• Quality Control: The QC unit is responsible for the acceptance and rejection of incoming, in-process materials and finished products. Laboratory practices include detailed procedures and adequate documentation to provide a high degree of data integrity and to assure adequate control, includes incoming QC, analytical, microbiology and in-process testing.
  
• Manufacturing Control: A system of controls designed to ensure raw materials and products have the identity, strength, quality and purity they are required to have. To assure uniformity from batch to batch, master production and batch history records are used. A unique lot number is assigned to identify a batch in order to track its history through manufacturing, testing, filling, packaging and distribution.
  
• Maintenance & Calibration Program: Provides the mechanism to ensure manufacturing and testing equipment are in good working order and to ensure reliance and confidence of data obtained.
  
• Validation Program: A program that encompasses Vendor Certification, Facility and Equipment Validation, Cleaning and Process Validation, and the methods used to test and control products.
  
• Out of Specification & Complaint Handling: A system to ensure an adequate investigation is performed on any unexpected discrepancy in batch processing or testing prior to re-testing or re-work and for ensuring product quality complaints are investigated and resolved.
  
• Training Program: A program covering GMP’s, ISO 9001 and Company SOP’s to ensure that personnel engaged in the manufacturing, processing, packaging and storage of all products have the education and training to perform their responsible function.
  
• Internal Auditing: A comprehensive self-inspection program used to monitor the implementation and compliance with current Good Manufacturing Practice principles and the McCuaig Solutions Corp. Quality Management System and to ensure that the necessary corrective measures are taken.

Regulatory Compliance is an integrated system of security, confidentiality, manufacturing controls, process validation, quality control, quality assurance, document control and on-going quality inspections. We maintain strict standards of compliance and continually review procedures to best serve our clients.

McCuaig Solutions Corp. maintains a comprehensive document control system to manage all documents involved in cGMP and ISO 9001 operations. This system includes such documentation as Quality Management procedures, raw material and finished product specifications and testing, standard manufacturing procedures as well as product batch records. Other critical systems such as change control protocols, document history filing and secure document storage all serve to fulfill regulatory compliance.

We monitor all operational processes for continuous improvement. This is our guarantee of the commitment we have to our customers, their products and the business relationships that we have established.