Accreditation
Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks.
Accuracy
The accuracy of an analytical Method is the closeness of test results obtained by that Method to the true value. Accuracy is a measure of the exactness of the analytical Method.
Advance Payment Invoice
An invoice payable before the completion of the Services to which it relates
Analysis
The process, using both physical and chemical techniques, used to identify components of a Material, to identify proportions of those components and/or their concentrations.
Analytical Raw Data
Specifically, Raw Data is produced as a record of the analysis of samples or during a project in the laboratory. This does not include supporting records such as training records and validation/calibration data unless where these have been performed specifically for the analysis and recorded in the write-up.
Analytical Equipment
A piece of scientific apparatus used in the analysis of Samples.
Analytical Instrument
A piece of Analytical Equipment used for the analysis of Samples and which produces, collects and/or manipulates Analytical Data.
API
Active Pharmaceutical Ingredient
Archive
Records retained specifically by an appointed Archivist; See Record Retention
Associated Companies
Any holding or intermediate holding Company and any Company over which control is exercised (either alone or in conjunction with any connected person) within the meaning of Section 840 of the Income and Corporation Taxes Act 1988.
Business Day
A day (other than a Saturday, Sunday or public holiday in England or any day falling in the period between Christmas Day and the New Year’s Day).
Butterworth
Butterworth Laboratories Limited, 54-56 Waldegrave Road, Teddington, Middlesex, TW11 8NY. Company No. 1185121
Butterworth Terms & Conditions
means the terms and conditions contained in Appendix A.
Calibration
The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a reference or traceable standard over an appropriate range of measurements.
Call-off Contract
A contract for the provision of the Services by Butterworth in accordance with clause 2.1.1.
Certificate of Analysis
A type of Report containing the results of the scientific tests carried out on Sample(s) and where specifications have been set, compliance or otherwise to those limits.
Certified Copy
A paper or electronic copy of the original record that has been verified (eg by a dated signature) or has been generated through a validated process to produce an exact copy having all the same attributes and information as the original.
Change Control
A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, Analytical Instruments/Equipment or processes.
Client Material
all documents, information, Samples, items, substances and materials which the Client provides to Butterworth in connection with the Services
Clinical Trial
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms Clinical Trial and Clinical Study are synonymous.
Complaint
Where either Party formally and in writing claims that the conduct by the other Party does not meet the required level of adherence to any Agreement, Contract or agreed Terms & Conditions, or where the other Party has not acted in an acceptable and professional manner. A Complaint may also be made by a Third Party against the conduct of either the Client or Butterworth.
Confidential Information
Shall mean information relating to the business products technical and analytical processing affairs and finances of either party for the time being confidential to it and trade secrets (including without limitation technical data, documentation and know-how) relating to the business of either party or of any of its suppliers clients or customers including in particular (by way of example only and without limitation) technical and analytical processes financial or marketing forecasts, details of suppliers and their terms of business, details of customers and their requirements, the prices charged to and terms of business with customers, marketing plans and sales forecasts, financial information, results and forecasts (save to the extent that these are included in published audited accounts), any proposals relating to the acquisition or disposal of a company or business or any part thereof or to any proposed expansion or contraction of activities, details of employees and officers and of the remuneration and other benefits paid to them, information relating to research activities, trade secrets, inventions, secret processes, designs formulae and product lines any information which either party is aware is or should reasonably be aware is or has been told is confidential and any information that has been given in confidence by customers, suppliers or other persons.
Data Integrity
The extent to which all Analytical Data is complete, consistent and accurate throughout the data life cycle.
Data Pack
Supporting information relating to the analysis for a job that is compiled and provided to the Client with the Certificate of Analysis or Report. The Raw Data Pack (or Data Pack for short) consists of Analytical Raw Data, Certified Copies or a combination of both depending on the origin and format of the Analytical Raw Data. Electronic versions of Raw Data Packs, which are essentially a Certified Copy, may also be produced for sending to the client electronically.
Design Qualification (DQ)
The documented verification that the proposed design of the facilities, systems and Analytical Equipment is suitable for the intended purpose.
Deviation
A departure, either intentional (Planned) or unintentional (Unplanned), from an agreed Method, procedure or protocol. A type of NCW.
FDA
Food and Drug Administration (USA).
GCP
Good Clinical Practice, as laid down in Regulation EU No. 536/2014..
GLP
The principles of Good Laboratory Practice in accordance with The Good Laboratory Practice Regulations 1999 (Statutory Instrument 1999 No. 3106) which are based on the Good Laboratory Practice Principles set out in Section II of Annex I to the European Parliament and Council Directive 2004/10/EC.
GMO
Genetically modified organism.
GMP
The principles of Good Manufacturing Practice as laid down in EU Commission Directive 2003/94/EC and also 21 CFR Parts 210 and 211 in respect of medicinal products for human use and investigational medicinal products for human use.
Health & Safety (H&S)
Those aspects of the Health & Safety at Work Act 1974, the Management of Health & Safety at Work Regulations 1999, and all other associated legislation which remains effective and relevant, as they relate to Butterworth.
ICH Guidelines
Guidelines of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
Installation Qualification (IQ)
The documented verification that new or modified systems and Analytical Equipment have been installed correctly and safely in accordance with the requirements and specifications.
Intellectual Property Rights
all patents, rights to inventions, utility models, copyright and related rights, trademarks, service marks, trade, business and domain names, rights in trade dress or get-up, rights in goodwill or to sue for passing off, unfair competition rights, rights in designs, rights in computer software, database rights, topography rights, moral rights, rights in confidential information (including know-how and trade secrets) and any other intellectual property rights, in each case whether registered or unregistered and including all applications for and renewals or extensions of such rights, and all similar or equivalent rights or forms of protection in any part of the world.
Interim Invoice
Invoices produced where work is carried out over a longer period, requiring reporting on an ongoing basis as and when agreed phases of the work are completed
Material
A general term used to denote Reagents, Raw Materials, process aids, intermediates, API’s, finished products, packaging and labelling materials.
Method
A detailed description of the process to be followed to perform an Analysis of Samples. These may be in the form of in-house developed methods prefixed with the letters BLM, methods supplied by clients or those published by internationally recognised bodies such as the BP, EP, USP, JP, BSi and AOAC.
Method Validation
The documented process demonstrating that a method is fit for its intended purpose i.e: it operates within established parameters and can perform effectively and reproducibly to test a material to predetermined specifications and quality attributes.
MHRA
Medicines and Healthcare products Regulatory Agency.
Month
A calendar month.
MSDQ
Material Safety Data Questionnaire.
MSDS
Material Safety Data Sheet.
Non-Conforming Result
Where a result does not fit a trend or the value expected by the Client, but is not OOS.
Non-Conforming Work (NCW)
Work not carried out to the specified or agreed method, procedure, policy, agreement or plan/protocol.
Order
the Client’s order for Services as set out in the Client’s written acceptance of a Quotation, or the Client’s purchase order form, or completed sample submission form/instruction, as the case may be
Out of Specification (OOS)
Any Result that falls outside the defined specification or acceptance criteria for the material tested. This term refers to results for the chemical testing of raw materials, API’s, in-process materials and finished drug products related to manufacture of registered drugs in order to meet current GMP requirements only.
Out of Trend Result
A type of Non-Conforming Result.
Operational Qualification (OQ)
The documented verification that the facilities, systems and Analytical Equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.
Party
Either one of the Client or Butterworth.
Planned Deviations
A change that has been considered and approved by the relevant party before implementation.
Performance Qualification (PQ)
The documented verification that the facilities, systems and Analytical Instruments/Equipment, as connected together, can perform effectively and be replicated, based on the approved process method.
Purchase Order
A document, uniquely identified, used to approve, track and process purchased products/services.
Quality Assurance (QA)
QA describes the overall measures that Butterworth uses to ensure the quality of its operations.
Quality Control
The operational techniques and activities that are used to fulfil requirements for quality.
Qualified Person (QP)
A person defined in Article 48 of Directive 2001/83/EC or Article 52 of Directive 2001/82/EC.
Quality Management System (QMS)
Butterworth’s system of documented policies, programmes, procedures and instructions to assure the quality of the Services provided. The QMS incorporates the requirements of the GLP, GCP and GMP regulations along with those for ISO17025.
Quotation
The cost for the Services and scope of the Services, as anticipated by and provided in writing by Butterworth.
Raw Data
Original records and documentation, which are the result of the original observations and activities relating to the test result. This may be in the format of hand written notes and calculations, instrument print-outs or in the form of electronic records.
Raw Data Pack
Supporting information relating to a job that is compiled and provided to the Client with the Certificate of Analysis or Report. The Raw Data Pack (or Data Pack for short) consists of Analytical Raw Data, Certified Copies or a combination of both depending on the origin and format of the Analytical Raw Data. Electronic versions of Raw Data Packs, are produced for sending to the client electronically.
Raw Material
A general term used to denote, reagents and excipients intended for use in the production of finished products, intermediates or API’s.
Reagent
Any Material used during analysis other than a Sample or a Reference Material/Standard.
Reference Material/Standard
Material or substance one or more of whose property values are sufficiently homogeneous and well established to be used for the Calibration of equipment, the assessment of a Method’s performance, or for assigning values to Materials.
Regulatory Authority/Regulator
A government agency or other entity, that exercises a legal right to control the use or sale of products within its jurisdiction, and may take enforcement action to ensure that products marketed within its jurisdiction comply with legal requirements.
Regulatory Status
Registration status with a Regulator or the holding of any licence or authorisation from a Regulator.
Report
An authorised document containing results and outcomes relating to the Service(s) provided. Reports may be in the form of a Certificate of Analysis, a validation report or otherwise.
Record Retention
The controlled and secure storage of records. Their maintenance and storage ensures their recovery in a readable format throughout the Retention Period. Only documents supporting GLP compliant work need to be specifically controlled as Archived as these fall directly under the control of an appointed Archivist as defined by the UK GLP Regulations.
Retention Period
A period of time for which records and materials are to be retained. Unless specified and agreed, items may be retained beyond the defined retention period where there are benefits to do so.
Risk Assessment
The assessment of the level of risk associated with a practice or procedure. Hazards may be present but if sufficiently controlled they may present little or low risk.
Sample(s)
Goods, substances or materials provided by the Client to enable the Services to be performed.
SDS
Safety Data Sheet.
Service(s)
Any analytical testing or consulting provided by Butterworth for the Client.
Site
As defined in Appendix D for both Parties.
SOPs
Written and approved Standard Operating Procedures which describe how to perform certain activities.
Tests
Shall mean the Method used by Butterworth to perform an Analysis on Sample(s).
Third Party
Any person other than the Parties to this Agreement.
Traceability
Property of the result of a measurement or the value of a Reference Material/Standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties.
Unplanned Deviation
A change or event that is not planned or anticipated and where no prior approval has been provided by the relevant party.
Validation
A documented programme that provides a high degree of assurance that a specific process, Method or system will consistently produce a result meeting predetermined acceptance criteria.
Validation protocol
A written plan stating how validation will be conducted and defining acceptance criteria.
