Vaccine Testing Standards in Iraq

Dr. Majid Hamid Al-Sayegh / Australia

12/ 7/ 2025

Laboratory Steps for Testing and Approving Imported Veterinary Vaccine Batches According to International Standards

Upon receiving an imported veterinary vaccine batch, the competent national laboratory must follow a series of technical procedures in accordance with the recommendations of organizations such as the World Health Organization (WHO), the International Association of Veterinary Inspectors (IHE), the American Medical Association (AMA), the FDA, and Health Canada to ensure the safety and effectiveness of the vaccine before authorizing its use. The approved steps are as follows:

1. Verify and record the batch receipt.
2. Examine accompanying documents, such as the certificate of origin, GMP certificate, and analysis results issued by the manufacturer.
3. Record vaccine information (trade name, batch number, expiration date, transportation conditions, and shipping temperature).
4. Visual and physical inspection of the product.
5. Ensure the integrity of the packaging, free of impurities or physical changes such as sedimentation or discoloration.
6. Verify the dose size, number of vials, and the diluent included, if any.
7. Antigen Identity Test
8. Use PCR or RT-PCR to match the genetic material of the vaccine strain to the strain approved in the technical file.
9. Confirm the compatibility of the vaccine with locally circulating field isolates through antigenic matching according to the WOAH Manual, by calculating the r value (a standard >0.3 is acceptable).
10. Bacteriological and viral tests for sterility
11. Cultivate the sample in standard nutrient media such as Thioglycolate and Sabouraud to detect bacterial and fungal contamination (according to USP <71>).
12. Detect mycoplasma using PCR or culture in a specialized medium (WOAH Manual, 2024).
13. Test for viral contamination using multiple cell lines and monitoring the cytopathic effect (CPE).
14. Potency Test: Determine the antigen concentration in inactivated vaccines using ELISA or Single Radial Immunodiffusion (SRD).
15. For live vaccines, the viral titer (TCID₅₀ or PFU/ml) is calculated.
16. Results must meet the minimum limits specified in an approved veterinary pharmacopoeia (e.g., Ph. Eur. or USDA CFR Title 9).
17. Safety Test: Inject a double dose into a number of animals (target species or mouse/rabbit) and monitor for at least 14 days for any adverse effects.
18. Storage Stability Test: An accelerated stability test can be performed to detect the impact of temperature changes on product quality during shipping.
19. 19. Review the technical file. The file must include field safety and efficacy studies, immunization and challenge tests, product stability data, post-marketing surveillance results (Pharmacovigilance), and potential environmental risks (Environmental Risk Assessment).
20. Prepare the final report and submit it to the competent authority. A detailed technical report is prepared, including all test results, for the regulatory body to issue its final decision, either to release or reject the batch.

References 2025:

• WOAH Terrestrial Manual (2024–2025 Edition)
• EMA: Guideline on Data Requirements for Vaccine Products (EMA/CVMP/IWP/206555/2022)
• FDA Guidance for Industry: Veterinary Vaccine Product Testing (CVM GFI #254, 2025)
• Health Canada: Veterinary Biologics Guidelines (2025 Edition)
• USDA 9 CFR Subchapter E – Virus-Serum-Toxin Act Regulations