Quality Control at HiGlance

HiGlance enjoys a reputation for quality. Manufacturing EP/BP/USP-grade formulations starts with a commitment that every HiGlance staff member shares. But producing the world's finest drugs requires more than just a pledge. It calls for ongoing, daily responsibility. And it's in HiGlance Quality Control Department that this obligation ultimately comes to rest. HiGlance is committed to ensure that every product it manufactures and distributes meets with internationally accepted standards of quality, purity, efficacy and safety. A periodic validation of processes, test methods, water and environment, as well as periodic calibration of all instruments, to guarantee product output of consistent top quality. Vendor assessment and assortment is carried out as per stringent quality, product, manufacturing, service and delivery parameters to ensure the highest quality raw materials.A separate Microbiology Laboratory with Class 100 Cleanliness. The full spectrum of microbiological and validation tests are conducted for on-going constant microbiological monitoring of all processes and products, as well as personnel and production areas, to ensure total product purity. Strict MVP (Master Validation Plan), GMP and GLP are applied in all processes in HiGlance, from facility planning to the shipment of end product. The compliance of these processes is controlled and approved by the Quality Control Department, which is equipped with high-tech laboratory instruments, highly qualified & experienced personnel.

Quality Control and Assurance Programme:
Quality assurance programme is broadly divided into four sub categories:

1. Raw material testing
2. In process sample testing
3. Finished product testing
4. Validation and documentation

Quality Control Department

A full fledged Quality Control Laboratory at HiGlance manufacturing facility follows Good Laboratory Practices (GLP) and integrates the most up to date testing equipments, validated software program for QC & QA to maintain the extensive batch datas to get batch - to - batch consistency as per US FDA/GMP guidelines in order to perform the stringent quality analytical tests prescribed by different Pharmacopoeia putting its whole supply chain under the microscope.

The Quality Control Laboratory has well equipped high-tech equipments. These include:

• Infrared spectrophotometer
• Ultraviolet visible spectrophotometer
• High performance liquid chromatograph
• Potentiometric titrator
• Programmable (Humidity and Temperature) Stability Chamber
• Karl Fischer Titrator
• Gas liquid chromatograph

These Analytical Chemical/ Instrumentation/ product stability studies Laboratory and a Microbiological Laboratory with a comprehensive stock of equipment is to assure quality by separating active ingredients from impurities, and to quantify active ingredients present in the formula.