Successful project work is dependent upon open and detailed discussions with clients to make full use of the expertise of our staff
Frequently Asked Questions
Below is a list of our current FAQs. Please click the question to display its answer.
Will outsourcing be time and cost effective?
From one-off sample testing to volume analysis, outsourcing to Butterworth's qualified and experienced team of scientists allows your staff and laboratory resources to be available to be focussed on your core business.
You will also have immediate access to a wide range of optimised analytical systems and qualified staff when needed. This ensures that you don't need to purchase instrumentation that may be infrequently used, or spend time and money recruiting highly specialised scientists.
Continued investment by Butterworth in the latest instrumentation enables you to benefit from fast, accurate and highly cost-effective analysis without any additional capital or running costs.
Will I obtain completely impartial advice?
The Company was founded as a limited liability company in 1974 and has remained completely independent. We therefore have no connection or loyalties to any other organisation. In all matters relating to analytical chemistry services that Butterworth Laboratories undertake for its clients, the Company limits its activities to fields in which it has direct experience and knowledge. It will adhere strictly to instructions, which will be agreed and fully documented prior to any work being undertaken. All results produced will be presented as a factual report.
Is Butterworth Laboratories able to match in-house quality standards?
We've been offering the highest standards in quality and service for three decades, we're UKAS accredited to ISO17025, and we're a member of the UK GLP Compliance Programme. Pharmaceutical and healthcare based companies are also assured of work being performed to GMP requirements by regular inspections from the MHRA and FDA. In addition, we always welcome customer audits.
Can our quality department audit Butterworth Laboratories' facilities?
Our QA Manager, David Hawkins, is always willing to arrange for the laboratories to be audited. As a company we welcome the opportunity to meet with our customers, show them round our laboratories and introduce them to the analysts involved with their work. To arrange a date for an audit, please contact David Hawkins (david.hawkins@butterworth-labs.co.uk).
Do Butterworth Laboratories offer the services of a qualified person?
At present we do not have a member of staff with the relevant qualifications. Customers are using their own members of staff with the relevant qualification, or employing an independent consultant for this role. To ensure there is no misunderstanding on this issue, we try to ensure that with all our customers who are working to GMP that we have a signed service/ technical agreement in place, as required by the regulations.
What is the Butterworth Laboratories stance with regards to computer compliance and, in particular, 21CFR Pt11?
We have a commitment to attaining the highest level of computerised system validation and compliance to quality regulations. As part of this commitment, each new analytical system is specifically selected to meet current and predicted future requirements. Existing systems have been assessed using a GAP analysis, which identified areas for improvement. These areas are being actively addressed.
Will deadlines be met?
At Butterworth, you are our number one priority. Being an independent company dedicated to analytical testing, we are able to focus our efforts on delivering the results of the analyses in an agreed time. We ensure that your needs are not compromised by other business issues. Many companies would attest to our proven trade record.
Do Butterworth Laboratories have the capacity and flexibility to handle changes in demands?
Butterworth understand that the demands on your business can change over time, so we always aim to provide a customer-driven service tailored to your prevailing requirements. Whether you have specific seasonal demands or the need to meet specific campaign strategies, our aim is to assist you in meeting your needs.
Do Butterworth Laboratories have the necessary equipment, staff and knowledge to perform the required analysis?
The analytical staff at Butterworth Laboratories have a variety of experience working as Analytical Chemists across a range of industries, prior to joining our staff team. This therefore allows Butterworth to draw from a significant pool of expertise to, working with only the latest relevant technology to the task at hand, address your testing requirements.
If we do not have the required technique to undertake the requested testing, we will inform you immediately. It is company policy not to subcontract any analysis, but we will endeavour to suggest other companies who may be able to assist you.
Can Butterworth Laboratories develop and validate methods for us?
Our staff have worked in partnership with a large number of our clients to either develop and validate new methods, or revalidate existing methods for new products. Many of the reports have then been used in regulatory submissions to the FDA and other authorities.
Will I be able to talk to the staff member performing the analysis?
At Butterworth we pride ourselves on the strength of the partnerships we have forged within the pharmaceutical, chemical, healthcare and environmental industries. Our consultants and analytical staff are committed to offering a personalised service to all our clients, with clear and open communication at all times.
Can I arrange for a meeting to discuss a project requirement in depth?
Prior to any major new project or starting work with a new customer we would encourage you to arrange a meeting with our staff. We do not charge for this initial consultation. Ideally we would suggest that you come and meet the staff and tour the laboratory facilities, but if required our Scientific Business Manager would be happy to arrange a visit to your own site if this is more convenient. To arrange a visit please contact John Welch (john.welch@butterworth-labs.co.uk) or David Bell (david.bell@butterworth-labs.co.uk).
Will all information supplied be kept confidential?
It is stated in the company regulations signed by all staff that:
- All work done by the laboratories is undertaken on a strictly confidential basis in accordance with the requirements of the Company's UKAS and GLP accreditations
- Staff must not disclose any of the Company's methods of work, costing, financial details, details of organisation, precedents or any procedures so adopted
In addition, we are happy to sign CDA's etc, provided that they are governed by English law.
Can I have the raw data for the samples analysed?
Sample specific Raw Data is supplied with every Report or Certificate of Analysis. Butterworth retain an electronic copy of the Raw Data sent electronically in their archives. Please note that we cannot supply electronic data - in these instances a certified hard copy will be supplied.
What is your archiving period?
At present we archive hard copies of original documentation supplied to Butterworth by clients, such as Sample Application forms etc. for a minimum of six years, at which point they are then disposed of in a secure manner. Internal Quality documentation such as SOP's, Instrument Service & QC Records etc are stored for a minimum of 25 years.
GLP Studies are archived as detailed in the Individual Study Plan.
Samples are stored for one calendar month from the date of issue of the Certificate of Analysis.
Do Butterworth publish a price list?
Given the very diverse nature of the analytical capabilities of Butterworth we do not publish a price list. Instead, it is the policy of the company to provide a written quotation for each sample submitted for analysis. As part of our ISO17025 accreditation we are required to document that there is an agreement between ourselves and our client that:
- The requirements, including the methods to be used, are adequately defined, documented and understood
- The laboratory has the capability and resources to meet the requirements
- The appropriate test method is selected and is appropriate to meet the clients' requirements
- A signed quotation acts as the contract agreement.
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Submitting a sample
How do I find out how much the work will cost?
We do not publish a price list, but rather provide individually tailored quotations for each request. To obtain a quotation please complete the Quotation Request Form or contact the Scientific Business Manager John Welch (john.welch@butterworth-labs.co.uk). We always try to make our quotations as open and comprehensive as possible. Where additional handling charges are required for H&S reasons, or surcharges are made for the supply of CRM's or raw data, these will be clearly stated within the main body of the quotation.
For customers who wish to submit samples on a routine basis for specified range of parameters etc. we can provide a contract price to cover a 6 or 12 month period.
What information do I need to provide when asking for a quotation?
To ensure that your request is responded to in a timely manner, the information supplied should be as detailed as possible. Please provide at least the following where possible:
- Name and address of company
- Contact name and details
- Type of sample to be analysed
- Number of samples to be submitted
- Frequency - if samples to be routinely submitted
- Full analytical requirements
- Methods to be employed
- Specification/ limits of detection to be met
- Analysis completion date/ turn-round required
- Quality system requirements (UKAS/GMP/GLP)
It is important to note that although we are accredited to ISO 17025 and all analyses are carried out to the same standard, not all tests appear on our schedule of accreditation. If you require accredited work, please state this as early as possible.
If you require a GLP compliant study, please state whether the work to be conducted by us is a full study or a delegated phase of a multi-site study.
Are there any hidden costs?
We attempt to be as open as possible about any charges in our quotation. Where required, the cost of supplying certified reference materials, project specific consumables are included in the quotation.
How should I send samples for analysis to Butterworth?
We routinely receive samples by post and courier firms. When deciding the most appropriate means of delivery, consideration should be given to the nature of the samples being submitted, the reliability of the means of transport and how urgently the analysis is required.
It is important that the relevant Material Safety Data Sheet is enclosed with all samples submitted. This not only ensures that our staff know exactly how to handle the sample on receipt, but also, in the case of damage occurring during the shipment process, that the staff of the postal or courier company know how to respond.
It is also a good idea to give us prior notification that sample submissions are being sent for routine testing.
How soon will my results be available?
Our standard turn-round time quoted on the majority of our quotations is 10 working days for routine sample submissions. Shorter turn-round times may be negotiated at the quotation request stage.
For the day of sample receipt to be considered as a "working day", samples must be received before 10.00am, on that day. In this respect, advance notice of sample submission is useful.
As soon as the results are available and have been typed into a report format, we can fax or email prior to putting the report in the post.
What is Butterworth's approach to sample retention?
Where there are remains of a sample following testing, it is retained for a minimum of one month following the date of issue of the report. If requested, this period can be extended or have the samples returned to you, but this must be agreed in writing at the sample quotation stage, and will incur a surcharge.
How do I make payment for the analysis?
It is Company policy that when analytical work is requested for the first time, all new clients are required to settle their account in advance in pounds sterling. For subsequent work, a purchase order requesting an invoice on completion of the analysis may be accepted.
To set up an account with us please contact the Accounts Manager, Albert Kitson (albert.kitson@butterworth-labs.co.uk).
What happens to the raw data?
Analytical raw data is supplied with your Certificate of Analysis. We scan the Raw Data and Report and Archive this electronically. Please note that we can only provide "hard" certified copies of electronic raw data. Original documentation supplied with the samples is held in our Archives for a minimum of 6 years.
All other data such as instrument records, controlled documentation and original electronic data is retained in our archive for a minimum of 25 years.
To ensure confidentiality, all hard copy archive records are securely disposed of at the end of their retention time.
Can I pay in Euros?
Provided that you have an account with Butterworth and pay by BACS transfer, we can arrange for your quotation to be in Euros and receive payment in the same currency. For further details, contact our Accounts Manager, Albert Kitson (albert.kitson@butterworth-labs.co.uk).
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Starting a project
If your company has not worked with Butterworth Laboratories previously, or you are new to outsourcing a project, the following information may be of assistance.
What type of projects can Butterworth Laboratories undertake?
The pages of the website list a number of areas in which we can undertake larger scale projects. Our main areas of work cover analytical chemistry and phys/chem testing. Using Vindon Scientific Ltd for storing samples to ICH Guideline requirements, we can undertake Storage Stability studies.
Whilst we have made every effort to illustrate the complete range of our services in this website, we are aware that you may still have further questions you wish to ask. If so, please contact our Scientific Business Manager John Welch (john.welch@butterworth-labs.co.uk) for further information.
Who do I contact to arrange to initiate a project?
What information will I be required to supply?
The following list is typical of the information required to provide a quotation:
- Name and address of company
- Contact name and details
- Type of sample to be analysed
- Number of samples to be submitted
- Frequency - if samples to be routinely submitted
- Full analytical requirements
- Methods to be employed
- Specification/ limits of detection to be met
- Analysis completion date/ turn-round required
- Quality system requirements (UKAS/GMP/GLP)
It is essential that we are made aware of the background and why the work is being requested. The more fully we are informed at the initiation of the project, the more comprehensive and accurate our estimation of costs can be. It may also have an impact on the advice we provide on the analysis requirements of the project concerned.
Due to the legal ramifications, it is essential that we know if the work is relating to Patent Infringements or Insurance Claims, so that we can take the relevant advice from our insurers and solicitors and make sure that we do not have a conflict of interest.
How are projects managed?
Following acceptance of the quotation, our Project s Manager or his Deputy oversee the analytical work and production of the final report. The Projects Manager will be your point of contact throughout the life of the project. It is their responsibility to ensure that the work is undertaken in a timely manner, to the highest analytical standards and in compliance with our Quality System.
For regulatory studies in compliance with GLP, the management of Butterworth will appoint a Study Director or Principal Investigator who will be responsible for the production of the analytical study plan and other relevant documents. For GLP Studies it is the Study Director or Principal Investigator who is responsible for the conduct of the Study and production of the final report. The QA Department audit all critical phases of the study or delegated phase and report their findings to the Principal Investigator and/or Study Director and management. Copies of all QA Inspection reports are enclosed within the report submitted.
Can I obtain a draft report?
We are able to accommodate those customers who wish to approve a copy of the report prior to its issue. To ensure that this stage is accounted for, we require to be informed of this requirement at the initial discussion phase so that the additional administration costs can be accounted for in the quotation.
Can I visit to observe/audit my project being performed?
How are projects costed?
As with all work, an assessment of the time required is made following the initial discussions. From this we provide an estimate of the costs based on a daily rate of the level of personnel required to perform the analytical work.
All project work is quoted on the basis of the expected time the work will take. If, during the course of the work, it appears that the time required will be more than our estimate we will seek your further instructions before undertaking any more work.
For larger projects we try to break down the work into smaller manageable stages, so that progress reports can be provided on completion of a particular aspect of the work. In this way, if the work, for whatever reason, is not progressing in the expected manner, the work can be terminated and an invoice produced for the work already completed.
How quickly will the project be undertaken?
The quotation will contain an estimate of expected completion dates of both the analysis and the report. Depending on the size of the project this is often between 3 - 4 weeks. As soon as the results are available and have been typed into a report format, we can fax or e-mail, prior to putting the report in the post.
How are projects reported?
A bound report is issued containing results, any other important observations and findings and the analytical raw data.
For GLP Studies, the report is produced in accordance with the regulations and shall also contain a copy of the QA Inspection report.
In certain circumstances results can be relayed prior to the production of the report. In these instances it may be that these have not been fully checked for accuracy. A statement to this effect will be attached to the communication and that the Butterworth Laboratories reserves the right to make alterations to these in the final report.
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