Documentation procedures, Good

It is essential that good documentation procedures be established during the first meeting of the team. 

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. 

Putting a reliable audit process into place is the second way to keep the audit objective. A good audit process has two parts. The first assesses and defines the site s formal programs, such as those with documented procedures, work methods, and processes. The second involves verifying that those procedures, methods, and processes are in place at the working level. 

Quality control encompasses all activities used to bring a system into statistical control. The most important facet of quality control is written documentation, including statements of good laboratory practices, good measurement practices, standard operating procedures, and protocols for a specific purpose. 

TQM involves all the organizations, all the functions, the external suppliers, the external customers and involves the quality policy. Similarly, TQM cannot be achieved without good Quality Management Systems (QMS) which bring together all functions relevant to the product, providing policies, procedures and documentation. The elements of a quality organization consist of these three mutually dependent items (Field and Swift, 1996) ... 

The standard doesn t require a procedure covering inspection and test status however, as clause 4.2 requires a documented quality system, you will need to document the methods employed to denote inspection and test status. If you use stamps you will need a register to allocate stamps to particular individuals and to indicate which stamps have been withdrawn. When a person hands in a stamp it is good practice to avoid using the same number for 12 months or so to prevent mistaken identity in any subsequent investigations. 

In accordance to GCP, the sponsor should appoint clinical trial monitors. These act as the main communication interface between the sponsor and the trial site, and should regularly visit the site to oversee that the trials are being conducted and correctly documented in accordance with the protocol and GCP. Reports should be supplied to the sponsor after each visit. It is also good practice for the sponsor to establish an auditing system for independently verifying that the activities in relation to the collection and processing of data at the trial site, and at related laboratories or sponsor s facilities, are conducted in accordance with applicable protocols, procedures, regulations, GCP and GLP. 

The GLP training should consist of two parts first, a classroom presentation of the materials described in Section 4 above, and second, a field training session where the principals of documentation of mixing, calibration, and applications can be demonstrated. Disposal, cleaning, and maintenance procedures should also be discussed and demonstrated. The classroom presentation should stress that the four key areas to successful implementation of GLPs are (1) Good Science, (2) Documentation,... 

Today, much more than just data are produced electronically. Many documents needed for studies that fall under the Good Laboratory Practice (GLP) standards regulations are being managed electronically. These records include not only data, such as chromatographic data from automated electronic capture systems and raw data collected in electronic field notebooks, but also other documents, such as methods, protocols, reports and standard operating procedures (SOPs). Frequently, these records are generated, distributed, reviewed, and archived electronically. 

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