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Glossary of Pharmaceutical Validation Terms

This is a glossary of validation terms used in pharmaceutical validation and computer system validation.

A . B  . CD . E . F . G . H . I . J . K . L . M . N . O . P . Q . R . S . T . U . V . W

A

Actual Result – What a system does when a particular action is performed

Autoclave – is a machine that uses water, pressure, and heat to create superheated steam that kills microorganisms and spores.

Auditing (ISO) – assess the effectiveness of your organization’s quality management system and your organization’s overall performance, ensures your Quality Management System (QMS) complies with the ISO 9001 standard, identifies any issues and potential improvements to your system with your Quality Management System and ensures your organisation takes appropriate action to meet its quality objectives.

ASTM International – formerly known as the American Society for Testing and Materials, is an international standards organization that develops and publishes voluntary technical standards for a wide range of materials, products, systems, and services.

B

Batch – A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture. (FDA 21 CFR 210.3)

See Validation Batch

Note: To complete certain stages of manufacture, it may be necessary to divide a batch into a number of sub batches, which are later brought together to form a final homogeneous batch. In the case of continuous manufacture, the batch must correspond to a defined fraction of the production, characterised by its intended homogeneity.

For the control of the finished product, a batch of a medicinal product comprises all the units of a pharmaceutical form which are made from the same initial mass of material and have undergone a single series of manufacturing operations or a single sterilisation operation or, in the case of a continuous production process, all the units manufactured in a given period of time. (PIC/S)…

Batch number (lot number) A distinctive combination of numbers and/or letters that specifically identifies a batch.

Baseline® Guide Vol 5: Commissioning and Qualification (Second Edition) – provides guidance on the implementation of a science and risk-based approach for the commissioning and qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are fit for intended use.

Business Continuity Management – is defined as the advanced planning and preparation of an organization to maintain business functions or quickly resuming after a disaster has occurred. It also involves defining potential risks including fire, flood or cyber-attacks.

C

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.

D

Data Integrity – is the accuracy, validity, and consistency of data over its entire life-cycle and is a critical aspect of the design, implementation, and usage of any system that stores, processes, or retrieves data.

Deliverable – something that is to be produced such as an engineering report, user requirements specifications, functional specifications, design specifications, proposal, design drawings. design documents, Technical interpretation. site investigation report. design review, etc. 

Design for Impact  – the practice of making conscious design decisions with respect to the impact of a system at the beginning of design development. By careful design, the number of systems capable of having a direct impact can be reduced. Where possible, the impact of systems should be set as design objectives early on in the design process. 

Deviations –  is a departure from standard procedures or specifications resulting in non-conforming material and/or processes. Or where there have been unusual or unexplained events that have the potential to impact product quality, system integrity or personal safety.  

Deviations can be classified from minor to critical depending on their impact. Deviations must be documented, investigated and remediated to ensure GxP compliance. A Deviation record should include a description of the event, the immediate action taken, date of occurrence, an impact assessment, an investigation and identification of the root cause, and a corrective/preventative action to take in response to the deviation. Deviation causes typically fall into 6 categories – material, man power, machine, measurement, method and environment.

Design Review – Review the overall design, or a specific aspect of a design, during any point in the development of a new or existing product. Discussions about the project schedule, development cost, staffing, and other project-related issues should not be discussed in design review meetings.

Direct Impact System – where the system is expected to have a direct impact on product quality. Direct Impact Systems may contain non-critical components, along with their critical components.  

Distributed Control System (DCS) – is a digital automated industrial control system (ICS) that uses geographically distributed control loops throughout a factory, machine or control area. Unlike a centralized control system that operates all machines, a DCS allows each section of a machine to have its own dedicated controller that runs the operation. A DCS has several local controllers located throughout the area that are connected by a high-speed communication network. While each controller works autonomously, there is central supervisory control run by an operator.

Design Qualification (DQ) –  provides documented QA approved evidence that: 

  1. Procured system or equipment meets user requirements specification.
  2. The equipment adequately controls risk as identified during the system risk assessment. 
  3. The critical aspects or critical design elements necessary to implement requirements and risk controls are present.

Ref: ISPE

Design Specification (DS) – describes how the hardware identified in the Functional Specification will be developed and implemented.

E

Effectiveness Checks – are a method of determining if the CAPA action put in place has remediated the issue that triggered the CAPA. For example the corrective action might be to implement a change to a process or system. Part of the root cause determination would be to perform verification i.e. be as sure as possible that the root cause is correct and that the planned remediation action will be successful and then to implement the change and validate its results as expected. Effectiveness check plans may include a procedure to monitor corrective actions over time and allow for trending the success or failure of remediation actions and improvements.

Electrical & Instrumentation – the provision of power, measurement and process control. Key documents are the P&IDs and equipment lists.

End-User – The person who uses the validated system.

European Medicines Agency (EMA) – is the decentralised agency of the European Union (EU), set up in 1995. They are tasked with evaluating, supervising and monitoring the safety of pharmaceutical products produced for use within the EU. The EMA also acts as a central point for pharmacovigilance, the safety monitoring of medicines, utilising the network of European monitoring agencies and tracking the safety of medicinal products.

Equipment Qualification – is a series of inspections and tests to make sure that critical requirements necessary for product quality are satisfied and that documents and procedures necessary to properly operate and maintain the system are in place.

Expected Result – What a system should do when a particular action is performed

F

Facility Design – is where the small scale process designed in the previous (process design) stage is studied and, from it, a large scale commercial manufacturing facility is developed that maintains all the critical quality attributes of the medicine. Facility design will also decide how big the manufacturing facility needs to be in order to make as much of the medicine as is required.

Food & Drug Administration (FDA) – is an agency of the United States Department of Health and Human Services and is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation, cosmetics, emitting devices and veterinary products.

Functional Requirement Specification – describes the functions necessary to achieve that particular requirement such as:

  • how the system, hardware or software works
  • what data needs to be captured
  • user interfaces (in the case of software)

Factory Acceptance Testing (FAT) – helps verify that the equipment or systems meet their intended purpose before they are shipped to the manufacturing site. The FAT validates the operation of the equipment and makes sure the customers’ purchase order specifications and all other requirements have been met.

G

Good Engineering Practice (GEP)  – consists of proven and accepted engineering methods, procedures, and practices that provide appropriate, cost-effective, and well-documented solutions to meet user requirements and compliance with applicable regulations. Ref: ISPE

Good Manufacturing Practice (GMP) – is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices and blood take proactive steps to ensure that their products are safe, pure, and effective.

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors.  This protects the consumer from purchasing a product that is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and even jail time. Ref: ISPE

Compare with “cGMP” See above. 

GxP – is the name given to a number of “Good Practice” regulatory frameworks which includes “GMPs”. These frameworks were created to make sure that high levels of quality and safety are built into every step from drug development, manufacture and all the way to distribution and storage as we don’t just want only the manufacturing process to be safe. We need these other steps and processes to be safe as well. These include:

  • Drug discovery: Good Laboratory Practice (GLP)
  • Drug trials: Good Clinical Practice (GCP)
  • Manufacturer: Good Manufacturing Practice (GMP)
  • Distribution: Good Distribution Practice (GDP)
  • Storage: Good Storage Practice (GSP)

And collectively, all these standards are known as GxPs.

H

Heat Exchanger – is a device built for efficient heat transfer from one medium to another. The media may be separated by a solid wall so that they never mix. Think of a radiator in a house.

Homogeneity – within a batch and consistency between batches are goals of process validation activities and is defined as the quality of being similar or comparable, of lacking diversity or variation and being uniform throughout in composition or structure.

I

Impact Assessment – the process of evaluating the impact of the operating processes and failure conditions of a system on the quality of a product. 

Indirect Impact System – where the system is not expected to have a direct impact on product quality. Indirect Impact Systems may or may not contain critical components.  

Installation Qualification – is a documented process that verifies that critical pieces of equipment, software, or instruments that directly impact product quality have been;

  • Properly delivered
  • Correctly installed
  • Configured according to standards set by the manufacturer or by an approved installation checklist

Instrumentation – the measurement and control of a process and its parameters. 

(ICH) International Council for Harmonisation – was formed in 1990 with the unique intention of bringing together the pharmaceutical industry and regulatory bodies to drug regulation from a scientific and technical perspective. As the industry became more globalised, the ICH has adapted to promote rationalisations and harmonisation of practices to ensure that pharmaceutical products are high quality, effective and safe and that registration of these products is efficient across the world.

L

Laboratory Information Management System (LIMS) – is software that allows you to effectively manage samples and associated data. By using a LIMS, your lab can automate workflows, integrate instruments, and manage samples and associated information.

M

Measurement system – any set of interconnected parts that include one or more measurement devices.

N

No Impact System – where the system will not have any impact, either directly or indirectly, on product quality.

Non-Critical Component – a component within a system where the operation, contact, data control, alarm, or failure will have an indirect impact or no impact on the quality of the product.

O

Operational Qualification – is a documented testing process to make sure that the equipment and systems operate as defined in the functional design stage and are within the operating ranges listed by the manufacturer. This is the next step in the IQ OQ PQ process and confirms that the equipment runs the way it’s supposed to run.

Operationally Critical – critical to the operation of the system; if the component/instrument fails, product quality is immediately affected.

P

Performance Qualification – confirms that the equipment and systems meet the users’ needs and is fit for intended use as defined in the user requirements specification (URS). It is the final step in equipment qualification. It is much like Operational Qualification, as it tests the operational requirements of the equipment, but in this case, the equipment will contain a load or process medium.

Piping & Instrumentation Diagram (P&ID) – is a schematic illustration or diagram used in the process industry which shows the piping and process equipment together with the instrumentation and control devices. It shows the process flow and interconnection of process equipment that is used to control a process.

It provides information to begin planning for the construction of the plant. There are different sets of symbols used to depict mechanical equipment, piping, piping components, valves, pumps and instrumentation and controls.

P&IDs are developed by process design or chemical engineers and are followed by instrumentation and piping engineers. They are the single most important document on every project. In summary, if P&ID’s are not technically correct, the project has to fail on every front. But, as well as being technically correct, the P&ID’s should also be user friendly and easy to read for any individual picking up a P&ID.

Process Design – is the initial stage of any process validation protocol. The ultimate aim of the process design stage is to develop and document a manufacturing process that can be used in commercial manufacturing to consistently produce a quality medicine every time.

Process Validation – is the name given to the specific validation activities carried out on manufacturing processes. Its goal is to establish, through documented evidence, a high degree of assurance that a specific process will consistently yield a product that meets predetermined specifications and quality characteristics.

Process Performance Qualification (PPQ) – having previously validated each component of the process individually, this stage tests that the system as a whole can consistently make medicines that meet the critical quality attributes. Usually, 3 consecutive batches of medicines are required to confirm the success of the process design and qualification stages. Essentially PPQ brings together the manufacturing process (including qualified facility, equipment, and utilities), process controls and personnel. It is the method of testing all aspects of the facility as one integrated system. The aim of this stage is to manufacture a small number of commercial batches of medicine, known as PPQ batches.

Product Contact Critical – the component/instrument in contact with the product, or in contact with a material that will contact the product downstream, and the materials of construction (MOC) of the component/instrument must be verified during Installation Qualification (IQ).

Product Development – is the complete process of delivering a new product or improving an existing one for customers. The customers can be external or internal within a company.

Product Lifecycle Management – is the process of managing the entire lifecycle of a product from its inception through the engineering, design, and manufacture, as well as the service and disposal of manufactured products.

A Programmable Logic Controller (PLC) – is an industrial computer control system that continuously monitors the state of input devices and makes decisions based upon a custom program to control the state of output devices.

Pump – a pump is a device used to move fluids, such as liquids or slurries, or gases. A pump displaces a volume by physical or mechanical action.

Purified Water (PUW) – is town water or Process Water (PW) which has gone through additional purification steps above and beyond the sanitation of ordinary drinking water. (e.g., deionization, reverse osmosis, distillation, etc.). PUW is a controlled liquid that is allowed to come into contact with the process (as towns water would not be sufficiently controlled to be allowed to contact the product).

Pure Steam or Clean Steam – is a general term that applies to steam that is used in the pharmaceutical industry and medical community. This clean steam is condensed to form water for injection (WFI) which is the water used in vials for vaccines and other injectable products. The process is necessary as purified water (PUW) is not allowed to be injected into patients.

P&ID Walkdown – is the physical walk through of an installed equipment system to make sure that all pipes, vessels, tanks, pumps, pumps, heat exchangers, etc, are properly connected to each other.

Process Qualification – is the qualification of manufacturing and production processes to confirm they are able to manufacture safe medicines as intended during commercial manufacture. Also known as Process Performance Qualification.

Protocol Test Deviations – are measured differences between the observed value and expected or normal value for a process or product or a departure from a documented standard or procedure. For simplicity in assessing risk, any deviation can be classified into one of three levels, as an example: Minor, Major and Critical, usually based on the magnitude and seriousness of the deviation.

Q

Qualification – this is the action of proving that any equipment works correctly and actually leads to the expected results. The word validation is sometimes widened to incorporate the concept of qualification.

Qualification extends beyond commissioning in that it meets the demands and criteria of the validation master plan (VMP). Moreover, qualification is primarily concerned with verifying and documenting that the facility, systems and process equipment that have a direct impact on product quality are rigorously tested and documented.

While commissioning can be viewed as primarily an engineering test and applies to all of the equipment in a manufacturing facility, qualification only applies to that equipment that has direct or indirect impact on the quality of the product and will be focused on by the regulatory authorities when they come to approve the medicines that are being manufactured in that facility.

Qualification of Equipment – is when the equipment to manufacture the medicine is installed in the manufacturing facility and is checked to see that it is working properly and can operate as intended. This stage can be thought of as checking each of the individual component parts that come together to make up the manufacturing facility (e.g. the vessels, the piping, the instruments, the electrical wiring etc). The qualification of equipment can be further broken down into 3 sub-categories: IQ OQ PQ.

Quality Assurance (QA) – is process-oriented and focuses on eliminating process variation by creating, revising and strictly implementing a set of tightly and precisely defined process/procedures/quality standards that when exactly followed, ensure the final quality of the product. Quality Assurance is preventative by nature.

QA cannot absolutely guarantee the production of quality products but makes it more likely. Two key principles characterize QA: “fit for purpose” and “right first time”. QA includes regulation of the quality of raw materials, assemblies, products and components; services related to production; and management, production and inspection processes.

Quality Control – is product-oriented and focuses on testing a sample of a manufacturing process to make sure that it meets the required design specifications or quality standards. The product can then be released to the next stage of the production process or deemed suitable to be released for sale or distribution. 100% sampling or Statistical Process Control (SPC) are some of them more widely used techniques in quality control.

Quality Management System (QMS) – is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It helps coordinate and direct an organisation’s activities to meet customer and regulatory requirements. ISO 9001 is the most recognised and widely implemented quality management system.

R

Risk Management Tools – are a set of techniques to identify and deal with the inherent risk with the design, construction and operation of a pharmaceutical plant. The purpose of risk management tools is to:

  • identify how these problems could occur
  • design them out (always the best solution)
  • put in place the necessary procedures/controls to prevent them from occurring in the first place
  • when a problem occurs, it is used to analyze how that happened

Regulatory Compliance – conforming to a rule, such as a specification, policy, standard or law. In the case of pharmaceutical or medical device manufacturing, that means conforming to GMPs.

S

Site Acceptance Test (SAT) – To ensure that the equipment has not been damaged from being shipped from the vendor to the manufacturing site.

Single line diagrams (SLD) – schematic representation of part or all of a power distribution system.

Supervisory Control and Data Acquisition (SCADA) – is a system that aims to monitor and control field devices at your remote sites. A SCADA system is critical as it helps maintain efficiency by collecting and processing real-time data. SCADA is a centralized system that monitors and controls the entire area.

Specification – describes in detail the requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation. (PIC/S, 4.1). Specifications usually relate to starting materials, components, bulk product and finished products but may also apply to critical steps of manufacture where failure to meet the acceptance criteria would result in a defective product. Failure to meet specification results in Non-conforming product, formal QA investigations, rejection of material or product or reprocessing, and probably corrective action.

Standard Operating Procedures (SOPs) – is a set of step-by-step instructions put together by an expert, a team or an organization to help workers carry out routine operations.

System – an organization of engineering components that have a defined operational function (e.g., piping, instrumentation, equipment, facilities, computer hardware, computer software, etc.).

System Boundary – A limit drawn around a system to logically define what is, and is not, included in the system.

System Owner – The individual who is ultimately responsible for a system

T

Test Plan – A testing methodology to establish and ensure that a system meets requirements. A test plan can also refer to the collection of protocols or qualifications used to test and document that a system meets requirements.

Traceability – The ability to ensure that requirements outlined in the specifications have been tested. This is usually recorded in a traceability matrix. In computer system validation, it can also refer to the ability to back in time in the electronic records to a specific event in the past.

Traceability Matrix – is a tool used to make sure that all requirements defined within the User Requirement Specifications (URS) for a system are tested in the test protocols. The traceability matrix is a tool both for the validation team, to ensure that requirements are not lost during the validation project, and for auditors, to review the validation documentation.

U

User Requirement Specification (URS) – is a document used to specify what the user expects the system to be able to do. These are usually written up in two or even three stages.

  1. Lists the end-users needs, what they want the item for and what they expect it to do.
  2. This breaks down the end-users needs and expectations into individual functions that are essential to reach these aims.
  3. This lists where the system is used. In this format of URS, traceability from the end-users expectations to the system performances is maintained.

V

Validation – creating a documented evidence trail to show that an action, process, or system leads to a consistent and reproducible result.

Another definition would be establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.

There are many other definitions of validation but the essence of all these definitions is “documented scientific proof of consistent performance“.

Validation Batch – A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture. (FDA 21 CFR 210.3)

See Batch

Validation Engineer – is responsible for planning, implementing and monitoring the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing. They measure and analyze the process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result to ensure the highest quality products are produced.

Validation Master Plan (VMP) – is a document which defines the specific validation scope and associated activities of a project. These include the final project design, design review, development of the VMP, and then the construction of the facility.

The VMP is a high-level documented plan that establishes an umbrella validation plan. It identifies the layout of the operation, the associated utilities and systems, the equipment, and the processes to be validated.

It also provides information as to the extent of the qualification (IQ, OQ, PQ), testing requirements, required documentation, acceptance criteria, SOPs, training, and responsibilities.

While these activities are being completed, the project is constructed. A VMP may be for the entire company, or there may be multiple VMPs for smaller business units. The VMP should be a clear and concise summary document.

V-Model – is a pictorial representation of a systems development lifecycle. It was developed in the ISPE Baseline® Guide: Commissioning and Qualification to provide practical guidance on the implementation of a science and risk-based approach for the Commissioning and Qualification (C&Q) of pharmaceutical manufacturing facilities, their equipment, systems, and controls to confirm that they are suitable for the intended purpose, i.e. make safe medicines for patients.

Validation Protocol – An IQ OQ PQ Validation Protocol is a written plan stating how validation will be conducted. It details factors such as product characteristics, production equipment, test scripts and methods, test parameters and acceptance criteria, test checksheets and final approval.

A list of inspections and or tests written specifically for verifying that the item under qualification, has been Designed (DQ), Installed (IQ), Operates (OQ) and Performs (PQ) in accordance with the end users requirements (URS).

There are many different types of protocol depending on the use case, including:

  • equipment validation protocol
  • autoclave validation protocol
  • cleaning validation protocol
  • sterilization validation protocol
  • medical device validation protocol
  • computer system validation protocol

Validation Risk Assessment – The Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to excute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.

Validation Team Member – This role is more focused on working on capital projects. It is typically equipment focused, and comes with a higher salary than Validation Technicians as there would be a lot of overtime associated with the role. You would also need to move to where the job is located and could be working away from home. Some pharma companies might call this role: Validation Specialist or CQV Specialist or C&Q Specialist.

(Note that actual job titles may vary – the distinction is more between who’d employ you and what type of projects you’d work on)

Validation Technician – works as part of the Validation team to measure and analyze the manufacturing process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result. This ensures that the product is consistently of the highest quality. Some pharma companies also might call this role: Validation Specialist or CQV Specialist or C&Q Specialist.

(Again, the actual job titles may vary – the distinction is more between who’d employ you and what type of projects you’d work on)

Valve – a valve is a device that regulates the flow of a fluid (gases, liquids, fluidized solids, or slurries) by opening, closing, or partially obstructing various passageways. Valves are technically pipe fittings. In an open valve, fluid flows in a direction from higher pressure to lower pressure. For comparison purposes, the tap on your sink is a valve. When you open the valve, water flows out and when you close it, it stops.

W

Water for injection – This is water of extra high quality without significant contamination.