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Medicine Good Manufacturing Practice (GMP) Inspection Procedure (Directive No. 830/2021)

Ethiopian Food and Drug Authority830/2021

Summary

This directive outlines the procedures for conducting Good Manufacturing Practice (GMP) inspections for pharmaceutical manufacturing plants, both local and foreign. It details the types of inspections, inspector qualifications, application procedures, and administrative measures for compliance and handling complaints.

Who's affected

Local and foreign finished pharmaceutical manufacturing plants.

Action required

Manufacturers must comply with the GMP inspection procedures outlined in the directive, including submitting applications and facilitating inspections.

Key points

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  • Establishes GMP inspection procedures for local and foreign pharmaceutical manufacturers.
  • Defines types of inspections: routine, concise, follow-up, special, SRA approved company, and remote.
  • Outlines qualifications, roles, and responsibilities of GMP inspectors and lead inspectors.
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    • Details application procedures and program administration.
    • Specifies classification of observations (critical, major, minor) and consequences of non-compliance.
    • Addresses administrative measures, compliant handling, confidentiality, and record keeping.
    • Repeals the previous Pharmaceutical Manufacturer GMP Inspection Directive.

Requirements

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  • Pharmaceutical manufacturing sites must be licensed by the country of origin and have a history of production.
  • Manufacturers must comply with current good manufacturing practice.
  • Finished pharmaceutical manufacturing facilities shall be inspected once every five years for re-registration.
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    • Site GMP inspection shall be carried out after dossier evaluation is completed, unless otherwise specified.
    • Manufacturers approved by Stringent Regulatory Authorities (SRAs) and WHO prequalified products may have inspections based on document review, with potential for onsite inspection.
    • Inspectors must possess a bachelor's degree in pharmacy or equivalent, undergo advanced GMP training and examinations, and complete continuing professional development.
    • Applicants must submit written applications in English, with certified translations if not in English.
    • Manufacturers must correct identified violations within a reasonable timeframe.
    • Manufacturers must declare and sign conflict of interest and confidentiality agreements.
    • Manufacturers must pay applicable service fees.

Rights and permissions

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  • The Authority may conduct inspections before dossier evaluation completion.
  • The Authority may provide a temporary GMP certificate during pandemics or challenging conditions.
  • The Authority may conduct confirmatory onsite inspections on randomly selected SRA approved facilities.
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    • The Authority may conduct remote inspections when necessary.
    • Manufacturers may appeal against any decision of the Authority within 30 working days.
    • Manufacturers may apply for re-inspection if not granted GMP compliance certificate.
    • Manufacturers may appeal to court if not satisfied with the final decision of the Director General.

Restrictions

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  • GMP inspections do not cover active pharmaceutical ingredients manufacturing plants.
  • Inspectors shall not use their position for personal gain or receive presents.
  • Inspectors shall maintain independence from outside influence.
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    • Manufacturers attempting to corrupt or deceive inspectors may be rejected for at least five years.
    • Manufacturers providing false information will be rejected and blacklisted for three years.
    • Manufacturers deliberately absent during inspection will be considered inspected and rejected.
    • Manufacturers showing a facility other than the one on the site master file will be rejected.
    • Customary practices inconsistent with this directive are inapplicable.

Penalties

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  • Rejection of inspection for at least five years for corrupting or deceiving inspectors.
  • Rejection and blacklisting for three years for providing false information.
  • Rejection for deliberate absence during inspection.
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    • Rejection for showing an incorrect manufacturing facility.
    • Rigorous disciplinary measures for inspectors violating the law, governed by Federal Civil Servants Proclamation No.1064/2017 and Federal Government Regulation No. 77/94.
    • Warning letters issued to inspectors for procedural or ethical violations.

Objectives

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  • To ensure compliance with current Good Manufacturing Practice (GMP) of pharmaceutical products.
  • To ensure products are consistently produced and controlled according to quality standards.
  • To utilize qualified expertise for GMP inspection programs.
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    • To achieve effective and efficient inspection coverage through consistency and uniformity.
    • To provide specific direction on accepting and processing applications, addressing logistical issues, and handling complaints related to inspections.

Organizations

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  • Ethiopian Food and Drug Authority (EFDA)
  • Medicine Facility Inspection Directorate (MFID)
  • Stringent Regulatory Authorities (SRAs)
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    • World Health Organization (WHO)
    • IGAD

Legal references

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  • Article 71 (2) of the Food and Medicine Administration Proclamation No.1112/2019
  • Article 2 sub-article (54) of the Food and Medicine Administration Proclamation No. 1112/2019
  • Article 2 of the Proclamation
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    • Federal Civil Servants Proclamation No.1064/2017
    • Federal Government Regulation No. 77/94
Original sourcehttps://justice.gov.et/en/directives/medicine-good-manufacturing-practice-gmp-inspection-procedure-directive-no-830-2021/
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