Quality Systems and Consultancy
Our customized solutions for your organisation include consultancy in Quality Standards Implementation & Improvement, Auditing, QP Services and Training Programmes
Quality Standards Implementation & Improvement
We provide support with the design, writing and implementation of quality management systems with its manual and Standard Operating Procedures to comply with the necessary regulations and standards e.g. ISO 9001, 13485, FDA regulations and EU Directives .
We provide customized solutions for core elements of quality such as deviation management, change control, complaint handling, validation and training competitiveness – providing greater efficiencies and reducing costs.
Today’s demanding environment requires great attention to detail: to analyse, trends and eliminate the root cause of issues with operations and processes resulting in the ability to deliver, meet and even exceed customer expectations on the one hand, and to produce and operate within the organisation in a cost effective way.
Through a comprehensive audit of the business we will identify areas for improvement. We will report back on the findings. A practical and cost effective plan is agreed and implemented. This plan is monitored by you to ensure effectiveness on the deliverables. Strategies employed are based on a scientific approach .
Self–Inspection (Internal Audits)
We provide auditing services supporting organisations with their Self-Inspection or Internal Audit programme, which is required to monitor the implementation and compliance with Good Manufacturing Practice principles. We also support organisations proposing necessary corrective actions.
For the regulated industries in today’s business model, vendors and third parties play a key role in an organisation’s compliance and success.
Quality management of these vendors is necessary. An effective balance between risk and monitoring needs to be established as this area is coming under increased regulatory focus.
Vendor auditing is integral to managing quality and compliance of API & excipients, raw materials & components, bulk product, packaging, distribution, testing and other services.
Auditing standards used:
- EU GMP Volume 4 Part 1 – Drug Products & Part 2 –Drug Substances
- EU Good Distribution Practices
- ISO Standards 9001 and 13485
- FDA CFR 201 & 211
Provision of contract QP services in compliance with EU Directives for the manufacture and release of finished pharmaceutical products
EU requirements (Article 51 of EC Directive 2001/83/EC and Article 55 of EC Directive 2001/82/EC )
Inspiration can come from anywhere and spotting ideas which can improve efficiency, find new customers or reduce costs is the language of successful organizations.
McGarry Consulting provides a comprehensive approach to this hot topic. We have training courses using a scientific systemized approach employing the principles of TQM, Six Sigma and Lean coupled with consultancy to provide successful outcomes addressing key areas of sound knowledge basis, assessment of the time span for feedback, dynamics to take effect and cultural commitment in the management population.
This approach combines the relationship between many factors including emphasis on more fundamental organizational culture change.