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

Section 1: Requester Information

• Company Name:
• Drug Establishment Licence Number:
• Contact Person:
• Title:
• Telephone No:
• Fax No:
• E-mail address:

Section 2: Foreign Building Information

• Foreign Building Name:
• Street:
• Suite No:
• Post Office Box:
• City:
• Province/State:
• Country:
• Postal/Zip Code:

Section 3: Drug Information

Product Name and/or DIN:

Activity

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

1. Biological
2. Chemistry
3. In-process
4. Microbiological – Sterility
5. Microbiological
6. Physicochemical
7. Stability
8. Other (specify

Category

1. = Pharmaceutical
2. = Active Pharmaceutical Ingredient
3. = Vaccine
4. = Blood & Blood Components
5. = Biological
6. = Radiopharmaceutical

Class Dosage Form

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

Active Pharmaceutical Ingredient (API)

13. = Solid 
14. = Liquid 
15. = Gas

Sterile (Yes No)

If you indicated non-sterile API, is the API being used to manufacture a sterile or non-sterile Drug in Dosage Form? ( Yes No)

Section 4: Status of Foreign Building

1. Is the building listed on your DEL or Table A? (Yes No)
2. Are you adding the building in support of a Drug Submission? (Yes No)
   1. If yes, when are you planning to submit the drug application?   
3. Have you contacted the foreign building to notify them of the request you have submitted for an on-site assessment by Health Canada? (Yes No)
   1. If yes, have they proposed dates? (Yes No)
   2. If yes again, what are the proposed dates?
4. Has the building fabricated, packaged/labelled or tested drugs destined for the Canadian market in the past 4 years? (Yes No)
   1. If yes, since when?
   2. If no, when do they expect to start activities for drugs destined for the Canadian market?
5. To the best of your knowledge, is there a planned inspection by a Qualified^{Footnote 1} Regulatory^{Footnote 2} Authority at this time? (Yes No)
   1. If yes, by whom and when? 
6. To the best of your knowledge, has there been a recent inspection by a Qualified^{Footnote 1} Regulatory Authority^{Footnote 2}? (Yes No)
   1. If yes, by whom and when?

Section 5: Rationale for Request

Section 6: Available Documentation

Is a Site Master/Reference file available? (Yes No)

* Do not submit the SMF/SRF with this request. It is to be provided upon request

Section 7: Authorization

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