GFR Pharma

Quality Assurance

CGMP COMPLIANCE the quality management program that GFR Pharma Ltd. adheres to is in compliance with the Good Manufacturing Practices Regulations, Part 3 of the Natural Health Product Regulations. Health Canada through its Natural Health Products Directorate only issue site license to establishments that meet all the requirements of the regulations and its corresponding guidance document. GFR Pharma Ltd. is GMP compliant and holds a site license.

QC Department GFR Pharma Ltd has a quality assurance/control department responsible for the implementation of the quality system management and good Manufacturing Practices. the department is independent to the operations and production department. the QC/QA department is composed of qualified and trained personnel.

“We believe that product quality should be built in the product from its conception and all throughout the processes it undergoes. Practices and procedures are in place for material control and process control to ensure that products are of high quality.”

Material Control Material control procedures ensure that all materials that will be used in the product are covered by specification; sampled, inspected and tested against the specifi cation, and released based on compliance with the specifications. This will further ensure that no substandard, rejected, expired or obsolete material will be used in production. We work closely with suppliers so they understand our quality requirements and collaborate with them to ensure that only quality materials are supplied to us all the time. All materials and components used in manufacturing and packaging are identified by distinctive code and received against unique lot number ensuring that there will be no product mixed-up. Label control procedures are in place from receiving, inspection, checking accuracy and limited access storage (locked up). These controls guarantee that no obsolete labels will be used in the product.

Process Control Process control procedures make certain that all manufacturing, packaging, and labeling activities are done in accordance with the approved master formula. Process control starts with the formulation.

Each product is formulated to ensure that it adheres to regulatory requirements, client’s specifications, and label claims.
A master formula is created for the manufacturing, packaging and labeling of each product.
Designated quality assurance/ control person reviews and approves the document, and only that time the document will be used to generate manufacturing work orders.
Material and process controls also allow for effective product traceability.
Standard operating procedures for operation of equipment are in-place.
Manufactuing procedures are established for each product.
In-process checks are done during the manufacturing and packaging stages, making sure that the product is manufactured againts the parameters specified.
Line clearances, equipment and room clean up are done at the end of each run to prevent cross contamination and product mixed up.

Finished Product Testing Finished product testing and inspection are done on products. Only products that meet the specifications are released for sale. Finished product testings ensure that the product can meet label claims and that they are free from chemical and microbial contamination. All testings are done by accredited third party laboratories.