Quality control of veterinary drugs - interesting facts you must know.
The main mission of ProVET TM is a care of your pets. The company is producing to the market the veterinary drugs of different pharmacological groups, oriented on the customer demands and modern achievemnts in veterinary.
We had created a multi-lvel system of quality control at each stage of production so that you were sure in quality of manufactured products.
Quality control and quality assurance - what's the difference?
Let's try to understand the notions of quality control and quality assurance.
The notion "Quality Control" means the conduction of product testing and the list of quality indices with defined acceptance criteria. The goal of product Quality control is to validate the correspondace of the manufactured product characteristics to a pre-set regulations (acceptance criteria) in documentation (specification).In other words the Quality Control is a validation and testing of veterinary drugs correspondance to specification requirements.
Quality assurance is more broad concept which includes a set of all organizational activities directed to assure that veterinary drugs posses the quality required for its predictable use, and all the processes maintain in working order. Namely it is planning, implementing and control of all the elements required for production and control of products (staff, equipment, documentation system etc.). This is the system which allows us to achieve the planned goals.
Quality control is part of quality assurance.
Three levels of ProVET veterinary drugs Quality Control
Veterinary drugs Quality Control includes the following:
- Input control of raw materials quality ;
- Interoperational and stage Quality Control of semi-products;
- Finished veterinary products Quality Control
On the stage of input control is carried out the testing of all raw materials, excipients, primary packaging and printed products.
Interoperational Control includes conducting studies for the intermediates, means the products did not pass all the technological studies yet. These are solutions which subjected to be packed in ampoules or vials; masses for tabletting, tablets before packing in blisters; collars before packing in foil bags (primary packaging) etc.
Quality Control of the finished products is the final stage of the veterinary drugs quality control process. Quality Control execution is carried out as follows: the required quantity samples is taken from the batch of fully packed products and conduct the studies..
У All stages of Quality control are implemented in accordance with the approved documents, and the results recorded in logs, protocols, etc. The records of product quality control are inspected and saved within 5 years
Who is responsible for quality control?
The responsibility for the quality of each batch of veterinary drugs is liable to specially appointed specialist - Authorized person.
The appointment of an Authorized Person in production is a legal requirement of the Licensing Conditions for the production of veterinary drugs and the current rules of Good Manufacturing Practice (GMP).
Incidentally only in the pharmaceutical industry of the production of medicines for humans and animals binds the manufacturer to have such Authorized Person. The Authorized Person. The Authorized person certifies each batch of the drugs (signing the Certificates of Quality) and bears legal responsibility for its activity.
In order to become an Authorized Person at production, one desire is not enough. The legislation sets forth clear requirements for the candidate's qualifications and competencies. Thus, according to the Licensing conditions for the production of veterinary drugs: " An Authorized Persons of the veterinary drugs manufacturer have a higher education in the specialties of "Pharmacy, industrial pharmacy", "Veterinary medicine", "Chemical technologies and engineering", "Biotechnology and bioengineering", "Biomedical engineering" , "Chemistry", "Biology" and professional work experience of at least two years in the field of production, quality control or veterinary drugs creation.
The Quality Control Department is responsible for all types of control and subjected to the Authorised Person. The Quality department is an independent structural unit and independent from the production department.
Thus only the Authorized Person based on the results of product tests by Quality Department, can decide about the quality of veterinary drugs series, and respectively gives a permission for the sale of a specific series.
ProVET TM supports and improves the current system of Quality Control and Assurance considering the high responsibility of produced veterinary drugs quality.
At all levels of the company, we have created and implementing the concept of quality assurance, as we understand that quality is not only the notion or tagline, but daily commitment for all ProVET TM employees. High-quality drugs is a guarantee of pets the health and good mood.
With care, TM ProVET.
