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    1.     
      GMP知識

      Glossary, Acronyms and General words for Pharmaceutical Industry

      Version: 00, Date: March 7, 2019

      Note:

      Glossary, Acronyms and General words are collected and collated from WHO, EU GMP, ISO14644, ISPE, FDA, ICH, PIC/S. And will be updated periodically by Foshan RuiTong Consulting Co.,Ltd.

       


      Table of Contents

       


      1.  Glossary. PAGEREF _Toc2853244 \h 3

      2.  Abbreviations & acronyms. PAGEREF _Toc2853245 \h 34

      3.  General words for water system.. PAGEREF _Toc2853246 \h 39

      4.  General words for QC Laboratory  PAGEREF _Toc2853247 \h 41

      5.  General words for HVAC system.. PAGEREF _Toc2853248 \h 44




      1.  Glossary

      accelerated testing

      Studies designed to increase the rate of chemical degradation and physical change of an active pharmaceutical ingredient or finished pharmaceutical product by using exaggerated storage conditions as part of the stability testing programme. The data thus obtained, in addition to those derived from long-term stability studies, may be used to assess longer-term chemical effects under non-accelerated conditions and to evaluate the impact of short-term excursions outside the label storage conditions, as might occur during shipping. The results of accelerated testing studies are not always predictive of physical changes.


      acceptance criteria

      Measurable terms under which a test result will be considered acceptable. (WHO)


      Numerical limits, ranges, or other suitable measures for acceptance of test results. (ICH)


      The criteria that a system, component1 must satisfy in order to be accepted by a user, customer or other authorized entity. (GAMP 5)


      accuracy

      The degree of agreement of test results with the true value or the closeness of the results obtained by the procedure to the true value (1)

      Note: It is normally established on samples of the material to be examined that have been prepared to quantitative accuracy. Accuracy should be established across the speci?ed range of the analytical procedure. It is generally acceptable to use a “spiked” placebo which contains a known quantity or concentration of a reference substance.


      action limit

      The action limit is reached when the acceptance criteria of a critical parameter have been exceeded. Results outside these limits will require speci?ed action and investigation.


      active pharmaceutical ingredient (API)

      Any substance or mixture of substances intended to be used in the manufacture of a ?nished pharmaceutical product (FPP) and that, when used in the production of a pharmaceutical product, becomes an active ingredient of the pharmaceutical product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body.


      active pharmaceutical ingredient (API) starting material

      A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API starting material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house.


      active pharmaceutical ingredient master file (APIMF) procedure

      The APIMF procedure is one of four ways to provide information on the preparation control and stability of an API intended for use in a prequalified finished pharmaceutical product (FPP). The other three options are: the use of a prequalified API; use of a certificate of suitability (known as a CEP) issued by the European Directorate for the Quality of Medicines; or the submission of complete API information as part of the FPP dossier.


      air changes per hour (ACPH)

      The volume of air supplied to a room, in m3/hr, divided by the room volume, in m3


      air-handling unit (AHU)

      The air-handling unit serves to condition the air and provide the required air movement within a facility.


      airlock

      An enclosed space with two or more doors, which is interposed between two or more rooms, e.g. of differing classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need to be entered. An airlock is designed for use either by people or for goods and/or equipment. (PAL, personnel airlock; MAL, material airlock).


      alert limit

      The alert limit is reached when the normal operating range of a critical parameter has been exceeded, indicating that corrective measures may need to be taken to prevent the action limit being reached.


      as-built

      Condition where the installation is complete with all services connected and functioning but with no production equipment, materials or personnel present.


      at-rest

      Condition where the installation is complete with equipment installed and operating in a manner agreed upon by the customer and supplier, but with no personnel present.


      applicant

      The person or entity who, by the deadline mentioned in the invitation, submits an expression  of interest (EOI) to participate in this procedure in respect of the product(s) listed in the invitation, together with the required documentation on such product(s).


      authorized person

      The person recognized by the national regulatory authority as having the responsibility for ensuring that each batch of finished product has been manufactured, tested and approved for release in compliance with the laws and regulations in force in that country.


      audit trail

      The audit trail is a form of metadata that contains information associated with actions that relate to the creation, modification or deletion of GXP records. An audit trail provides for secure recording of life-cycle details such as creation, additions, deletions or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record. An audit trail facilitates the reconstruction of the history of such events relating to the record regardless of its medium, including the “who, what, when and why” of the action.

      For example, in a paper record, an audit trail of a change would be documented via a single-line cross-out that allows the original entry to remain legible and documents the initials of the person making the change, the date of the change and the reason for the change, as required to substantiate and justify the change. In electronic records, secure, computer-generated, time-stamped audit trails should allow for reconstruction of the course of events relating to the creation, modification and deletion of electronic data. Computer-generated audit trails should retain the original entry and document the user identification, the time/date stamp of the action, as well as the reason for the change, as required to substantiate and justify the action. Computer-generated audit trails may include discrete event logs, history files, database queries or reports or other mechanisms that display events related to the computerized system, specific electronic records or specific data contained within the record.


      backup

      A backup means a copy of one or more electronic files created as an alternative in case the original data or system are lost or become unusable (for example, in the event of a system crash or corruption of a disk). It is

      important to note that backup differs from archival in that back-up copies of electronic records are typically only temporarily stored for the purposes of disaster recovery and may be periodically overwritten. Such temporary back-up copies should not be relied upon as an archival mechanism.


      batch (or lot)

      A defined quantity of starting material, packaging material, or product processed in a single process or series of processes so that it is expected to be homogeneous. It may sometimes 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 terminal sterilization, the batch size is determined by the capacity of the autoclave. In continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity. The batch size can be defined either as a fixed quantity or as the amount produced in a fixed time interval.


      batch number (or lot number)

      A distinctive combination of numbers and/or letters which uniquely identi?es a batch on the labels, its batch records and corresponding certi?cates of analysis, etc.


      batch records

      All documents associated with the manufacture of a batch of bulk product or ?nished product. They provide a history of each batch of product and of all circumstances pertinent to the quality of the ?nal product.


      barrier technology

      A system designed to segregate people from the product, contain contaminants or segregate two areas, which could be a barrier isolator (BI) or a restricted access barrier system (RABS):

      A BI is a unit supplied with high-ef?ciency particulate air (HEPA) ?ltered air that provides uncompromised continuous isolation of its interior from the external environment, including surrounding clean room air and personnel.

      A RABS is a type of barrier system that reduces or eliminates interventions into the critical zone. In practice, its level of contamination control is less than that of a barrier isolator.


      bioavailability

      The rate and extent to which the active moiety is absorbed from a pharmaceutical dosage form and becomes available at the site(s) of action. Reliable measurements of active pharmaceutical ingredient (API) concentrations at the site(s) of action are usually not possible. The substance in the systemic circulation, however, is considered to be in equilibrium with the substance at the site(s) of action. Bioavailability can therefore be defined as the rate and extent to which the API or active moiety is absorbed from a pharmaceutical dosage form and becomes available in the systemic circulation. Based on pharmacokinetic and clinical considerations it is generally accepted that in the same subject an essentially similar plasma concentration time-course will result in an essentially similar concentration time-course at the site(s) of action.


      biobatch

      The batch used to establish bioequivalence or similarity to the comparator product as determined in bioequivalence or biowaiver studies, respectively.


      bioburden

      The level and type (objectionable or not) of microorganisms present in raw materials, media, biological substances, intermediates or finished products. Regarded as contamination when the level and/or type exceed specifications.


      bioequivalence

      Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives, and their bioavailabilities, in terms of rate (Cmax and tmax) and extent of absorption (area under the curve), after administration of the same molar dose under the same conditions, are similar to such a degree that their effects can be expected to be essentially the same.


      bioequivalence test

      A test that determines the equivalence between the multisource product and the comparator product using in vivo and/or in vitro approaches.


      biogenerator

      A contained system, such as a fermenter, into which biological agents are introduced along with other materials so as to effect their multiplication or their production of other substances by reaction with the other materials. Biogenerators are generally fitted with devices for regulation, control, connection, material addition and material withdrawal.


      Biological agents

      Micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not.


      Biopharmaceutics Classification System (BCS)

      The BCS is a scientific framework for classifying active pharmaceutical ingredients based upon their aqueous solubility and intestinal permeability. When combined with the dissolution of the pharmaceutical product, the BCS takes into account three major factors that govern the rate and extent of drug absorption (exposure) from immediate-release oral solid dosage forms: dissolution, solubility and intestinal permeability.


      Biopharmaceutics Classification System (BCS) highly soluble

      An active pharmaceutical ingredient (API) for which the highest dose recommended by WHO (if the API appears on the WHO Model List of essential medicines (EML)) or highest dose strength available on the market as an oral solid dosage form (if the API does not appear on the EML) is soluble in 250 ml or less of aqueous media over the Ph range of 1.2–6.8 at 37 °C (8).


      Biosafety level (BSL)

      The containment conditions required to safely handle organisms of different hazards ranging from BSL1 (lowest risk, unlikely to cause human disease) to BSL4 (highest risk, cause severe disease, likely to spread and no effective prophylaxis or treatment available).


      biowaiver

      The term biowaiver is applied to a regulatory drug approval process when the efficacy and safety part of the dossier (application) is approved based on evidence of equivalence other than through in vivo equivalence testing.


      blister

      A multi-dose container consisting of two layers, of which one is shaped to contain the individual doses. Strips are excluded.


      bulk product

      Any pharmaceutical product that has completed all processing stages up to, but not including, final packaging.


      calibration

      The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (especially weighing), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard. Limits for acceptance of the results of measuring should be established.


      calibration of equipment

      The documented act of proving that the equipment is performing to predefined tolerances or criteria.


      Cell bank

      Cell bank system: A cell bank system is a system whereby successive batches of a product are manufactured by culture in cells derived from the same master cell bank. A number of containers from the master cell bank are used to prepare a working cell bank. The cell bank system is validated for a passage level or number of population doublings beyond that achieved during routine production.

      Master cell bank: A culture of [fully characterised] cells distributed into containers in a single operation, processed together in such a manner as to ensure uniformity and stored in such a manner as to ensure stability. A master cell bank is usually stored at - 70°C or lower.

      Working cell bank: A culture of cells derived from the master cell bank and intended for use in the preparation of production cell cultures. The working cell bank is usually stored at - 70°C or lower.


      certificate of a pharmaceutical starting material

      A document containing the information that is validated and issued for a specific starting material by the competent authority of the exporting country and intended for use by the competent authority in the importing country or in the absence of such an authority by, for example, the manufacturer of the finished product when exporting.


      certificate of analysis

      The list of test procedures applied to a particular sample with the results obtained and the acceptance criteria applied. It indicates whether or not the sample complies with the specification.


      change control

      A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated status. The intent is to determine the need for action that would ensure that the system is maintained in a validated state.


      chemical reference substance

      The term chemical reference substance, as used in this text, refers to an authenticated, uniform material that is intended for use in speci?ed chemical and physical tests, in which its properties are compared with those of the product under examination, and which possesses a degree of purity adequate for its intended use.


      clean area

      An area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation, and retention of contaminants within the area.


      clean room

      A room or area with de?ned environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation and retention of contaminants within the area.


      cleaning validation

      Documented evidence to establish that cleaning procedures are removing residues to predetermined levels of acceptability, taking into con-sideration factors such as batch size, dosing, toxicology and equipment size.(WHO)


      Cleaning 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.


      climatic zone

      The zones into which the world is divided based on the prevailing annual climatic conditions


      clinical trial

      Any systematic study on pharmaceutical products in human subjects, whether in patients or other volunteers, in order to discover or verify the effects of, and/or identify any adverse reaction to, investigational products, and/or to study the absorption, distribution, metabolism and excretion of the products with the object of ascertaining their efficacy and safety. Clinical trials are generally divided into Phases I–IV. It is not possible to draw clear distinctions between these phases, and different opinions about details and methodology do exist. However, the individual phases, based on their purposes as related to the clinical development of pharmaceutical products, can be briefly defined as follows:

      Phase I. These are the first trials of a new active ingredient or new formulations in humans, often carried out in healthy volunteers. Their purpose is to make a preliminary evaluation of safety, and an initial pharmacokinetic/ pharmacodynamic profile of the active ingredient.

      Phase II. The purpose of these therapeutic pilot studies is to determine activity and to assess the short-term safety of the active ingredient in patients suffering from a disease or condition for which it is intended. The trials are preformed in a limited number of subjects and are often, at a later stage, of a comparative (e.g. placebo-controlled) design. This phase is also concerned with the determination of appropriate dose ranges/regimens and (if possible) the clarification of dose–response relationships in order to provide an optimal background for the design of extensive therapeutic trials.

      Phase III. This phase involves trials in large (and possibly varied) patient groups for the purpose of determining the short- and long-term safety-efficacy balance of formulation(s) of the active ingredient, and assessing its overall and relative therapeutic value. The pattern and profile of any frequent adverse reactions must be investigated, and special features of the product must be explored (e.g. clinically relevant drug interactions, factors leading to differences in effect, such as age). The trials should preferably be randomized double-blind, but other designs may be acceptable, e.g. long-term safety studies. In general, the conditions under which the trials are conducted should be as close as possible to the normal conditions of use.

      Phase IV. In this phase studies are performed after the pharmaceutical product has been marketed. They are based on the product characteristics on which the marketing authorization was granted and normally take the form of post-marketing surveillance, and assessment of therapeutic value or treatment strategies. Although methods may differ, the same scientific and ethical standards should apply to Phase IV studies as are applied in premarketing studies. After a product has been placed on the market, clinical trials designed to explore new indications, new methods of administration or new combinations, etc., are normally regarded as trials of new pharmaceutical products.


      collaborative procedure

      Procedure for collaboration between the World Health Organization (WHO) Prequalification Team (WHO/PQT) and interested national regulatory authorities (NRAs) in the assessment and accelerated national registration of WHO prequalified pharmaceutical products and vaccines.


      commissioning

      Commissioning is the documented process of verifying that the equipment and systems are installed according to speci?cations, placing the equipment into active service and verifying its proper action. Commissioning takes place at the conclusion of project construction but prior to validation.


      comparator

      The finished pharmaceutical product with which a fixed-dose combination finished pharmaceutical product (FPP) is to be compared. The comparison may be by means of bioequivalence studies or clinical studies of safety and/or effectiveness. A single study may use more than one comparator, for example several single entity FPPs. A comparator may be a placebo.


      comparator product

      The comparator product is a pharmaceutical product with which the multisource product is intended to be interchangeable in clinical practice. The comparator product will normally be the innovator product for which efficacy, safety and quality have been established. If the innovator product is no longer marketed in the jurisdiction, the selection principle as described in Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products (WHO Technical Report Series, No. 992, Annex 8 (2015)) should be used to identify a suitable alternative comparator product.


      computer system

      A group of hardware components and associated software, designed and assembled to perform a speci?c function or group of functions.


      computerized system

      A computerized system collectively controls the performance of one or more automated processes and/or functions. It includes computer hardware, software, peripheral devices, networks and documentation, e.g. manuals and standard operating procedures, as well as the personnel interfacing with the hardware and software, e.g. users and information technology support personnel. (WHO)


      A system including the input of data, electronic processing and the output of information to be used either for reporting or automatic control. (EU GMP)


      concurrent validation

      Validation carried out during routine production of products intended for sale. (WHO)


      Validation carried out in exceptional circumstances, justified on the basis of significant patient benefit, where the validation protocol is executed concurrently with commercialisation of the validation batches. (EU GMP)


      containment

      The action of confining a biological agent or other entity within a defined space.

      Primary containment: A system of containment which prevents the escape of a biological agent into the immediate working environment. It involves the use of closed containers or safety biological cabinets along with secure operating procedures.

      Secondary containment: A system of containment which prevents the escape of a biological agent into the external environment or into other working areas. It involves the use of rooms with specially designed air handling, the existence of airlocks and/or sterilisers for the exit of materials and secure operating procedures. In many cases it may add to the effectiveness of primary containment.


      Contained area

      An area constructed and operated in such a manner (and equipped with appropriate air handling and filtration) so as to prevent contamination of the external environment by biological agents from within the area.


      contamination

      The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or on to a starting material or intermediate during production, sampling, packaging or repackaging, storage

      or transport.


      container-closure system

      The sum of packaging components that together contains and protects the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the finished pharmaceutical product. A packaging system is equivalent to a container-closure system.


      contract manufacturer

      A manufacturer performing some aspect of manufacturing on behalf of the original manufacturer.


      controlled area

      An area within the facility in which speci?c environmental facility conditions and procedures are de?ned, controlled, and monitored to prevent degradation or cross-contamination of the product. (WHO)


      An area constructed and operated in such a manner that some attempt is made to control the introduction of potential contamination (an air supply approximating to grade D may be appropriate), and the consequences of accidental release of living organisms. The level of control exercised should reflect the nature of the organism employed in the process. At a minimum, the area should be maintained at a pressure negative to the immediate external environment and allow for the efficient removal of small quantities of airborne contaminants. (EU GMP)


      critical quality attribute (CQA)

      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.


      cross-contamination

      Contamination of a starting material, intermediate product or finished product with another starting material or product during production.


      contract manufacturer

      A manufacturer performing some aspect of manufacturing on behalf of the original manufacturer.


      contract research organization (CRO)

      A scientific organization (commercial, academic or other) to which a sponsor may transfer some of its tasks and obligations. Any such transfer should be defined in writing. In the context of this guidance document, bioequivalence studies are often contracted by the sponsor to a CRO, which will perform some of the tasks of the sponsor, but which will also perform the trial. The investigator (clinical part of the study) and the study director (bioanalytical part of the study) are then employees of the CRO.


      contract research organization master file (CROMF)

      A CROMF is a document prepared by the CRO containing specific and factual information about the CRO, the conduct of clinical studies as well as the analyses of samples and related operations (including clinical trials, clinical data management, pharmacokinetics and statistical analysis, regulatory affairs, etc.) carried out at the named site. If only part of the operations referred to below is carried out at the site, the site master file needs to be presented only for those operations. 


      co-packaged product

      A product consisting of two or more separate pharmaceutical products in their final dosage form that are packaged together for distribution to patients in the co-packaging.


      correction

      Any action taken to eliminate a nonconformity. However, corrections do not address causes. When applied to pharmaceutical products, corrections can refer to reworking, reprocessing, or regrading of products, or assigning them to a different use, or simply destroying them.


      corrective action

      Corrective actions are steps that are taken to eliminate the causes of existing nonconformities in order to prevent recurrence. The corrective action process tries to make sure that existing nonconformities and potentially undesirable situations do not happen again. While corrective actions prevent recurrence, preventive actions prevent occurrence. Both types of actions are intended to prevent nonconformities.


      corrective and preventive action (CAPA, also sometimes called corrective action/preventive action)

      Refers to the actions taken to improve an organization's processes and to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept common across the GXPs (good laboratory practices, good clinical practices and good manufacturing practices), and numerous International Organization for Standardization business standards. The process focuses on the systematic investigation of the root causes of identified problems or identified risks in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).


      counterfeit pharmaceutical product

      A pharmaceutical product which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products, and counterfeit pharmaceutical products may include products with the correct ingredients, with the wrong ingredients, without active ingredients, with an incorrect quantity of active ingredient or with fake packaging.


      critical observation

      A critical observation observed by the WHO inspection group during inspection of a contract research organization, manufacturing site or quality control laboratory indicates that it considers that the product as manufactured risks causing harm to the user.


      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. (ICH Q8)


      Cross contamination

      Contamination of a material or of a product with another material or product.


      Cryogenic vessel

      A container designed to contain liquefied gas at extremely low temperature.


      Cylinder

      A container designed to contain gas at a high pressure..


      data integrity

      Data integrity is the degree to which data are complete, consistent, accurate, trustworthy and reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, such that they are attributable, legible, contemporaneously recorded, original or a true copy and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.


      date of manufacture

      A date fixed for the individual batch, indicating the completion date of the manufacture. It is normally expressed by a month and a year. The date of the release analysis may be taken as a date of manufacture, provided that the period between the beginning of production and the release of the product is not longer than one-twentieth of the shelf life.


      deviation

      Departure from an approved instruction or established standard.


      design quali?cation (DQ)

      Design quali?cation is the documented check of planning documents and technical speci?cations for conformity of the design with the process, manufacturing, GMP and regulatory requirements. (WHO)


      Documented evidence that the premises, supporting systems, utilities, equipment and processes have been designed in accordance with the requirements of GMP. (WHO)


      The documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose. (EU GMP)


      dosage form

      The form of the completed pharmaceutical product, e.g. tablet, capsule, elixir, injection, suppository.


      drug

      Any substance or pharmaceutical product for human or veterinary use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient. The terms drug, medicine and pharmaceutical product are commonly used interchageably.


      drug master file

      Detailed information concerning a specific facility, process or product submitted to the medicines regulatory authority, intended for incorporation into the application for marketing authorization.


      environmental control system (ECS)

      Environmental control system, also referred to as heating, ventilation and air-conditioning (HVAC).


      essential pharmaceutical products

      Those pharmaceutical products that satisfy the health care needs of the majority of the population. WHO’s Expert Committee on the Selection and Use of Essential Medicines updates the WHO Model List of Essential Medicines at two-year intervals. Each country may use this model to generate its own list of essential pharmaceutical products.


      established multisource (generic) product

      A multisource product that has been marketed by the applicant or manufacturer associated with the dossier for at least five years and for which at least 10 production batches were produced over the previous year, or, if less than 10 batches were produced in the previous year, not less than 25 batches were produced in the previous three years.


      excipient

      A substance or compound, other than the active pharmaceutical ingredient and packaging materials, that is intended or designated to be used in the manufacture of a pharmaceutical product.


      expiry date

      The date after which a compounded preparation should not be stored, transported or used; the date is determined from the date or time the preparation is compounded. It is also known as beyond-use date.


      finished pharmaceutical product (FPP)

      A finished dosage form of a pharmaceutical product that has undergone all stages of manufacture, including packaging in its final container and labelling.


      fixed-dose combination (FDC)

      A combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio of doses. This term is used generically to mean a particular combination of APIs irrespective of the formulation or brand. It may be administered as singleentity products given concurrently or as a finished pharmaceutical product.


      generic product

      The term generic product has somewhat different meanings in different jurisdictions. The use of this term is therefore avoided as much as possible, and the term multisource pharmaceutical product (see below) is used instead. Generic products may be marketed either under the approved nonproprietary name or under a brand (proprietary) name. They may be marketed in dosage forms and/or strengths different from those of the innovator products (see below). Where the term generic product is used, it means a pharmaceutical product, usually intended to be interchangeable with the innovator product, which is usually manufactured without a license from the innovator company and marketed after expiry of the patent or other exclusivity rights. The term should not be confused with generic names for active pharmaceutical ingredients.


      good clinical practices (GCP)

      A standard for clinical studies which encompasses the design, conduct, monitoring, termination, audit, analysis, reporting and documentation of the studies and which ensures that the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical product (diagnostic, therapeutic or prophylactic) under investigation are properly documented.


      good documentation practices

      In the context of these guidelines, good documentation practices are those measures that collectively and individually ensure documentation, whether paper or electronic, is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate.


      good engineering practice (GEP)

      Established engineering methods and standards that are applied throughout the project life-cycle to deliver appropriate, cost-effective solutions


      good laboratory practices (GLP)

      A quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.


      good manufacturing practice (GMP)

      That part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.


      GXP

      Acronym for the group of good practice guides governing the preclinical, clinical, manufacturing, testing, storage, distribution and post-market activities for regulated pharmaceuticals, biologicals and medical devices, such as good laboratory practices, good clinical practices, good manufacturing practices, good pharmacovigilance practices and good distribution practices.


      heating, ventilation and air-conditioning (HVAC)

      Heating, ventilation and air-conditioning, also referred to as environmental control system (ECS).


      impermeable containers

      Containers that provide a permanent barrier to the passage of gases or solvents, e.g. sealed aluminium tubes for semisolids, sealed glass ampoules for solutions and aluminium/aluminium blisters for solid dosage forms


      impurity pro?le

      A description of the identi?ed and unidenti?ed impurities present in an API


      innovator pharmaceutical product

      Generally the pharmaceutical product which was first authorized for marketing (normally as a patented product) on the basis of documentation of efficacy, safety and quality according to requirements at the time of the authorization. When a substance has been available for many years, it may not be possible to identify an innovator pharmaceutical product.


      in-process control

      Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its specifications. The control of the environment or equipment may also be regarded as a part of in-process control.


      inspection observation

      An inspection observation is a finding or a statement of fact made during an inspection and substantiated by objective evidence. Such findings may be positive or negative. Positive observations should take the form of a description of the processes that the firm is carrying out particularly well and that may be considered examples of particularly good practice. Negative observations are findings of non-compliance with requirements.


      installation quali?cation (IQ)

      Installation quali?cation is documented veri?cation that the premises, HVAC system, supporting utilities and equipment have been built and installed in compliance with their approved design speci?cation. (WHO)


      The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer's recommendations. (EU GMP)



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