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.

»Pharmaceutical products are a sensitive issue, as it is ultimately a matter of manufacturing an effective medication or dietary supplement for us to consume.«
URSULA BAUMGARTNER-DURCHSCHLAG

HEAD OF LABO­RA­TORY & QUA­LI­FIED PERSON

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