Quality Control Processes

A robust quality system facilitates both a Good Manufacturing Practice & a Good Business Practice. The well-organized quality system which is effectively managed, has resulted in consistent predictable outcomes. Amanta products are therefore reliable.

Being a cGMP facility, we strive continuously to determine proper implementation of good manufacturing systems & regulations through continuous training of the factory personnel. Our ceaseless efforts are directed towards maintaining highest quality standards. We continuously enhance our facilities, upgrade our technology and install new instruments as per 21 CFR.

Quality Control

• Assessing the suitability of Incoming Components, Closure Labeling, In Process Materials & Finished Products.
• Evaluating the performance of the manufacturing process to ensure adherence to proper specification & limits.
• Determining the acceptability of each batch for release.

To carry out the above activities at Amanta, we have developed a state-of-art & most sophisticated quality control laboratory equipped with instruments like;

• TOC Analyzer
• HPLC (High Pressure Liquid Chromatography)
• FTIR (Fourier Transfer Infra Red Spectroscopy)
• UV – Visible Spectrophotometer
• Flame Photometer
• Polari meter
• Liquid Particulate Counter
• Stability Chamber
• Air Particulate Counter
• Quantitative Air Sampler
• PICO pHmeter

Quality Assurance

Amanta concept of QA covers all matters that individually or collectively influence the quality of the finished product. These include:

• Developing norms, standards and guidelines for quality assurance.
• Review & Approval of all procedures related to production & maintenance.
• Review of Associated Records.
• Auditing & Performing/Evaluating Trend Analysis.