Good Manufacturing Practice personnel

All stages of antibiotic manufacture from fermentation through to finished product are governed by the code of good manufacturing practice (GMP), of whieh quality eontrol is one aspect. GMP requires that there should be a eomprehensive system, so designed, documented, implemented and controlled, and so furnished with personnel, equipment and other resourees as to provide assuranee that products will consistently be of a quality appropriate to their intended use. ... 

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. 

Minor amounts of protein could also potentially enter the product stream from additional sources, e.g. protein shed from production personnel. Implementation of good manufacturing practice (GMP), however, should minimize contamination from such sources. 

Current Good Manufacturing Practices for Finished Pharmaceuticals Section 211.25 — Personnel Qualifications... 

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. 

Manufacture of any pharmaceutical product must satisfy the requirements of Good Manufacturing Practice (GMP). These are basically that the equipment be properly designed, maintained and cleaned, that Standard Operating Procedures are written, approved and followed, quality to be independently monitored and that all personnel... 

Good Manufacturing Practice (GMP) standards are a further step towards the concept of "total quality". Implementing and maintaining a GMP status requires commitment of the entire organization and constant attention by those who are in charge of quality assurance. Because of the complexity and wide scope of the subject and the amount of paperwork (some translate GMP as "Give Me Paper") extra personnel or external consultants will most likely be required. 

A person (among key personnel of a manufacturing establishment) responsible for the release of batches of finished products for sale. In some good manufacturing practice (GMP) guides and legal texts, the term qualified person is used to describe analogous functions. 

Analytical method transfer should be performed using a validated procedure this transfer data can be useful in determining intermediate precision of the method. The transferring laboratory should ensure that the recipient laboratory(s) is (are) current Good Manufacturing Practice (cGMP) compliant a record of successful audit by QA personnel is essential, especially if the laboratory is a contractor. 

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