biofen

Who owns the company?

This is a private company which is based in Brooks, Alberta, Canada, and is 100% Canadian owned & operated.

What is the regulatory status of our Manufacturer and where are they located?

Our contract manufacturer is also based in Western Canada. The manufacturer carries both a GMP Establishment Licence for drugs through Health Canada’s Therapeutic Products Directorate (TPD), a Site Licence through Health Canada’s Natural Health Products Directorate (NHPD), and a Therapeutic Goods Administration (TGA) GMP certificate for export to Australia.

What other government permits and licences do we hold?

The Bio-Fen shampoo & conditioners are registered with Health Canada’s Cosmetics Programme. This means that Health Canada has reviewed all of the ingredients and label claims for compliance. Health Canada assigns Notification numbers, however, these numbers are retained only within Health Canada and not issued to the product owners. Although not legally required for personal care products, the contract Canadian manufacture of the shampoo and conditioner also has a Drug GMP establishment licence.

What regulations are we required to comply with?

The BioFen Plus capsules must be manufactured, packaged, and labelled to at least the NHPD’s version GMP (see definition below). However, the contract manufacturer exceed these requirements, since they also have certification for the Drug version of GMP.

As the distributor of the capsules, HGT also has GMP in place, but is exempt from requiring a Site Licence.

HGT has applied for a Natural Product Number for BioFen Plus back in August, 2005. It’s Submission Receipt Acknowledgement Number (SRAN) is 109652. However, due to the present backlog of applications, it will take some time to receive our Natural Product Number (NPN), This 8-digit NPN will then be placed onto the product label, similar to a Drug Identification Number (DIN) on drug products.

What is GMP?

It stands for Good Manufacturing Practices. These are measures that ensure an effective overall approach to product quality control, safety and risk management. It can also help identify exposure to risk, therefore enables one to be proactive, rather than reactive.

This requires that appropriate standards, practices and controls regarding product manufacture, storage, handling, labelling, testing and distribution are attained. Written Standard Operating Procedures (SOPs) must be created. Various forms and/or checklists must then be completed to demonstrate that those SOPs are being followed.

Here are some examples of key SOPs that are required:

Receipt, inspection, sampling and testing of the raw materials & finished product
Storage & distribution
Sanitation, hygiene & pest control
Complaint handling & product recall
Determining product stability (shelf life)
Training of personnel & outlining responsibilities
Storage, backup and disposition of electronic and paper records (in case of recall)

What types of quality control testing is done for the BioFen Plus?

The following applies to all of the raw materials and finished product:

1. Identity: to ensure the correct genus & species of herbs are used.

2. Purity: to ensure no contamination from fungus (yeast & moulds), bacteria, heavy metals, solvent & pesticide residues.

3. Potency: to ensure the amount of active ingredients listed on the label are actually in the product.

Is HGT subject to GMP audits?

Yes, an internal inspection of HGT for GMP compliance by a highly qualified third party auditing firm is carried out once per year. The contract manufacturer is audited by Health Canada once each year, as well.

Do we have a quality assurance person, and are they qualified for the job?

HGT presently contracts the QA Officer services of Innovative Consulting Solutions Inc. (www.innovating-canada.com). The QA Officer is a member of the Association of Chemical Professionals of Alberta (ACPA), which has a code of ethics as a Professional Chemist (P.Chem.).

The responsibilities of our QA officer include, but are not limited to:

assuring the quality of the NHP before it is made available for sale;
investigating and recording every complaint received in respect of the quality of the NHP;
ensuring conformance to specifications and regulatory requirements;
ensuring SOPs are being followed;
approving or rejecting: formulations, procedures, specifications, test methods & results;
approving or rejecting contract-manufactured products;
ensuring that completed batch records are reviewed, maintained, and a decision is made to approve or reject the product for distribution;
sending the product to appropriately accredited QC testing labs;
determining and documenting the education, training and / or experience required for all personnel performing work affecting Quality;
performing internal & external quality audits; and
performing GMP training.

What is our stance on Genetically Modified Organisms?

Our company is against using GMOs in our products. Our QA / Regulatory Officer has kept abreast of these regulations and has been lobbying Health Canada to implement regulations, forcing products known to have GMO ingredients in them, to list them on their labels.
Therefore, our products only use ingredients that the suppliers can attest that they are GMO-free.