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Pharmaceutical Manufacturer GMP Inspection (Directive No. 338/2020)

Ethiopian Food and Drug Authority338/2020

Summary

This directive establishes a legal framework for conducting Good Manufacturing Practice (GMP) inspections of pharmaceutical manufacturers, both local and foreign. It outlines objectives, principles, types of inspections, roles and responsibilities of inspectors, procedures for application, inspection conduct, reporting, and administrative measures for non-compliance. The directive aims to ensure pharmaceutical products are consistently produced and controlled according to quality standards, utilizing qualified personnel and maintaining consistency and uniformity in inspection and enforcement activities.

Who's affected

Local and foreign pharmaceutical manufacturing plants, pharmaceutical quality assurance professionals, and regulatory inspectors.

Action required

Pharmaceutical manufacturers must adhere to the GMP inspection procedures, maintain quality standards, and be prepared for routine, follow-up, or sudden inspections. Manufacturers should familiarize themselves with the requirements for application, inspection conduct, reporting, and potential penalties for non-compliance.

Key points

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  • The directive establishes a formal framework for GMP inspections of pharmaceutical manufacturers.
  • It defines different types of inspections: Routine, Follow-up, and Sudden.
  • It specifies the qualifications, roles, and responsibilities of GMP inspectors and Lead Inspectors.
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    • Procedures for application, inspection conduct, report writing, and quality assurance are detailed.
    • Administrative measures and penalties for both inspectors and manufacturers in case of non-compliance are outlined.
    • Complaint handling procedures for various issues are established.

Requirements

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  • Pharmaceutical manufacturing sites must be licensed and have continuous production for at least three years in their country of origin.
  • Manufacturers must comply with current Good Manufacturing Practice.
  • All finished pharmaceutical facilities shall be subjected to site GMP Inspection once every five years, unless otherwise notified.
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    • Site GMP Inspection shall be carried out after Dossier Evaluation is completed.
    • Facilities in countries with stringent Regulatory Authorities and WHO prequalified products may be subject to document review, with onsite inspection as a possibility.
    • GMP inspection shall be carried out using Ethiopian National GMP Guideline and/or WHO GMP Guideline.
    • A 3-member inspection team shall be assigned in response to inspection applications.
    • All production lines must be running a major processing activity during inspection.
    • Two days or more shall be allocated for inspection, depending on available lines.
    • Local licensed agents or local manufacturing facilities must submit a written application for inspection.
    • All correspondence and documents must be in English or accompanied by a certified translation.
    • Inspectors must maintain high ethical standards, avoid conflicts of interest, and conduct inspections impartially.
    • Manufacturers must submit corrective and preventive measures within 15 working days for minor and major non-compliance findings.
    • Inspection reports must be written daily, compiled within 14 calendar days, and sent to the inspected facility within 30 calendar days.

Rights and permissions

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  • Manufacturers have the right to appeal against decisions of the Authority within 30 days of receiving an official letter.
  • Potential candidates have the right to appeal against the assignment of inspectors.
  • Inspectors have the right to be nominated and assigned based on qualifications and experience.
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    • Manufacturers have the right to be informed of inspection findings and decisions.

Restrictions

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  • GMP inspections for Active Pharmaceutical Ingredients manufacturing plants are not covered by this directive.
  • Manufacturers must have at least three years of continuous production and marketing history in their country of origin to be considered.
  • Inspectors must avoid any conflict of interest, including association with questionable enterprises or using their position for personal gain.
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    • Inspectors shall not receive presents in any form.
    • Manufacturers may be suspended for one or two years for non-compliance, attempting to corrupt inspectors, failing to facilitate inspection, or showing a false facility.
    • Inspectors committing minor offenses may be subjected to educational measures or warnings, with disciplinary measures for repeated offenses.
    • Manufacturers with critical or multiple major findings may be refused registration.

Penalties

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  • Manufacturers failing to comply with requirements for two consecutive inspections may be suspended for two years.
  • Manufacturers attempting to corrupt or deceive inspectors may be suspended for two years.
  • Manufacturers failing to arrange, prepare, or facilitate the inspection process, or being absent during inspection, may be suspended for one year.
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    • Manufacturers showing a facility other than the one reviewed on the site master file may be suspended for two years.
    • Inspectors committing major offenses related to corruption may face criticism, admonishment, suspension from promotion or reward, suspension from future nomination, or formal proceedings.
    • Manufacturers with a single critical finding or five or more major findings in critical areas may be refused registration.

Objectives

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  • To set a legal framework for GMP inspections by the Authority and overcome existing problems.
  • To provide direction on application processing, logistical issues, and complaint handling for inspections.
  • To provide direction on inspector assignment, report writing, classification of findings, and recommendations, ensuring transparency and accountability.
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    • To ensure compliance with Good Manufacturing Practice for pharmaceutical products, which is a prerequisite for marketing authorization.
    • To ensure products are consistently produced and controlled according to quality standards.

Organizations

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  • Ethiopian Food, Medicine and Healthcare Administration and Control Authority (EFMHACA)
  • World Health Organization (WHO)
  • PIC’s
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    • EMA

Legal references

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  • Article 55 (3) of the Food, Medicine and Healthcare Administration and Control Proclamation No.661/2009
  • Article 98 of the Food, Medicine and Healthcare Administration and Control Regulation no 299/ 2013
  • Regulation No.370/2015
Original sourcehttps://justice.gov.et/en/directives/pharmaceutical-manufacturer-gmp-inspection-directive-no-338-2020/
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