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 Physic-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.