In 2006, comments were made this column on the disconnection of the first edition of the GAMP GPG for validation of laboratory computerized systems from the rest of the regulated organization (13). However, with the way the current versions of USP (6) and the GAMP laboratory systems GPG (12) are written, this is not possible, as we will illustrate now.Ĭritique of the GAMP GPG Laboratory Guide It would be highly advantageous if the regulations and guidance could all say similar things and avoid duplicate tasks.

Furthermore, because of organizational structures, instrument qualification may be carried out by the vendor and considerable time may elapse before the computer validation is conducted and the system is released into operational use. This approach is in contrast to conducting an initial qualification of the instrument and a separate validation of the software, which is inefficient and may duplicate some work. An integrated approach is not only beneficial from a regulatory and auditable context, but it also is cost effective for the business. However, as we have both maintained for a number of years, only an integrated approach to instrument qualification and computer validation - focusing on the key elements that must be controlled in a single combined process - is efficient and effective (13–16). Writing guidance for the qualification of this wide range of instrumentation and software is not easy, as qualification needs also depend on the intended use of the instrument or system. Furthermore, the software associated with an instrument can vary from firmware in basic instruments to servers and workstations for multiuser networked data systems.

The major problem with analytical instruments that are used in a regulated laboratory is their great variety, complexity, and variations in intended use. The GAMP Good Practice Guide on the Validation of Laboratory Computerized Systems is one such guide that was published in 2005 (12). After the publication of version 4 of this guide in 2001 (11), ISPE published several 'good practice guides' (GPGs) on specific topics that were intended to take the principles of the version 4 guide and tailor them for a particular subject or focus area.

The second source for guidance in a regulated laboratory comes from ISPE's Good Automated Manufacturing Practice (GAMP) Guide, which is seen by many as a standard for computerized system validation. The white paper published by AAPS in 2004 (7) was the major input to USP, which became effective in 2008. One decision that came from that conference was that the terminology being used at the time was incorrect, because the conference name itself should have referred to analytical instrument qualification. The first is USP general chapter on analytical instrument qualification (AIQ) (6), which was derived from an AAPS meeting on analytical instrument validation held in 2003. There are two main sources, however, of regulatory guidance and advice for qualification of analytical instruments and validation of computerized systems used in the laboratory. All of these organizations have published guidance on instrument qualification or computer validation either for a general regulated audience or specifically for a regulated laboratory. Information also can be obtained from scientific societies or associations such as the American Association of Pharmaceutical Scientists (AAPS) (7), the Parenteral Drug Association (PDA) (8), the Drug Information Association (DIA) (9), and the International Society of Pharmaceutical Engineering (ISPE) (10). There are many sources of advice on computerized system validation and analytical instrument qualification for the laboratory, including regulatory agencies, such as the United States Food and Drug Administration (FDA) (1,2) regulatory associations such as the Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) (3,4) the Official Medicines Control Laboratories (OMCL) in Europe (5) and pharmacopeias such as the United States Pharmacopeia (USP) (6). This column explains the discrepancies between the two documents as well as changes now being made to both in an attempt to enable an integrated approach to qualification and validation of laboratory instruments and systems. The United States Pharmacopeia general chapter on analytical instrument qualification ( USP ) and the ISPE's Good Automated Manufacturing Practice (GAMP) Good Practice Guide on laboratory computerized systems are the two main sources of guidance for qualifying analytical instruments and validating computerized systems used in the laboratory.

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