| Scientists and professionals in the biotechnology, | | | | laboratory professionals have a fundamental |
| biopharmaceutical and pharmaceutical industries apply | | | | understanding of the basis of the regulations, as well |
| strict guidelines for good practices in drug | | | | as the conditions that necessitate them. |
| manufacturing. | | | | Drug manufacturing firms must have a quality control |
| Also known as cGMP, the high standards require, at | | | | unit for each drug development project that |
| the very least, compliance with the strict regulations | | | | guarantees consistency and adherence to |
| of state agencies such as the US Food and Drug | | | | specifications, set by the client firm and US law. |
| Administration (FDA). The Federal government has | | | | During manufacture, records must be made manually |
| also issued as minimum requirement compliance with | | | | or through instrumentation. Good documentation is an |
| quality and safety standards in drug manufacture. | | | | essential element of cGMP, as this assures the |
| This includes standards in methods, facilities, and | | | | traceability of the complete history of a product |
| controls that are applied from the formulation to the | | | | batch, as well as the defined procedures in each |
| packaging of the drug. Effective compliance | | | | phase of the production. |
| techniques are essential in the development of safe, | | | | One of the basic marks of a reputable pharmaceutical |
| high quality pharmaceutical products. | | | | manufacturing firm is the practice of good |
| There are various aspects of cGMP regulations, | | | | manufacturing standards. The firm must have staff |
| including the manufacturing operations, personnel and | | | | and facilities that meet the highest levels of |
| facilities, and laboratory validation. In assuring | | | | regulatory compliance, as well as the clients' quality |
| compliance with standards in Good Manufacturing | | | | assurance audits for drug manufacturing. |
| Practice, it is essential that all managerial and | | | | |