Quality Assurance & Quality Control
J&K follows established policies and standard operating procedures (SOPs) for all our products and services to ensure a robust Quality Management System. From the manufacturing process to the safe delivery of our products, ISO9001:2015 is at the core of maintaining our high quality and regulatory standards. Targeted improvement plans based on input from sources such as authority inspections, internal audits, and customer feedback, is also a key aspect of our quality management systems.
Our quality management assurance programs include comprehensive quality control measures (e.g. NMR, LC-MS, GC-MS, FT-IR, HPLC and other advanced detection methods) at all steps of our process, from raw materials, to production, to the final product.
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Procedures
Standard Operating Procedures direct product production processes and define testing protocols for final products.
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Quality Records
J&K uses a strict product and batch numbering and tracking system so that information records relating to all parts of a product lifecycle (from raw material to final quality analysis) can be retrieved as needed.
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Equipment
All critical equipment is calibrated and tested on a defined regular schedule to ensure reliability.
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Nonconformance
A vital component of J&K’s quality control of our processes is the protocol to address a batch that is determined to be nonconforming to product specifications. Such a batch is "flagged" electronically to prevent sales and shipment. The batch may also be physically labeled and/or segregated to clearly indicate that it is not to be sold or shipped to customers.
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Purchasing Materials and Outer Packaging Material
When materials are received from our suppliers, we review Certificates of Analysis. If warranted, purchased materials may also pass through a physical quality inspection and review process. Materials will be maintained in a "Quarantined" status until the review is complete. We have also established strict quality standards for outer packaging materials to ensure product quality.
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Chemical Intermediates
For critical intermediate processes, parameter controls and test indicators are used.
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Chemical Intermediates
For critical intermediate processes, parameter controls and test indicators are used.
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Final Product
All batches are tested to ensure that final products conform to the stringent standards of J&K’s Product Specification System.
J&K uses a wide range of analytical and testing methods to assure Quality Control. All J&K personnel involved in Quality Analysis and Testing have relevant academic qualifications to at least a Bachelor’s degree level. Over 25% of those staff also have relevant Masters’ degrees. Our internal staff training and development programs address both universal and job specific requirements.
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Analytical Methods:
J&K uses Analytical Methods that have been established for the majority of our products based upon specific product characteristics and by comparing the best practices and outcomes of different available methods.
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Result Verification:
J&K has well-established verification procedures. All analytical results are verified by two different independent Quality Control staff. Any nonconforming results are investigated according to defined standardized procedures.
Please contact your local J&K Customer Service Department to learn specific information about our Analysis and Testing methods and procedures.
