Capability

STATEMENTALS Europe

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Introduction

ALS Pharmaceutical is one of the key business streams within the ALS Group, focussing on delivering high quality technical and service solutions to clients in the pharmaceutical industry.

At ALS we are committed to providing a responsive and flexible service to meet our customers’ needs, with the aim of exceeding their expectations and establishing productive, long-term partnerships.

Our pharmaceutical operations in Europe employ around 100 professional and support staff. People and knowledge are key priorities for the group and as such, internal development programs are routinely run to foster both technical and service skills.

ALS Pharmaceutical is part of the Life Sciences division with operations on all continents. Globally ALS employs more than 13 000 staff with 1 200 staff employed in the Life Sciences division in Europe. Our network of pharmaceutical laboratories are all GMP compliant and most laboratories are inspected by the FDA on a regular basis.

Core ValuesOur Core Values are simple and we incorporate them in our daily operations, never forgetting the foundations of our success:

• Honesty and Integrity• Exceeding Client Expectations• Belief in our Ability• Hard Work and Continuous Improvement

• Doing it Better• Celebrating Success• Safety as a Priority

4 Capability Statement Pharma Europe

ALS laboratories

Ely, United Kingdom

ALS Pharmaceutical Ely is one of the UK’s leading providers of pharmaceutical testing services. A comprehensive range of services are provided from the Ely site. The portfolio includes testing of API’s, finished products for batch release, raw materials, intermediates, purified water, water for injection and waters for steam sterilisers and washer disinfectors (to HTM and CFPP guidelines). Pharmacopoeial or customer specific methods are employed.

The Ely facility is a dedicated pharmaceutical facility and offers a full range of chemical and microbiological testing testing including storage stability trials. Six storage stability rooms are available operating at the standard ICH conditions. All rooms are monitored in real time for temperature and humidity with a 21 CFR Part 11 compliant data system.

Ely’s enviable reputation for providing a high quality service is underpinned by its team of highly qualified and experienced staff. With extensive pharmaceutical expertise, many staff are members of relevant professional bodies, ensuring that we remain at the forefront of the industry. Our understanding of the pharmaceutical market and customers’ requirement enables us to provide knowledgeable, proactive support and advice. Our staff pride themselves on their technical expertise and are always more than willing to discuss a customer’s specific testing needs.

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Luleå, Sweden

The ALS site in Sweden is a dedicated metals testing facility. The laboratory is amongst the best equipped globally with the latest in High-Resolution techniques. In the purpose built laboratory all instruments are placed under clean-room conditions. During the past 20 years, this laboratory has gone from serving mainly Swedish emerging pharmaceutical companies to assisting pharmaceutical companies all over the world with tasks that ordinary laboratories are unable to accomplish.

Most of the senior staff in the laboratory have been part of the development from the beginning. Today more than 100 client specific method validations have been delivered to satisfied clients. The majority of the validations have been in accordance with ICH guidelines Q2 (R1) and USP <233>.

Although the site is equipped to industry leading standards ALS appreciate that without personal service from dedicated staff we will not be able to meet and exceed the expectations of our clients. Hence, we regularly train staff in client service and listen very carefully to our clients feed-back to make sure we are as up to date and unique in this field as we are technically.

Prague, Czech Republic

The ALS Pharmaceutical laboratory in Prague carries out testing of quality, potency and/or quality compliance of raw materials, intermediates and final products for the pharmaceutical industry.

Our laboratory meets the demanding requirements of national and international regulatory authorities whilst our established stable quality assurance system enables processing of both standard orders and non-standard individual projects.

Thanks to our highly qualified and experienced staff, modern analytical instruments and specially secured systems, we can process the orders quickly and effectively. Precision and accuracy of the results is always our top priority.

6 Capability Statement Pharma Europe

ComprehensiveRange of services

Pharmaceutical Testing Services

• Chemical, physical and microbiological analysis of human and veterinary products, intermediates and raw materials

• Pharmacopoeial Standards and methodologies according to:

• Ph. Eur. - European Pharmacopoeia

• USP - United states Pharmacopoeia

• ČL - Czech Pharmacopoeia

• BP - British Pharmacopoeia

• ICH Guidelines

• International Standards and in-house methods as well as customer specific methods as required

• QC testing for batch release

• Method validation/transfer/verification

• Stability studies, including storage at ICH conditions (25°C/60%RH, 30°C/65%RH, 40°C/75%RH)

• Routine or specialist projects and investigations

• Water testing – Chemical and Microbiological analyses, according to Pharmacopoeia Monographs

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Chemical & Physical Parameters

• API Assay

• Excipient Assay

• Identification

• Related substances

• Dissolution profile

• Disintegration

• Tablet hardness

• Tablet friability

• Tablet Dimensions (diameter, width, thickness, length)

• pH

• Conductivity

• Loss on drying (oven and vacuum oven)

• Loss on ignition

• Sulfated ash

• Water content Karl Fischer

• IR identification

• UV/VIS Spectrophotometric parameters

• Optical rotation

Instrumental

• Specific optical rotation

• Refractive index

• Appearance and colour of solutions

• Metals Assay

• Total organic carbon

• Residual solvents

• Potentiometric titration

ComprehensiveRange of services

8 Capability Statement Pharma EuropeALS Czech Republic, Praha

ComprehensiveRange of services - Microbiology

Environmental

• Settle Plates – Total Bacteria, Yeast and Mould

• Air Plates – Total Bacteria, Yeast and Mould

• Air Plates – Total Bacteria, Yeast and Mould

• Contact plate analysis

• Swab and sponge analysis

General

• Microbial Enumeration and Identification Tests

• Total Aerobic Viable Count

• Total Yeast and Mould Count

• Bile Tolerant Gram Negative Bacteria

• Coliforms & Escherichia.coli

• Salmonella

• Staphylococcus aureus

• Pseudomonas aeruginosa

• Clostridia

• Preservative Efficacy Testing (PET)

• Bacterial Endotoxin Test (LAL) – Gel Clot and Turbidimetric methods

• Bioburden

• Evaluation of disinfectants and antiseptics

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Quality Management System

ALS is committed to consistently providing quality data and service to satisfy the requirements of each client. Therefore ALS methodologies are performed and developed in accordance with Pharmacopoeial, regulatory and customer requirements.

ALS Pharmaceutical achieves premium service levels through continued investment in quality systems and technology to guarantee on-going compliance.

Regulatory Compliance

ALS pharmaceutical laboratories in Europe host more than 50 audits annually including:• FDA

• National Regulatory Agencies (GMP, GLP)

• National Accreditation Bodies (ISO 17025)

• International pharmaceutical companies

ALS welcomes clients to visit and/or audit our laboratories. In addition to external audits, we have our internal, independent quality department, which undertakes a programme of self-inspection.Our laboratories in Europe have the following licences:

Ely:Licence Issuer ReferenceGMP Compliance MHRA UK GMP 15936ISO 17025 UKAS 1282

Lulea:Licence Issuer ReferenceGMP Compliance Medical Products Agency, Sweden 24:2009/520599FDA FDAGLP Compliance SWEDAC 09-1808-51.7839ISO 17025 SWEDAC 2030

Prague:Licence Issuer ReferenceGMP Compliance SUKL 536FDA FDAISO 17025 CIA 273/2014

Your notes

Czech RepublicPrague

Na Harfě 336/9190 00 Prague 9

T: +420 226 226 228E: customer.support@alsglobal.com

SwedenLuleå

Aurorum 10SE - 977 75 Luleå

T: +46 920 289 900E: info.lu@alsglobal.com

United KingdomEly

2 Bartholomew‘s Walk, Cambridgeshire Business Park,Ely Cambridgeshire CB7 4ZE

T: +44 (0) 1353 660040E: sales.uk@alsglobal.com

www.alsglobal.eu