Quality Control Measures in Poultry Medicine Third-Party Manufacturing
The poultry farming segment is one of the most intense in the global market, and ensuring the well-being of the birds is equally essential. Contract third-party manufacturing in poultry medicine allows a pharmaceutical firm to outsource production while retaining strict quality requirements. However, safety, efficacy, and compliance requirements in poultry medicines involve strong quality controls.
In this blog, we will analyze QC requirements in poultry medicine third party manufacturing to guarantee that the products are compliant with the regulations and industry standards.
Why Quality Control is Important in Poultry Medicine Manufacturing
Quality control in poultry medicines manufacturing is necessary for numerous reasons:
- Ensures Safety & Efficacy – Administration of low-quality medicines will cause harm to birds and also increase the risk of antibiotic resistance.
- Compliance with Regulations – The market approval depends on compliance with the Good Manufacturing Practices and veterinary medicines guidelines.
- Maintains Consistency – With the application of the standardised QC, uniform, reliable medicines are produced in every batch.
- Prevention of Contamination – The appropriate measures of QC remove the possibility of microbial contamination, heavy metals, and toxins.
- Builds Brand Reputation – Offering high-quality products fosters trust among farmers and veterinarians.
Key Quality Control Measures in Poultry Medicine Third-Party Manufacturing
Testing of Raw Materials
Quality control begins with raw material selection, verification, and testing, and manufacturers should confirm that all ingredients, including active pharmaceutical ingredients, excipients, and additives, are of acceptable quality. This includes:
- Evaluating the degree of impurity, potency, and stability.
- Conducting microbiological tests for pathogenic bacteria.
- Compliance with relevant quality standards.
Compliance with Good Manufacturing Practices
Compliance with robust guidelines related to manufacturing ensures that product quality and safety remain the same. Other manufactured products must comply with:
- Set guidelines for manufacturing and quality control.
- Quality documents for verification and validation.
- Hygiene, health, safety, and manufacturing training for employees.
Quality Control during Production
Manufacturing involves active quality control processes. Some of the crucial in-process quality control activities include:
- Control of environmental parameters such as temperature, humidity, and pressure.
- Assessment of mixing, granulation, and coating for uniformity.
- Determination of weight, pH, and dissolution rate at various levels of production.
Control of Sterility and Contamination
In the prevention of contamination in poultry medicines, manufacturers do:
- Routine cleaning and disinfecting of the production area.
- Air filtration and purification systems are used to maintain a clean environment.
- Microbiological examination of samples from the cell culture for sterility testing.
Finished Product Testing
Custom testing for every batch before the medicine hits the market includes:
- Potency testing to ensure the active ingredient meets all given specifications.
- Dissolution and stability testing assess the performance of the product in question over time and in differing conditions.
- Analysis of heavy metals and toxins to screen for any harmful contaminants.
Standards of Packaging and Labelling
Considered ‘proper’ would be packaging that ensures both the stability of the medicine and prevents any degradation. Quality control is maintained by:
- Moisture-proof and light-resistant labeling material.
- Correct labeling for batch numbers, expiry dates, and dosage instructions.
- Liquid formulations undergo leak testing.
Studies of ‘Stability’
Testing the shelf life and stability of poultry medicine under varying conditions falls under ‘stability testing.’ This includes:
- Testing different products over an extended period with varying temperatures and humidity to assess the stability of all add-ons.
- Assessing product degradation over time during long-term stability testing.
- Medicine stability during packaging compatibility studies.
Compliance Regulation Along with Documentation
National and international regulations on veterinary medicines from other parties require concrete cross-examination proof and must include:
- Adherence to Good laboratory practice ensures that there is quality consistency.
- Document certifications from aiding bodies within the industry.
- The batch and any test reports alongside the audit documentation.
Conclusion
To partner with a manufacturer who follows proper Quality Control Measures in Poultry Medicine Third-Party, reach out to Nualter Herbovet. We have established manufacturing facilities equipped with ISO, GMP, and WHO GMP compliance certifications.