Methodology and Equipment Make the news with product breakthroughs-not product breakouts!

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• GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix ups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
• GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.
• GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mix ups, and errors, which may have been "top-of-the-line" 20 years ago, may be less than adequate by today's standards.
• GMP is a good business tool which will help to refine both compliance and performance at your company. GMP requirements are largely common sense practices which will help your company better itself as it moves toward a quality approach using continuous improvement. First, set standards of performance. These include GMP regulations and other standards which are necessary for your company. Then, train to those standards. All departments in the company should be trained (to varying degrees) on GMP and other standards. Because training is such an important part of maintaining a GMP Lifestyle, the GMP Institute focuses heavily on training.
• The next step in the GMP Lifestyle is to reinforce what was learned in training. This falls on the managers and supervisors in a plant. Therefore, it is important that managers and supervisors be involved in training, so that they can support it through reinforcement. The same four job categories are listed as being the most critical in promoting and receiving reinforcement.
• The third stage is to audit to ensure that your efforts have provided adequate controls by auditing. Audits fall in the following three categories: personal, whereby every individual does a self-check to make sure that he/she is complying with all appropriate standards; internal audit, which should be performed by the quality assurance department as required by GMP, and external audits, which can consist of an FDA audit, a consultant checking your compliance status, or you performing a supplier audit. The GMP Institute also offers workshops for auditors needing training.
• Equipment: Methods only will not ensure safe manufacturing if it is not coupled with equipment designed and suited for GMP. To ensure a process procedure is followed, equipment that humans interface with must be ergonomic, safe and easy to access.
• Outside accessibility: A safe approach that positions operators outside of equipment while in the cleaning process. Equipment that must be physically entered runs the risk of fugitive migration hazards from potential bio-mass stuck to the person entering the equipment.
• Tool-Free: While not always practical, equipment is safest in operation where no tools are required for dis assembly. Tools are not typically cleaned and can be a carrier of fugitive bio-mass.
• Attachment: equipment should be designed with minimal equipment detachment. Items should hinge open. Anything that can be removed will find its way to an unclean floor.
• Fit-Finish: equipment should be designed for pragmatic cleaning. Their should be no ledges or spots where an operator does not have a natural line of vision. All fabrications should be of robust construction to prevent external leakage.