KRONOX Lab follows Good Manufacturing, laboratory and documentation practices that ensure consistently high quality results. The company’s state-of-the-art analytical facilities monitor and maintain strict quality of its products, processes and services, while always meeting national and international quality requirements.
key functional areas
- Quality Control
- Quality Assurance
KRONOX Lab Sciences understands the importance of quality in high purity fine chemical segment and pays high attention to the quality control approach to achieve accuracy in analysis. It is for this reason that KRONOX’s customers always remain assured to receive high quality products at all times. All the manufacturing and quality processes are documented and recorded as per GMP, FSSC 22000 & ISO standards.
KRONOX has a well-equipped Quality Control (QC) laboratory, which ensures that its products are pure, safe and effective and are released only after thorough analysis as per stringent specifications, methods and procedures developed according to international guidelines.
For this purpose the company’s QC department has all necessary instruments for analysis of Raw Materials & Finished Products.
The QC department performs following activities
- Raw Material analysis
- Finished Products analysis
- In-process Checks
The QA is a high ranking concept, appropriate for production of pharmacopoeia and food products that covers all issues which can individually or collectively impact the quality of the products. It is a summary of all organizational arrangements composed in order to ensure that all the pharmacopoeia & food products are of high quality, safe and efficient for use, and they also correspond to the marketing authorization requirements.
In order to remain steadfast on its determination of providing high quality products, KRONOX has established simple and correctly implemented systems for Pharmaceutical and Food Quality assurance that is fully documented. The efficiency of KRONOX’s Quality Assurance program reflects in the fact that not only permanent monitoring of processes is done but even the team of the company equally participates in its quality assurance endeavors.
The organizational unit of quality assurance comprises the following activities
- Appropriate implementation of the procedure for batch release
- Issuing appropriate Quality Certificate
- Developing annual reviews on the products
- Implementation, maintenance, surveillance and improvement of the quality and the Environment System, in compliance with GMP, FSSC 22000 and ISO 9001
- Development and implementation of internal quality audits for purpose of verification of the efficiency and application of the System for Quality Assurance
- Managing the Change Control procedure
- Research and management of deviations and results beyond the specifications (if any)
- Handling complaints for products (if any)
- Defining and implementation of corrective/preventive measures
- Evaluation, verification and approval of suppliers
- Implementation of training programs
- Accompanying external GMP inspections/quality controls.
- Provide documentation support as per customers requirement