Quality Systems, Good Manufacturing Practice, ICH Q10

The company discuss the importance of good GMP management and training.  Somerset House are experienced in helping companies through good manufacturing practice inspections.

Good Manufacturing Practice Deficiencies

Amongst the most common Good Manufacturing Practice deficiencies cited in regulatory authority inspections are poor management structures, inadequate staff training and insufficient documentation.  The penalties for these failures are high.  Inspectors in both USA and EU have closed down facilities or demanded recalls of products because of quality system and documentation deficiencies, and very few companies ever recover from this.

ICH Q10

The ICH Q10 guidance document on ‘Quality Systems’ has recently been developed with the intention of harmonising the requirements between EU, USA and Japan.

GMP Management and Training

Official GMP guidelines define the management structures required; in particular, that production and quality should be separate, and that staff at each level should be appropriately trained and experienced for their job.  This also means that staff should continue to receive training so that they maintain or build on their expertise.  It is common in less well-run companies to find that this training is non-existent.

GMP Documentation

The GMP guidelines also state that all processes and data must be properly recorded as they happen and checked by suitably qualified staff.  Inspectors often find production data that has not been entered in the formal batch record, or analytical data recorded on scrap paper in the laboratory rather than the pristine ‘official’ documentation in the writing area down the corridor.

Company Responses to GMP deficiencies

Companies’ responses to these findings are often along the lines of ‘the junior employee has been disciplined or retrained’.  This misses the point; while the actual error was made by that employee, the fault often lies deeper within the quality system.  Had the employee been properly instructed to know what they were meant to do?   Was their manager properly supervising or checking their work?  A single GMP deficiency is often a symptom of a larger failing in the quality system.  That is why inspectors expect companies to look for the ‘root cause’ of failures and deviations rather than solving the immediate problem.

How Can Companies Improve Their Quality Systems?

Companies should regularly review their quality systems, including ‘mock’ audits carried out by GMP experts, to identify and resolve potential problems at an early stage.  Any deficiencies cited by official inspectors or arising from the ‘mock’ audits should be thoroughly investigated to see whether they are symptoms of wider problems.  Any corrective actions must also be checked to ensure that they have not created a new problem.  Somerset House Consultants has helped many companies to achieve this by carrying out GMP inspections and devising action plans to correct deficiencies.