2012 Corporate Capabilities - Spectroscopy

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14 <strong>Spectroscopy</strong> 26(12) December 2011 www.spectroscopyonline.com Focus on Quality USP and the GAMP Guide on Laboratory Computerized Systems — Is Integration Possible? 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. 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. R.D. McDowall and C. Burgess 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). 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). 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. 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. 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. 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 white paper published by AAPS in 2004 (7) was the major input to USP , which became effective in 2008.
www.spectroscopyonline.com December 2011 <strong>Spectroscopy</strong> 26(12) 15 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. 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 GAMP Good Practice Guide on the Validation of Laboratory Computerized Systems is one such guide that was published in 2005 (12). The major problem with analytical instruments that are used in a regulated laboratory is their great variety, complexity, and variations in intended use. Furthermore, the software associated with an instrument can vary from firmware in basic instruments to servers and workstations for multiuser networked data systems. 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. 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). An integrated approach is not only beneficial from a regulatory and auditable context, but it also is cost effective for the business. 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. 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. It would be highly advantageous if the regulations and guidance could all say similar things and avoid duplicate tasks. However, with the way the current versions of USP (6) and the GAMP 5 & GPG software-driven approach Continuum of computerized laboratory systems USP instrument-driven approach Apparatus Group A 1. Instruments with firmware 2. Instruments with integral calculations Group B Figure 1: Mapping USP and GAMP software categories. GAMP laboratory systems GPG (12) are written, this is not possible, as we will illustrate now. Critique of the GAMP GPG Laboratory Guide 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). The version of the GPG at that time had, from our perspective, the following issues: • The guide had an unnecessarily complex classification of laboratory computerized systems (13) that did not match the software-based classification in the main GAMP guide (17,18). • According to the GAMP GPG, everything required validation; there was no consideration of instrument qualification. • There was no linkage with USP on AIQ. • There was no reference to the seminal instrument qualification papers, such as the discussion of modular and holistic qualification approaches by Furman and colleagues (19). To be fair, the GAMP GPG embraced a simplified life cycle model that was a great advance compared to the traditional V model shown in GAMP 4. In 2008, GAMP 5 was released (10) and was an improvement to the previous version of the guide (11). The new GAMP 5 was more risk-based and introduced several life cycle models depending on the software category. However, the major problem with this new version of the GAMP guide was the removal of category 2 (firmware) from the categorization of software (17,18). Category 3 3. Instruments with user-defined programs 4. Instruments with commercial non-config SW Group C 5. Instruments with commercial config SW Category 4 6. Instruments with commercial config SW+ macros Category 5 While understandable from a software system perspective, it is in direct conflict with USP , in which group B instruments are firmware-based (6). Critique of USP Two earlier “Focus on Quality” columns commented on USP (13,16). The classification of analytical equipment into one of three groups (A, B, and C) is a simple risk assessment, which is a good approach, but conflicts with the more complex GAMP laboratory GPG. Some of the other problems of are • It makes the vendor, rather than the user, responsible for design qualification and defining the intended purpose for a specific laboratory. This is wrong. Only users can be responsible for defining their requirements and selecting the instrument or system that is appropriate to meet their scientific, regulatory, and business needs. The role of a vendor’s specification is to sell instruments. • The true role of the vendor is missing from the data quality triangle in (16). • There are subcategories within group B (instruments) and group C (systems) that are not covered in the current version of . This can lead to noncompliance with 21 CFR 211.68(b) with regard to checking calculations embedded in some group B instruments (16). • There is no control or guidance in group B instruments for users to program routines. • There is poor software validation guidance for group C systems that could result in regulatory observations for a laboratory.
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