Computerized pharmaceutical system

Confirm that hardware and software descriptions are available. 

Confirm that the documentation is appropriate, up-to-date, relevant, and complete. 

Verify the digital transmission inputs and outputs as appropriate. 

Verify data entry and boundary testing as appropriate. 

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Computerized Pharmaceutical System Quality Assurance/Control Laboratory Validation... 

The installation qualification of automatic control systems shall consist of a logical panoply of tests. The tests are carried out step-by-step on each component. The structure of the installation qualihcation shall be standardized for all installation qualihcations of computerized pharmaceutical systems as follows. 

Aseptic filling validation (media fill studies) Cross-contamination control Computerized pharmaceutical system Quality assurance/control laboratory validation... 

Computer systems are used worldwide in the pharmaceutical industry and have direct bearing on product quality. The purpose of validation is to demonstrate that the intended product manufactured, packed, or distributed using a computerized controlled system will meet the safety, efficacy, and potency requirements per the individual monograph. 

The performance qualification of computerized control systems consists of a group of tests pooled in functional checks. The tests shall be carried out on the integrated system. The structure of the performance qualification shall be standardized for all performance qualification of computerized pharmaceutical equipment. 

OQ verifies that the control and monitoring instrumentation, as integrated with the process equipment and any associated computerized control system, meets the operational and functional requirements defined in the instrument application design documentation and/or computerized control system User Requirements Specification (URS). PQ verifies that the control and monitoring instrumentation, as integrated with the process equipment and any associated computerized control system, meets the operational and functional requirements defined in the instrument application design documentation and/or computerized control system URS, and prodnces pharmaceutical product consistently to specification. ... 

Wall GM, Morgan J, Wrinkle M, Scott B, Dorsey E, Brammer 1. Irr The design of a Computerized Pharmaceutical Stability Monitoring System. Scientific Computing and Automation, June 13-16, 1998. 

It was very time-consuming to screen substances in animal tests for efficacy and to prepare lead analogues by classical synthesis. Therefore, it is not surprising that the researchers looked for alternatives. Today pharmaceutical companies apply computerized robotic systems in drug discovery. The starting point is the chemical library. This library does not contain books, but chemicals. Many companies keep small samples of all chemical compounds that they ever synthesized or extracted from the plant material. The amount of the samples is usually small and they are kept in microplates in dedicated temperature-controlled storage facilities. Chemical libraries of large pharmaceutical companies contain several million different compounds. 

Wyn, S. Regulatory requirements for computerized systems in pharmaceutical manufacture. Softw. Eng. J. 1996, 11. Huber, L. Validation of Computerized Analytical Systems Interpharm Press USA, 1995. 

Based on the lecture notes of A. Bmtsche on the subject of Calibration and Qualification of Analytical Equipment in Pharmaceutical Quality Control , the four concepts of equipment qualification in the field of analysis are listed here and elucidated in the form of headings [148]. The subject is discussed in more detail by L. Huber in the book Validation of Computerized Analytical Systems [149],... 

The guidance presented in this chapter only applies to the IT system and its Interfaces to other pharmaceutical systems (Figure 4.1). The whole computerized system can only regarded as being "validated" if all the parts of the IT system and its interfaces to other pharmaceutical systems have undergone quality assurance. 

A pharmaceutical company has to adopt a proactive policy of validation for its facilities, production processes, production equipment and support systems, analytical methods, and computerized systems. A properly validated approach will help to assure drug product quality, optimize the processes, and reduce manufacturing cost. 

User requirement specifications (URS) for the computerized system are provided by the pharmaceutical firm to the computer systems vendor. The vendor generates functional and design specifications as a basis for designing and coding software for the computerized system. The system is then built, together with all the interfaces to the hardware, and tested by the vendor. After installation of the computerized system, IQ, OQ, and PQ are performed at the pharmaceutical facility to verify that the system is able to meet the URS and design and functional specifications. 

Advances in information technology are now impacting upon the pharmaceutical industry. Many documents are now maintained in electronic format. In fact, some regard it as likely that in the future paperless facilities will become commonplace, with all documentation being computerized. Several aspects of such electronic document maintenance deserve special attention. Adequate back-up files should always be retained. Also, restricted access to computerized systems is required to ensure that data/documentation is only entered/amended by persons authorized to do so. 

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

Networked systems with integrated databases are used extensively in the pharmaceutical industry. These are computerized systems, and as such, must be qualified and validated to demonstrate suitability of their intended use. While validation of stand-alone computer systems is well described [8] and understood, there is still uncertainty on how to qualify networks and networked systems. On the other hand, inspectors are looking more and more into such systems, and validation of... 

On satisfactory completion of the computer system qualifications, with PQ conducted in conjunction with a successful process validation, a final report must be prepared by the pharmaceutical manufacturer s validation team. This is normally referred to as the validation report. The objective of the report is to give an overview of the results of the execution of the validation program for the computerized operation and to draw a conclusion as to the suitability of the computerized operation for pharmaceutical manufacturing. This may be unconditional use or there may be restrictions. In the latter case the proposed remedial ac-tion(s) must be approved and, as applicable, considered under change control. A schedule to complete any outstanding actions must be documented and progress formally reported. 

This phase of the computerized operation is usually the longest phase of the validation life-cycle, covering the operational period of the computer system in pharmaceutical manufacturing. 

The proliferation of computers in the production of pharmaceuticals resulted in the U.S. Food and Drug Administration (FDA) publishing the "Guide to Inspection of Computerized Systems in Drug Processing" in 1983. FDA Inspectors have been using this guideline for the past three years to cite firms for their failure to validate their computer systems. 

Motise, Paul J. Pharmaceutical Technology March, 1984, "Validation of Computerized Systems in the Control of Drug Processes An FDA Perspective". 

Wyn, Sion, Regulatory Requirements for Computerized Systems in Pharmaceutical ... 

F.W. Rosa, Computerized on-line Medicaid pharmaceutical surveillance system (COMPASS) human teratology, Teratology, 33(3) (1986) 54C. 

That is quite an accomplishment. Granted, some industries have made immense fortunes over the same period, which many chemicals players have not in 1980, Microsoft was just launching MS-DOS, Cisco Systems had not yet been founded. The advance of computerization, electronics, and new technology has seen the core businesses of a number of sectors transformed - apart from the IT world itself, pocket calculators, cash registers, and the world of home entertainment are cases in point. The pharmaceutical industry and financial institutions also created a great deal of wealth in this period. However, some other major players, particularly telecommunications, have seen enormous value destroyed following the post-deregulation boom. 

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