Description:

Responsibilities for the Quality Control Department:

The basic requirements of QC are:

Adequate facilities, trained personnel, and approved procedures are available for sampling, inspection, and testing starting materials, packaging materials, intermediate, bulk, and FP;

Test methods are validated; Records are made, manually or by recording instruments, which demonstrate that sampling, inspection, and testing procedures were actually carried out.

Any significant deviation is recorded and investigated.

FP contains active ingredients complying with the qualitative and quantitative composition of marketing Authorization, are of the purity required, and are enclosed in proper containers with correct labels.

Records are made of results of inspection and testing of materials, intermediate, bulk, and finished products are formally assessed against specification.

Good Laboratory Practices and Equipments: Ensure that lab carry out its testing, calibration, validation, and all other technical activities in such a way as to meet GLP requirements.

Premises: The laboratory shall be designed, constructed and maintained so as to: Prevent entry of insects and rodents besides cross contamination; Interior surface shall be smooth and free from cracks and permit easy cleaning and sanitization; Provision made for the space, equipment and also for utilities like water, power and gas; air ventilation system; Table top shall be constructed with alkali, acid and solvent resistant material and shall be smooth and free from cervices as far as possible;

Personal: Staff in lab shall possess necessary qualification, proper training and shall have adequate experience for the assigned duties. Ensuring the control and maintenance of documents including the quality system as per the requirements of regulatory authorities which involve all raw data, SOP’s, documentation protocols, etc.

Equipment: Instruments requiring calibration shall be calibrated at regular intervals and records shall be maintained. The instruments, instrument bench and surroundings areas shall be kept clean and tidy all the times. Glassware such as burettes, pipettes and volumetric flasks shall be calibrated. Weight boxes and thermometers etc. shall also be calibrated. Autoclaves must meet the requirements described for operations, safety and validation procedure. Work involving the evolution of harmful and obnoxious vapours shall be carried out in a fume hood.

Chemicals and Reagents:The storage and handling of chemicals and reagents shall be done in a manner considering the physiochemical properties of these substances and hazards involved in their use. All reagents and solutions shall be identified with a label. Containers of stock solutions and standard solution should bear name of analytical chemist who prepared the solution, date of preparation, use before date and strength of solution.

Good housekeeping and safety: Standard Operating Procedures for safety, house-keeping shall be prepared in accordance with various rules, and regulations of Government of India and include the following requirements; Drinking, eating and smoking shall not be permitted in the laboratories; food for human consumption shall not be kept in working or storage areas; Staff must wear laboratory coats or other protective clothing including gloves and mask; The laboratories shall have firefighting equipments and eye washer. Protective precautions to be taken in Laboratories Safety Shower shall be installed; Rubber suction bulbs must be used on pipettes; Appropriate facilities for the collection, storage, and disposal of wastes shall be made available; Staff must be aware of methods for safe disposal of corrosive or dangerous products; A standard operating procedure for handling, collection, disposal of chemical and biological wastes be prepared. Maintenance, calibration and validation of all instruments, equipments and other devices used in laboratory. Reference materials are necessary for testing, calibration, validation and verification of a sample or of equipment or other devices and all such materials shall be traceable to agency authorized by Government of India or any other international body. The laboratory shall prepare working standards by comparing with the reference standards and shall be routinely checked for their purity. Standard Operating Procedure for maintenance of microbial culture and sub-culture must be prepared by the laboratories. All activities are carried out under Laminar Airflow. Raw data refers to the laboratory worksheet, note books or analysis sheet, records, memorandum, notes or extract copies that may be results of observations and other activities shall be maintained. Data integrity and security shall be maintained and data shall not be accessible to any unauthorized person.