GMP EthanolBrüggemannAlcohol Heilbronn GmbH

“For maximum safety”

Our GMP Ethanol – maximum safety for you!The main focus of GMP (“Good Manufacturing Practice”) are the increased requirements on hygiene, facilit ies, equipment, documentation, traceability and analy tics.

What impact does GMP have for BrüggemannAlcohol?

Innovation Being par tner of the pharmaceutical

industr y Future orientation Customer orientation

Why should you buy our GMP Ethanol?

Fast and f lexible deliver y Shor t response time Personal contact person, shor t

communication channels Packaging size f rom cargo to bulk Kosher, grape-f ree ethanol

What are the differences to Ethanol Ph.Eu.?

100 percent traceability and transparency of manufacturing practice

Complete documentation of manufacturing practice

Validated processes Four-eye-principle Reproducibility Inspection by authorities Detailed approval process Qualif ied facilit ies

What does GMP Ethanol provide you?

Maximum safety Reproducibility Reliability Control Transparency Purity Traceability

In which application is it NECESSARY to use GMP-certifiedEthanol?

According to §13 (3) of AMWHV only raw materials which are produced according to GMP guidelines are approved and can be used as ac tive pharmaceutical ingre-dient or excipient for the manufacturing of pharmaceutical drugs.

Our GMP-cer tif ied ethanol of fers highest quality standards approved by the German authorities.

Produc t range GMP Ethanol 30l can 200l drum 1000l IBC Bulk in tank truck

Ethanol 96 %, GMP undenatured X X X X

Ethanol 100 %, GMP undenatured X X X X

Ethanol 96 %, GMP denatured with 1l MEK X X X X

Ethanol 100 %, GMP denatured with 1l MEK X X X X

1.Foundation

Qualif ied raw material suppliers for manufac-

turing GMP Ethanol

2.Quality Control

Written approval of raw alcohol for the production af ter comprehensive

documentar y control throughhead of quality assurance

4.Filling and Logistics

Loading of tank truck in closed system (dedicated for GMP)

Filling of cargo under clean roomconditions (overall, hairnet, laminar

f low in f illing room etc.)

Label output control process

3.Produc tion / Approval

Dedicated raw alcohol tank is being fully emptied before ref illing

Single-batch production

All processes for the manufacturing of GMP quality are validated

All process steps are regulated through SOPs

5.Additional Documentation Batch record for each batch

Approval for loading through head of quality

control

Complete documentation – from raw material to delivery

GMP Pharma

Raw material raw material out of grain, sugar beets, starches f rom qualif ied suppliers

raw material out of grain, sugar beets, starches f rom qualif ied suppliers

Incoming goods inspec tion according to control plan GMP according to control plan Ph. Eu.

Storage raw alcoholseparate tanks, tank is being emptied before production of ac tive ingredient batches

separate tanks

Tank inspec tionaccording to control plan GMP, approval af ter pre-analy tics and check of documentation

according to control plan Ph. Eu.

Manufac turing instruc tions SOP for manufacturing API quality work instructions for production

Manufac turing qualif ied facilit ies qualif ied facilit ies

Approval of intermediate stages paper-based with signature automatically in SAP R3

Storage of f inished produc tseparate tanks, always one manufactured batch, tanks are being emptied before star ting ac tive ingredient batch-production

separate tanks

Approval of f inished produc t check and release of tank batch through head of quality control

check and release of tank batch through head of quality control

GMP Pharma

Finished produc t quality API quality excipient quality

Filling tank truck f illing by closed system, bot tom-up f illing by top loader

Filling packages clean room (categor y ISO 8) f illing room

Hygiene measures hygiene clothes safety clothes

Empty packages require batch, according to control plan GMP do not require batch

Label output control process yes no

Batch record as pharma, according to SOP for each batch, paper-based

documentation through Excel and SAP R3

Release for shipment release of f illing batches through head of quality control

release of f illing batches through head of logistics

Reliability, Promptness, Flexibility, Quality and Service – these are the strengths that you can expect from us!

With BrüggemannAlcohol you are always on the safe side! Since 1868 manufacturing and sales of ethanol are our core competencies. With our two production sites – Heilbronn and Wit tenberg, Lutherstadt – a fast and f lexible deliver y is possible any time.

Have we caught your at tention? Please contact us – we are looking for ward to you!

BrüggemannAlcohol Heilbronn GmbHSalzstraße 12974076 Heilbronn / Germanywww.brueggemann.comF +49 (0)7131 / 1575-888

Your contact persons:

Mar tha SchwaebeP +49 (0)7131 / 1575-807M mar tha.schwaebe@brueggemann.com

Manuel DonaubauerP +49 (0)7131 / 1575-804M manuel.donaubauer@brueggemann.com