Calibration – is a comparison of a measurement standard or instrument of known accuracy with another standard or instrument to detect, correlate, report or eliminate by adjustment any variation in the accuracy of the item being compared with the standard traceable to a Recognised National Standard.
This is a crucial process as instrumentation and equipment need to be monitored and maintained to ensure they continue to give accurate and reliable results. Within a manufacturing environment, equipment is used to complete tasks such as measuring, analysis and recording data.
Calibration Technician – will routinely test equipment and instruments to check that their readings and output meet expected results. If a deviation is found, that piece of equipment will be further analyzed, adjusted or repaired as necessary.
Capital Project – is a long-term project to build, improve, maintain, or develop a capital asset such as a new pharmaceutical manufacturing plant. This type of project involves a significant and consistent flow of investment. A capital project can be large scale, needing constant management and resources for completion. Put simply; a capital project is a huge project that costs a lot of money, lasts a long time, and is generally extremely complex.
Capital assets – in the world of business, include land, buildings, machinery, factories, vehicles, and computer equipment. In other words, for a company, a capital asset is something it needs to produce goods or services.
cGMP – also referred to as GMP stands for current Good Manufacturing Practices. The cGMP acronym originated in the USA, where the US Food and Drug Administration (FDA) wanted to impress upon drug manufacturers the need for continuous improvement in their approach to product quality. The FDA warned against a ‘set and forget’ approach to compliance to the GMP guidelines, and wanted manufacturers to make sure that product quality became a core focus within their organisations. In most other countries, the ‘c’ for ‘current’ is not used as it’s assumed that manufacturers will keep up to date with changes to the GMP guidelines and will be continually striving to meet them. And so for most practical purposes the terms cGMP and GMP are largely interchangeable terms. Ref: Pharmaout
Compare with “GMP” See below.
Cause and Effect Diagrams – is a visual tool used to identify, sort, and display possible root causes of a specific problem or event by graphically displaying them in increasing detail. They are also referred to as fishbone or Ishikawa diagrams (named after the Japanese organisational theorist, Karou Ishikawa).
Change Control – a process/record which captures the details of change in order to mitigate the risk of introducing the change and minimise disruption to business processes. Details may include a description of the change, the current situation, justification for the change, an impact assessment based on the areas it affects, a risk assessment, an action plan and final evaluation of the change (European Medicines Agency 2007, p.13). Review and approval of the change is required by the appropriate members of the affected areas and QA. A change control may have multiple actions which may be assigned to different users. When the tasks have been completed the assignee will close their associated action. Once all actions are closed the change control can be finalised and closed as well.
Change Control for Validated Systems – is a term that describes the process of managing how changes are introduced into a controlled system. Change control can demonstrate to regulatory authorities that validated systems remain under control during and after system changes. These processes are a favourite target of regulatory authorities because they demonstrate an organisation’s capacity to control its systems.
Change Management – A systematic approach to proposing, evaluating, approving, implementing, and reviewing changes. The scope of change management is much broader than change control, which was typically applied to one change at a time.
Clean In Place – is an automated cleaning process that relies on both chemical removal and physical agitation to chemically clean a manufacturing process for making pharmaceutical, biopharmaceutical, beer, wine, cheese, casein, butter, yoghurt, etc, products. The insides of manufacturing equipment can be cleaned without being taken apart. The manufacturing equipment is literally “cleaned in place”.
Cleaning Validation – is the name given to validation activities that prove the equipment used to manufacture the medicine is clean and cannot contaminate the medicine that is made in it. It sets out to prove that the documented cleaning procedure will consistently remove the previous product, cleaning agent, and reduce the microbial population to a safe and acceptable level.
Commissioning – is a systematic approach to the start-up of a manufacturing system and covers all aspects of bringing a system or subsystem to a position where it is regarded as being ready for use in pharmaceutical (and other) manufacture. Commissioning involves all the basic requirements of Installation Qualification (IQ) and Operational Qualification (OQ). The results ensure that the design requirements, specification documents, and all stakeholder expectations are met.
Commissioning verifies that what was specified was installed, that it functions properly, and that it was successfully turned over to the user. During commissioning, the operations and maintenance manuals are verified, and personnel are trained. Activities in this phase may include design reviews, factory acceptance testing, site acceptance testing, and functional testing. Summary reports are generated after commissioning and are an overview of the results and any deviations encountered during testing. During commissioning, the primary focus is placed on satisfying engineering requirements for the facility, defined earlier in the project.
Complaints – In relation to the implementation of a Quality Management System, complaints capture negative feedback from customers relating to products and offer the opportunity for process improvement in response to the issue. Complaints can be classified from minor to critical depending on their impact. Complaints must be documented, investigated and remediated to ensure GxP compliance. A Complaint record should include a description of the complaint, the customer’s information i.e. name and contact details, any immediate action taken, date of occurrence, an impact assessment, an investigation to substantiate the complaint and identification of the root cause and a corrective/preventative action to take in response to the complaint. Review and approval of the cause and resolution is required by the impacted areas and QA.
Component – a component is any equipment item or instrument that carries a discrete tag number.
Component Level Impact Assessment – is a process that evaluates the criticality and importance of the components in the systems as they relate to product quality. To conduct a component level impact assessment, you need to determine the relationship between the type of impact a system, or one of its components, has on the product and the criticality of those systems or components.
Computer Systems Validation (CSV) – is a process used to test, validate and formally document that a regulated computer-based system does exactly what it is supposed to do as per its design requirements in a consistent and accurate manner that is safe, secure and reliable
The process is used to replace paper with electronic data within highly regulated environments that directly impact public health and safety such as pharmaceutical and medical device manufacturing and the BioTech industries and make sure the system is:
- completely transparent, robust and tamper-proof
- and can store those electronic data records so that they stand the test of time
These industries use computer systems to operate and record a range of manufacturing processes. So it’s critical that these systems can be relied upon to produce data consistently and store those electronic data records so that they stand the test of time.
Continued Process Verification (CPV) – This stage is ongoing throughout the manufacturing lifecycle of the facility. The aim of this stage is to ensure that the previously validated system remains in a reliable and validated state. And ultimately, that the facility continues to produce reliable and consistent medicines.
Failure to complete this stage of validation could result in compromised batches of unreliable quality medicine that are unsuitable for the market. CPV picks up from where process performance qualification (PPQ) and its enhanced testing finishes.
Corrective Action Preventive Action (CAPA)
- Correct Action is defined as the action taken to rectify, fix or correct a specific deviation defect or undesirable situation.
- Preventative Action is defined as the action taken to eliminate the cause of a deviation, defect, or other undesirable situation in order to prevent the future occurrence of such an event.
CAPAs may result from deviations, complaints, recalls, audits, inspections or trends in process monitoring. CAPA actions can be both reactive, correcting an event that has already occurred and proactive, identifying a risk and putting a control in place to prevent the issue from occurring. “CAPA methodology should result in product and process improvements and enhanced product and process understanding” (European Medicines Agency 2007, p.12). A CAPA record should contain a description of the action to be taken and evidence of the action implementation where possible.
Critical Component – a component within a system where the operation, contact, data, control, alarm, or failure may have a direct impact on the quality of the product.
Critical Quality Attributes (CQA) – is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. Critical quality attributes are the things that are essential for a pharmaceutical product (the medicine) to have its desired effect. Any variation in these product qualities would alter how well the medicine performs for the patient.