Quality Assurance & Control

 

From each batch of raw materials and additives, samples are evaluated and only approved batches as per applicant current regulatory systems requirements are released for production. Capsule samples are checked during processing by a system of operator inspection, which consists or taking random samples at regular intervals. Dimensions, visual defects, moisture content, color and microbial purity are thus regularly monitored during production and further sampling inspection is carried out at the final stage.

Stringent process control and monitoring ensure consistency, uniformity and conformance to specifications. Before the release of each lot, a review is made of all process control documents and records to ensure conformance to in-process control and operator inspection during manufacture. Key salient features of our Quality Assurance & Control is:

  • Capsules are designed to avoid deformation in transit.
  • 100% sorting to ensure defect free capsules at the customer end.
  • Colors and additives used as per regulatory requirements.
  • Statistical analysis helps maintain consistency in capsule dimensions.
  • Capsules are made free from preservatives.
  • Capsules perform with equal ease on Manual/ Semi-Automatic/ High Speed
    Automatic Filling machines.
  • Facility and processes as per ISO 9001:2008, WHO GMP, US FDA.