Good Manufacturing Practices (GMP) / Quality System (QS) Regulation

1. Good Manufacturing Practices (GMP) / Quality System (QS) Regulation The current Good Manufacturing Practice (GMP) requirements set forth in the Quality System regulation are promulgated under section 520 of the Food, Drug and Cosmetic (FD&C) Act. They require that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States.

2. GMP REGULATIONS • The regulation requires that various specifications and controls be established for devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality system; that finished devices meet these specifications; that devices be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and that complaints be processed. Thus, the QS regulation helps assure that medical devices are safe and effective for their intended use. The Food and Drug Administration (FDA) monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with the GMP requirements in the QS regulation.

3. The requirements of the new QS regulation and provides detailed guidance in the following areas: obtaining information on GMP requirements; GMP GUIDELINES • Determining the appropriate quality system needed to control the design, production and distribution of the proposed device; • Designing products and processes; • Training employees; • Acquiring adequate facilities; • Purchasing and installing processing equipment; • Drafting the device master record; • Noting how to change the device master records; • Procuring components and materials; • Producing devices; • Labeling devices;

4. GMP GUIDLINES • Evaluating finished devices; • Packaging devices; • Distributing devices; • Processing complaints and analyzing service and repair data; • Servicing devices; • Auditing and correcting deficiencies in the quality system; and • Preparing for an FDA inspection.

5. Registration Standards Fitness to Practise Education The Four Functions of the GMP

6. Sample Certificate

7. What is continual improvement? • Continual improvement is an approach that enables operators and managers to understand the operation of ongoing processes, learn from the data and outcomes, and think about process changes. It must include the capability of testing and validating proposed changes and incorporating the improvements in the standard operating procedures. It also demands good two-way communications with others in similar processes, in order that learning can be shared and to ensure that people do not have to rediscover the same solutions.

8. Why is continual improvement needed? • Because in its absence things will get worse. Anyone with children, a garage or a garden knows that tidiness is not a natural state. It takes a lot of effort to establish, and more to keep it that way. • Some organisations are run as if they don't need continual improvement. Management may think its customers are satisfied, competition may be ineffective, or there are enough resources to do the job without compromise. But experience shows that organisations may thrive (or survive) as long as these conditions prevail, but will struggle to respond as soon as the environment changes.

9. Continual improvement is the result of a system that: Develops a mindset Trains the relevant people Encourages the use of a simple but robust methodology and tools Shares the learning across the organisation. The tools of continual improvement help people to understand and improve processes, and are relevant to changes affecting the wider organisational system. Continual improvement leads to benefits which at the point of implementation often look low key and are sometimes free, but which collectively may build to profound changes. Organisations that successful embed continual improvement can maintain the capability of their system even though natural disorganisation takes its toll.

10. Continual Improvement Benefits It is expensive and time consuming to develop the capability for continual improvement across the whole organisation, and it demands persistence over many years from top management, but all who practise it see it as worth the trouble. The alternative is to be continually repairing the consequences of deterioration in process performance, and that is much more expensive and bad for customer relationships and staff morale.

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