Quality Assurance at Rhine Laboratories
The QA department is our backbone and guiding force in the endeavour to manufacture pure and all complying products. Full Traceability is maintained at all times for your benefit. The latest Protocols are always available with us, to ensure complete compliance with IP, BP, USP, FCC and BP Ph Eur. Changes are closely tracked and our in-house database is constantly updated with necessary Change Control measures.
We attach great importance to the Validation of Processes, Equipments, Test Methods and Cleaning Methods. High standards of Data Integrity are a given and SOPs are considered sacrosanct. Highly robust Recall Plans are followed for transparent and immediate response to our esteemed customers.
Quality Control at Rhine Laboratories
Our QC laboratory follows GLP compliant and certified systems. All reagents are suitably validated and usage history is duly documented. Samples are retained for all batches as per stipulations. Long Term Stability and Short Term Stability studies are an ongoing process at Rhine Laboratories. The Water Quality is monitored regularly as per pharmacopoeial standards.
This ensures safe and all complaint production processes. In house Quality Checks are in place to test Raw Materials, Intermediate Materials, Packaging Materials and Finished Products. The testing of Vanadium, Lead, Arsenic, Mercury, Nickel and Cobalt is done on ICP-MS to ensure accuracy levels of 0.01 ppm. We have systems in place for accurate testing of all parameters in our QC Department and welcome you to audit these systems.
Production at Rhine Laboratories
The complete production chain is designed to be free from human contact and all machinery is made of GMP approved SS316 material. The product does not get exposed at any stage from raw material to finished product, thereby ensuring product purity. Custom designed Pneumatic Material Handling Systems are used for all material handling. These systems are thoroughly cleaned as per validated GMP protocols.
The entire spectrum of powders and granules is sieved via custom built Magnetic Separators to ensure zero metallic impurity. Line clearance protocols are designed to keep cross contamination to zero. Mesh Integrity is managed by well established protocol SOPs. The entire plant has 5 micron air supply to ensure Clean and Safe environment for production processes.
Our manufacturing processes are custom designed to keep bacteria contamination within limits. We do not need to treat our Magnesium Carbonates, Magnesium Oxides and Magnesium Hydroxides with Ethylene Oxide. Hence, you are always assured of products which are safe, pure and odourless with zero Ethylene Oxide residue.
Certifications of Rhine Laboratories
