Extending the outsourcing concept

The majority of pharmaceutical companies outsource validation to some degree. This may range from procuring an item of laboratory equipment with IQ/OQ templates and execution included in the vendor supply to the turnkey validation of a new system or facility through to the end of operational qualification.

In order to develop and extend the outsourcing concept, the next logical step would be to establish a partnership with a validation specialist organisation, which would meet the cyclical validation requirements of an organisation, leaving in-house resource to deal with higher-level compliance governance issues. Developing a partnership with a single partner with the critical mass to support outsourced needs would be a bold step, but the potential rewards and benefits are significant. These include:

• Access on an as-needed basis to a pre-qualified work force who are fully familiar with company policies, procedures and templates
• Predictable validation costs through the implementation of clear role and competence frameworks and fixed cost structures
• De-bottlenecking validation, taking much of it off the critical path of projects enabling faster project completion
• Analysis and re-application of key learning, facilitating continuous improvement of validation-driven risk reduction and cost reduction opportunities
• Clear quality and compliance governance remit for internal staff
• Direct access to a pool of subject matter experts reflecting current thinking across a broad spectrum of validation
• Access to an independent auditing group
• Ongoing collaborative review of validation procedures, securing timely opportunities to implement risk-based, pragmatic validation at reduced cost
• Management of peaks and troughs in workload

Validation activities and responsibilities

The mechanism of achieving regulatory compliance is not currently viewed by pharmaceutical organisations as core intellectual property giving competitive edge. It is common for companies to enter into cross-sector forums and special interest groups, which involve close working with a range of direct competitor organisations to seek common interpretation of regulations and pragmatic compliance solutions.

Therefore, with appropriate confidentiality agreements, it is unlikely that outsourcing a range of validation and regulatory compliance activities would adversely affect the competitive edge of a company. In fact, the opposite would be true, with cost benefit from resource management.

An organisation must be accountable for the validated status of its cGMP systems and processes and also needs to support its rationales for validation approach and extent during an external inspection. The nature of the outsourcing partnership and the operating and organisational structure of the arrangement are key to ensuring that these objectives are met. Templates and procedures should demonstrate the underlying assumptions and outcomes from the validation activity. Validation documentation should tell its own story such that site compliance staff are able to use it with confidence during an inspection.

The continuity of an outsourcing partnership means individuals are more likely to be available to assist during later regulatory inspections. The outsourcing arrangement should deliver familiar faces who are motivates, are trusted by the organisation and who are results-orientated rather than task-orientated. Therefore, outsourcing via a partnership is a feasible proposition.

Further information

Keith Beresford
ABB Process Solutions
Tel: +44 1925 741059
Email: keith.beresford@gb.abb.com
Website: www.abb.com/lifesciences