Frequently Asked Questions

• 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.

Butterworth are not registered as expert witnesses and therefore cannot enter into discussions or proffer opinions on the application or consequence of the results, other than those directly relating to the analytical procedures undertaken.

• 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. Last year over 98% of samples were analysed within the agreed time.

• 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.

• 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 Business Development 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).

• 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 Sefvice & QC Records etc are stored for a minimum of 10 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.

 
• 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.

• 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).