A distillation of pharmaceutical knowledge and experience

 

 

Inspection Compliance Excellence

 

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The QED-QED definition of Inspection Compliance Excellence (ICE) is:

"compliant facility + good inspection management = successful outcome"

ICE is divided into short and long term inspection preparation programmes. Depending on your current company situation emphasis on which strategy to adopt will determine the most appropriate programme mix. QED-QED consultants have helped to achieve many inspection successes for companies of varying sizes.

Direct links to more details for some key areas of interest are as highlighted in the diagram below.

Inspection Management

Achieving regulatory inspection successes is dependent on having robust and compliant systems, validated products/processes, trained personnel and a good inspection management programme. QED-QED consultants have helped companies achieve successful regulatory inspections. We have the skills and experience to support you in the development of a good, sound inspection management programme including some of the following elements:

Inspection strategy – long and short term
Risk assessment and gap analysis
Core team selection
Back-room control and logistics
Planning, preparation and monitoring
Behavioural training

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Internal Audit Programme

An Internal Audit programme is a cGMP requirement and most companies within the pharmaceutical industry have such a programme in place. However, the management of internal audit programmes often prove to be a challenge to many organisations resulting in, typically, lack of follow-up and corrective actions not implemented or fully completed. QED-QED consultants have extensive experience and can assist in the development of new or improved existing internal audit programmes through structured assessment and utilisation of proven techniques.

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External Audits

The number of external audits received by companies within the industry varies but without a doubt all companies host external audits at some time. External audits can be from corporate, customer or partners and the aim of an external audit is typically different to that of a regulatory inspection. As such, preparation for external audits will vary depending on the reasons for such audits. QED-QED consultants have led numerous external audits with successful outcomes with a wide range of products and companies. We have the capabilities and skills to develop audit strategies and programmes to ensure your audit successes.

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 Supplier QA and Audits

Supplier quality assurance is key to ensure material, components, and product supplies are consistent and reliable. This is achieved through a sound Supplier QA programme with built in alerts so that potential issues are prevented and problems resolved effectively in the shortest time. At QED-QED, we have proven track successes in achieving Supplier QA and we can support you in the development of a sound programme.

 Supplier audits are typically performed either as part of initial supplier selection process, or as part of the on-going Supplier QA programme. QED-QED consultants have performed over 250 supplier/third party audits, specific expertise include:

cGMP, ISO, quality systems, “for cause”, regulatory dossier compliance, and “mock” regulatory audits
Raw materials, drug substances, drug products, primary and secondary packaging components
Clinical trial supplies manufacture and packaging
Clinical pharmacy and Phase I units
Analytical, Bioanalytical, and Microbiology Laboratories
Animal units
Biotechnology, cell banks

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Training - Behavioural

The outcome of an inspection not only depends on the compliance status of your facility, or the technical knowledge of your people. The way people behave during an inspection can have a very positive, or very negative, impact on the outcome. QED-QED consultants can provide training for fronters, hosts, escorts, and operational staff. We use role-play and case studies to cover typical inspection scenarios such as dealing with difficult questions and coping with multiple inspectors. We also explain typical inspector strategy and tactics and how to deal with these different approaches.

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Last modified: February 02, 2006
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