Quality
Quality
K K Animal Health has well trained personnel for quality control ensuring strict adherence to quality systems and procedures.
At K K Animal Health, Quality Management Team ensures that every product manufactured and distributed by us complies with all accepted good practices and standards of quality, purity, efficacy and safety. To maintain quality standards, our plant has well defined procedures and systems in place in compliance with the requirements of the GMP (Good Manufacturing Practices).
Quality Policy
- Enacted by management as follows:
To continuously improve quality of product and quality of service to provide customer satisfaction with the quality of operations - With teamwork and standards-based operation.
- Based on our goal, all employees at all levels of our factory and in the office are devoted to their own jobs and actively participate in quality management activities. We rely on our quality policy so as to win the confidence of customers.
- Quality policy can be summarized as:
Quality Policy Commitment
K K Animal Health is committed for providing purity with surety considering safety and efficacy as utmost concern, adhering to quality standards and regulatory requirements. To provide quality products that meet the demand of Animal Health Industry, we have defined and follow an international quality system. Product efficiency is always our priority, we are happy to have feedback from the customers who says K K Animal Health all products are up to “Brand Builders”. We are happy to discard the products which are not proved to be the up to the mark. We never offer the product which can cause any damage to our image and goodwill K K Animal Health standing is with its top notch quality and we will maintain it forever. We can bear any loss but can’t bear any damage to our credibility. Our reputation is everything for us. We understand if you have a long Vision of a classic Reputation, income is bound to come. So when you deal with K K Animal Health be assured that you are in the perfect hands.
Quality Control
Quality Control System
We have separate quality control department which is supervised by approved expert staff. Our quality control laboratory checks and controls the quality and stability of raw materials as well as finished goods.
Our department of quality control is staffed with technicians responsible for the analytical testing of incoming raw materials and inspection of packaging components, including labelling. They conduct in-process testing where required, perform environmental monitoring and inspect operations for compliance, finally, they conduct the required tests on the finished dosage form.
Our Quality Control is responsible as part of its testing and inspection functions, for monitoring the environmental conditions under which products are manufactured and/or held.
The technical team is assisted installation of most modern and sophisticated instruments such as:
- High Performance Liquid Chromatography (HPLC)
- UV-VIS Scanning Spectrophotometer
Our quality control laboratory has the following principal duties: –
- To prepare detailed instructions in writing for carrying out each test and analysis.
- To release or reject
- each batch of raw materials
- Semi-finished products
- packaging and labeling materials and the final container in which drugs are to be packed.
Quality Assurance
We always determine and follow that the product meets all the applicable specifications and that it is manufactured according to international standards and the GMPs (Good Manufacturing Practices). SOP’s are designed for all level of production, regular BMR and BPR been followed to maintain the systemation production. Various check points are defined to make the regular and continuous checks during the production. All production is interrelated through requisite forms and followed symmetrically. The complete hierarchy of QA team is deputed from Raw Material Dispensing until the final dispatch of the goods.
Few basic reference of controls maintained at various stages Before going into Process Raw Materials are checked for
- Name
- Reference Numbers
- Gross Weight, Tare Weight, Net Weight
- Product/Batch No.
- Signature and Date
- Quarantine/Under Test & Approved Label
- All Records are Maintained
During Filling
- Checking Empty and Filled Bottles and Cartons for
- Gross weight
- Quality of Sealing
- Individual Filling Variations
- Leakage if any
Tests During Packaging
- Finished Boxes are checked for
- Quantity of overprinted matter on Labels and Boxes if any
- Box Fill Value for First Box of batch and First Box after Every Break
Quarantine Tests (In Comparison with the Approved Standard) Liquids
- Color, Odor and Taste of the Liquid is Examined
- Filtration and Mixing is Ensured
Powder
- Color, Odor and Taste of the Powder is Examined
- Particle Size and Mixing is Ensured
Working Conditions
WORKING SPACE
Adequate working space and adequate room for orderly placement of equipment and materials is provided to eliminate any risk of mix up between different formulation and cross contamination. In storage area separate space is provided for under test, approved and rejected materials.
HEALTH, CLOTHING AND SANITATION OF WORKERS
All the personnel coming in direct contact with the products including raw materials are always free from contagious and obnoxious diseases and they undergo periodic health check up. Just before entry to the manufacturing area change room with facility for personnel cleanliness etc is provided.
MEDICAL SERVICES
We have provided-
- Adequate facilities for the first aid
- Medical Examination of worker at the time of employment and periodic check up thereafter time to time
SANITATION IN THE MANUFACTURING PREMISES
The manufacturing area is not be utilized for any other purpose and it is maintained clean and in an orderly manner, free from accumulated waste, dust, debris etc. We always draw up and observe a routine sanitation programme.
EQUIPMENTS
All equipments used for the manufacturing of drugs are constructed, designed, installed and maintained in a manner so that they minimize the contamination like physical, chemical or Physico-chemical contamination.
RAW MATERIALS
All raw materials are
- Identified and their containers are examined for damage and assigned control number.
- Stored at optimum temperatures and relative humidity.
- Systematically sampled by quality control personnel, these are checked for compliance with required standards of quality.
MANUFACTURING OPERATIONS AND CONTROLS
All manufacturing operations of our factory are carried out under the supervision of competent technical staff. All vessels, containers and mechanical manufacturing equipment are conspicuously labeled with the name of the product and batch no. etc.
PRODUCT CONTAINERS AND CLOSURES
All containers and closures are complied with the pharmacopoeia requirements. These are non reactive (inert) in nature.
LABORATORIES
- FORMULATIONS
- QUALITY CONTROL
- CONTROL SAMPLES ANALYSES
- MICROBIOLOGY
