Health is an essential ingredient for a good life! And we humans are living ever healthier and ever longer lives. Health is a central aim in life and shapes many aspects of it. The general public now lead a more aware lifestyle and do a lot for themselves to promote their own health.
This trend is due not least of all to advances in medicine and achievements in the pharmaceutical industry. Whether we have a headache, a graze or the flu, pharmaceutical products keep us healthy and ensure our well-being!
Value-added services – Expertise – Certifications
The pharmaceutical industry is highly complex in a number of respects, one reason being that it is not enough to simply find the ideal active ingredient for a pharmaceutical. To manufacture any pharmaceutical, an active ingredient is processed together with a variety of excipients and intermediates in myriad dosage forms. As a distributor that also operates in the pharmaceutical industry, Brenntag not only has to offer a broad range of value-added services, such as filling and transferring or mixing raw chemicals under controlled conditions, storing products in a temperature-controlled environment and taking on customers’ supply chain management. We also have to hold GMP certification* and meet extensive and steadily increasing regulatory requirements.
Brenntag Pharma provides individual solutions and innovative ideas for pharmaceuticals, medical products and dietary supplements in liquid, semi-solid and solid dosage forms. This also includes the Brenntag site in Guntramsdorf, Austria, a holder of several certifications whose pharmaceutical department specializes in filling and transferring active ingredients and excipients for both the healthcare and the veterinary industry. It can also fill a number of different active ingredients and excipients into the smallest of containers from one gram upwards.
Ursula Baumgartner-Durchschlag has been working at Brenntag for almost five years and is in charge of quality control in Guntramsdorf. She talks about the particular requirements in the pharmaceutical industry, the filling we carry out for pharmaceutical wholesalers and what it is that Brenntag customers in this segment particularly value.
“Pharmaceutical products are a sensitive issue, as it is ultimately a matter of manufacturing an effective medication or dietary supplement for us to consume. That is why there are a number of laws and we have to work with a great deal of care, precision and integrity. When filling products for our customers, we have to both accommodate their wishes and meet numerous statutory and operational requirements. We are helped in this by the certifications that we have acquired for the site and by our product portfolio here in Guntramsdorf, which is very extensive and diverse. Our customers are always able to select from several hundred products, ranging from active ingredients such as paracetamol or menthol through to various excipients such as almond oil, St John’s wort oil or dietary supplements such as cod liver oil.”
The customers appreciate this diverse range of products and usually expect delivery within a short time of placing an order. The specialist team in Guntramsdorf can deliver products in myriad types of packaging – from plastic containers such as bags, jars or tubs through coated canisters to various glass containers that meet both quality and safety standards in the pharmaceutical industry. The focus here is on small containers in units of 1 kilogram, 500 grams, 250 grams down to 1 gram, as these sizes work well in pharmacies.
Regular product controls
Before a product can be delivered, however, it has to go through various different checks: this process starts back at the manufacturer from which Brenntag purchases the product. Brenntag audits the manufacturer and checks whether it meets statutory and qualitative requirements – a process known as supplier qualification. Once the goods arrive at Brenntag, a laborious and well-documented process gets under way locally. Quality control and assurance plays a central role in the manufacture of pharmaceutical products. In our quality control lab, we carry out all the necessary analyses to check the dentity, purity and effectiveness of an ingredient, for example.
For this, we need in-depth chemical expertise and appropriate equipment to perform the measurements.
“So, behind the pure delivery of the products, there is a laborious process where we ultimately produce a certificate of analysis, thereby assuring the customer that its product meets all requirements laid down by European and national law makers. Because of our GMP certification and other requirements, we are obliged to carry out different analyses. In this case, Brenntag must be able to ensure high standards of quality and a flawless process, essentially meaning ransparency across the entire supply chain, while at the same time operating in a flexible, reliable and swift manner. These processes are absolutely essential in the processing of our products and something our customers can rely on!”
PRODUCTS PROCESSED AT BRENNTAG PHARMA IN GUNTRAMSDORF, AUSTRIA:
ACETYLSALICYLIC ACID reduces pain, inflammation and fever.
ASCORBIC ACID / VITAMIN C is an important vitamin that acts as an antioxidant and boosts the immune system.
QUININE has anti-parasitic properties and is used as an anti-malarial medication.
MENTHOL is an essential oil with cooling, anti-pruritic and analgesic properties; it is used for skin ailments, chills and colds.
PANTHENOL/VITAMIN B5 is needed in the body for the metabolism of carbohydrates, lipids and proteins.
TETRACAINE is a local anaesthetic used in eye drops, for example.
THEOPHYLLINE is an anti-asthmatic with anti-inflammatory and bronchodilatory properties.
You are responsible for the lab and quality control at the site. What are your main tasks?
URSULA The lab is an internal service department for many other departments and colleagues. My main tasks are to check analyses and approve products that have to meet certain requirements or specifications. I am also responsible for ensuring that the lab is compliant with all statutory GMP requirements. This includes regularly maintaining and calibrating the equipment, good documentation practice, preparing reports and providing experts for the development of new formulations. And I represent the department during audits and inspections.
At the site in Guntramsdorf, you are the “qualified person” under section 7 of the 2009 Austrian Pharmaceuticals Regulation (AMBO). Most people who use pharmaceutical products will never have heard of it. What does it mean in the context of pharmaceuticals?
URSULA Under the applicable EU legislation, every single batch of a pharmaceutical or an active ingredient that is produced at a pharmaceuticals manufacturing site must be checked before it is sold to determine whether it conforms to the laws and internal
requirements. In Austria, the Pharmaceuticals Regulation (AMBO) specifies who is authorized to check and approve pharmaceuticals, their manufacture and quality control. This requires training in pharmaceuticals and natural sciences and several years’ experience in the pharmaceutical industry.
What makes your work at Brenntag so special?
URSULA I find it interesting to see which products are manufactured from individual ingredients and inspiring that they can be used to cure diseases and even save lives. The requirements are very diverse and pose a challenge for companies aiming to remain competitive. So, as a team and together with our customers, we are continually developing. There is no standing still.
URSULA BAUMGARTNER-DURCHSCHLAG
HEAD OF LABORATORY & QUALIFIED PERSON
