Dossier of division of veterinary drugs manufacturer: a mandatory condition for obtaining a license for veterinary drugs manufacturing

If you want to begin commercial operations associated with veterinary drug manufacturing you need to have a license. Most entrepreneurs are aware of this fact. But unfortunately, only a few people know the requirements for the full list of the documents, which a licensing authority requires in order to obtain this license.

One of the documents called for by the licensing terms for the implementation of activities for the production of veterinary drugs is the dossier of a division of veterinary drug manufacturer.

We pay attention to this particular document because the requirements for its content are formulated as broadly as possible: it should contain information about the policies and activities for quality management and control. At the same time, it depends on the accuracy of filling out the dossier whether you will receive a license or not.

Therefore, in this material, we will try to come to grips with what this dossier is.

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Methodological recommendations were developed by the State Research Control Institute of Veterinary Medicines, which explains in more detail what information should be indicated in the dossier. Such information includes:

1. General information about the manufacturer:

• name and address, information about the means of communication with the manufacturer;
• list of products, the availability of permits and certificates.

2. Information about the quality management system.

The international standards for the production of veterinary products can be taken as a basis.

The qualification level of the Authorized Person should also be described: his/her education, further education courses, general experience in this area.

It is important to describe the functions and role of the Authorized Person in the manufacture of products, their testing, and certification.

In this section, it is also recommended to provide information on contractors, if any. In particular, about manufacturers of active ingredients and suppliers of materials.

2.1. Management of risks.

Here you need to specify methods of quality assurance (checking the ingredients and materials provided by contractors) and a description of the actions that will be carried out in case of detection of counterfeiting or falsification of ingredients, as well as infection of materials.

3. Information about the staff.

It is recommended to provide it in the form of a diagram highlighting the personnel management structure, which is directly involved in the manufacture of drugs.

The diagram should indicate the positions of workers.

4. Description of the premises.

We are talking about a premises layout with an indication of the area and the purpose of the rooms.

In addition, you need to indicate which markets the products are manufactured for. The logic of this recommendation is not explained.

4.1. The characteristic of each room and its functions.

Here you need to pay attention to:

• storage conditions;
• heating systems;
• air conditioning and ventilation;
• temperature conditions and humidity.

A brief description of the steam, compressed air, water supply, and water quality systems should also be briefly described.

4.2 Equipment of the production workshop.

This is a list of technological equipment and laboratory devices, given the computerized systems needed for production. The specified information can be presented in the form of a separate application.

A separate paragraph highlights information on methods of cleaning and surface treatment.

5. Documentation of the manufacturer’s production workshop.

The methodological recommendations are not about the list of documents that should be stored on the manufacturer’s site, but rather about the method of documentation: electronic document management or manual filling.

It is also noted that if some documents will not be stored at the address of the manufacturer, you need to specify where they can be found.

6. Description of the process.

It is necessary to provide a list of all types of products that will be produced. This can be issued in a separate addendum. Also in this paragraph should be:

• information about the dosage forms of veterinary drugs that will be produced for clinical trials;
• description of the working process with toxic substances, including the use of process analytical technology, a general description of a specific technology;
• A description of the manufacturer’s policy regarding the validation of reprocessing and recycling processes;
• a description of the measures to be taken with the refused materials;
• Description of output quality control.

7. Supply and sale of manufactured products, recall of products in connection with identified defects.

It is necessary to provide information on:

• types of companies to which the products will be delivered, their location;
• measures to verify distributors (whether  they have the necessary documents for the purchase of veterinary products and their implementation), as well as measures for tracking products, preventing the illegal circulation of manufactured products;
• measures to ensure environmental safety;
• measures to identify complaints about products, identify defects and recall products;
• self-inspection measures.

Unfortunately, even with a complete list of the data to be indicated, it is difficult to immediately navigate and fill out all the documents correctly. And to do this is very important, because the dossier is a prerequisite for obtaining a license for the production of veterinary drugs.

Any delay in the process can negatively affect your business because time is money.

We hope this information has been useful to you. And if you still have any questions or need help with developing a dossier, give us a call!