Redwood Services for the pharmaceutical industry
Comprehensive and distinctive quality advice and support service

Auditing

GMP compliance and risk-based audits of product quality and the supply chain all have their place in assessing controls. Roger has many years of global auditing within GSK, followed by extensive independent auditing of primary and secondary manufacturing sites globally for various clients as Director of Redwood Pharma Consulting.

Quality and Risk Management Systems

Redwood Pharma Consulting has proven experience in the application and assessment of Quality Risk Management (QRM). This extends beyond the basics to a comprehensive evaluation of potential risks for likelihood and impact, interfacing with teams at all levels to ensure that the processes are fully understood and owned.

A thorough review of existing Quality Management System (QMS) content and implementation can also be undertaken.

Root Cause Investigation and CAPA

Redwood Pharma Consulting recognises the importance of a structured approach to conducting Root Cause Investigations and can provide guidance and support in this critical area.

By performing a thorough review of systems and identifying any capability gaps, it is then possible to make permanent and sustainable improvements in such investigations. Not only will this deliver effective remedial, corrective and preventive actions, but also create the environment in which underlying or recurrent trends can be identified and managed in a compliant manner to protect patient safety.

Regulatory Inspections

Redwood Pharma Consulting can help organisations prepare for MHRA and FDA inspections, particularly through conducting a GMP Gap Analysis. Potential areas of non-compliance can be identified, with possible solutions and corrective actions to address any gaps detected.

Additional GMP training can be given on specific topics as required.