Even the best quality program requires diligent application to succeed. ChemRite’s Quality Control team is uncompromising about the quality of the products we produce. We believe our customers have a right to expect this of us. Each Quality Control technician has been trained and are supervised to adhere to the standard operating procedures contained in the CRCP QA Manual. We manufacture every project in the same manner, with an intense focus on standardized quality from beginning to end.
ChemRite’s Quality Control Procedures Include:
- Incoming raw material and packaging component inspection
- In-process batch assays, production inspections and final product release protocol
- Ongoing audits and corrective action procedures
- Defect corrective action for complaint resolution
- Archive of raw material and batch retain samples
Incoming Raw Material and Packaging Component Inspection
A product is the direct result of the compounds which constitute it. Therefore, each raw and packaging material we receive is inspected and approved before it is used in production. All incoming materials are quarantined upon receipt, and may only be used after they have been “Green” tagged, or passed quality inspection. Records of each inspection are kept as a component history. All materials are electronically lot coded and stored for use in FIFO (First In, First Out) order.
In-Process Batch Assays, Production Inspections and Final Product Release Protocol
Meticulous quality inspection continues as each product is filled and packaged. Quality Control technicians monitor every step of the operation - from line start up inspections to customer specified recurring line run checks. QC personnel oversee packaging factors such as fill weight, cap placement, leakage, label placement, and much more. Intensive inspection and recording assure the job will be done right the first time. Date coding is affixed to all packages and shipping cartons.
Ongoing Audits and Corrective Action Procedures
ChemRite works with a large network of quality vendors and service providers. To insure our high standards are being upheld, we maintain an extensive audit and validation program of all products, equipment, vendors and service providers. New material vendors must provide ChemRite with a current quality control policy or a certificate to show that a quality control system is in place. Service providers must comply with ChemRite quality protocols and OSHA safety standards. Any material vendor or service provider which has a quality issue passes through a corrective action procedure.
Defect Corrective Action for Complaint Resolution
Many quality and production issues can be avoided by defining defects in incoming components before they reach the production lines. ChemRite’s procedures for defect corrective action increases the quality of a finished product and supports in-house production efficiency. Defects may be classified as critical, major or minor. A defect memorandum is issued to the vendor of the defective product and a corrective action is agreed upon. ChemRite complies with its own defect corrective action procedures for any product it produces outside of a customer’s quality specifications.
Archive of Raw Material and Batch Retain Samples
Raw materials and batch retain samples are archived per cGMP compliance requirements. Raw material retains are stored along with the products assay sheet. All batch retains are batch coded. They are stored in a temperature controlled, password locked room which is monitored by our Quality Control director.