Quality Assurance

Quality is the buzzword. The assurance of quality starts from the Raw Material itself as soon as it enters the premises. It goes without saying that Qualification studies are mandatory for all equipment and all production and analytical procedures. Quality assurance department assures, validate system by verifying all equipments periodically and maintaining Cleanroom class of Air-borne particulate matter controlled by Met-one(modelA-2408)/Clit (CI-7300) particle count, live organism detection by air sampler (SAS-700),disinfectant efficacy, steam quality testing.

The quality assurance check points are built into the entire process, including issuance of raw materials, blending and mixing for uniform dispersion in tablets/encapsulation for accurate fill weight, and ensuring the proper count in each pack. All these check points guarantee that what's indicated on the label, matches the content of the pack. In-house quality checks, which are detailed in our Standard Operating Procedures (SOP) , have been drawn up in addition to the recommendations specified in the United States, European & British Pharmacopoeias and cGMP guidelines for each of our operations commencing from the raw material audit to in-process checks through finished product release, self audits, annual product reviews, validation qualification and others. Environmental Monitoring and Validation is done by our Quality assurance department. Our Quality Assurance Team is constantly engaged in guaranteeing adherence to our rigorous manufacturing standards based on Good Manufacturing Practices.

Regular training of our FDA approved Production experts and FDA approved Testing experts through continuous professional development has played a significant role in this direction. Company has regular interaction with experts at international level to maintain the latest available information. This ensures that the latest advances in production and quality testing standards are quickly incorporated in our processes. Apart from following ISO 9001-2000 and maintaining an effective Quality Management System, HiGlance conducts periodic self-assessments through a voluntary self audit of its operations, in order to maintain leading edge in the Pharma industry.