Documentation procedures, Good Manufacturing Practice

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. 

Action of proving, in accordance with the principles of good manufacturing practice, that any procedure, process, equipment, material, activity, or system actually leads to the expected result Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes and characteristics... 

Quality control is that part of good manufacturing practice concerned with sampling, specifications, and testing. Its organization, documentation, and release procedures ensure that the necessary and relevant tests are actually carried out, that materials are not released for use and products released for sale or supply, until their quality has been judged to be satisfactory. 

A variety of product safety, work safety, environmental safety aspects and other legal aspects must be taken into consideration when a process is designed. Good Manufacturing Practice standards for facilities, equipment, and working procedures must be met. GMP approval is subject to inspection and requires constant attention and updating. Extensive documentation must be provided to comply with these requirements. 

There are no records to document that the Information Technology (IT) service provider staff persormel have received training that includes current good manufacturing practice regulations and written procedures referred by the regulations. [FDA 483, 2000]... 

Software and computer systems used in analytical laboratories that must comply with good laboratory practice (GLP) and good manufacturing practice (GMP) regulations require formal validation to confirm that they meet the criteria for intended use. Both new and existing systems, regardless of age, must be validated for their suitability for indented use. Whereas the first three articles in this series [1-3] focused on validation during development, vendor qualification, and installation and operational qualification of new systems, this article describes the procedures for systems that have been purchased, installed, and used prior to formal validation and that must be newly documented. 

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