Sunday, April 22, 2018

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SECTION 5: Technical information about the product quality.

5.1. Production process: The production process must be described fully, exactly and the factor that can pollute the product must be clearly indicated.

5.2. Criteria on the quality and testing method:
The standard quality of the components, active ingredients and the exipient  (adjuvant) of the product must be suitable with the technical information promulgated in the national and international pharmaceutical dictionary. Without the evidences relating to those components, the producer must provide the evidence with the tantamount quality.
The producer must build up the quality for the finished products and must comply with the current criteria that are internationally accepted. On checking the quality of the products, the content of any active ingredient can be approximately 10% (≤ 10%) in comparison with the promulgated content. The tolerance about the volume (weight, volume) of the finished products must be within 5% (≤ 5%).
The applicant must provide the testing method with the following requirements:
+ In accordance with the science, technology in this field.
+ In accordance with the set of criteria of ISO
+ Describing clearly about the testing method so that the official of the Experiment Department can check the quality in accordance with the testing method of the applicant.

5.3. Analysing Certificate (testing sheet)

a. Testing from the producer: The producer must be responsible for the quality of veterinary products as well as testing the quality of the veterinary products. The testing of the quality of veterinary products can be executed by producer or the Testing Organisation of veterinary products in accordance with the contract between the applicant and this organisation.

b. Testing from the state body: The DAH request the applicant to send the sample products or the .......................... relating to the products (if requested) to the State Testing Body so that this Body can proceed with testing the products. The testing result must be attached in the dossier.

5.4. Expiry date: The applicant must provide the DAH with information proving the stable period of the veterinary products in use and the proposed expiry date.
It is necessary to study the stability about the content of the main active ingredient containing in the formula. The standard quality of the products must be evaluated based on the fluctuation of the content of the active ingredient, the fluctuation must be within 10% (≤ 10%) in comparison with the promulgated content. The method used to study the stability of the finished products is required to provide the DAH.

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