisting for three years
Deliberate absence during the inspection
Rejection of an inspection, which should be considered as completed
Showing or an attempt to show the facility, other than indicated in a file
Rejection
Complaint Handling Procedure
The guidance also provides clarifications regarding the way different types of complaints should be handled.
- Complaints related to the assignment of the inspector. An inspector may submit a complaint within 2 business days from the date he was appointed. Such a complaint should be submitted in writing to the Deputy Director-General. Should the inspector be not satisfied with the decision of the Deputy Director-General in the first instance, the complaint could further be submitted to the respective complaint handling committee of the authority.
- Complaints related to inspection findings and decisions. As set forth under the applicable legislation, any manufacturer may appeal against any decision of the Authority within 30 working days from the receipt of the inspection report from the Authority. Such a complaint should contain the details about the grounds for the decision taken by the authority, the objected decision itself, and also the reason why the manufacturer deems the decision to be unjustifiable or inappropriate. A complaint should be submitted in writing, and be accompanied by the relevant documentary evidence. Should the complaint submitted by the manufacturer meet the aforementioned criteria, it will be reviewed by the complaint handling committee within 60 days from the date of submission. The final decision should be communicated to the manufacturer within 5 days from the date the said review process has been completed. However, should the manufacturer still be unsatisfied with the decision taken, it is entitled to object to the decision in court.
Other Aspects
The scope of the guidance also covers other specific aspects related to the on-site inspections and the way they should be performed. The matters covered by the document include, inter alia, the following ones:
- Under the applicable record-keeping requirements, MFID is obliged to keep the records associated with the inspection at least until the new (next) inspection will be completed.
- A manufacturer who seeks the GMP compliance inspection by the Authority shall pay an appropriate service (GMP inspection service fee).
In summary, the present EFDA guidance highlights the most important aspects associated with the on-site inspections to be conducted. The document outlines the roles and responsibilities of all the parties involved, including medical device manufacturers and inspectors participating in the assessment, and also describes in detail the most important regulatory requirements to be considered.
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