Certificate of Good Manufacturing Practices for Household Health Supplies (CPPKRTB)

UMKU Details

Parameter:

All

Authority:

Minister/Head of Agency

Requirements:

  1. PKRT Production Certificate (for High-Risk)

    2. Duration: -

  2. Electronic PKRT production reports

    3. Duration: -

  3. Medical Device Marketing Authorization data

    4. Duration: -

  4. Quality guidelines

    5. Duration: -

  5. Conducted internal audits

    6. Duration: -

  6. Conducted management reviews

    7. Duration: -

  7. Master Document List for CPPKRTB quality management system implementation

    8. Duration: -

  8. Quality procedures and records

    9. Duration: -

  9. Certificate issuance based on comprehensive production facility audits.

    10. Duration: -

Responsibilities:

Sector: Health
Status: Available
Belongs to:
17091
20212
20231
22194
23121

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