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Regulatory compliance

As a GLP accredited laboratory, Alderley Analytical can meet regulatory compliance requirements for pre-clinical studies in addition to claiming GCP compliance for clinical studies. Our Quality Management System (QMS) allows us to fulfil the requirements of the governing regulatory bodies including Medicines and Healthcare products Regulatory Agency (MHRA) and ICH.

Our Quality Management System template

Our Quality Management System (QMS) is governed via a hierarchy of controlled documents owned, approved and reviewed periodically by the leadership team.

Alderley Analytical Policies

Study/Analytical Work Plans

SOPs

Internal Audit Programme

Training Programme, Training Records

Controlled documents: Checklists, Audit Guides, Forms, Templates, Floor plan, org chart

The QMS is underpinned by careful staff selection, training and development, and our internal Quality Assurance (QA) audit programme. We review the system continuously and make improvements based on customer feedback, regulatory intelligence, internal suggestions plus internal and external audits.

When new GLP or GCP guidance or regulations are introduced, or if there are changes to them, we promptly evaluate them for impact on our functional working practices and associated Standard Operating Procedures (SOPs).

Our QA procedures for both clinical and non-clinical work are modelled on GLP requirements to maintain formal GLP compliance. Project plans, in-life activities and reports are subject to inspection by QA.

A SOP for the internal QA programme describes how audits are reported, followed up and closed. An audit schedule is compiled annually detailing the audit types. Facilities eg laboratory operations, archives, computerised systems and documentation are audited annually. QA will audit third party facilities (where Alderley Analytical have the responsibility for sub-contracting to another laboratory), suppliers and vendors to assess compliance with GLP and/or GCP regulations or to assure quality status using a risk based approach. An independent review of QA is also conducted annually. Audits may include:

Study plan/analytical plan

Sample receipt

Sample preparation

Sample analysis

Calibration Standard/QC prep

Study/Analytical phase Report

Our Quality Assurance system ensures that Alderley Analytical’s studies maintain a high level of GLP and GCP compliance when required.