GMP regulation

Besides internal quaUty audits, there are audits conducted by external authorities for conformance to estabUshed quaUty systems. The two chief standards affecting the chemical industry are the U.S. Food and Dmg Administration Current Good Manufacturing Practice (GMP) regulation and the International Organization for Standardization ISO 9000 series. A quaUty system performance-related standard is the Malcolm Baldrige National QuaUty Award... 

Cyclic-AMP Response Element Binding Protein Cyclic GMP-dependent Protein Kinase Cyclic GMP-regulated Phosphodiesterases Cyclic Guanosine Monophosphate (Cyclic GMP cGMP)... 

By virtue of the broad diversity of products covered under the medical devices umbrella, GMP regulations and standards for devices tend to be less specific than their drug GMP counterparts. However, it is expected that the manufacturer will use risk analysis to identify specific measures that are appropriate to the manufacturing process under consideration. In effect, this means that many of the GM P measures applicable to drugs will also apply to devices. For example, if a manufacturer is... 

Reproducibility of experiments indicates whether measurements are reliable or not under GMP regulations this is used in the systems suitability and the method validation settings. 

FDA GMP regulation, 21 168 FDA Sugars Task Force, 23 478 Select Committee on Nutrition and Human Needs, 23 479 Fe(IV), mixed oxides of, 14 543. See also Iron entries... 

Excipients also meet the definition of component in the Good Manufacturing Practice (GMP) regulations in 21 CFR Section 210.3(b)(3) Component means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product. ... 

On a global level, GMP regulations are very similar for various countries. There are, however, differences in emphasis and implementation in specific areas. We will explain the GMP regulations from the United States, Europe, and the International Conference on Harmonization (ICH) in this chapter. In Chapter 10, we will discuss the manufacturing processes for small molecule synthetic and large molecule protein-based drugs. 

GMP regulations came into effect in the United States in 1963. They have since undergone several major revisions. The implementation of GMP is the result of a number of tragedies to ensure that drugs are safe for the patients and effective for treatment. Some of these tragedies are described in Exhibit 9.1. 

The Food and Drug Administration (FDA) is charged with the responsibility for ensuring drug manufacturers comply with GMP regulations in the... 

Manufacturing of drugs, whether the API or finished dosage form, is required to comply with GMP regulations (see Chapter 9). Figure 10.1 shows the implementation of GMP concepts in drug manufacture. 

The production of the API and finished dosage form is required to comply with GMP regulations discussed in Chapter 9 and Section 10.2. The quality system, quality control, and validation of equipment and processes have to be developed and adhered to in the manufacturing process. Proper records and documentation are required to be kept in the forms of batch records. 

While these external and internal factors already provided a difficult foundation, a routine investigation into the company by the US Food Drug Administration (FDA) identified areas of non-compliance with Good Manufacturing Practice (GMP) regulations. The resulting... 

Frequently, in early trials of a new study drug, the expiry date is extended as more stability data become available. Any additional labelling by the sponsor or by the investigator should be documented fully and, where possible, a second person should (2C the process. The labelling should always meet the GMP regulations applicable in the location. 

The proposed regulations went beyond these basic requirements for a valid study by requiring each study to have a study director who would have ultimate responsibility for implementation of the protocol and conduct of the study [ 3e/31(a)], and each testing facility to have a quality assurance unit to monitor conduct of studies. The concept of a quality assurance unit to monitor study conduct was a new one to most laboratories but a familiar one in manufacturing facilities operating under various GMP regulations. 

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