for the pharmaceutical industry: gmp-grade ethanol€¦ · •halal •kosher, kosher ... ethanol...
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For the pharmaceutical industry:GMP-grade ethanolAdvantages of the Swissmedic GMPmanufacturing licence
For the pharmaceutical industry:GMP-grade ethanolAdvantages of the Swissmedic GMPmanufacturing licence
alcosuisse ag produces a variety of unique GMP-grade ethanol products. Specifically, this offers the following benefits for customers in the pharmaceutical industry:
• fully automated production of high-quality blends• 100% traceability of all raw materials back to the
original producer• 5 µm-filtration of all ethanol products and mixtures• qualified production facilities and validated
production processes• systematic organoleptic testing• dedicated tank, pump and piping systems• batch-specific analysis certificates (European
Pharmacopoeia, Ph. Eur.)• guaranteed quality in logistics/containers• documentation of all process steps and of risk and
change management
The Swissmedic GMP manufacturing licence requires alcosuisse ag to keep complete documentation of the entire value-added chain: suppliers, production, distribution, quality management, handling, storage, handling of dangerous goods and customer support.
As the Swiss pharmaceutical industry’s established, long-standing and preferred partner and supplier, alcosuisse ag undergoes regular and strict auditing by the major Swiss pharmaceutical companies. The Swissmedic GMP manufacturing licence provides all pharmaceutical clients – both in Switzerland and abroad – with a guarantee that ethanol production at alcosuisse ag is subject to the same quality standards as in the Swiss pharmaceutical industry.
2 3
GMP-certified ethanol for pharmaceutical production
alcosuisse ag – the Swiss producer of ethanol
GMP-grade ethanol from Switzerland for the pharmaceutical industry: whether as the basis for industrial processes, in the production of alcohol-containing medicines, or for use in research – GMP-certified ethanol is an indispensable resource in the pharmaceutical industry. With extensive experience and a long tradition of providing excellent quality and service, alcosuisse ag is familiar with the exacting standards of pharmaceutical clients and therefore operates a GMP-certified production process.
SUPPLIERS
QUALITY CONTROL
PRODUCTION
LOGISTICS
DOCUMENTATION
CERTIFICATES
In the procurement of raw materials, alco-suisse ag follows a clearly defined strate-gy. Many products require specially defined production processes, partly under GMP conditions. alcosuisse ag carries out regular auditing and quality control at all suppliers.
GMP quality is established at an accredited analytical laboratory. The highly effective quality systems and processes therefore allow reduced receiving inspections by end customers in the pharmaceutical industry.
International directives impose clear GMP requirements on the raw materials for APIs. In order to meet the requirements in full, al-cosuisse ag is GMP-certified by Swissmedic for all manufacturing processes. All of the above processes can be audited at any time.
All filling and logistics processes take place in dedicated tank and piping systems, allow-ing contamination and batch mix-ups to be ruled out. The product recall concept incor-porates regular mock recall exercises and therefore guarantees 100% traceability.
All processes are documented according to GMP requirements. The risk and change management is specifically defined and is available for all alcosuisse clients to view at any time. Standardised communication supports internal and external quality assur-ance.
The following additional certifications and confirmations are available on request:
• ISO 9001:2015 Quality management systems• Food Safety System Certification (FSSC) 22000• HALAL• Kosher, Kosher for Passover• CH – U.S. Organic Equivalency Arrangement• bio.inspecta
Significance of the Swissmedic GMP manufacturing licence
Ethanol manufacturing at alcosuisse ag is GMP-certified by Swissmedic. The Swissmedic GMP manufacturing licence is
extremely important for customers in the pharmaceutical industry, as Swissmedic strictly regulates and monitors the quality
assurance of therapeutic products (active pharmaceutical ingredients, or APIs) in Switzerland. Swissmedic provides the
consumer with a guarantee that the production of medicines is subject to strict quality control. For the pharmaceutical
industry, the Swissmedic GMP manufacturing licence signifies that alcosuisse ag is a raw material producer that is
familiar with the pharmaceutical industry’s quality standards and knows how to apply them. With alcosuisse ag, the drug
manufacturing sector therefore has at its disposal a trustworthy producer and supplier that makes the API manufacturing/
refining process efficient, traceable and cost-effective.
Cornerstones of the Swissmedic GMPmanufacturing licence
• BUD CERTIFICATE from Bio Suisse• REACH registration• REACH biocidal listing, Art. 95• FDA Food Facility Registration (FFR) number• CSR standards EcoVadis and Sedex
alcosuisse ag produces a variety of unique GMP-grade ethanol products. Specifically, this offers the following benefits for customers in the pharmaceutical industry:
• fully automated production of high-quality blends• 100% traceability of all raw materials back to the
original producer• 5 µm-filtration of all ethanol products and mixtures• qualified production facilities and validated
production processes• systematic organoleptic testing• dedicated tank, pump and piping systems• batch-specific analysis certificates (European
Pharmacopoeia, Ph. Eur.)• guaranteed quality in logistics/containers• documentation of all process steps and of risk and
change management
The Swissmedic GMP manufacturing licence requires alcosuisse ag to keep complete documentation of the entire value-added chain: suppliers, production, distribution, quality management, handling, storage, handling of dangerous goods and customer support.
As the Swiss pharmaceutical industry’s established, long-standing and preferred partner and supplier, alcosuisse ag undergoes regular and strict auditing by the major Swiss pharmaceutical companies. The Swissmedic GMP manufacturing licence provides all pharmaceutical clients – both in Switzerland and abroad – with a guarantee that ethanol production at alcosuisse ag is subject to the same quality standards as in the Swiss pharmaceutical industry.
2 3
GMP-certified ethanol for pharmaceutical production
alcosuisse ag – the Swiss producer of ethanol
GMP-grade ethanol from Switzerland for the pharmaceutical industry: whether as the basis for industrial processes, in the production of alcohol-containing medicines, or for use in research – GMP-certified ethanol is an indispensable resource in the pharmaceutical industry. With extensive experience and a long tradition of providing excellent quality and service, alcosuisse ag is familiar with the exacting standards of pharmaceutical clients and therefore operates a GMP-certified production process.
SUPPLIERS
QUALITY CONTROL
PRODUCTION
LOGISTICS
DOCUMENTATION
CERTIFICATES
In the procurement of raw materials, alco-suisse ag follows a clearly defined strate-gy. Many products require specially defined production processes, partly under GMP conditions. alcosuisse ag carries out regular auditing and quality control at all suppliers.
GMP quality is established at an accredited analytical laboratory. The highly effective quality systems and processes therefore allow reduced receiving inspections by end customers in the pharmaceutical industry.
International directives impose clear GMP requirements on the raw materials for APIs. In order to meet the requirements in full, al-cosuisse ag is GMP-certified by Swissmedic for all manufacturing processes. All of the above processes can be audited at any time.
All filling and logistics processes take place in dedicated tank and piping systems, allow-ing contamination and batch mix-ups to be ruled out. The product recall concept incor-porates regular mock recall exercises and therefore guarantees 100% traceability.
All processes are documented according to GMP requirements. The risk and change management is specifically defined and is available for all alcosuisse clients to view at any time. Standardised communication supports internal and external quality assur-ance.
The following additional certifications and confirmations are available on request:
• ISO 9001:2015 Quality management systems• Food Safety System Certification (FSSC) 22000• HALAL• Kosher, Kosher for Passover• CH – U.S. Organic Equivalency Arrangement• bio.inspecta
Significance of the Swissmedic GMP manufacturing licence
Ethanol manufacturing at alcosuisse ag is GMP-certified by Swissmedic. The Swissmedic GMP manufacturing licence is
extremely important for customers in the pharmaceutical industry, as Swissmedic strictly regulates and monitors the quality
assurance of therapeutic products (active pharmaceutical ingredients, or APIs) in Switzerland. Swissmedic provides the
consumer with a guarantee that the production of medicines is subject to strict quality control. For the pharmaceutical
industry, the Swissmedic GMP manufacturing licence signifies that alcosuisse ag is a raw material producer that is
familiar with the pharmaceutical industry’s quality standards and knows how to apply them. With alcosuisse ag, the drug
manufacturing sector therefore has at its disposal a trustworthy producer and supplier that makes the API manufacturing/
refining process efficient, traceable and cost-effective.
Cornerstones of the Swissmedic GMPmanufacturing licence
• BUD CERTIFICATE from Bio Suisse• REACH registration• REACH biocidal listing, Art. 95• FDA Food Facility Registration (FFR) number• CSR standards EcoVadis and Sedex
alcosuisse ag produces a variety of unique GMP-grade ethanol products. Specifically, this offers the following benefits for customers in the pharmaceutical industry:
• fully automated production of high-quality blends• 100% traceability of all raw materials back to the
original producer• 5 µm-filtration of all ethanol products and mixtures• qualified production facilities and validated
production processes• systematic organoleptic testing• dedicated tank, pump and piping systems• batch-specific analysis certificates (European
Pharmacopoeia, Ph. Eur.)• guaranteed quality in logistics/containers• documentation of all process steps and of risk and
change management
The Swissmedic GMP manufacturing licence requires alcosuisse ag to keep complete documentation of the entire value-added chain: suppliers, production, distribution, quality management, handling, storage, handling of dangerous goods and customer support.
As the Swiss pharmaceutical industry’s established, long-standing and preferred partner and supplier, alcosuisse ag undergoes regular and strict auditing by the major Swiss pharmaceutical companies. The Swissmedic GMP manufacturing licence provides all pharmaceutical clients – both in Switzerland and abroad – with a guarantee that ethanol production at alcosuisse ag is subject to the same quality standards as in the Swiss pharmaceutical industry.
2 3
GMP-certified ethanol for pharmaceutical production
alcosuisse ag – the Swiss producer of ethanol
GMP-grade ethanol from Switzerland for the pharmaceutical industry: whether as the basis for industrial processes, in the production of alcohol-containing medicines, or for use in research – GMP-certified ethanol is an indispensable resource in the pharmaceutical industry. With extensive experience and a long tradition of providing excellent quality and service, alcosuisse ag is familiar with the exacting standards of pharmaceutical clients and therefore operates a GMP-certified production process.
SUPPLIERS
QUALITY CONTROL
PRODUCTION
LOGISTICS
DOCUMENTATION
CERTIFICATES
In the procurement of raw materials, alco-suisse ag follows a clearly defined strate-gy. Many products require specially defined production processes, partly under GMP conditions. alcosuisse ag carries out regular auditing and quality control at all suppliers.
GMP quality is established at an accredited analytical laboratory. The highly effective quality systems and processes therefore allow reduced receiving inspections by end customers in the pharmaceutical industry.
International directives impose clear GMP requirements on the raw materials for APIs. In order to meet the requirements in full, al-cosuisse ag is GMP-certified by Swissmedic for all manufacturing processes. All of the above processes can be audited at any time.
All filling and logistics processes take place in dedicated tank and piping systems, allow-ing contamination and batch mix-ups to be ruled out. The product recall concept incor-porates regular mock recall exercises and therefore guarantees 100% traceability.
All processes are documented according to GMP requirements. The risk and change management is specifically defined and is available for all alcosuisse clients to view at any time. Standardised communication supports internal and external quality assur-ance.
The following additional certifications and confirmations are available on request:
• ISO 9001:2015 Quality management systems• Food Safety System Certification (FSSC) 22000• HALAL• Kosher, Kosher for Passover• CH – U.S. Organic Equivalency Arrangement• bio.inspecta
Significance of the Swissmedic GMP manufacturing licence
Ethanol manufacturing at alcosuisse ag is GMP-certified by Swissmedic. The Swissmedic GMP manufacturing licence is
extremely important for customers in the pharmaceutical industry, as Swissmedic strictly regulates and monitors the quality
assurance of therapeutic products (active pharmaceutical ingredients, or APIs) in Switzerland. Swissmedic provides the
consumer with a guarantee that the production of medicines is subject to strict quality control. For the pharmaceutical
industry, the Swissmedic GMP manufacturing licence signifies that alcosuisse ag is a raw material producer that is
familiar with the pharmaceutical industry’s quality standards and knows how to apply them. With alcosuisse ag, the drug
manufacturing sector therefore has at its disposal a trustworthy producer and supplier that makes the API manufacturing/
refining process efficient, traceable and cost-effective.
Cornerstones of the Swissmedic GMPmanufacturing licence
• BUD CERTIFICATE from Bio Suisse• REACH registration• REACH biocidal listing, Art. 95• FDA Food Facility Registration (FFR) number• CSR standards EcoVadis and Sedex
alcosuisse ag produces a variety of unique GMP-grade ethanol products. Specifically, this offers the following benefits for customers in the pharmaceutical industry:
• fully automated production of high-quality blends• 100% traceability of all raw materials back to the
original producer• 5 µm-filtration of all ethanol products and mixtures• qualified production facilities and validated
production processes• systematic organoleptic testing• dedicated tank, pump and piping systems• batch-specific analysis certificates (European
Pharmacopoeia, Ph. Eur.)• guaranteed quality in logistics/containers• documentation of all process steps and of risk and
change management
The Swissmedic GMP manufacturing licence requires alcosuisse ag to keep complete documentation of the entire value-added chain: suppliers, production, distribution, quality management, handling, storage, handling of dangerous goods and customer support.
As the Swiss pharmaceutical industry’s established, long-standing and preferred partner and supplier, alcosuisse ag undergoes regular and strict auditing by the major Swiss pharmaceutical companies. The Swissmedic GMP manufacturing licence provides all pharmaceutical clients – both in Switzerland and abroad – with a guarantee that ethanol production at alcosuisse ag is subject to the same quality standards as in the Swiss pharmaceutical industry.
2 3
GMP-certified ethanol for pharmaceutical production
alcosuisse ag – the Swiss producer of ethanol
GMP-grade ethanol from Switzerland for the pharmaceutical industry: whether as the basis for industrial processes, in the production of alcohol-containing medicines, or for use in research – GMP-certified ethanol is an indispensable resource in the pharmaceutical industry. With extensive experience and a long tradition of providing excellent quality and service, alcosuisse ag is familiar with the exacting standards of pharmaceutical clients and therefore operates a GMP-certified production process.
SUPPLIERS
QUALITY CONTROL
PRODUCTION
LOGISTICS
DOCUMENTATION
CERTIFICATES
In the procurement of raw materials, alco-suisse ag follows a clearly defined strate-gy. Many products require specially defined production processes, partly under GMP conditions. alcosuisse ag carries out regular auditing and quality control at all suppliers.
GMP quality is established at an accredited analytical laboratory. The highly effective quality systems and processes therefore allow reduced receiving inspections by end customers in the pharmaceutical industry.
International directives impose clear GMP requirements on the raw materials for APIs. In order to meet the requirements in full, al-cosuisse ag is GMP-certified by Swissmedic for all manufacturing processes. All of the above processes can be audited at any time.
All filling and logistics processes take place in dedicated tank and piping systems, allow-ing contamination and batch mix-ups to be ruled out. The product recall concept incor-porates regular mock recall exercises and therefore guarantees 100% traceability.
All processes are documented according to GMP requirements. The risk and change management is specifically defined and is available for all alcosuisse clients to view at any time. Standardised communication supports internal and external quality assur-ance.
The following additional certifications and confirmations are available on request:
• ISO 9001:2015 Quality management systems• Food Safety System Certification (FSSC) 22000• HALAL• Kosher, Kosher for Passover• CH – U.S. Organic Equivalency Arrangement• bio.inspecta
Significance of the Swissmedic GMP manufacturing licence
Ethanol manufacturing at alcosuisse ag is GMP-certified by Swissmedic. The Swissmedic GMP manufacturing licence is
extremely important for customers in the pharmaceutical industry, as Swissmedic strictly regulates and monitors the quality
assurance of therapeutic products (active pharmaceutical ingredients, or APIs) in Switzerland. Swissmedic provides the
consumer with a guarantee that the production of medicines is subject to strict quality control. For the pharmaceutical
industry, the Swissmedic GMP manufacturing licence signifies that alcosuisse ag is a raw material producer that is
familiar with the pharmaceutical industry’s quality standards and knows how to apply them. With alcosuisse ag, the drug
manufacturing sector therefore has at its disposal a trustworthy producer and supplier that makes the API manufacturing/
refining process efficient, traceable and cost-effective.
Cornerstones of the Swissmedic GMPmanufacturing licence
• BUD CERTIFICATE from Bio Suisse• REACH registration• REACH biocidal listing, Art. 95• FDA Food Facility Registration (FFR) number• CSR standards EcoVadis and Sedex
alcosuisse ag produces a variety of unique GMP-grade ethanol products. Specifically, this offers the following benefits for customers in the pharmaceutical industry:
• fully automated production of high-quality blends• 100% traceability of all raw materials back to the
original producer• 5 µm-filtration of all ethanol products and mixtures• qualified production facilities and validated
production processes• systematic organoleptic testing• dedicated tank, pump and piping systems• batch-specific analysis certificates (European
Pharmacopoeia, Ph. Eur.)• guaranteed quality in logistics/containers• documentation of all process steps and of risk and
change management
The Swissmedic GMP manufacturing licence requires alcosuisse ag to keep complete documentation of the entire value-added chain: suppliers, production, distribution, quality management, handling, storage, handling of dangerous goods and customer support.
As the Swiss pharmaceutical industry’s established, long-standing and preferred partner and supplier, alcosuisse ag undergoes regular and strict auditing by the major Swiss pharmaceutical companies. The Swissmedic GMP manufacturing licence provides all pharmaceutical clients – both in Switzerland and abroad – with a guarantee that ethanol production at alcosuisse ag is subject to the same quality standards as in the Swiss pharmaceutical industry.
2 3
GMP-certified ethanol for pharmaceutical production
alcosuisse ag – the Swiss producer of ethanol
GMP-grade ethanol from Switzerland for the pharmaceutical industry: whether as the basis for industrial processes, in the production of alcohol-containing medicines, or for use in research – GMP-certified ethanol is an indispensable resource in the pharmaceutical industry. With extensive experience and a long tradition of providing excellent quality and service, alcosuisse ag is familiar with the exacting standards of pharmaceutical clients and therefore operates a GMP-certified production process.
SUPPLIERS
QUALITY CONTROL
PRODUCTION
LOGISTICS
DOCUMENTATION
CERTIFICATES
In the procurement of raw materials, alco-suisse ag follows a clearly defined strate-gy. Many products require specially defined production processes, partly under GMP conditions. alcosuisse ag carries out regular auditing and quality control at all suppliers.
GMP quality is established at an accredited analytical laboratory. The highly effective quality systems and processes therefore allow reduced receiving inspections by end customers in the pharmaceutical industry.
International directives impose clear GMP requirements on the raw materials for APIs. In order to meet the requirements in full, al-cosuisse ag is GMP-certified by Swissmedic for all manufacturing processes. All of the above processes can be audited at any time.
All filling and logistics processes take place in dedicated tank and piping systems, allow-ing contamination and batch mix-ups to be ruled out. The product recall concept incor-porates regular mock recall exercises and therefore guarantees 100% traceability.
All processes are documented according to GMP requirements. The risk and change management is specifically defined and is available for all alcosuisse clients to view at any time. Standardised communication supports internal and external quality assur-ance.
The following additional certifications and confirmations are available on request:
• ISO 9001:2015 Quality management systems• Food Safety System Certification (FSSC) 22000• HALAL• Kosher, Kosher for Passover• CH – U.S. Organic Equivalency Arrangement• bio.inspecta
Significance of the Swissmedic GMP manufacturing licence
Ethanol manufacturing at alcosuisse ag is GMP-certified by Swissmedic. The Swissmedic GMP manufacturing licence is
extremely important for customers in the pharmaceutical industry, as Swissmedic strictly regulates and monitors the quality
assurance of therapeutic products (active pharmaceutical ingredients, or APIs) in Switzerland. Swissmedic provides the
consumer with a guarantee that the production of medicines is subject to strict quality control. For the pharmaceutical
industry, the Swissmedic GMP manufacturing licence signifies that alcosuisse ag is a raw material producer that is
familiar with the pharmaceutical industry’s quality standards and knows how to apply them. With alcosuisse ag, the drug
manufacturing sector therefore has at its disposal a trustworthy producer and supplier that makes the API manufacturing/
refining process efficient, traceable and cost-effective.
Cornerstones of the Swissmedic GMPmanufacturing licence
• BUD CERTIFICATE from Bio Suisse• REACH registration• REACH biocidal listing, Art. 95• FDA Food Facility Registration (FFR) number• CSR standards EcoVadis and Sedex
alcosuisse ag produces a variety of unique GMP-grade ethanol products. Specifically, this offers the following benefits for customers in the pharmaceutical industry:
• fully automated production of high-quality blends• 100% traceability of all raw materials back to the
original producer• 5 µm-filtration of all ethanol products and mixtures• qualified production facilities and validated
production processes• systematic organoleptic testing• dedicated tank, pump and piping systems• batch-specific analysis certificates (European
Pharmacopoeia, Ph. Eur.)• guaranteed quality in logistics/containers• documentation of all process steps and of risk and
change management
The Swissmedic GMP manufacturing licence requires alcosuisse ag to keep complete documentation of the entire value-added chain: suppliers, production, distribution, quality management, handling, storage, handling of dangerous goods and customer support.
As the Swiss pharmaceutical industry’s established, long-standing and preferred partner and supplier, alcosuisse ag undergoes regular and strict auditing by the major Swiss pharmaceutical companies. The Swissmedic GMP manufacturing licence provides all pharmaceutical clients – both in Switzerland and abroad – with a guarantee that ethanol production at alcosuisse ag is subject to the same quality standards as in the Swiss pharmaceutical industry.
2 3
GMP-certified ethanol for pharmaceutical production
alcosuisse ag – the Swiss producer of ethanol
GMP-grade ethanol from Switzerland for the pharmaceutical industry: whether as the basis for industrial processes, in the production of alcohol-containing medicines, or for use in research – GMP-certified ethanol is an indispensable resource in the pharmaceutical industry. With extensive experience and a long tradition of providing excellent quality and service, alcosuisse ag is familiar with the exacting standards of pharmaceutical clients and therefore operates a GMP-certified production process.
SUPPLIERS
QUALITY CONTROL
PRODUCTION
LOGISTICS
DOCUMENTATION
CERTIFICATES
In the procurement of raw materials, alco-suisse ag follows a clearly defined strate-gy. Many products require specially defined production processes, partly under GMP conditions. alcosuisse ag carries out regular auditing and quality control at all suppliers.
GMP quality is established at an accredited analytical laboratory. The highly effective quality systems and processes therefore allow reduced receiving inspections by end customers in the pharmaceutical industry.
International directives impose clear GMP requirements on the raw materials for APIs. In order to meet the requirements in full, al-cosuisse ag is GMP-certified by Swissmedic for all manufacturing processes. All of the above processes can be audited at any time.
All filling and logistics processes take place in dedicated tank and piping systems, allow-ing contamination and batch mix-ups to be ruled out. The product recall concept incor-porates regular mock recall exercises and therefore guarantees 100% traceability.
All processes are documented according to GMP requirements. The risk and change management is specifically defined and is available for all alcosuisse clients to view at any time. Standardised communication supports internal and external quality assur-ance.
The following additional certifications and confirmations are available on request:
• ISO 9001:2015 Quality management systems• Food Safety System Certification (FSSC) 22000• HALAL• Kosher, Kosher for Passover• CH – U.S. Organic Equivalency Arrangement• bio.inspecta
Significance of the Swissmedic GMP manufacturing licence
Ethanol manufacturing at alcosuisse ag is GMP-certified by Swissmedic. The Swissmedic GMP manufacturing licence is
extremely important for customers in the pharmaceutical industry, as Swissmedic strictly regulates and monitors the quality
assurance of therapeutic products (active pharmaceutical ingredients, or APIs) in Switzerland. Swissmedic provides the
consumer with a guarantee that the production of medicines is subject to strict quality control. For the pharmaceutical
industry, the Swissmedic GMP manufacturing licence signifies that alcosuisse ag is a raw material producer that is
familiar with the pharmaceutical industry’s quality standards and knows how to apply them. With alcosuisse ag, the drug
manufacturing sector therefore has at its disposal a trustworthy producer and supplier that makes the API manufacturing/
refining process efficient, traceable and cost-effective.
Cornerstones of the Swissmedic GMPmanufacturing licence
• BUD CERTIFICATE from Bio Suisse• REACH registration• REACH biocidal listing, Art. 95• FDA Food Facility Registration (FFR) number• CSR standards EcoVadis and Sedex
alcosuisse ag produces a variety of unique GMP-grade ethanol products. Specifically, this offers the following benefits for customers in the pharmaceutical industry:
• fully automated production of high-quality blends• 100% traceability of all raw materials back to the
original producer• 5 µm-filtration of all ethanol products and mixtures• qualified production facilities and validated
production processes• systematic organoleptic testing• dedicated tank, pump and piping systems• batch-specific analysis certificates (European
Pharmacopoeia, Ph. Eur.)• guaranteed quality in logistics/containers• documentation of all process steps and of risk and
change management
The Swissmedic GMP manufacturing licence requires alcosuisse ag to keep complete documentation of the entire value-added chain: suppliers, production, distribution, quality management, handling, storage, handling of dangerous goods and customer support.
As the Swiss pharmaceutical industry’s established, long-standing and preferred partner and supplier, alcosuisse ag undergoes regular and strict auditing by the major Swiss pharmaceutical companies. The Swissmedic GMP manufacturing licence provides all pharmaceutical clients – both in Switzerland and abroad – with a guarantee that ethanol production at alcosuisse ag is subject to the same quality standards as in the Swiss pharmaceutical industry.
2 3
GMP-certified ethanol for pharmaceutical production
alcosuisse ag – the Swiss producer of ethanol
GMP-grade ethanol from Switzerland for the pharmaceutical industry: whether as the basis for industrial processes, in the production of alcohol-containing medicines, or for use in research – GMP-certified ethanol is an indispensable resource in the pharmaceutical industry. With extensive experience and a long tradition of providing excellent quality and service, alcosuisse ag is familiar with the exacting standards of pharmaceutical clients and therefore operates a GMP-certified production process.
SUPPLIERS
QUALITY CONTROL
PRODUCTION
LOGISTICS
DOCUMENTATION
CERTIFICATES
In the procurement of raw materials, alco-suisse ag follows a clearly defined strate-gy. Many products require specially defined production processes, partly under GMP conditions. alcosuisse ag carries out regular auditing and quality control at all suppliers.
GMP quality is established at an accredited analytical laboratory. The highly effective quality systems and processes therefore allow reduced receiving inspections by end customers in the pharmaceutical industry.
International directives impose clear GMP requirements on the raw materials for APIs. In order to meet the requirements in full, al-cosuisse ag is GMP-certified by Swissmedic for all manufacturing processes. All of the above processes can be audited at any time.
All filling and logistics processes take place in dedicated tank and piping systems, allow-ing contamination and batch mix-ups to be ruled out. The product recall concept incor-porates regular mock recall exercises and therefore guarantees 100% traceability.
All processes are documented according to GMP requirements. The risk and change management is specifically defined and is available for all alcosuisse clients to view at any time. Standardised communication supports internal and external quality assur-ance.
The following additional certifications and confirmations are available on request:
• ISO 9001:2015 Quality management systems• Food Safety System Certification (FSSC) 22000• HALAL• Kosher, Kosher for Passover• CH – U.S. Organic Equivalency Arrangement• bio.inspecta
Significance of the Swissmedic GMP manufacturing licence
Ethanol manufacturing at alcosuisse ag is GMP-certified by Swissmedic. The Swissmedic GMP manufacturing licence is
extremely important for customers in the pharmaceutical industry, as Swissmedic strictly regulates and monitors the quality
assurance of therapeutic products (active pharmaceutical ingredients, or APIs) in Switzerland. Swissmedic provides the
consumer with a guarantee that the production of medicines is subject to strict quality control. For the pharmaceutical
industry, the Swissmedic GMP manufacturing licence signifies that alcosuisse ag is a raw material producer that is
familiar with the pharmaceutical industry’s quality standards and knows how to apply them. With alcosuisse ag, the drug
manufacturing sector therefore has at its disposal a trustworthy producer and supplier that makes the API manufacturing/
refining process efficient, traceable and cost-effective.
Cornerstones of the Swissmedic GMPmanufacturing licence
• BUD CERTIFICATE from Bio Suisse• REACH registration• REACH biocidal listing, Art. 95• FDA Food Facility Registration (FFR) number• CSR standards EcoVadis and Sedex
Contactalcosuisse ag Länggassstrasse 35 CH-3012 BernTel. +41 31 309 17 04 Fax +41 31 309 17 08 www.alcosuisse.ch
Purchasing from alcosuisse ag – the advantages for you:
• GMP-grade ethanol
• maximum delivery capacity
• no risks in terms of denaturation, importation and taxes
• wide selection of containers (from 7 kg)
• free delivery
• professional advice from our customer service team
Contactalcosuisse ag Länggassstrasse 35 CH-3012 BernTel. +41 31 309 17 04 Fax +41 31 309 17 08 www.alcosuisse.ch
Purchasing from alcosuisse ag – the advantages for you:
• GMP-grade ethanol
• maximum delivery capacity
• no risks in terms of denaturation, importation and taxes
• wide selection of containers (from 7 kg)
• free delivery
• professional advice from our customer service team
Contactalcosuisse ag Länggassstrasse 35 CH-3012 BernTel. +41 31 309 17 04 Fax +41 31 309 17 08 www.alcosuisse.ch
Purchasing from alcosuisse ag – the advantages for you:
• GMP-grade ethanol
• maximum delivery capacity
• no risks in terms of denaturation, importation and taxes
• wide selection of containers (from 7 kg)
• free delivery
• professional advice from our customer service team