EXCELLENCE ANALYTICAL CHEMISTRY

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1 EXCELLENCE IN ANALYTICAL CHEMISTRY

2 An Independent laboratory run by scientists for scientists Doris Butterworth Managing & Technical Director 2

3 Contents Butterworth Laboratories 5 Commitment to Quality 7 Quality Control Testing 9 Raw Materials and APIs; Finished Products; Packaging Materials 11 Laboratory Facilities 12 Projects 15 Method Development; Validation 17 Stability Testing 19 Customer Focused Service 21 Our Vision for the Future

4 Integrity, Flexibility and Reliability are more than just words to the staff at Butterworth John Welch Head of Business Development 4

5 Whatever your needs Butterworth will work in partnership with you to develop a bespoke solution that will fit your precise requirements, which will be delivered to you by our expert team in complete confidence. Butterworth Laboratories We have over 35 years of experience in analytical chemistry and continue to maintain our first-class reputation as one of the UK s premier independent providers of contract analytical chemistry services to the Pharmaceutical and other industries. Our primary aim is to deliver to our Clients, a reliable, rapid and cost-effective analytical service. We are able to achieve this due to the professionalism, dedication and skill of our staff as well as a continuing investment in new and up-to-date instrumentation, infrastructure and facilities. Our ability to combine classical and modern instrumental techniques with our expertise allows us to satisfy and exceed our Clients expectations. Many companies recognise the benefits of outsourcing their quality control and stability testing and their method development and validation. This has enabled us to develop a diverse customer base, ranging from small independent organisations and consultancies to multi-national blue-chip companies. Our flexibility, responsiveness and customer focus allow us to accommodate contracts of all sizes, from small one-off assignments to major long-term partnerships. Why not contact us today and allow us to develop a tailor-made solution for you? Tel: +44 (0) marketing@butterworth-labs.co.uk 5

6 We have provided the highest standards of quality and service for three decades David Hawkins, Head of Quality Assurance & IT 6

7 Our qualified team comprises graduates and technicians drawn from both manufacturing industries and R&D. Having worked in industry, they fully appreciate our Clients outsourcing requirements. Above all, our staff remain dedicated and proactive. Commitment to Quality Our on-going commitment to quality is fundamental to our reputation. We always aim for excellence, both in terms of the technical services we offer and our interaction with Clients. We have always worked to guarantee the highest standards of quality and service. The result is a mature and welltested quality system which has been finely tuned and crafted to meet the specific demands of the Pharmaceutical and related industries. Staff training and development is a key priority. Every employee is encouraged to play an active role in quality assurance, not only in terms of their own performance but across all areas of the business. This open and proactive approach allows us to anticipate and respond to the demands of our Clients and also helps to ensure that all members of staff are involved in the evolution of the quality system. We receive quality audits from both regulatory bodies and Clients. In particular Client audits represent an excellent opportunity to share ideas, identify areas for potential improvements and develop a better understanding of our Clients requirements. The laboratories are currently approved by the MHRA and FDA for GMP & GLP compliance. We are also accredited by UKAS to ISO If you have any questions regarding Quality contact our Head of Quality Assurance & IT Tel + 44 (0) david.hawkins@butterworth-labs.co.uk 7

8 We are constantly reviewing the range of techniques we can offer and are happy to discuss investment in new instruments with clients David Riches Head of Analytical Operations 8

9 By taking advantage of our services, you can reduce expenditure on laboratory facilities, specialist instrumentation and on trained in-house scientific staff, helping to minimise investment in non-core areas of your business. Quality Control Testing Outsourcing proves to be a cost-effective option for many organisations and we continue to provide flexible, tailored and innovative solutions. Whether you require to contract out testing due to lack of in-house facilities; to meet seasonal or periodic high workloads; or to provide independent certification, we are able to help. Our staff can follow pharmacopoeial monographs, internationally published standards, Client in-house methods or use methods that have been developed and validated by our Projects Department. The use of the classical techniques of Titrimetric, Gravimetric and Colorimetric analysis remain a core competency requirement for all laboratory staff. New staff, regardless of previous experience, are expected to train, or demonstrate their proficiency in these areas, as we believe the discipline of performing these techniques is the foundation of a good analytical chemist. To compliment these classical techniques we have a wide range of analytical instruments, which are all maintained and qualified to GMP standards. Instruments are replaced on a regular basis to ensure the laboratory maintains its ability to provide a reliable service. We value meetings with our Clients to discuss their current and future requirements. Where there is sufficient demand, we are always willing to consider investing in new techniques to expand the services we can offer. Whilst our core business is in the Pharmaceutical and associated industries, the Laboratory provides a Quality Control (QC) testing service for a wide variety of industrial sectors. To discuss your QC requirements contact our Head of Analytical Operations Tel + 44 (0) david.riches@butterworth-labs.co.uk 9

10 The analytical staff understand the chemistry behind the methods they are performing Client 10

11 Pharmaceutical and healthcare based companies can rest assured of work being performed to GMP requirements by regular inspections from the MHRA and FDA. The quality system is also accredited by UKAS to ISO17025 Raw Materials and APIs We specialise in the testing of raw materials to ensure that they meet their required specification. Testing of this type involves setting up and qualifying instruments for one-off sample batches which is both time-consuming and inefficient for in-house QC laboratories that are dedicated to testing finished products. Finished Products Although our primary QC focus is the testing of raw materials, the laboratory also has experience in finished product testing. Samples originate from either current production or stability studies. Clients are supplied the original raw data with all certificates of analysis, allowing scrutiny by a Qualified Person (QP) prior to release. Packaging Materials Pharmaceutical packaging materials are also subject to various pharmacopoeial requirements. At Butterworth we routinely test extractable and leachable components from containers and closures. Due to our extensive experience for the determination of residual solvents in APIs and excipients we also perform similar analysis on printed packaging. To discuss your requirements contact our Head of Analytical Operations Tel + 44 (0) david.riches@butterworth-labs.co.uk 11

12 Laboratory Facilities It is essential that the Company maintains a wide range of techniques and GMP qualified instruments to supply analytical testing services to the Pharmaceutical and related industries. Spectroscopy We have capabilities in both Atomic and Molecular Spectroscopy. Atomic Spectroscopy Used for the determination of metals and certain non-metallic elements, usually as minor or trace constituents in pharmaceutical raw materials and finished products. Techniques available include: ICP-MS, ICP-OES, AAS and GF-AAS Molecular Spectroscopy Used for the identification and structural analysis of organic compounds. Techniques available include: FTIR (Including ATR), UV/Vis (With Reflectance Sphere attachment) and Fluorimetry Classical Wet Chemistry Our ability to provide classical analytical chemistry techniques enables the wide range of qualitative and quantitative tests, as found in pharmacopoeial monographs, to be performed. These include but are not limited to: Titrimetry Potentiometry Coulometry Gravimetry Colorimetry Elemental Microanalysis The original focus of the Company was to undertake elemental microanalysis, the determination of percentage levels of carbon, hydrogen, nitrogen, sulfur and halogens in organic compounds on milligram amounts of sample. This definition has now been extended to encompass other elements such as metals that can be determined by ICP. Instrumentation and Techniques include: Carbon, Hydrogen and Nitrogen Analyser Nitrogen Chemiluminescence Analyser Oxygen Flask Combustion for Sulfur and Halogens 12

13 We continually review our techniques and capabilities taking into consideration Clients requirements. We replace all our instruments on a regular basis thus ensuring the reliability of our service. Chromatography We use Chromatography predominantly to perform Assays, Related Substances and Residual Solvents testing of Raw Materials, APIs and Finished Products. The Chromatography Section is equipped to perform: Gas Chromatography Our GCs have the facility for headspace analysis as well as direct injection and are fitted with a range of detectors such as ECD, FID, TCD and MS. GC is used primarily for the analysis of volatile and semi-volatile organic compounds. Liquid Chromatography Our HPLCs have UV, Diode Array and RI detection and are capable of undertaking GPC analysis. HPLC is used primarily for the analysis of non-volatile organic compounds. Ion Chromatography Our ICs have PAD, UV as well as Conductivity detection capabilities. IC is primarily used for the analysis of Inorganic Anions and Organic Acids. In addition we also undertake Antibiotic, Carbohydrate and Surfactant analysis. Physical Chemistry Testing We have the capability to perform Phys/Chem testing that includes: Dissolution Viscosity of liquids Specific Optical Rotation (SOR) Refractive index (RI) Specific Gravity or Density of liquids Particle size (by Sieve technique) Bomb Calorimetry Distillation range Differential Scanning Calorimetry (DSC) Melting point/melting range Boiling point/boiling range Sub-visible Particulate Matter To discuss the services currently available or other techniques not listed contact our Business Development Department. Telephone: +44 (0) marketing@butterworth-labs.co.uk 13

14 Successful project work is dependent upon open and detailed discussions with clients to make full use of the expertise of our staff David Bell, Head of Projects 14

15 Whilst the primary focus of the Company is pharmaceutical analysis, the experience of our chemists enables us to consider work from all sectors of industry. Projects A significant and expanding proportion of our work relates to non-routine testing, termed Projects. This includes, but is not limited to, method development, validation and stability testing. Many Clients are now outsourcing this work as a cost effective and time saving solution, to allow them to concentrate on their core business activity. We believe our key to successful project work is open and detailed discussion with Clients enabling both parties to make full use of the expertise and experience of our staff. These initial discussions facilitate an effective understanding, by both parties, of the requirements of the project which often result in time and cost savings. Being members of the UK Good Laboratory Practice (GLP) Compliance Programme, we are able to undertake work associated with health and environmental safety studies that will be submitted to regulatory authorities for the purpose of risk assessment. This is of particular importance with regards to the REACH Regulations. Butterworth Laboratories Limited is a totally independent company. As a result we are employed for insurance claims and patent litigation work and undertake work, acting in the role of an arbitrator, where results are in dispute. To discuss your requirements contact our Head of Projects Tel + 44 (0) david.bell@butterworth-labs.co.uk 15

16 Like a breath of fresh air being able to talk to people who wanted to work together Client Project Manager 16

17 Our longstanding pharmaceutical and cosmetic sector partners not only trust us with their analytical testing, but increasingly rely on us to develop and validate new methods for them. Method Development Our analysts and managers come from a variety of different industrial backgrounds and are therefore able to use this experience to introduce new ideas and analytical solutions to our Clients, often providing more cost effective solutions. To ensure successful method development robust enough for Quality Control purposes, analytical expertise is required. With our wealth of experience in QC testing this is an area where we bring together, both expert understanding of the technique employed and the practical working knowledge of our analysts. Validation Following development of a method, it is vital that its performance is fully validated. Unless the Client specifies otherwise we validate methods to ICH guidelines as required by most regulatory authorities. In addition, during the life cycle of a method, it is not uncommon that the method will be adapted or developed for additional applications, requiring further validation an exercise frequently undertaken by our Projects Team. Performing analysis in parallel with our Clients on method validation, enables projects to be delivered in shorter time frames, with the additional benefit of increased robustness and ruggedness. To discuss your requirements contact our Head of Projects Tel + 44 (0) david.bell@butterworth-labs.co.uk 17

18 18 Butterworth have a clear committment and understanding of the need to meet the standards of the Pharmaceutical industry Client Audit Report

19 Managed by Scientists for scientists, Butterworth have provided independent Contract Analytical Services for nearly four decades. The management remains committed to these ideals. Stability Testing The nature of stability studies make them ideally suited to outsourcing. Samples need to be stored securely over several years with intensive testing in the early stages, diminishing as time progresses. This variation in resource requirements can cause adverse pressure within an in-house QC laboratory. We provide assistance in the design of standard real time studies, stress testing over short periods at elevated temperatures, and photo stability studies, all of which need to be in compliance with ICH. Butterworth are able to handle the complete studies including the storage of samples or alternatively perform testing on samples that have been stored at a Client s own facilities. To discuss your requirements contact our Head of Projects Tel + 44 (0) david.bell@butterworth-labs.co.uk 19

20 All our staff are fully committed to meeting the clients requirements John Welch Head of Business Development 20

21 By taking advantage of our services, you can reduce expenditure on laboratory facilities, specialist instrumentation and on trained in-house scientific staff, helping to minimise investment in non-core areas of your business. Customer Focused Service We aim to provide a fast, reliable and cost-effective extension to your in-house capabilities. At Butterworth we have a policy of open communication, which means that you can always speak directly to the analyst performing your tests. We are well aware that our staff is one of our key assets and we continue to invest heavily in the recruitment and retention of skilled and well-motivated staff. This has resulted in a low level of staff turnover; more than half have worked with us for at least a decade. We encourage face-to-face meetings with our Clients to discuss their requirements, which can take place at our laboratories enabling direct contact with the analysts involved in the work. Additionally a tour of the facilities allowing a critical review and evaluation of our capabilities can take place. Alternatively, we will gladly arrange for a member of our staff to visit your site. Good ongoing communications enable our staff to build up in-depth knowledge about the specific requirements of individual Clients. To arrange a visit or discuss your requirements contact our Head of Business Development Tel + 44 (0) john.welch@butterworth-labs.co.uk 21

22 We expand all the time. There are no limits Doris Butterworth Managing & Technical Director 22

23 The business has evolved through various phases to the current emphasis on pharmaceuticals. We keep one step ahead by expanding our range of services to pre-empt today s demand for contract analytical services. Our Vision for the Future Firstly, because we think this is most important for you to know, we shall remain totally independent and all profits will continue to be re-invested in the Company. Secondly, as we always have done, we shall continue to fulfil our promise of delivering a personalised service based entirely on the needs of you, our Clients. Thirdly, we look forward to the inevitable changes that will arise from the future developments in analytical techniques. We shall keep pace and ensure our staff are always fully trained and are developing to their own maximum potential. Scientific staff will continue to be recruited to meet demands as the Company expands. We intend to maintain our policy of reviewing and up-grading all instruments in an on-going five-year plan. We shall welcome each and every one of you to visit or audit us whenever you wish. In turn we shall try to visit all of you regularly for consultation on your present work and to establish what your future requirements may be. We are motivated by our Clients requirements. We expand all the time, and there are no limits. We are proud of our heritage and we are looking forward to the future with confidence. Doris Butterworth Managing & Technical Director 23

24 New Enquiries, Client Visits, Contracts & Agreements John A S Welch CChem MRSC MRQA Head of Business Development john.welch@butterworth-labs.co.uk Quality Control Analysis David A Riches BSc CChem MRSC Head of Analytical Operations david.riches@butterworth-labs.co.uk Projects, Method Development, Validation, Stability and Non-Routine Analysis David Bell BSc Head of Projects david.bell@butterworth-labs.co.uk Quality Audits & Regulatory Issues David J Hawkins BSc CBiol MIBiol MRQA Head of Quality Assurance & IT david.hawkins@butterworth-labs.co.uk Waldegrave Road, Teddington, Middlesex TW11 8NY Telephone: +44 (0) Fax: +44 (0) info@butterworth-labs.co.uk Website: Designed by: Delaney Goss Ltd