Quality comes first! At Celmark International Inc., we proudly operate in an FDA-inspected, cGMP-compliant and organic-certified facility. We provide top-notch quality control at all stages of the manufacturing process. Some of the ways we achieve this include:
- Incoming chemical-analytical testing
- Incoming chemical-bacteriological testing
- Full microbiological testing prior to product release
- Production-line sampling
- Ongoing audits performed by 3rd party audit organizations and key clients
Our team also performs other extensive HPLC testing, which includes structured methods and validation, wet chemistry testing, microbiological testing and stability testing. Standard Operating Procedures (SOPs) cover all aspects of production, including facilities, equipment, components and closures, production processes, sanitation and maintenance, packaging and labeling, with requisite record keeping and controls at every stage.
Additionally, we have an on-site, full-service analytical and microbiological laboratory that is staffed with microbiologists and outfitted with state-of-the-art equipment. We also provide ongoing internal training programs for our staff that are taught by our in-house experts of each appropriate discipline, allowing our team to always function quickly and effectively.
Celmark maintains strict quality control throughout every step of operations.
Testing processes include formulation (stability and bacterial); batch (QC review, organoleptic and Certificates of Analysis); Finished Products (fill, batch control and retained samples)