Quality Assurance and Testing
The Quality Management System at UniWell Laboratories is a comprehensive quality program designed to meet and exceed the cGMP requirements set forth in Title 21 of the CFR for parts 211, 110, and 111. The Quality department is involved in all aspects of UniWell’s business from R&D, Product Development, to the completion of the Finished Product in Operations. Quality Department is strategic in assuring that the facility is designed to enable proper flow of incoming raw materials to the distribution of finished product. All raw ingredients and packaging materials are received into our electronic warehouse system (SAGE). All raw material and intermediate bulk testing are performed in our State-of-the-Art laboratory. Each raw material undergoes vigorous testing and includes Infrared Spectrometry (FTIR) or wet chemistry for Identification testing, Karl Fischer, LOD or moisture analyzer for water determination in the raw material, ICP-MS for Heavy metal determination and a Rapid Microbial Method System for Microbiological determination which can be completed within three days. A batch records is created for each significant step in the process of a product. The significant steps in a process is the Weighing/Blending, Filling and Packaging. The Batch record documents each step performed by the operators to assure each ingredient is weighed correctly and added at the precise time according to the original formula in Product Development. Each intermediate blend is submitted to the lab for a panel of tests to assure the blend is homogenous. These tests include bulk density, brix and organoleptic testing. The finish good testing is performed after Packaging is completed to assure that the physical, chemical and microbial testing such as product weights, lot code placement, expiration dating, seal integrity, absence of Heavy metals, Microbial challenge for Total Plate Count, Yeast and Mold, Coliforms, E. coli., Salmonella, Staph aureus, Pseudomonas, and Enteriobacteriaceae meets the customer specifications and expectations.
The water used in this facility for the manufacturing of product and rinsing of equipment meets the current USP Purified Water requirements and specifications. The system was installed and validated according to the USP 35 guidelines. The water System is designed to provide 10 gallons a minute at any given time. The system is equipped with an Ozone generator that provides a layer of protection in the storage tank to maintain or decrease the bioburden level in the closed system. The Purified Water Ports are sampled and tested daily for total organic carbon, conductivity, and microbial contamination to ensure adherence to current USP Purified Water requirements.
During the filling and packaging of the finished product the batch record documents that qualified personnel performed pre and post line clearances, perform statistical sampling and testing of the product to assure that the physical requirements of the package meets the specifications supplied in the batch record. All employees undergo extensive training and documentation on all Batch Records, SOPs, Test specifications, and safety procedures. All shipments are palletized according to specific instructions in batch record. Each pallet is securely wrapped with polyethylene film. A pallet tag is attached to the front of the pallet for identification. All completed pallets are stored in the shipping area awaiting shipment.
Each production room is designed with the quality of the product in mind. Separate air handlers are utilized in each room to prevent cross contamination for air return. Rooms are air balanced to eliminate any cross-contamination issues. Rooms are constructed with washable walls, floors and ceiling to remove any unwanted product from previous runs. Each piece of equipment and rooms have a bound cleaning log that remains in the room or on the equipment at all time. This log book documents the type of clean and sanitization, ATP test results, performed by and checked by, Lot Code and Product start and end date of each product manufactured on that line. The facilities Temperature and Humidity is monitored by 30 sensors every 5 minutes that are strategically place in the facility to assure that all hot and cold spots are being monitored. The system sends an e-mail to specified personnel when any of the sensors drop outside the specified ranges. We provide customers with lockable secured areas for all printed material such as Film, labels, shippers. We currently provide our customers with the ability to determine shelf life of their product. An Accelerated stability chamber (40°C and 75% relative humidity) and a Real Time stability chamber (25°C and 60% relative humidity). UniWell Laboratories Quality Control Group maintains a retain program for all product, as well as, raw materials used or produced in this facility.
The Quality Assurance Department maintains a secured documentation system which includes a change control process for each document that is created or modified. All documents are maintained in a secured computer server. All old documentation revision is archived and stored as required by the FDA. Quality Assurance Department provides the customer a Certificates of Analysis (C of A) on all approved product that is manufactured at the plant. The C of A contains the Lot code, test results, expiration Date, manufacturing date, and quantity approved.