Before a batch of veterinary medicine is prepared for export, product quality is one of the key areas partners focus on. Which parameters are tested? What standards are used to evaluate the results? What information does a test report provide about product quality?
To answer these questions, it is helpful to understand the work carried out in the testing laboratory. A test report presents analytical results and is also linked to the process of receiving samples, identifying standards, performing tests, reviewing data, and approving results.
At
Fivevet, the veterinary medicine testing process follows the procedures and standards that apply to each product. This article introduces seven main steps, from receiving a testing request to issuing a test report to support product quality assessment.
1. Receiving the Testing Request: Clearly Defining the Scope From the Start
The veterinary medicine testing process begins with receiving and reviewing the testing request.
At this stage, all relevant product information must be clearly identified, including the medicine’s name, dosage form, batch number, purpose of testing, and parameters to be tested.
For products intended for export, requirements from the partner or importing market also need to be reviewed to identify relevant testing requirements.
Clarifying requirements from the start helps define the scope of work and reduces the risk of missing information or needing to provide additional details during testing.
At Fivevet, we focus on checking product information against the testing request before moving on to the next steps. This provides a basis for organizing the work to suit each product and the purpose of testing.
2. Sampling and Sample Receipt: Ensuring Proper Sample Identification and Management
Test samples are used directly to assess quality, so they must be collected, packaged, transported, and stored according to procedures suited to the product’s characteristics.
When samples are received, the following information needs to be checked:
- Product name, dosage form, and batch number.
- Condition of the packaging, labels, and identification information.
- Quantity of samples available for testing.
- Storage conditions and sample condition.
After receipt, samples are identified and managed to ensure traceability throughout the testing process.
Managing sample information helps ensure that analytical results are linked to the correct test sample, batch number, and corresponding records.
For veterinary medicines being prepared for export in particular, sample identification information must be checked carefully against the product records and the agreed testing requirements.
3. Identifying In-House Standards and Testing Parameters
Before analysis begins, the quality standards and testing parameters that apply to the product must be identified.
In-house standards (TCCS) are one of the key references used to define quality requirements, test methods, and acceptance limits for products within their scope.
The list of testing parameters is not the same for every veterinary medicine. For example, powders and solutions may have different testing requirements because of differences in their formulations and dosage forms.
Test methods and acceptance limits must be selected based on the appropriate standards. A single set of testing parameters should not be applied to all products.
4. Preparing for and Performing Tests According to the Applicable Methods
Laboratory analysts prepare the samples, equipment, tools, reagents, reference standards, and other necessary conditions according to the test methods.
Each test has its own requirements for sample preparation, analytical conditions, operating sequence, and data recording. The equipment and methods selected must be suitable for the parameters being tested and the product’s standards.
At Fivevet, tests are performed within the defined scope, and information is recorded to support calculations and result reviews. Any unusual findings during analysis need to be reviewed and addressed according to the relevant procedures.
5. Recording, Calculating, and Reviewing Test Results
Once testing is complete, analytical data must be processed, calculated, and reviewed before conclusions are drawn.
This is an important step in veterinary medicine quality control.
Errors in data entry, calculations, or result processing can affect the reported values. Reviews must therefore be based on the relevant data and records, rather than the final figures alone.
Any unclear information or unusual findings must be clarified according to the applicable procedures before moving on to quality assessment.
The goal of this step is to ensure that results are calculated, recorded, and reported in accordance with the test methods used.
6. Comparing Results Against Quality Standards and Evaluating the Findings
The reviewed results are compared against the requirements and acceptance limits for each parameter to assess compliance.
If an out-of-specification (OOS) result occurs, it must be reviewed and investigated according to the applicable procedures to identify the cause and determine the appropriate action. Retesting must be justified; tests must not be repeated arbitrarily to obtain a passing result.
Conclusions must accurately reflect the results and the scope of testing. Passing results provide a basis for assessing quality against the parameters tested; other requirements relating to registration, labeling, and export documentation still need to be reviewed separately.
7. Reviewing, Approving, and Issuing the Test Report
The records are reviewed and approved by authorized personnel before the test report is issued. Depending on the template and specific requirements, the report may include:
International partners may request a Certificate of Analysis (CoA). The document’s content and format must be specifically agreed upon; it should not be assumed that every test report meets CoA requirements.
8. What Role Does a Veterinary Medicine Test Report Play in Export Activities?
In veterinary medicine exports, a test report gives the parties involved a specific basis for reviewing product quality information.
Through this document, partners can identify which batch the tested sample belongs to, which parameters were analyzed, which standards were applied, and what results were recorded.
The test report also helps partners cross-check information across the product, quality records, and their requirements.
However, it is important to understand that a test report only reflects results within the scope of the testing performed. It does not replace the full set of regulatory documents, registration records, or other documents required by the importing market.
For this reason, identifying the destination market’s quality and documentation requirements early is important when preparing an export order.
At Fivevet, we discuss requirements relating to standards, testing scope, and the quality information to be provided with our partners to support the preparation of product documentation.
9. Fivevet – Focusing on Quality Control When Preparing Products for Export
From receiving requests, managing samples, identifying standards, and performing tests to reviewing results and issuing test reports, each step contributes to the assessment of product quality.
The veterinary medicine testing process at Fivevet aims to determine whether results pass or fail while also focusing on consistency among test samples, the methods used, analytical data, and testing records.
For products intended for export, clarifying quality standards and documentation requirements early helps Fivevet and its partners agree on the work that needs to be carried out.
Partners who would like to learn more about quality documentation, product standards, or the scope of veterinary medicine testing for export can contact Fivevet to discuss information relevant to each product and market.
To learn more about the product range and international distribution opportunities, please contact Fivevet's export team by email at export@fivevet.vn or by phone at +84 96 333 7900.
Frequently Asked Questions
1. Are All Veterinary Medicines Tested Using the Same Process?
The steps involved in managing and performing tests may follow common principles. However, quality parameters, test methods, and acceptance limits depend on each product, its dosage form, and the applicable standards.
Therefore, the same list of testing parameters cannot be used for all veterinary medicines.
2. Which Parameters Are Commonly Tested in Veterinary Medicines?
Depending on the product’s characteristics, testing parameters may include appearance and physical characteristics, identification, active ingredient content, physicochemical parameters, and microbiological requirements.
The specific list must be determined according to the quality standards that apply to each product.
3. How Long Does Veterinary Medicine Testing Take?
Testing time depends on the number and nature of the parameters, the test methods, the conditions under which testing is performed, and the process for reviewing and approving results.
The completion timeline must therefore be determined for each specific testing request.
4. Are a Test Report and a Certificate of Analysis (CoA) the Same?
Both can be used to provide information about product quality analysis results. However, their content, format, scope of certification, and acceptance requirements may differ depending on the documentation system and the partner’s requirements.
When preparing export documentation, the required document type must be clarified so that the appropriate document can be provided.
5. Does Passing the Tests Mean a Product Is Eligible for Export?
No. Passing test results demonstrate compliance with the parameters evaluated under the applicable standards.
The export and import of veterinary medicines also depend on each market’s legal requirements, product registration, labeling, and related documentation.
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