Good Manufacturing Practice inspections

K. Bredal Jensen, Good manufacturing practice inspection in Europe, Drug Info J 29 1211-1216,1995. 

Guidance on good manufacturing practices inspection report... 

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. 

If the product is to be marketed in the United States, the plant must meet the FDA s good manufacturing practices (GMP) requirements (which now apply in most of the developed countries). If other products are being manufactured in a given plant for sale in the United States, it is not a certainty that the FDA will inspect the plant for the production of each new compound fhaf is to be produced therein. It is virtually certain that the plant will be inspected, however, if the company has not been previously cleared by the FDA for manufacturing or sale in the United States. Inspection is also likely if the new process represents a significant deviation from the processes that have been carried out in the plant in the past. Requests to the FDA for plant inspection should be made as early in the NDA cycle as the law permits as scheduling the actual date for inspection can be a problem. 

In early 2007, the EMEA reported the analysis of GMP deficiencies in its document entitled Good Manufacturing Practice An Analysis of Regulatory Inspection Findings in the Centralised Procedure. It detailed the deficiencies reported in 435 inspections of manufacturers of medicinal products and starting materials in the European Union and third countries in the period 1995 to 2005. Altogether there were 9465 deficiencies, of which 193 were critical (2%), 989 major (10%), and 8283 (88%) others. The top 20 deficiencies are presented in Table 10.1. 

Source EMEA Inspections. Good Manufacturing Practice An Analysis of Regulatory Inspection Findings in the Centralized Procedure, Doc. Ref. EMEA/INS7GMP/23022/2007 [accessed August 28,2007]. 

Manufacturing sites within Australia must comply with the Australian Code of GMP for Medicinal Products - August 2002, which is based entirely on the international standard Guide to Good Manufacturing Practices for Medicinal Products, Version PHl/97 (Rev.3) 15 January 2002, published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The ICH GMP Guide for Active Pharmaceutical Ingredients has also been adopted. 

WHO. Quality assurance of pharmaceuticals. A compendium of guidelines and related materials, vol 2, 2nd update ed. Good manufacturing practices and inspection. Geneva World Health Organization 2007. 

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