Good Automated Manufacturing

Figure 11.12 Categorisation of software systems according to Good Automated Manufacturing Practice guidelines (CAMP4).

Good Automated Manufacturing Practice 3, Supplier User Guide , 1998, ISPE. 

Source International Society for Pharmaceutical Engineering. Guide for Validation of Automated Systems GAMP 4—Good Automated Manufacturing Practice, ISPE, 2001. 

Good Automated Manufacturing Practice Good Agricultural Practice Good Clinical Practice... 

International Society for Pharmaceutical Engineering (ISPE) (2005), GAMP (Good Automated Manufacturing Practice) Good Practice Guide Validation of Laboratory Computerized Systems, ISPE. 

Note The instruments used in the laboratories vary significantly in the design and operation complexity. The validation requirements should reflect the level of complexity of the instrument. It is obvious that the amount of effort required to validate a simple pH meter will be different from that required for a fully automated dissolution system. The Good Automated Manufacturing Practice (GAMP)... 

The Good Automated Manufacturing Practices (GAMP) Forum has developed guidelines for computer validation [5] and a draft guidance on quality assurance of information technology (IT) infrastructure [6]. 

The control system of the freeze-drying unit provides control, monitoring and documentation of the process. Such a system must be reliable and comply with GM P and GAMP (Good Automation Manufacturing Practice) demands with respect to computer validation. It should be SCADA (Supervisory Control and Data Acquisition) compatible. A possible hardware architecture is shown in Figure 2.55.1. 

Good Automated Manufacturing Practices (GAMP), February 1994... 

It is particularly important to put in place quality control procedures for the development of hardware and software for plant automation. Good automated manufacturing practice provides a systematic and structured approach to the development of these systems including change control and validation methods. 

Trill, A.J. (1995), EU GMP Requirements and the Good Automated Manufacturing Practice (GAMP) Supplier Guide for the Validation of Automated Systems for Pharmaceutical Manufacturing, Pharmaceutical Engineering, May/June, pp. 56-62. 

ISPE (2001), Good Automated Manufacturing Practice Guide for Validation of Automated Systems (known as GAMP 4), available through www.ispe.org. 

Good Automated Manufacturing Practice (GAMP) Forum,... 

The good automated manufacturing practice (GAMP) guide for validation of automated systems in pharmaceutical manufacture (GA.MP4) ISPE - International Society for Pharmaceutical Engineering, December 2001. 

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