Fortcaps Healthcare Limited

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Quality Policy

Fortcaps Healthcare Ltd is committed to support our customers in preserving or improving patient health by consistently delivering high quality, safe and effective Empty Hard Capsules that meet or exceed customer expectations.

To meet this commitment, we maintain appropriate systems in place to ensure quality-focused behavior and a scientifically sound, risk-based, and data-driven decision-making process. At Fortcaps, Quality is everyone's responsibility. Our management and employees are committed to upholding our Quality Policy.

As part of Fortcaps' commitment to Quality:

  • Our business is conducted in compliance with cGMP guidelines and applicable quality regulations, codes and standards.
  • Q Records, Documentation, and Data are managed in accordance with cGMP guidelines.
  • People are continually trained to maintain a qualified and motivated workforce.
  • We continuously review our various operations to make them more efficient and environment friendly in relevance with emerging international scenarios.

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Our Quality Policy is implemented through a comprehensive Quality Management System and we are committed to make continual improvements to the same.


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

  • 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 : 2015, WHO GMP, US FDA.
  • Country-wise regulatory compliance as per customer and particular agency requirements.