Quality

All of Pharma Nord’s manufacturing facilities and standard routines comply with the rigid GMP (medical drugs) and HACCP (food supplements) rules. The reason for this is that the exact same manufacturing team produces both our medical drugs and food supplements. Every production staff member is trained to follow the exact same procedures with respect to quality, hygiene, and documentation, regardless of what type of product they are in the process of manufacturing. That way the 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.

At the raw materials inventory, we receive all items needed to produce the finished goods: Packaging, excipients, and active ingredients for tablet- and 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 must be complied with. This is the case not only with active ingredients but even filling agents and packaging. Pharma Nord’s Quality Control Manager personally inspects the manufacturing facilities at every one of our suppliers of drug standard active ingredients.

Full traceability

All raw materials are registered and supplied with unique batch numbers so they can be traced throughout the entire manufacturing process.

Quarantine

Upon arrival, all raw materials and packaging components are placed in our quarantine inventory. The reason for this is to ensure that only goods that comply with the specified specification are used. Once they have been controlled and released they are allowed to enter the actual production site. Goods that do not meet the requirements are either returned to the supplier or destroyed.

Pharma Nord’s laboratory conducts many of the analyses that are required in connection with the manufacturing of food supplements and medical drugs. Although we fully trust those raw material suppliers with whom we have collaborated for years, we always conduct our own analysis of the raw materials we receive. In addition, random samples are taken out during the manufacturing process and examined, just like the finished products are carefully analysed. Certain analyses that require highly specialised equipment are conducted by accredited external laboratories.

Strict demands

Both food supplements and medical drugs are examined in accordance with a detailed plan. For instance, we test if capsules and tablets dissolve within a specified period of time to ensure that the active ingredients are effectively released and absorbed by the body. Also, we control that size and weight correspond with the specifications. All finished food supplements must, as a minimum, undergo a random-sample control analysis once a year, whereas each individual production batch of medical drugs must undergo a control analysis in order to document that it meets the specifications.

Shelf life testing

All medical drugs and certain nutritional supplements are submitted to a shelf life test in order to ensure that the active ingredients maintain the right strength at the expiration date of the preparation. The test is conducted in special climate cabinets with specified temperature and humidity 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 required 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).

GMP 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’s entire production staff, including the inventory staff, is trained to follow the 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

The 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. Once the specifications are met, the products are released. If not, they are destroyed.
The Quality Department stores reference samples of every single raw material batch and finished goods batch for at least six years in 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 that the GMP and HACCP rules are followed. If necessary, the Quality Department must suggest required changes to make sure that the quality assurance systems are kept up-to-date.

External control

Besides Pharma Nord’s self-inspection we are visited regularly by representatives from the Danish Medicines Agency and the Danish Veterinary and Food Administration who carefully examine the documentation and inspect our facilities and procedures. Furthermore, we are frequently visited by several of our large customers.
 

Registration

Any manufacturer of medical drugs and food 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.

The 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.

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

The first room is for mixing tablets. Here, the different ingredients are mixed in accordance with a long list of standard procedures that are thoroughly controlled throughout the entire process.
The ready-mixed powder is poured into a mobile container that can be moved to the next machine where the powder is pressed to tablets or filled in hard capsules.
Afterwards, the tablets are coated 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

The 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, the content is carefully measured and verified, and we also make sure that the gelatin shell has the correct thickness. All of this is documented at specified time intervals during the production and controlled afterwards by means of random sampling from the finished capsules in Pharma Nord’s own laboratory.
Once the capsules have been assembled they are led through a series of chambers that serve as tumble dryers. Afterwards, the capsules are collected in large plastic trays and placed in a special drying compartment for another day or two. The dried capsules are sorted and capsules with the wrong shape or size are discarded. The rest of the batch is now ready for packaging in large plastic bags that are quarantined until the quality control has been completed.

Control

During the actual production, several control procedures help to ensure that everything is on track. Upon the completion of every single production, the capsules or tablets are thoroughly controlled in terms of weight, content, dissolution time, etc.
At the same time, we go through all control documents showing that all procedures have been carried out as specified. The production of one single preparation involves filling in as much as 32 different control documents.

Cleaning

After each round of production, the machines are cleaned, effectively removing any trace of the former product and preparing the machines 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 are validated, which means that their efficacy is proven so no products are exposed to contamination. The cleaning act is controlled and documented on check lists.

When the different products have been released from the Quality Department, they are ready for packaging. After the production has been completed, the finished tablets and capsules are stored in large containers in the inventory until they are ready to ship off. A sufficient amount of tablets and capsules are taken out from these containers (for control) every time a new batch is ready to pack in boxes and ship off to retailers in all the countries that sell our products.

Food supplement or medical drug

One single production may be divided in a variety of smaller operations, 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 food supplement in one country or a medical drug in another.

For this reason, all products are manufactured in accordance with the highest standard. A product that is manufactured as a medical drug can easily be sold as a food supplement. This is not the case the other way around.

Hygienic packaging

All Pharma Nord’s tablets and capsules are packaged in hygienic blisters. This increases the shelf life of the product after opening.

Inventory

When the finished products have been packaged in boxes and released by the Quality Department they are sent by truck to distributors and retailers worldwide. You can find Pharma Nord’s food supplement and medical drugs in shops in over 45 different countries.
Pharma Nord’s products are primarily retailed 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.