Process equipment, Good Manufacturing Practice

Good manufacturing practice (GMP) comprises that part of quality assurance which is aimed at ensuring that a product is consistently manufactured to a quality appropriate to its intended use. GMP requires that (i) the manufacturing process is fully defined before it is commenced and (ii) the necessary facilities are provided. In practice, this means that personnel must be adequately trained, suitable premises and equipment employed, correct materials used, approved procedures adopted, suitable storage and transport facilities available and appropriate records made. 

Action of proving, in accordance with the principles of good manufacturing practice, that any procedure, process, equipment, material, activity, or system actually leads to the expected result Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes and characteristics... 

One must also stress the importance of quality considerations during compounding and full adherence to current good manufacturing practices while producing parenteral products. Personnel responsible for the process design and scale-up of the equipment must assure proper documentation... 

Good manufacturing practice is that part of the quality management system (QMS) that is concerned with the production and quality control of medicinal products (drugs) for human and veterinary use. It includes documentation, personnel training, facility, equipment, and process controls for the manufacture of pharmaceuticals. 

A variety of product safety, work safety, environmental safety aspects and other legal aspects must be taken into consideration when a process is designed. Good Manufacturing Practice standards for facilities, equipment, and working procedures must be met. GMP approval is subject to inspection and requires constant attention and updating. Extensive documentation must be provided to comply with these requirements. 

CGMP. (Current Good Manufacturing Practices). Refers to the body of regulations that describe the methods, equipment, facilities, and controls required for producing human and veterinary products, medical devices, and processed food. 

Prior to beginning validation, controls should exist to ensure that the method has been properly developed and is capable of the objectives outlined prior to beginning the method development endeavor. Because validation is considered a good manufacturing practice (GMP) activity, validation experiments must be properly documented and performed on qualified and calibrated instrumentation and equipment. At this stage, there should be documented evidence that the method is robust. A generalized flowchart of the validation process is detailed in Figure 1. 

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