The article provides a brief overview of the Ethiopian guidelines for medical device manufacturers’ Good Manufacturing Practices site inspection management.
The Ethiopian Food and Drug Administration (EFDA), a 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 is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered to achieve and sustain compliance thereto. At the same time, provisions of the guidance are non-binding and are not intended to introduce new rules or impose new requirements.
The authority acknowledges the importance of ensuring the safety and effectiveness of medical devices allowed for marketing and use in the country. For this purpose, five conformity assessment elements have been implemented. One of them is the Quality Management System (QMS) which is duly developed and implemented by the medical device manufacturer. According to the guidance, medical device manufacturers are obliged to register their products with the authority, and also comply with the GMP. The scope of the document describes the approach to be applied concerning on-site inspections the authority may undertake both during the initial premarket review and in the course of on-market conformity assessment. The guidance also describes the way the proper experts should be chosen depending on the scope of the assessment and competencies needed. In particular, this guideline is prepared to specify the required minimum competencies of the inspectors and requirements for ethical integrity, complaint handling, and the quality assurance mechanism of the inspection of the medical device manufacturer’s GMP. The document also describes the matters related to the responsibilities of the inspectors and lead inspectors in terms of conducting an inspection and preparing reports.
First of all, the document provides the definitions of the most important terms and concepts used in the context of the guidance including, inter alia, the following ones:
- Quality Management System – a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, packaging, labeling, storage, distribution, recall procedures, Good Practices in Quality Control Laboratory, and servicing. The main purpose of QMS is to ensure the products manufactured are compliant with the applicable regulatory requirements in terms of quality, safety, and effectiveness by ensuring the compliance of the manufacturing processes and procedures.
- Inspection or audit – a systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.
- Non-conformity stands for the non-fulfillment of specified requirements within the planned arrangements. The authority also mentions that the term is interchangeable with “non-compliance” and “deficiency”.
Apart from the ones listed hereinabove, the document also provides the definitions of such terms as “inspector or auditor” and “lead inspector/auditor” referring to the qualified persons entitled to perform audits and on-site inspections on behalf of the authority.
The scope of the guidance covers any medical devices registered with the EFDA to be allowed for marketing and use in the country. It is stated that it applies to medical device manufacturers based in Ethiopia or abroad.
The document is intended to provide additional clarifications regarding the procedures associated with on-site inspections. According to the guidance, its main objectives are to:
- Set requirements for inspectors and lead inspector’s code of conduct;
- Set requirements (including pre-requisite education, experience, training, and technical competence) for selecting relevant experts to conduct medical device manufacturer GMP inspection;
- List the responsibilities of GMP inspectors and lead inspectors while conducting the regulatory inspection;
- Describe how the medical device GMP inspection programs are managed;
- Put up administrative measures and complaint handling procedures.
Requirements for Auditors and Lead Auditors
The document further describes the requirements to be applied for auditors and lead auditors entitled to conduct on-site inspections. According to the guidance, the selection of an auditor should be based mostly on the product regulation sector. The authority explicitly states that the experts dealing with medicines should not be engaged in the respective activities related to medical devices.
As it is mentioned by the EFDA, it is important to take all the measures to prevent the conflict of interest and biased approach to ensure the reliability of the inspection results and findings. Such measures are to be developed and implemented by the authority. As one of the parts of the said process, the EFDA intends to keep signed statements of adherence to a code of conduct covering the following commitments:
- To act professionally and ethically at all times;
- To faithfully represent the interests of the authority;
- The selected inspector shall declare and sign the conflict of interest and confidentiality agreement before participating in the GMP inspection and shall follow respective MIFD SOPs and directives;
- The inspector shall properly maintain confidential information of the manufacturer unless it is disclosed by the manufacturer;
- The inspector shall properly maintain confidential information unless it is required by the judiciary body.
- To disclose any relationship, or financial interest, past or present, that may create a conflict of interest or the appearance of a conflict of interest, and to notify the authority of any new conflicts of interest or potential conflicts of interest as soon as the case may arise.
- To record and report truthfully and accurately inspection/audit evidence in an impartial and unbiased way.
The document also outlines the requirements the auditors should meet in terms of education. In particular, it is stated that at least a Bachelor’s degree is required in one of the spheres related to healthcare (e.g., Microbiology or Bioengineering). Based on this information, the scope of activities the auditor is eligible for will be determined.
Apart from that, there are requirements related to the experience of working in the sphere of regulatory compliance by being a part of a medical device manufacturing entity or regulating authority. The authority also mentions that the dedicated audit team should have at least one person with a technical background understanding the manufacturing and operational aspects related to medical devices.
In summary, the present EFDA guidance describes the approach to be applied concerning on-site inspections and the way they should be undertaken to ensure the accuracy and reliability of the results. The document outlines the requirements the auditors should meet to be allowed to conduct the inspections being a part of an audit team.
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