Quality Control & Assurance
Total quality management conforming to national and international regulations — with zero rejection as our standard.
Quality Is Our Most Important Attribute
Alexander Lifesciences Private Limited recognizes that quality is the most important attribute and is committed to total quality management that conforms to National and International Regulations.
The manufacturing process is carried out under strict supervision of our technically competent staff as per predefined processes and procedures. Quality control measures are implemented at various stages of production — starting from approval of raw materials and in-process materials, extending to checking of finished products.
Batch Manufacturing Records and Batch Packaging Records are maintained for all manufactured products. Final products are tested to the strictest available international pharmacopeia standards and norms. Stability studies are conducted on all our manufactured products.
Global Regulatory Support
We have the requisite infrastructure and expertise to ensure proper regulatory approvals by our clients and international regulatory bodies such as USFDA, TGA, KFDA, EDQM, COFEPRIS, ANVISA, UKMHRA, and others.
The QA department ensures that all activities associated with the design, development, and manufacturing — including Purchase, Warehouse, Production, Quality Control, Release, and Distribution — are carried out in a systematic and approved manner in compliance with regulatory and cGMP requirements.
We have the capability to develop and file CTD DMF, US DMFs, CEP, and other registrations required in various markets — supported by our well-equipped QC laboratories.
Scope of Quality Activities
Our comprehensive QA/QC framework covers every stage of the product lifecycle.
Request Quality Documentation
COA, stability data, DMF status, and audit schedules available on request for qualified partners.
Contact QA Team