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Quality

Quality - Production StaffPharma Nord’s manufacturing facilities and standard routines comply with the rigid GMP (medical drugs) and HACCP (dietary supplements) rules. The reason for this is that the exact same manufacturing team produces both our medical drugs and dietary supplements. All production staff follow the same procedures with respect to quality, hygiene, and documentation, regardless of the product. That way employees do not have to worry about which set of standards they follow in the different situations.

Only one standard applies – the highest of all.

Quality - Raw Materials InventoryAt the raw materials inventory we receive all items needed to produce the finished goods:

  • Packaging
  • Excipients
  • Active ingredients for tablet/capsule manufacturing.

Purchase
Pharma Nord only uses raw materials from suppliers that are able to meet our extremely high quality demands. Every single raw material item has its own specification that we must comply with. This is the case not only with active ingredients but even filling agents and packaging. Our Quality Control Manager personally inspects the manufacturing facilities at every one of our suppliers of drug standard active ingredients.

Full Traceability
At Pharma Nord, we register and supply all raw materials with unique batch numbers so they can be traced throughout the entire manufacturing process.

Quarantine
Upon arrival, the quarantine inventory is where all the raw materials and packaging components go. This is to ensure that the goods comply with the specified specification. We either destroy or return any goods to the supplier should they not meet our requirements. Once the raw materials have been through quarantine they enter the actual production site.

The laboratory conducts many of the analyses that are required in connection with the manufacturing of food supplements and medical drugs. At Pharma Nord we fully trust those raw material suppliers with whom we collaborate with  however we still conduct our own analysis. In addition, we select random samples during the manufacturing process to examine. Certain analyses that require highly specialised equipment are conducted by accredited external laboratorities.

Laboratory - Quality Strict Demands - Quality

 

 

 

 

Strict Demands
According to a strict plan we examine all dietary supplements and medical drugs. For instance, we test if capsules and tablets dissolve within a specific period of time to ensure that the active ingredients effectively release and absorb in the body. Also, we control their size and weight to ensure they correspond with our specifications. All finished dietary supplements must, as a minimum, undergo a random-sample control analysis once a year. Each individual production batch of medical drugs must undergo a control analysis in order to document that it meets the specifications.

Shelf Life Testing
We carry out shelf life tests on all medical drugs and certShelf Life Testing - Qualityain dietary supplements in order to ensure that the active ingredients maintain the right strength at the expiration date of the preparation. To ensure the reliability of this test we conduct it in special climate cabinets with specific temperature and humidity levels. This is in order to document the quality of the products throughout their entire shelf life.

The Quality Department is responsible for quality assurance and quality control. It is important that the person in charge of this function (Quality Control Manager) is independent of the production.

Certifications
Pharma Nord is a certified manufacturer of both food supplements and foodstuffs. We always employ the toughest requirements for drug manufacturing (GMP) and food manufacturing (HACCP).

Good Manufacturing Practice - QualityGMP is short for Good Manufacturing Practice and includes a number of protocols that form the basis for the quality assurance used in the manufacturing of medical drugs and active pharmaceutical ingredients.

Pharma Nord makes sure they train their entire production staff (including the inventory staff) in regards to GMP rules. This includes self-inspection and external inspection.

Besides GMP, Pharma Nord uses HACCP (Hazard Analysis and Critical Control Points), a system based on risk analyses and critical control points in the production of food.

Internal Control
Internal Control - QualityThe Quality Department is responsible for such things as controlling raw materials, intermediate products, packaging components, and finished goods. As part of these control procedures, the Quality Department evaluates the batch documentation, results of the process control, and results of analyses in relation to pre-determined specifications. We release the products once they meet the specifications. Should they not meet our specifications, we destroy the product.

The Quality Department stores reference samples of every single raw material batch and finished goods batch for at least six years for situations such as control analyses by the authorities, or complaints.

In addition, the department is responsible for ensuring that every single department carries out regular self-inspection to guarantee they’re following the GMP and HACCP rules. If necessary, the Quality Department must suggest the necessary changes to make sure that the quality assurance systems are up-to-date.

External Control
The Danish Medicines Agency and the Danish Veterinary and Food Administration regularly visit Pharma Nord to carefully examine their documentation and inspect their facilities and procedures. Furthermore, some of Pharma Nord’s larger customers frequently visit the site.

Registration
Any manufacturer of medical drugs and dietary supplements needs to keep track of a variety of rules, especially if the manufactured goods are exported to and sold in other countries. Pharma Nord’s registration department handles this extensive task.

Same Product but Different Rules
Our registration department is responsible for registering and reporting all Pharma Nord products in order for them to be marketed legally in different countries. It is tedious work to keep track of each country and its local rules for which products are medical drugs or food supplements, and which amounts of active ingredients are allowed. In many cases, a product that is marketed as a medical drug in one country is marketed as a food supplement in another.

This is the ‘heart’ of Pharma Nord’s production plant in Vojens. Here, all the different raw materials are converted to tablets and capsules under tightly controlled conditions. In order to ensure full traceability, every single production is supplied with a unique batch number.

Production Area - QualityHygiene - Quality

 

 

 

 

 

Hygiene
Before entering the production area, you are guided through a locker room and instructed to put on a gown (white coat), a hair net, and clean footwear. Furthermore, you are instructed to carry out a thorough hand wash.The entire production area has slight over pressure in order to prevent polluting particles on the outside from entering.

The entire production staff must use gloves at all times when carrying out manufacturing processes that involve direct contact with the products, for instance, weighing and taking out samples.

Tablet Production
Tablet Production - QualityThe first room is for mixing tablets. Here,  we mix the different ingredients in accordance with a long list of standard procedures that we control thoroughly throughout the entire process. We pour the powder into a mobile container which can move to the next machine where we either press the powder into tablets or fill it into hard capsules.

Afterwards, we coat the tablets with a protective layer that extends their shelf life and makes them easier to swallow. Certain tablets must even have a special colour, either for the sake of protecting the active ingredients or to make them easy to recognise.

Capsule Production
Capsule Production - QualityThe Production Department also manufactures different types of capsules. Pharma Nord’s specialty is the manufacturing of soft gelatin capsules in different varieties. The active ingredients are mixed in an oil solution and encapsulated in soft gelatin.

During the manufacturing we measure and verify the content, while also making sure the gelatin shell has the correct thickness. We document all of this at time intervals during the production. Upon completion of the capsules we also control this by means of a random sample in Pharma Nord’s own laboratory.

Once the assembly of the capsules is complete they pass through a series of chambers that serve as tumble dryers. Afterwards, we collect the capsules in large plastic trays and place them in a special drying compartment for another day or two. We sort the dry capsules and discard any which are the wrong shape or size. The rest of the batch is now ready for packaging in large plastic bags which we quarantine until the completion of quality control.

Control
Control - QualityDuring the actual production, several control procedures help to ensure that everything is on track. Once we complete each production, we thoroughly check each capsule and/or tablet in terms of weight, content, dissolution time, etc.

At the same time, we go through all control documents to ensure that we carry out procedures correctly. The production of one single preparation involves filling in as much as 32 different control documents.

Cleaning
After each round of production we clean the machines. This effectively removes any trace of the former product and prepares the machine for the next production. The cleaning procedure is very time-consuming. In fact, the cleaning routines are that tedious it may take between 6 and 24 hours to prepare one single machine for the next round of production.
All cleaning procedures in the production area go through validation. This proves the product’s efficacy and means that no products face exposure to contamination. There are checklists to document and control the cleaning.

Packaging and Inventory - Quality When the Quality Department releases products they are ready for packaging. Upon completion of production, we house the tablets and capsules in large containers until they are ready for shipment. Every time a batch is ready for shipment, we remove a small amount of capsules or tablets for control purposes.

Dietary Supplement or Medical Drug
Sometimes we may require breaking down one single production into a variety of smaller operations. An example of this, for instance, in cases where the product is available in several countries or in different box sizes. With some products, there may be different rules, so two identical products end up as either a dietary supplement in one country or a medical drug in another.

For this reason, the manufacture of all products is to the highest standard. A product that is manufactured as a medical drug can easily be sold as a dietary supplement. This is not the case the other way around.

Dietary Supplement or Medical Drug - Quality

Hygienic Packaging
All Pharma Nord tablets and capsules are packaged in hygienic blister packs. This increases the shelf life of the product after opening.

Inventory
Once the Quality Department releases products that are complete they send them to distributors and retailers worldwide. You can find Pharma Nord’s dietary supplement and medical drugs in shops in over 45 different countries.

Pharma Nord’s products are primarily in shops where the customers are able to get qualified assistance. That way we can provide the best conditions for making the right choices when it comes to selecting the most suited preparation.

The combination of documented products and sales through stores and pharmacies that can provide consumers with useful advice is the main reason why Pharma Nord has worldwide success and recognition.

Over the years, Pharma Nord has won several awards from branch organizations and consumer organizations on the different markets.

Produced in Denmark

All Pharma Nord’s products are manufactured at our state-of-the-art production plant in Vojens, located in the southern part of Jutland. When we say “Produced in Denmark” it is much more than an empty phrase. Our products are not merely capsules and tablets from foreign suppliers which are packed in boxes in Denmark. All our products are made from scratch by Danish hands. The products are manufactured in accordance with Danish legislation and are under the auspices of the Danish health authorities.

Denmark - Quality

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