Capabilities::Quality Systems

A robust quality system facilitates both a Good Manufacturing Practice & a Good Business Practice. If the quality system is efficiently developed and effectively managed, it leads to consistent predictable outcome. This ensures that pharmaceuticals are safe, effective and available for the consumer.

Being a cGMP facility, we strive continuously to determine proper implementation of good manufacturing systems & regulations.  Our ceaseless efforts are directed towards maintaining highest quality standards as well as we look forward to enhance our facilities, upgrade our technology & install new instruments as per 21 CFR.

Quality Control

Our Quality Control involves;

  • 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 Marck, 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

Our Quality Assurance involves;

  • Review & Approval of all procedures related to production & maintenance
  • Review of Associated Records
  • Auditing & Performing/Evaluating Trend Analysis