How Good Manufacturing Practice (GMP) Works

AOR is committed to producing products of the highest quality and safety. We operate a Government licenced facility in compliance with Good Manufacturing Practices (GMP). Here is a brief look at the five processes and procedures involved in manufacturing an AOR product.

Master Formulae
It starts with the recipe – or Master Formula. This details everything in the formula: both the active ingredients and the excipients. In addition, all the procedures required to produce the solid dosage form (the product) are also listed.

Sourcing of Raw Materials
Using the right supplier is critical in producing the quality finished product. The raw materials must consistently meet all the specifications from batch to batch. The Vendor Certification Programme requires performing Due Diligence in certifying potential suppliers. Quality and consistency is the key issue at this stage. AOR only uses superior materials sourced from leading suppliers.

Quality Control (QC)
The quality of a product is defined as consistently meeting North American Pharmacopeia specifications with little or no contamination while being of a stable nature. Canadian regulations require routine testing of batches for identity, purity, microbiology and heavy metals. AOR exceeds these regulations by performing regular testing on the raw materials from each supplier by independent third-party laboratories.

GMP - Manufacturing
Since January 2004, all Canadian food supplement manufacturers have been required to obtain an Establishment Licence from the Canadian Government in compliance with Good Manufacturing Practice (GMP).

GMP acts as an umbrella that covers the entire manufacturing process and includes the premises, production procedures, equipment and personnel.

Compliance is achieved by using a series of Standard Operating Procedures (SOPs), a list of steps for each process carried out in a specified manner. Proper record keeping is vitally important for complete traceability and to maintain the Licence.

The basic manufacturing process involves: blending, encapsulation, cleaning and polishing, packaging, and final testing of the finished product before release. QC is involved in every step from raw materials to finished products.

Clean premises and machinery are vital as are proper filtration systems such as HVAC filters on the air intake units.

Personnel
One of the key components of GMP is having the right staff for each department. AOR only appoints staff with the relevant qualifications and industrial experience and regular training is provided for new SOPs and equipment training.