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. With more than 12 years of global auditing within GSK, followed by extensive independent auditing in the EU and India, Roger has an excellent track record of reviewing Quality Systems at primary and secondary pharmaceutical manufacturing sites.

These audits can include above site functional audits as well as audits of commercial operations, market based ambient and cold chain warehouses and logistics service providers.

Redwood Pharma Consulting can apply this expertise to deliver a thorough independaent assessment of GMP controls at your facilities, contractors and suppliers. In addition, it can provide insights into Quality Risk Management Systems, Quality Governance and Oversight. This can extend to setting up effective internal audit systems.

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Quality and Risk Management Systems

It is a regulatory requirement that pharmaceutical organisations have effective Quality and Risk Management Systems, in alignment with ICH Q9 and Q10. In particular, Risk Management is an increasing area of focus for EU regulators during site inspections. Good Risk Management practices are a very effective tool to proactively manage and mitigate quality risks.

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. The embedding of a good QRM culture is a key principle, so that current and emerging risks can be considered and monitored to closure.

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

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Root Cause Investigation and CAPA

Many pharmaceutical organisations face ongoing challenges in conducting Root Cause Investigations related to the handling of deviations, out of specification results, product complaints and major manufacturing incidents. Human error can often be attributed as the primary cause, and insufficient effort may be made to understand the underlying issue or the wider consequences and implications of the failure.

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.

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Regulatory Inspections

As pharmaceutical regulatory inspections increase in number, complexity and scope, so organisations need to maintain an effective quality culture that is well prepared for both announced and unannounced inspections at their premises.

Intelligence and inspection outcomes are routinely shared between regulatory authorities. Organisations not only have to ensure full compliance with country/regional regulatory requirements, but also with the varied expectations of market authorities to which they supply licensed product.

Redwood Pharma Consulting can help organisations prepare for MHRA and FDA inspections, particularly through reviewing areas of concern (such as documentation, systems and incidents) with individuals who may be less confident in presenting material. This can be achieved by techniques such as conducting mock interviews and coaching of individuals likely to be interacting with inspectors.

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

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