MAVERICKS ASSOCIATION

guidelinepharma

Pharma Definitions

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Alvina
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Pharma Definitions

1.Aseptic processingA process performed maintaining the sterility of a product that is assembled from components, each of which has been sterilized by steam, dry heat, ionizing radiation, gas or sterile filtration. This is achieved by using conditions and facilities designed to prevent microbiological contaminants.
2.BioburdenThe total number of micro-organisms associated with a specific item prior to any sterilisation or bioburden reduction step.
3.Biological indicatorBiological indicators are test systems containing viable microorganisms (usually spores of bacteria) that provide a defined challenge to verify the required effectiveness of a specified sterilisation process.
4.Critical Quality AttributeA physical, chemical, biological or microbiological property or characteristic that should be within an appropriate acceptance criteria, range, or distribution to ensure the desired product quality
5.DepyrogenationA process used to destroy or remove pyrogens (e.g. endotoxins).
6.D-value (decimal reduction value)The value of a parameter of sterilisation (duration or absorbed dose) required to reduce the number of viable organisms to 10 per cent of the original number. It is only of significance under precisely defined experimental conditions. D121 is the D-value of the relevant spores at 121 C.°
7.F0 valueThe F0 value of a saturated steam sterilisation process is the lethality expressed in terms of the equivalent time in minutes at a temperature of 121 °C delivered by the process to the load in its container with reference to micro-organisms possessing a theoretical Z-value of 10.
8.Overkill sterilisationA process with a lethality of F0BIO > 12 minutes. For example a process that provides at least a 12 log reduction of biological indicator microorganisms having a minimum D value of 1 minute.
9.SALSterility Assurance Level. The SAL for a given sterilisation process is expressed as the probability of micro-organisms surviving in a product item after exposure to the process. An SAL of 10-6, for example, denotes a probability of not more than 1 non-sterile item in 1 × 106 sterilised items of the final product.
10.SterilisationA suitably designed, validated and controlled process that inactivates or removes viable microorganisms in a product until sterility is obtained.
11.SterilitySterility is the absence of viable microorganisms, as defined by a sterility assurance level equal to or less than 10−6. The inactivation of microorganisms by physical or chemical means follows an exponential law; thus there is always a finite statistical probability that a micro-organism may survive the sterilising process. For a given process, the probability of survival is determined by the number, types and resistance of the microorganisms present and by the environment in which the organisms exist during treatment.
12.TAMCTotal aerobic microbial count: The total aerobic microbial count (TAMC) is considered to be equal to the number of CFU found using casein soya bean digest agar.
13.ValidationEstablishing 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.
14.Worst caseA set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, that pose the greatest chance of process or product failure (when compared to ideal conditions). Such conditions do not necessarily induce product or process failure.
15.z-valueThe z-value is the change in temperature required to alter the D-value by a factor of 10.
16.Change Control A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes. The intent is to determine the need for action to ensure and document that the system is maintained in a validated state.
17.Cleaning ValidationCleaning validation is documented evidence that an approved cleaning procedure will reproducibly remove the previous product or cleaning agents used in the equipment below the scientifically set maximum allowable carryover level.
18.Cleaning verificationThe gathering of evidence through chemical analysis after each batch/campaign to show that the residues of the previous product or cleaning agents have been reduced below the scientifically set maximum allowable carryover level.
19.Concurrent ValidationValidation carried out in exceptional circumstances, justified on the basis of significant patient benefit, where the validation protocol is executed concurrently with commercialization of the validation batches.
20.Continuous process verificationAn alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated.
21.Ongoing Process Verification / continued process verification).Documented evidence that the process remains in a state of control during commercial manufacture.
22.Critical process parameter (CPP)A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality
23.Critical quality attribute (CQA)A physical, chemical, biological or microbiological property or characteristic that should be within an approved limit, range or distribution to ensure the desired product quality.
24.Design qualification (DQ)The documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose.
25.Design SpaceThe multidimensional combination and interaction of input variables, e.g. material attributes, and process parameters that have been demonstrated to provide assurance of quality. Working within the design space is not considered as a change.

Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval.

26.Installation Qualification (IQ)The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations.
27.Operational Qualification (OQ)The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.
28.Performance Qualification (PQ)The documented verification that systems and equipment can perform effectively and reproducibly based on the approved process method and product specification.
29.LifecycleAll phases in the life of a product, equipment or facility from initial development or use through to discontinuation of use.
30.Process ValidationThe documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.
31.Product realisationAchievement of a product with the quality attributes to meet the needs of patients, health care professionals and regulatory authorities and internal customer requirements.
32.Prospective ValidationValidation carried out before routine production of products intended for sale.
33.Quality by designA systematic approach that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management.
34.Quality risk managementA systematic process for the assessment, control, communication and review of risks to quality across the lifecycle.
35.State of controlA condition in which the set of controls consistently provides assurance of acceptable process performance and product quality.
36.User requirements Specification (URS)The set of owner, user and engineering requirements necessary and sufficient to create a feasible design meeting the intended purpose of the system.