Microsoft Word - GLP Inspection Checklist.doc



GMP (Good Manufacturing Practices) Qualification

Utilize the list below in qualifying each vendor. A Vendor is a person, organization, company, or institution providing product or services to support clinical trial activities. Note: A vendor that was previously qualified to provide an investigational product for one study may not be qualified to provide an investigational product for another, depending on the type of investigational product required, the duration of the study, etc. Therefore, it may be necessary to requalify a vendor.

For Questions related to GMP vendor qualification activities, contact the Office of Clinical Research (OCR) at OCR@exchange.upenn.edu or 215-746-8334.

|Investigational Product or Service |[Include details such as quantity and form for product] |

|provided | |

|Protocol(s) qualified for |[include version] |

|Follow this list for each Investigational Product. |Comments/Remarks |

|Please evaluate all “no” responses & contact the OCR. | |

|What vendor is providing the Investigational product(s)? |Name of Vendor: |

|[Obtain and review credentials of Vendor Director or Leader. Record | |

|information in Comments/Remarks column.] | |

|Does the vendor have a Quality System (Q 10) system? | |

|This system assures overall compliance with GMPs and internal procedures. The | |

|system includes the quality control unit and all of its review and approval | |

|duties. | |

|If yes: Who is the Quality Leader? |Name and Contact Information of Quality Leader: |

|[Obtain & Review credentials. Include information in Comments/Remarks column.]| |

|Note: The Quality leader is an individual who has primary responsibility for | |

|ensuring GMP compliance. | |

|If no quality system: Are there appropriate quality assurance SOPs | |

|established? | |

|Has the FDA and/or another major Health Authority (FDA counterparts in other | |

|countries) inspected the manufacturing facility in the last 2 years? | |

|If yes, did any of the inspections (in the last 2 years) result in a FDA 483 | |

|or other Agency observation/violation? | |

|[If yes, obtain and review.] | |

|Is the vendor capable of supplying the investigational product for the | |

|duration of the trial? | |

Device/Device Combinations Studies, if your protocol references ISO 14155:2011 (device international standard), please review additional GMP requirements. The OCR is available to assist your team.

|Signature |Name |Title |Date |

| | |[vendor] | |

| | |[sponsor] | |

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