Current good manufacturing practices compliance

Other offices within ODER may become involved in the review process via consults. Eor example, the Office of Epidemiology and Biostatistics analyzes statistical data, the Office of Research Resources provides bioavailabiHty reviews, and the Office of Compliance determines from the results of inspections whether the firms meet EDA s Current Good Manufacturing Practice (cGMP) regulations. Advisory committees composed of independent experts are often asked to meet and further analyze the data. Often they also advise as to what additional data and information may be needed. After PDA s review is completed, PDA issues either a Summary Basis of Approval (SBA) for the dmg or a recommendation against approval. If approved, PDA releases the SBA and a summary of the safety and effectiveness data to the general pubHc. 

The current Good Manufacturing Practice (cGMP) regulations are guidelines that FDA requires a pharmaceutical manufacturer to meet. Compliance with the cGMPs is a prerequisite for the approval of NDAs, INDs, and antibiotic forms. General areas in which... 

Examples of the U.S. regulations applicable to computer system application in a GMP environment are shown in Table 1. The FDA also publishes compliance policy guides [7] related to pharmaceutical drag products and views the guidance provided on related products (e.g., medical devices [8]) to be current good manufacturing practice that should be considered for comparative GMP applications. 

The current good manufacturing practices (GMP) state that Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards [5]. This includes all electronic and hard copies of raw data, laboratory notebooks, and/or worksheets and reports. Additionally, the regulations require that records shall be readily available for authorized inspection [6]. Consequently, the organization must have a well-defined audit trail for the generation, storage, and retrieval of reports and raw data. It must also be shown that there is adequate document management and security of all raw data and reports in terms of both disaster recovery and prevention of falsification of results. 

Compliance to Current Good Manufacturing Practices (cGMP)... 

Drug Application Regulatory Compliance. The approval process for new drug applications includes a review of the manufacturer s compliance with Current Good Manufacturing Practice. This Web page provides resources to help meet compliance. 

FDA, Current Good Manufacturing Practices for Finished Pharmaceutical Products 21 CFR 211.25(a). European Union Food Manufacturing Practice for Pharmaceuticals, Medicines Controls Agency, 1997. David Begg Associates (2002), Computers and Automated Systems Quality and Compliance, June,... 

Compliance with cGMP requires that responsible employees in a firm be knowledgeable about the practices that other firms follow in order to comply. FDA investigators visit many firms and find a broad picture of current manufacturing and control practices. Thus, Current Good Manufacturing Practices are... 

ABC Pharmaceutical is a medium-sized pharmaceutical industry in New York state and employs approximately 500 employees. The plant intends to produce millions of units annually. The annual sales of the plant are above U.S. 200 million. The total covered area is 50,000 square feet. ABC Pharmaceutical places basic emphasis on the concept of quality and on strict compliance with the rules of current Good Manufacturing Practice (cGMP) in all steps of manufacturing, shipping, and marketing. 

The PAI will essentially be targeted at the commercial manufacturing facility to gain assurance that the facilities, equipment, procedures and controls to manufacture the product are in place and conform with the NDA submission. The FDA will also want to check for compliance with current Good Manufacturing Practice (cGMP). 

---