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.


Testimonials

I always prefer to make our products at GFR if possible, because I am confident with your product quality and service for us.

We are growing well steadily in the Korean market and so orders are continuous and items keep increasing.

I really hope to work closely with GFR with most of our products.
James T.President
Please forward my sincere gratitude to the GFR team. You guys are seriously, seriously on-it!
Chris GFounder
We appreciate our relationship with GFR. From QC to communications, we have found working with GFR to be a pleasure, highlighted by excellent communications and reliable delivery dates. Thank you.
Michael BentleySierraSil Health Inc.
In all my years, I can honestly say, no other company I have ever worked with has provided me with such an unparalleled level of care and service. Literally, GFR Pharma has provided my company with the best level of service I have ever experienced. You are that good, that efficient, that professional.

If there was a problem, it was fixed. If there was a challenge, it was met. If there was a deadline, it was met.

It’s time for an official thank you.
Great first experience manufacturing my product with GFR. I am definitely going to be utilizing your services in the future for more of our products and look forward to our next project with you. Thanks again!
We cannot wait any longer to express our appreciation for your help during our production process.

We thank you for your professional suggestions and the quick responses to every question we have had; you have been so patient in helping us with every one of our inquiries.

Your guidance throughout the entire product development and production is a tremendous support to us.