Current good manufacturing practice inspections

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. 

Current Good Manufacturing Practice (CGMP) Inspection for more information... 

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. 

Guidance for FDA Review Staff and Sponsors Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (draft guidance) (November 2004) Current Good Tissue Practices for Human Cell, Tissue, and Cellular Tissue-Based Product Establishments Inspection and Enforcement (November 2004)... 

Authorized written standard operating procedures (SOPs) for all sections of Good Manufacturing Practices guidelines are retained for reference and inspection. These SOPs are regularly reviewed and kept up to date by authorized persons. The reasons for revision are documented. A system is in place to ensure that only current SOPs are in use. Records of SOPs for all computer and automated systems are retained where appropriate. 

FDA Proposed Rule Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products Inspection and Enforcement (66 FR 1508 January 8,2001)... 

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