Pharma Nord Sweden passes strict demands for documentation and safety

The Swedish trade association for dietary supplements and drug registered health products, has along with Swedish authorities established a number of industrial guidelines as a "gold standard" for quality, safety and self-monitoring systems, which must be in place with reputable suppliers of dietary supplements in the Swedish market.

In this context, the Supplement Association have teamed up with an independent certification agency: LRQA who also performs ISO certifications. There are very strict requirements to companies, but Pharma Nord Sweden have now become certified.

In Sweden as in most of the EU, there are increasing demands for quality and documentation of food and also dietary supplements. Pharmacy chains and health food stores go still further in their demand on suppliers to ensure that they can vouch for the products and that the contents are safe for customers.

The criteria for certification are developed by the independent company LRQA which is part of Lloyd's Register Group working in over 120 countries.

The certification process consists basically of two phases and requires management, systematics and documentation:

• Step 1 consists of a document review. Documents describing the company's quality, safety and self-monitoring systems are reviewed and considered in relation to the standard requirements on everything from raw material qualification to the labeling of the finished product.

• Step 2 consists of an analysis and a review of the implementation of the company's routines where auditors with the company closely examines the company's quality systems and self-monitoring programs to assess whether they comply with the stringent criteria.

There are requirements in areas such as production and HACCP procedures, traceability, labeling, safety and general compliance with existing legislation.

The company must among other things show that its staff possess the skills necessary to meet the organization's guidelines and regulatory requirements.

The final approval involves a very high degree of assurance that the company has a grip on things. The benefits of certification are obvious. The company gains increased focus on safe work practices, a better overview, safety, and smooth control visitations. For one thing the company gets an increased focus on safe work routines. Another thing is that a certificate of approval gives the company an official seal of quality and thus unhindered access to deliver goods to for example, pharmacies and health food stores.