QC & QA

» Sterility

All drugs 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-
(i) Adequate facilities for the first aid
(ii) Medical Examination of worker at the time of employment and periodic check up thereafter time to time
(iii) 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
(i) Identified and their containers are examined for damage and assigned control number.
(ii) Stored at optimum temperatures and relative humidity.
(iii) 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.

» 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 quality control laboratory has the following principal duties:-

(i) To prepare detailed instructions in writing for carrying out each test and analysis.
(ii) To release or reject
     (a) each batch of raw materials
     (b) Semi-finished products
     (c) packaging and labeling materials and the final container in which drugs are to be packed.
     (d) each batch of finished products ready for distribution.
(iii) To evaluate the adequacy of the conditions under which raw material, semi finished products and finished products are stored.
(iv) To evaluate the quality and stability of finished goods and raw materials.
(v) To examine returned products as to whether such products should be released, reprocessed or destroyed.

» 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).

Our department of quality control is staffed with scientists and 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

» Quality Control of Herbal Ingredients

Quality control is an essential component in the development of any herbal product with the availability of standardised herbal ingredients. The standerd components and active ingredients are mixed with synergistic compounds and consists of following procedure:

» Identification and Authenticity of Plant Material

All the herbal ingredients meet stringent Quality Control Standards, set for each particular ingredient. Botanist select the best herbal materials from its pristine and native locations, harvest at the optimum time ensuring that correct post-harvest treatment and storage criteria is met with. Quality Assurance (QA) department maintains a Specimen and relevant information of all plant species used by AROSOL. Every herb is authenticated both macroscopically and microscopically.

The quality control department performs the following functions and tests to ensure that the high standards are met with:

Chemical Tests: Test involving assay of chemical component of active ingredients are conducted for herbs to ensure its quality.

Moisture: The moisture content of herbal ingredients is tested and brought to desired level for proper storage of herbs.

Total Ether Extract: Quantification of terpenoides and other oils in the herb and assayed.

Water & Alcohol Soluble Extracts: Analysis of water and alcohol soluble extracts are assayed for the quality of the herbal material.

Ash Value: Mineral content and extraneous foreign materials are identified for the purpose of quality of the herbs.

» Analysis by HPLC and HPTLC

Standardization of various components of herbs are done by sophisticated and newer instruments like HPLC and HPTLC for effective identification and quantification of active ingredients and various components of the herbs.

» Quality Control of Finished Products
Finished products are subjected to stringent quality control tests involving:

• Physico-chemical analysis.
• HPTLC/HPLC analysis.
• Pharmacological evaluation and field trials.

The chromatograph taken for each manufactured batch is compared with the standard reference chromatograph to ensure batch-to-batch consistency.

» Good Manufacturing Practices

The facilities at our manufacturing location are well equipped with latest equipment and well-trained manpower backed by highly motivated and refined manufacturing culture. The end product meets stringent quality norms stipulated by GMP.

AROSOL aims to offer herbal products which combine the best of Indian traditional / herbal medicine with the quality that is now achievable using modern analytical and biological methods. The Herbal Drug Research unit focuses on developing standardized, clinically proven and safe herbal products for therapeutic and supplemental use.

AROSOL has dedicated scientists with expertise in botany, pharmacognosy, phytochemistry, analytics and pharmacology, as well as consultants having a long association with the herbal drug industry. The experience in natural products research and the use of modern analytical instruments and spectroscopic tools will ensure that AROSOL's products are standardized with reference to markers or standard active molecules. Procuring authentic plant material, pharmacological evaluation in laboratory models, formulation development and modern clinical trials is be an integral part of the herbal product development activities.

Currently AROSOL has programmes in the fields of immunomodulation, dermatological disorders (particularly wound therapy & eczema), hepatotoxicity, gastrointestinal disorders, cold and cough as well as Hypogalactia. It plans to enter the areas of allopathic range especially in dewormers & antibiotics in the near future.

Arosol Chemicals Pvt. Ltd. Is engaged its efforts in Research & Development activities and now the group is expertise in Medicinal Herbs - identifying, growing, formulating new herbs, new formulas, and new applications. We are already manufacturing and marketing more than 50 unique formulations. Continuous research has helped in developing many innovative products especially in those therapeutic segments where modern or English system of medicine does not provide satisfactory solutions and similarly not much has been offered, so far, by alternative systems of medicine. A dynamic and learned team of scientists includes Pharmacists, Chemists, Botanists, Microbiologists, Pharmacologists, Medical Scientists, Veterinarians and Clinicians etc., in different departments such as Pharmacology, Formulation, Phytochemistry, Microbiology, Quality Control, Literature Survey, Universities, Animal House and Experimental Farms conduct various research and developmental activities

Traditional Herbologists are the expertise of modern Herbal Medication and supplementation, the research & experience of several years, the knowledge of their forefathers, their time & devotion for the science of Ayurveda made us draw our attention to promote this science Worldwide, their knowledge helps us to research and develop the new formulations. The various combination of herbs and their quantity in each formulation are decided by them who make the right combinations as desired by the bodies. There are certain technical fact for making the formulations such as the combination quantity, form of herbs to be used, their processing, the dosage etc which are kept secrets and are only with these herbologists. Once the formulation is prepared they make their calculations to set the dosage etc and further send the formulation to other pharmacists to evaluate the various trials in the laboratory.

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.

If the products stands up to the mark with its lab tests they are taken under the trials by Veterinarians and Animal nutritionists in the Agriculture & Veterinary Universities to study for the products with the various university technicians to give the report on the application, working on animals, their safety, results, performance of the products. Then we also conduct the farm trials to make our officials to study the products and to have the detailed information about the products: How they work and how they give the satisfactory results.

After the complete analysis and the detailed study by all the teams we have the team of all directors, marketing generals, production managers, Veterinarians and other technical staff to explain and discuss about the products and to adopt the strategy to market and produce the product keeping in mind the customer satisfaction.