Welcome

Come on in an see how D GMP-Consulting can work with you in assessing your needs and help create bespoke quality solutions to current Quality Management and GMP challenges in your organisation. At D  GMP-Consulting  we work on evaluating current requirements and expectation and the working with you in applying “real world” solution projects delivered in full and on time within resource constraints.

The Quality System World

The base principles for quality management are the same in all industries with good quality management systems being the culmination of ongoing: Quality Planning Quality Control/Assurance Quality Improvement All ultimately supporting the Quality Strategy.

Quality Planning

“If you do not know where you are going (plan), any road will get you there”. We can provide a complete Quality Strategy review: Dovetail to company strategy. Gap analysis followed by SWOT and PEST report. Negotiate a workable plan including resources and timeline to meet the strategy.

Quality Control/Assurance

Alignment with the strategy then informs and allows for focus on GMP hot spots, this can be coaching through to hands on creation of Bespoke systems and documentation: Quality systems and documentation. Quality resources and structure. Validation master planning for facility, equipment, processes, IT and QC analytical. cGMP facility review and update of critical utilities: o HVAC o Purified water system o Environmental monitoring o Compressed Air. o Material and equipment flows. Materials management, vendor assurance, auditing, training, data integrity and Quality Metrics.
GMP-Consulting “To be effective and efficient…energy must be focussed”
Quality Strategy
/Assurance

Quality Improvement

When the quality systems are all working holistically it all comes  together to maintain and provide the information for improvements: Feedback loops for deviations, nonconformances, root cause  analysis, risk analysis, corrective and preventative  actions. Selection of meaningful quality  metrics. Summarised in annual product  quality reviews.