Quaity Policy

Amorvet 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 Amorvet 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. Amorvet 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 AMORVET be assured that you are in the perfect hands.

Quaity Control

QUALITY CONTROL SYSTEM

We have separate quality control department which is supervised by many 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 labeling. 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 Thin Layer Chromatography (HPTLC)
• High Pressure Liquid Chromatograph with PDA (HPLC)
• Gas Chromatograph Mass Spectrometry
• 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.

Sampling each Herbal Ingredient on the basis of Plant Part Used

• Extract – Assay in boiling water containing Calcium Carbonate
• Roots – Identification by Transverse Section
• Stem – Identification by Transverse Section
• Fruit – Identification by T.S. depending upon the need
• Rhizome – Identification by T.S.

Analyzing for

• Organoleptic Properties
• Color
• Pharmacology specified (Idiosyncrasy Test)

The efficacy of various ingredients been tested inhouse and outer labs as required. Every ingredient used is strictly controlled to ensure that we produce the standard products with desired results.

Routine and random checks are scheduled on finished goods, each batch s to pass through terminal inspection to ensure confirmed checks.
Policy is clear, any rejection in our factory is just a rejection; if it’s in the market then it’s a disaster to our image and value much more then when it was in our premises.
Quality controls is the most important key to ensure what we produce and how we sell it.

The pharmacists, technicians & Chemists thus conduct their tests for the product safety, Organoleptic Test for Taste and Odor, Physico-chemical Properties such as pH, Specific Gravity, Total Dissolved Solids, Presence of Heavy Metals like Lead, Chromium and Arsenic should not be more than Permissible level, Microbiological Analysis for Total Bacterial count, Pathogenic Microorganisms like E. coli, Pseudomonas aeroginosa, Staphylococcus aureus, Phytochemical Analysis for Total Bitters, Total Tannins, Total Flavonoids, Alkaloids, To maintain the Consistency TLC and HPLC Tests are done parallel to their parameter. Various toxicity tests are conducted to judge the safety by taking the trials on the rats and mice.

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. The complete parallel team of 30 members working with full alertness to ensure that nothing to pass by which can cause any bad image to the reputation of the company.

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
• Pass Label
• All Records are Maintained

During Filling

• Checking Empty and Filled Jars and Cartons for
• Group 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

STERILITY

All ingredients are provided with air locks, dust free, ventilated with air supply. Access to the manufacturing area is restricted to authorized personnel.

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 formulations 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
• Facility for vaccination or other exigencies, We have provide service of a qualified physician for assessing the health status of personnel involved in the manufacturing and quality control of drugs is also made available.

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 pharmacopoeial requirements. These are non reactive (inert) in nature.

LABORATORIES

• FORULATIONS
• QUALITY CONTROL
• CONTROL SAMPLES ANALYSES
• MICROBIOLOGY