SUBMISSION OF CONTAGIOUS BOVINE PLEUROPNEUMONIA FOR INTERNATIONAL QUALITY CONTROL
To: PAN AFRICAN VETERINARY VACCINE CENTRE (PANVAC)
c/o FAO, P.O.Box 5536, Addis Ababa, Ethiopia
Telephone: (251-1) 338001
Facsimile: (251-1) 338844
Telex: 21216 FAOAA ET
| Producer Laboratory: | |
| (Name and Address) | |
| Batch Number: | Number of Vials Produced: |
| No. of Doses per Vial: | |
| Filling Volume per Vial: | |
| Date of Manufacture (Freeze Drying): | |
| Stabilizer Used: | |
| Expiry Date: | |
| Number of Vials Submitted: | |
| (minimum 10, preferably 15, required) | |
| Medium for Working Seed preparation: | Medium for inoculum: |
| Medium for final vaccine preparation: | |
| Passage level in the final vaccine preparation: | |
| Seed Strain: | Cattle Challenge Strain: |
| Designation: | Designation: |
| Source: | Source: |
| Passage Level: | Passage Level: |
| Streptomycin Resistance: Yes/No |
IN-HOUSE QC RESULTS:
| Vacuum: | PASS/FAIL/NOT DONE | |
| Moisture (%): | ||
| Sterility: | ||
| Aerobic Medium used: | PASS/FAIL/NOT DONE | |
| Anaerobic Medium used: | PASS/FAIL/NOT DONE | |
| Fungus Medium used: | PASS/FAIL/NOT DONE | |
| Titre per Dose (CCU50): | ||
| Medium used for titration: | ||
| Method used (Micro/Tube): | ||
| Innocuity: | - Mice | PASS/FAIL/NOT DONE |
| - Guinea pigs | PASS/FAIL/NOT DONE | |
| Identity Test: | ||
| Agar gel immuno-diffusion | PASS/FAIL/NOT DONE | |
| Growth Inhibition | PASS/FAIL/NOT DONE | |
| Colony morphology | PASS/FAIL/NOT DONE | |
| Digitonin sensitivity | PASS/FAIL/NOT DONE | |
| Streptomycin Resistance | YES/NO/NOT DONE | |
| Other (specify) | ||
| Safety in Cattle: | PASS/FAIL/NOT DONE | |
| Number of Field Doses used: | ||
| Potency in Cattle: | ||
| Challenge | PASS/FAIL/NOT DONE | |
| Antibody (titre) | PASS/FAIL/NOT DONE | |
| Pathology | PASS/FAIL/NOT DONE | |
| Culture | PASS/FAIL/NOT DONE | |
Name and Qualification of Officer Responsible for Quality Control:
| Signature of Head of QC: | Date: / / |
SUBMISSION OF COMBINED CBPP AND RINDERPEST VACCINE FOR INTERNATIONAL QUALITY CONTROL
TO: PAN AFRICAN VETERINARY VACCINE CENTRE (PANVAC)
c/o FAO, P.O.Box 5536, Addis Ababa, Ethiopia
Telephone: (251-1) 338001
Facsimile: (251-1) 338844
Telex: 21216 FAOAA ET
Producer Laboratory: (Name and Address)
| A. Production Data | Rinderpest | CBPP | ||
|---|---|---|---|---|
| 1 | Batch No. | |||
| 2 | Number of vials produced | |||
| 3 | Number of doses per vial | |||
| 4 | Filling volume per vial | |||
| 5 | Stabilizer used | |||
| 6 | Manufacturing date (Freeze-drying) | |||
| 7 | Expiry date | |||
| 8 | Number of vials submitted (Minimum 20 required) | |||
| 9 | Cell substrates used | N/A | ||
| 9.1 For seed-virus preparation | ||||
| Type | ||||
| Passage level | ||||
| 9.2 For vaccine production | ||||
| Type | ||||
| Passage level | ||||
| 10 | Medium for inoculum preparation | N/A | ||
| 11 | Medium for vaccine production | N/A | ||
| 12 | Vaccine seed strain | |||
| 12.1 Designation | ||||
| 12.2 Source | ||||
| 12.3 Passage level | ||||
| 12.4 Passage level in final vaccine | ||||
| B. In-house QC Results | Rinderpest | CBPP | ||
|---|---|---|---|---|
| 1 | Titre per Vial | TCID50: | CCU50: | |
| Titre per field dose | TCID50: | CCU50: | ||
| 1.1 Titration method used: | ||||
| a) Micro | ||||
| b) Tube | ||||
| 1.2 Cell Substrate/Medium used: | ||||
| 2 | Identity test | PASS/FAIL/ND | PASS/FAIL/ND | |
| 2.1 Method used: | ||||
| 3 | BVD test | |||
| 3.1 Cell substrate | PASS/FAIL/ND | |||
| 3.2 Serum | PASS/FAIL/ND | N/A | ||
| 3.3 Vaccine | PASS/FAIL/ND | |||
| 3.4 Test method (reference) | ||||
| 4 | Adventitious viruses | PASS/FAIL/ND | ||
| 4.1 Cell substrate used in QC | ||||
| 4.2 Test method (Reference) | ||||
| 5 | Safety test in cattle | PASS/FAIL/ND | PASS/FAIL/ND | |
| 5.1 Number of field doses used | ||||
| 6 | Potency test in cattle | |||
| 6.1 Challenge test | PASS/FAIL/ND | PASS/FAIL/ND | ||
| 6.2 Antibody titre | PASS/FAIL/ND | PASS/FAIL/ND | ||
| 6.3 Challenge strain | ||||
| Designation | ||||
| Source | ||||
| Passage level | ||||
| 7 | Vacuum test | PASS/FAIL/ND | PASS/FAIL/ND | |
| 8 | Moisture content(%) | |||
| 9 | Sterility test | |||
| 9.1 Aerobic-medium used: | PASS/FAIL/ND | PASS/FAIL/ND | ||
| 9.2 Anaerobic-medium used: | PASS/FAIL/ND | PASS/FAIL/ND | ||
| 9.3 Fungus-medium used: | PASS/FAIL/ND | PASS/FAIL/ND | ||
| 10 | Innocuity test | |||
| 10.1 Mice | PASS/FAIL/ND | PASS/FAIL/ND | ||
| 10.2 Guinean pigs | PASS/FAIL/ND | PASS/FAIL/ND | ||
| Note: | N/A = Not applicable | CCU50 = Colour Changing Units50 |
| N/D = Not done | TCID50= Tissue Culture Infectious Units50 |
Name and Qualification of Officer Responsible for Quality Control:
| Signature of Head of QC: | Date: / / |
