Important Pharmaceutical Definitions



Acceptance criteria The product, equipment, and /or process specifications and limits, such as acceptable quality level and unacceptable quality level, that are necessary for making a decision to accept or reject
Calibration Demonstrating that a measuring device produces results within specified limits of those produced by a reference standard device over an appropriate range of measurements. This process results in corrections that may be applied if maximum accuracy is required.
Certification Documented testimony by qualified authorities that a system qualification, calibration, validation or revalidation has been performed appropriately and that the results are acceptable.
Concurrent validation Establishing documented evidence that a process does what it purports to do based on information generated during actual implementation of the process.
Control parameters Those operating variables that can be assigned values that are used as control levels.
Grouted equipment An equipment in which the basic unit or its ancillary components are fixed to floor and/or wall and/or ceiling, or an equipment in which its shifting might have an impact on its functionality
Inspection The process of measuring, testing or otherwise comparing the item to requirements.
Installation qualification Documented verification that all key aspects of the installation adhere to appropriate codes and approved design intentions and that manufacturer’s recommendations are suitably considered.
Non-grouted equipment Equipment that is installed without using grouting process
Operating variables All factors, including control parameters that may potentially affect process state of control and /or fitness for use of the end product.
Operational qualification Documented verification that the system or subsystem performs as intended throughout all anticipated operating ranges.
Performance qualification Documented verification that the equipment performs as intended for the process, as specified by operating ranges.
Process development Establishing evidence that all process control parameters and all control parameters ranges are validated and optimized.
Process validation Process Validation is defined as ‘the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product’. It shall involve a series of activities taking place over the lifecycle of the product and process.
Protocol A document that gives details of the critical parts of the manufacturing process, the parameters that should be measured, their allowable range of variability, and the manner in which the system will be tested.
Protocol supplement A document that explains a change to the original protocol, including reasons for its need.
Proven acceptable range All values of a given control parameter that fall between proven high and low worst case conditions.
Portable equipment An equipment that is designed to facilitate portability
Qualification Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.
Quality assurance The activity of providing, to all concerned, the evidence needed to establish confidence that the quality function is being performed adequately.
Quality control The regulatory process, through which industry measures actual quality performance, compares it with standards and acts on the difference.
Quality function The entire collection of activities from which industry achieves fitness for use, no matter where these activities are performed.
Representative sample A sample that consists of units that are drawn based on rational criteria such as random sampling, and is intended to assure that the sample accurately portrays the material being sampled.
Revalidation Repetition of the validation process or a specific portion of it.
State of control A condition in which all operating variables that can affect performance remain within such ranges that the system or process performs consistently and as intended.
Validation A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.
Validation change control A formal monitoring system  by  which  qualified representatives  of    appropriate disciplines review proposed or actual changes that might affect validated status and cause corrective action to be taken that will ensure that the system retains its validated state of control.
Validation protocol A prospective experimental plan that, when executed, is intended to produce documented evidence that the system has been validated.
Worst case The highest or lowest value of a given control parameter that fall between proven high and low worst case conditions. The set of conditions including those within standard operating procedures, which pose a greater chance for product or process failures than ideal conditions.
Instrument A device used to measure, record or identify an entity. For example: pH Meter, RTD Sensor
Equipment A device which operates either as a ‘stand-alone’ or combines several instruments or pieces of equipment to give an output. Equipment performs a unit operation or many unit operation(s). In pharmaceutical manufacturing, equipment is generally, associated with unit operation and equipment is generally associated with ‘operating principle’  and ‘design characteristic’ For example: Mixer, Autoclave.

A set, consisting of instrument(s) or equipment or both, which operates as a single unit to deliver an output. For example: Water for Injection Still, HVAC system


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