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Drugs and Health Products

Good Manufacturing Practices - Request for Inspection of a Foreign Site Form (FRM-0213)

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Section 1: Requester Information

  • Company Name:
  • Establishment Licence and/or Drug Submission Control Number(s):
  • Contact:
  • Telephone:
  • Fax:
  • E-mail:

Section 2: Foreign Site Information

  • Company Name:
  • Street:
  • Suite:
  • Post Office Box:
  • City:
  • Province/State:
  • Country:
  • Postal Code:

Section 3: Product(s) Information

Product Name and DIN (Drug Identification Number):

Activity

  • F = Fabricate
  • P = Package/Label
  • T = Test

Category

  • 1 = Pharmaceutical
  • 2 = Vaccine
  • 3 = Blood & Blood Components
  • 4 = Biological
  • 5 = Radiopharmaceutical

Dosage Form Class

  • 1 = Parenteral
  • 2 = Tablet
  • 3 = Capsule
  • 4 = Solution
  • 5 = Suspension
  • 6 = Aerosol
  • 7 = Powder
  • 8 = Suppository
  • 9 = Medical Gas
  • 10 = Veterinary Premix
  • 11 = Bulk Intermediates
  • 12 = Other (Specify)

Sterile (Yes No)

Section 4: Reason for request

Section 5: Site Reference File
Site Reference File available?  (Yes No)

Section 6: Confirmation
Has as inspection been conducted, within the last three years, by a Qualified or Regulatory Authority, as defined in the document Guidance on Evidence to Demonstrate Drug Compliance for Foreign Sites, which covered the activity(ies) and dosage form(s) requested at the aforementioned foreign site?   (Yes No)
If so, by whom was it conducted?

  • Name of Authorized Signing Official
  • Title
  • Signature
  • Date