Quality control computer related systems used

A fundamental objective of a computer system applied to automate a pharmaceutical GMP operation is to ensure the quality attributes of the drug product are upheld throughout the manufacturing process. It is therefore important that quality-critical parameters are determined and approved early in the validation life cycle. The exercise should be undertaken to a written procedure with base information from the master product/production record file examined and quality-critical parameter values and limits documented and approved for the process and its operation. In addition, the process and instrument diagrams (P IDs) should be reviewed to confirm the measurement and control components that have a direct impact on the quality-critical parameters and data. This exercise should be carried out by an assessment team made up of user representatives with detailed knowledge of both the computer system application and process, and with responsibility for product quality, system operational use, maintenance, and project implementation. This exercise may be conducted as part of an initial hazard and operability study (HAZOP) and needs to confirm the quality-related critical parameters for use in (or referenced by) the computer control system URS. 

It takes a lot more than just connecting an IR instrument to a pipe to make the instrument into a process analyzer. The system not only has to be constructed correctly and be capable of flawless operation 24 hours a day, but it also has to be packaged correctly, and be able to access the stream correctly and without any interference from process-related disturbances such as bubbles, water, particulates, etc. Finally, the data acquired from the instrument has to be collected and converted into a meaningful form and then transmitted to the process computer, where the information is used to assess the quality of the product and to report any deviations in the production. Beyond that point, the process computer, typically not the process analyzer, handles any decisions and control issues. There are a few exceptions where robotics are integrated with the analyzer, and good vs. bad product quality are assessed at the point of measurement. The use of... 

Interim measures are additional controls applied in relation to computer functionality that support critical quality-related activities. They are implemented where compliance gaps are considered to exist, to provide added assurance of control, and to justify the continued use of a computer system. Interim measures are used to supplement or replace defined computer functionality. Examples of interim measures include ... 

The FDA will consider the lack of computer validation as a significant inspection finding and log it as a 483 noncompliance citation. The MHRA may take a more lenient view depending on the criticality of the system on GxP operations. The lack of a detailed written description of an individual computer system (kept up to date with controls over changes), its functions, security and interactions (EU GMP Annex 11.4) a lack of evidence for the quality assurance of the software-developed process (EU GMP Annex 11.5), coupled with a lack of adequate validation evidence to support the use of GxP-related computer systems may very well be either a critical or major deficiency. Ranking will depend on the inspector s risk assessment. 

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