If any of the above questions are answered “Yes” then the system has a GxP impact and the system requires a level of Validation and control through the Computer Systems Validation.
area or location)?ġ6. Does the system support a GxP application i.e. Perform GxP assessment using the below Questioners.ġ. Is the system used to generate data used in support of a regulatory submission?Ģ. Is the system is used to monitor, control or supervise a GxP manufacturing or packaging process and has the potential to affect Product Quality, Safety, Identity, or Efficacy?ģ. Is the system used to hold and/or manipulate clinical study data?Ĥ. Is the system used to monitor, control or supervise packaging and labeling operations?ĥ. Is the system used to create critical study control data?Ħ. Does the system hold electronic records that are or could be used in the electronic form to make GxP decisions?ħ. Is the system used to transmit e-data/ records to other systems for the execution of GxP activities?Ĩ. Is the system is used for GxP analytical quality control?ĩ. The system manipulates data or produces reports, to be used by GxP quality-related decision authorization/approval processes, where the data supports the decision process or the electronic record constitutes the master record.ġ0. Is the system is used to maintain compliance with a GxP requirement?ġ1. Is the system is used to monitor, control, or supervise warehouse or distribution within a GxP requirement?ġ2. Is the system is used for GxP batch sentencing or batch records?ġ 3. Is the system used to store GxP documents for example SOPs, Specifications, BMR, BPR, DMFġ4. Is the system used for GxP data backup, restore, archival or storage, data security, or access/domain control?ġ5. Is the system used for physical access to GxP to the environment (i.e. All GxP impact computer systems must comply with applicable regulatory requirements. The GxP impact assessment is carried out to determine if the computer system has an impact on product quality, patient safety, or data integrity.
#Gamp categories examples full
However the GAMP Category can support the decision as to the level of supplier assessment that needs to be performed (Postal Questionnaire rather than Full Site Audit.ĮU Annex 11 states that the need for an audit should be based on a risk assessment refer to the Validation Determination post.
#Gamp categories examples verification
It can support decisions as to lifecycle steps that may not need to be performed for example Source Code Reviews, limited verification activities and greater reliance on vendor test documentation.Īs with any supplier you should ensure that the software has been performed in accordance with an appropriate quality management system. This should be combined with the impact or criticality of the process that the system is monitoring and / or controlling. There is no fixed rule as to the validation approach for GAMP Category 3 systems. Within the pharmaceutical industry there are many examples of these including Labelling and Packaging equipment. Other examples that would fit under GAMP category 3 would be systems that are provided with computerised controllers, including Programmable Logic Controllers (PLC’s) where the application is not modified (although may be parameterised) to meet the business need. It is important to understand the distinction between true configuration and parameterisation when assigning the category. would fall under GAMP Category 3 for while it is has parameters entered under the configuration it does not define functionality or a process flow.
In a process control system a DCS would be configured from standard modules to control a specific process and would fall under GAMP Category 4.Īn electronic chart recorder which is also configured with Input Ranges, Alarm Setpoints, etc. Configuration relates to adding functionality through standard modules, library items to standard software applications to meet the business requirements.
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