JW Quality Consulting Limited

JW Quality Consulting Ltd (JWQC) support sponsor companies with GMP oversight of Investigational Medicinal Products (IMP).  Our established processes, trackers and directory structures are easily transferred to companies who are just starting out on their GMP journey.  Our systems help you to demonstrate oversight of the complete supply chain from active substance to clinically labelled drug product at various levels: batch oversight, product oversight, and vendor oversight.  Systems are risk focussed with hazards identified monitored on a risk register.  Our processes are appropriate for any dosage form, including ATMPs.

Our personnel have a wealth of GMP Quality experience to support sponsors in achieving their GMP responsibilities.  We help you to organise manufacturing development reports and technical transfer documents into Technical Reference Files for full traceability.  We have established comprehensive checklists to make sure Quality Agreements with your CDMOs are robust and compliant.  All vendors are assessed and qualified for specific activities and audited when required.  Ongoing oversight required is identified through these activities.  We also help you to impact assess events and changes notified to you by your vendors.

Regular discussion during GMP campaigns builds up competency in GMP processes so that they can be confidently incorporated into your systems.

Availability for Work

United Kingdom, Europe, North America

Areas of Expertise

Auditing, Good Manufacturing Practice (GMP), Quality Management Systems (QMS), Quality Risk Management (QRM), Standard Operating Procedures (SOPs), Inspection Preparation

Contact Details

Julie Walker

Telephone: +44 (0)7803603041

Email: julie@jwqc.co.uk

Website: www.jwqc.co.uk

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