Solutions Corp. is committed to Total
Quality Management and all the products
of McCuaig Solutions Corp. are manufactured under Good
Manufacturing Practices (cGMP). The selection of raw materials,
blending of ingredients, packaging, labeling, storage
and distribution of products are all critically important.
The Quality Assurance program
ensures the effective implementation and monitoring of
the following systems:
- 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
- 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
- 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
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.