Pharmaceutical Quality & GMP Compliance
At Butterworth Laboratories, quality assurance is embedded into every stage of our operations. As a GMP-compliant and MHRA-inspected pharmaceutical testing laboratory, we uphold the highest standards of integrity, traceability, and regulatory compliance in everything we do.
A Fully Integrated Quality Management System
Our Quality Management System (QMS) ensures compliance with current Good Manufacturing Practice (cGMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), ISO17025 and meets the expectations of UK and international regulatory authorities. Regular internal audits, continuous training, and electronic quality controls are core to our operations.
MHRA-Approved Facility
We are regularly inspected by the Medicines and Healthcare products Regulatory Agency (MHRA) and maintain full compliance with UK and EU GMP guidelines. Our inspection history and audit readiness demonstrate our long-standing commitment to quality and transparency.
Experienced Quality Team
Our Quality team comprises trained professionals with extensive experience in pharmaceutical testing compliance. Their responsibilities include:
- Review and approval of all analytical documentation
- Oversight of deviation and CAPA systems
- Supplier qualification and audit management
- Ensuring regulatory readiness for GMP inspections
Continuous Improvement Philosophy
Butterworth Laboratories fosters a culture of continuous improvement. We regularly invest in:
- Quality training and staff development
- Risk-based process reviews
- Implementation of digital QA tools
- Feedback-driven improvements
Our clients rely on us not just for accurate testing, but for dependable regulatory support. Whether preparing for MHRA audits or ensuring batch release compliance, Butterworth Laboratories is your trusted partner in pharmaceutical quality assurance.
It is standard practice at Butterworth Laboratories to provide the highest levels of service in order to meet the highly regulated and ever changing requirements of the international scientific business world. Our Quality Policy underpins our commitment to quality, reliability and confidentiality in Analytical Chemistry and Consultancy.
The policy is led and championed by the senior management team which is committed to ongoing compliance with current quality requirements including GMP, GLP, GCP, and ISO 17025, and to ensuring continual improvement throughout the organisation.
Staff at all levels play a vital role in quality performance and ownership of the quality system is encouraged through training, communication and leadership.
Ultimately the quality system provides our clients with assurance that the services we provide are of the highest standard and that results issued are reliable, accurate and precise.
Stuart Davey
Chief Regulatory Officer & Head of Quality
Frequently Asked Questions
Good Manufacturing Practice (GMP) compliance ensures that pharmaceutical products are consistently produced and controlled according to quality standards. It encompasses all aspects of production, from raw material sourcing to final product testing, to guarantee safety and efficacy.
The Medicines and Healthcare products Regulatory Agency (MHRA) conducts inspections to assess compliance with GMP and GLP standards. These inspections evaluate quality management systems, documentation, staff training, and facility conditions to ensure products meet regulatory requirements.
Quality Assurance (QA) in contract pharmaceutical labs involves systematic processes to ensure products meet specified quality criteria. This includes validating procedures and ensuring compliance with regulatory standards.
Butterworth Laboratories maintains GMP compliance through rigorous quality management systems, continuous staff training, regular internal audits, and adherence to MHRA guidelines, ensuring the highest standards in pharmaceutical testing.
MHRA approval signifies that a laboratory meets the UK’s stringent regulatory standards for pharmaceutical testing, ensuring the reliability and safety of test results for healthcare products.
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