Certifications
Quality Assurance
We are a WHO and GMP certified Company. The quality assurance with us is an organized effort and starts from the very top that is policy-making and decision stage. We always emphasize on quality aspects of every product being manufactured at our facility. We are committed to comply with the quality standards set by the WHO, USFDA, UKMHRA and TGA. Therefore, we ensure that our medicines efficiently qualify the predetermined quality norms and remain safe, effective and acceptable throughout self-life.
Quality Control of Raw Material Attestation
Given below the standard procedure for quality control of raw material:
- Vendor specification
- Supplier’s Protocol of analytical results
- Testing based on reference and protocol of random samples from each bag/ box/container
- QC Manager’s acceptance/rejection of material
- Record of all the testing and decisions made
- Storage specification as per standards
- Testing of material at specified frequency during storage
With nearly two decades of experience and a clear vision, Kirat Lifesciences aims at reaching the zenith of the world pharmaceutical industry
Standard Procedures for In-process Quality Control Attestation
We follow the standard of procedure as per lay down in company WHO GMP Pattern. Given below is the standard procedure for In-process quality control:
In process control of Active & Inactive ingredient in routine
- Appearance
- Moisture
- Identification of Active ingredient
- Content of Active ingredient
Routine quality control test
- Visual test
- Appearance
- Dot, spot, mot of Florence color
- Identification
- Assay of active ingredients
- Range of mean weight
- Uniformity of weight
Quality Policy
Practices, Good Documentation Practices and Monitoring guidelines throughout the manufacturing process. We also take steps for raising quality standards through our research activities keeping customer satisfaction in mind. There is an established Quality Management System (QMS) that helps us in raising product quality in every phase of the production.
Quality Control
Kirat Lifesciences follows a firm quality control system that applies at every phase of the production process right from the procurement of APIs to the distribution. The predefined Standard Operating Procedure is strictly implemented to meet cGMP norms formulated by the National and International Regulatory Bodies. Our laboratories are equipped with modern and necessary instruments and qualified staff. Our QA and QC professionals make sure that standard guidelines are followed and the product quality is uncompromised. Therefore, testing and evaluation activities are carried out in a controlled environment to ensure safety, effectiveness, purity and strength of the products before they reach the end users.
Quality Product Innovation
Like many other world-class WHO pharmaceutical companies, Kirat Lifesciences also believes in investing in research and development of new formulations to treat diseases more efficiently and effectively. We have a team of scientists and technicians who are specialized to operate modern lab equipments to test the quality and efficacy of new and generic formulations.
Validation and Quality Optimization
Quality optimization is a continuous process that we always take care of. It is necessary to optimize product quality at a reduced cost. The installation of any new process, facility, system and/or equipment is a part of this optimization. It is achieved through certain steps like:
- Technology transfer
- Analytical development
- Evaluation process
- Innovative developments
- Automation installation