Dietary supplements with superior quality
All of Pharma Nord’s manufacturing facilities and standard routines comply with the rigid GMP (medical drugs) and HACCP (dietary supplements) rules. The simple reason for this is that it is the exact same manufacturing team that produces our medical drugs and our dietary supplements. Every staff member on the manufacturing team is trained to follow the exact same procedures for quality, hygiene, and documentation, regardless of what type of product they are in the process of making. That way, the employees do not have to worry about which set of standards they follow in the different situations. There is only one standard that applies – the highest.
Raw materials inventory
At the raw materials inventory, we receive all the different items needed to make the finished goods: Packaging, excipients, and active ingredients for tablet- and capsule manufacturing.
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, with which it must comply. This is the case not only with our active ingredients but even filling agents and packaging materials. Pharma Nord’s Quality Control Manager personally inspects the manufacturing facilities at every one of our suppliers of pharmaceutical-grade active ingredients.
All raw materials are registered and labeled with unique batch numbers so they can be traced at any stage throughout the entire manufacturing process.
Upon arrival, all raw materials and packaging components are placed in our quarantine inventory. 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.
Both dietary supplements and medical drugs are examined in accordance with a detailed plan. For example, 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 dietary 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.
Test of shelf life
All medical drugs and certain dietary supplements are submitted to a shelf life test in order to ensure that the active ingredients maintain the right strength right up to the expiration date of the preparation. The test is conducted in special climate cabinets with specified temperature and humidity settings in order to document the quality of the products throughout their entire shelf life.
Quality control and registration
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.
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.
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.
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.
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.
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 into tablets and capsules under tightly controlled conditions. In order to ensure full traceability, every single production is supplied with a unique batch number.
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 overpressure 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 example weighing and taking out samples.
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 color, either for the sake of protecting the active ingredients or to make them easy to recognize.
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 process, 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 of 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.
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 many as 32 different control documents.
After each round of production, the machines are cleaned to effectively remove any trace of the former product and prepare 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 their efficacy is proven so no products are exposed to contamination. The cleaning act is controlled and documented on check lists.
Advantages of blister packaging
Blister packs protect against moisture
As soon as you break the seal on a bottle of vitamins, the tablets inside begin to lose strength. Moisture is the biggest enemy of vitamin tablets. Even a tight-fitting lid cannot prevent moisture from entering the bottle and affecting the tablets.
Every time you open the lid to take your pills, moisture penetrates. Studies have shown that if you store the bottle in areas with very high humidity such as the kitchen or bathroom, the nutritional value of water-soluble vitamins can decline drastically and, in the worst case, even disappear completely in just a week. This is known as deliquescence. Gelatin capsules naturally absorb moisture from the surrounding air and become more sticky. Although not all types of blisters are 100% moisture-proof, they will always provide substantially better protection than a pill bottle.
Protects against bacteria
Blister packs are also most hygienic. When you need to fish tablets and capsules out of a bottle or some other container, you tend to stick your fingers down. Alternatively, you pour too many into your hand and pour the excess pills back into the container. Gelatin capsules in particular tend to stick together in a bottle, which is why you need to separate them with your fingers. In doing so, you will quickly spread bacteria in the container with dietary supplements.
In many cases, the container sits on the shelf or tabletop for several months - and perhaps there are other family members who stick their fingers down in it? In any case, these conditions form a really good breeding ground for bacteria to multiply.
With blisters, this problem is avoided. Blister production and packaging takes place under regulatory control and complies with both the EU's and the FDA's requirements for moisture penetration (Water Vapor Permeability) - as well as protecting against dust. With a blister pack, you are only in contact with the tablets / capsules that are to be used immediately.
Overview and dosing aid with blisters
With a blister pack, you as a customer get the opportunity to see the contents without opening the pack. Blister packs offer the best protection of the supplements you have paid for - even after you start taking them. Not only does the blister pack make it easier to take out the desired number of tablet/capsules. You can see immediately how many tablets or capsules are left in the pack. This way you can effectively avoid taking too few or too many pills.
Also, on holidays and weekend trips, tablets and capsules in blister packs can be divided into more manageable sizes simply by cutting the blister with a pair of scissors. The aforementioned hygienic benefits of the blister will not be lost by doing that. There will often be room for a few tablets or capsules with blisters in dosing boxes. If there is no space, you can take them along in an empty container.
No finger strength
In some cases, it can be a challenge for seniors and people with lack of finger strength to squeeze tablets and capsules out of the blister. However, if you turn the blister with the tin foil upwards, you can easily open the blister with a small, sharp knife or a scissor tip and pry out the tablet or capsule. If you have long nails, it can be done without the use of tools.
Certified for medicine
All parts of Pharma Nord's blister pack - also those used for dietary supplements - are certified for pharmaceutical manufacturing. Moreover, the handling of the preparation compies with the GMP protocol and the guidelines for pharmaceuticals. The metal foil is coated and does not come into contact with the contents.
Packaging and inventory
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. For control purposes, a certain amount of tablets and capsules are taken out from the containers every time a new batch is ready to pack in boxes and ship off to retailers in all the countries that sell our products.
Dietary supplement or medical drug
One single production may be divided into a variety of smaller operations, for example in situations where the product is available in several countries or in different box sizes. With some products, different rules may apply. That way, two identical products can end up as a dietary supplement in one country and a medical drug in another.
For this reason, all products are manufactured in accordance with the highest standard. A product that is manufactured the same way as a medical drug can easily be sold as a dietary supplement but not the other way around.
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 dietary supplements 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.
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” we mean every word. Our products are not merely capsules and tablets from foreign suppliers that we have 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.