» Working SpaceAdequate 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 workersAll 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 ServicesWe 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 premisesThe 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.
» EquipmentsAll 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 MaterialsAll 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 controlsAll 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 closuresAll containers and closures are complied with the pharmacopoeial requirements. These are non reactive (inert) in nature.
» Quality Control SystemWe 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 IngredientsQuality 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 MaterialAll 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 HPTLCStandardization 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.