Quality Assurance
Our focus on Quality Assurance enables GFR Pharma to consistently produce high quality supplements. Our Quality team has systems in place to minimize product variances, and has established multiple quality control measures to test that the products meet established quality standards.
GFR Pharma has implemented a comprehensive set of Standard Operating Procedures (SOPs) in accordance with Good Manufacturing Practices (GMP) and the requirements of Canadian and international regulatory bodies. Our staff carefully adhere to the SOPs to maintain consistency in every step of the manufacturing process. SOPs are regularly reviewed and updated as necessary to ensure that procedures are modified when changes are made to equipment or processes.
GFR Pharma’s quality management system enables our production staff gets it right the first time by the placement of manufacturing processes and controls including: preventative machine maintenance performed at regular intervals, having staff thoroughly trained in GMP & hygiene procedures, and a facility designed and maintained for sanitary operations.
Our GMP-compliant facility and operations are regularly audited by independent certifying organizations.
Facility
We minimize potential issues by maintaining the structural integrity of our manufacturing facility. Our facility was designed to reduce the possibility of contamination from outside sources and a security system prevents unauthorized personnel from accessing the building. Our facility promotes hygienic practices by including features such as hand washing stations strategically located throughout the building. An air filtration and ventilation system is in place to minimize cross-contamination. Storage, manufacturing and packaging areas are entirely separate from each other and clearly identified.
Equipment
GFR Pharma’s maintenance team keeps all equipment functioning to a set of pre-determined quality standards. When new equipment is purchased, it undergoes a validation test for a specified set of quality parameters and is then tested against these criteria over time. Equipment is regularly inspected and calibrated when required. Routine preventative machine maintenance is performed on a scheduled basis following written protocol.
Staff Training
All production staff are extensively trained on GMP regulations. GFR Pharma employs a full-time training coordinator to provide training and keep personnel training records up-to-date. Our highly experienced production supervisors are “hands-on” in all areas of production to monitor various quality aspects.
Sanitation
The Facility Sanitation Program covers cleaning procedures for the facility and equipment. In accordance with documented cleaning procedures, all surfaces, including walls, ceilings, and machinery, are thoroughly cleaned and sanitized after every production run. These exhaustive line clean-ups are conducted and recorded per validated procedures to prevent any possibility of cross-contamination. Once equipment has been cleaned, it is stored in a way to prevent recontamination until it is needed again. A list is kept of all cleaning agents used and the chemicals are stored away from raw materials and packaging. Procedures are also in place for the safe disposal of waste materials.
Health & Hygiene
The Health & Hygiene Program covers regulations for all workers that come in contact with materials or equipment used in production. GFR Pharma supplies its personnel with outer garments, shoe coverings, and hair restraints to maintain a hygienic work area. Personal effects, including jewelry or outside food are kept out of processing areas.
Manufacturing Controls
Our Manufacturing Process begins by ordering pre-qualified raw materials from verified suppliers to guarantee consistent quality. Our Quality team ensures that raw materials are properly received, stored, sampled and tested before being used in production. When materials are received they are assigned a barcode through our SAP Business system. Every time a material is used or moved, it is tracked electronically. Operators must scan ingredients before use in production to minimize any potential human error. Finished products are again scanned after the end of production and their lot numbers recorded before being shipped out. SAP provides an extra check mechanism at every stage of the manufacturing process.
Product Testing
Through an established quality control system, we are continually checking that finished products meet specified requirements throughout the manufacturing process. We not only perform in-house quality checks but also send all finished supplements to certified third-party laboratories for further testing depending on the customer’s requirements. If required, GFR Pharma can assist in setting up stability testing to determine expiry dating. GFR Pharma retains samples of all production lots in case further testing or quality checks are required. All quality documentation and records are signed, dated, and kept secure for the period of time required by regulations.
Continuous Improvement
There are systems in place to continually evaluate each process and we seek continuous improvement. Our goal has always been to exceed client expectations in every aspect of the manufacturing process, starting with a foundation of quality.
