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Annual Review – An evaluation, conducted at least annually, that assesses the quality standards

of each drug product to determine the need for changes in drug product specifications or
manufacturing or control procedures
CAPA – Corrective and preventive action: A systematic approach that includes actions needed to
correct (“correction”), prevent recurrence (“corrective action”), and eliminate the cause of
potential nonconforming product and other quality problems (preventive action) (21CFR
Continual Improvement – Ongoing activities to evaluate and positively change products,
processes, and the quality system to increase effectiveness
Correction – Repair, rework, or adjustment relating to the disposition of an existing discrepancy
Corrective Action – Action taken to eliminate the causes of an existing discrepancy or other
undesirable situation to prevent recurrence
Customer – A person or organization (internal or external) that receives a product or service
anywhere along the product’s life cycle
Discrepancy – Datum or result outside of the expected range; an unfulfilled requirement; may be
called non-conformity, defect, deviation, out-of-specification, out-of-limit, out-of-trend
Harm – Damage to health, including the damage that can occur from the loss of product quality
or availability
Non-conformity – A deficiency in a characteristic, product specification, process parameter,
record, or procedure that renders the quality of a product unacceptable, indeterminate, or not
according to specified requirements
Preventive Action – Action taken to eliminate the cause of a potential discrepancy or other
undesirable situation to prevent such an occurrence
Product/Service – The intended results of activities or processes; products/services can be
tangible or intangible
Quality – A measure of a product or service’s ability to satisfy the customer’s stated or implied
Quality Assurance – Proactive and retrospective activities that provide confidence that
requirements are fulfilled
Quality Control – The steps taken during the generation of a product or service to ensure that it
meets requirements and that the product or service is reproducible
Quality Management – Accountability for the successful implementation of the quality system
Quality Objectives – Specific measurable activities or processes to meet the intentions and
directions as defined in the quality policy
Quality Plan – The documented result of quality planning that is disseminated to all relevant
levels of the organization

which has been appropriately evaluated for safety and is included in a drug delivery system to: — aid in the processing of the drug delivery system during its manufacture. 3rd edition. that specified requirements have been fulfilled. mitigation. or to affect the structure and function of the body. Cross-contamination . The process consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.P. www. controlling.pharmatechbd. results.The undesired introduction of impurities of a chemical or microbiological nature. packaging or repackaging. when used in the production of a drug. (Reference: The ASQ Auditing . Risk Management – The systematic application of quality management policies. and practices to the tasks of assessing. procedures.Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that. support or enhance stability. Quality System – Formalized business practices that define management responsibilities for organizational structure. intermediate product or finished product with another starting material or product during production. or of foreign matter. method or system will consistently produce to the required specification in accordance with accepted standards of cGMP. communicating. — protect. J. Russell. cure. and metrics of the quality system framework or business process improvements Verification – Confirmation. through the provision of objective evidence. other than the active ingredient.blogspot. or patient acceptability. Contamination . Active pharmaceutical ingredient (API) . Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis. Excipient.A substance. and Editor) Validation – Validation is a documented evidence which provides a high degree of assurance that a specific process. becomes an active ingredient of that drug. and reviewing risk Senior Management – Top management officials in a firm who have the authority and responsibility to mobilize resources Stakeholder – An individual or organization having an ownership or interest in the delivery.Contamination of a starting material. or intermediate or finished product during production. bioavailability. storage or transport.Quality Planning – A management activity that sets quality objectives and defines the operational and/or quality system processes and the resources needed to fulfill the objectives Quality Policy – A statement of intentions and direction issued by the highest level of the organization related to satisfying customer needs. treatment or prevention of disease. ASQ Quality Audit Division. customer satisfaction. sampling. and resources needed to fulfill product/service requirements. procedures. It is similar to a strategic direction that communicates quality expectations that the organization is striving to achieve. processes. into or onto a starting material. and continual improvement Quality Unit – A group organized within an organization to promote quality in general practice Risk – The combination of the probability of occurrence of harm and the severity of that harm Risk Assessment – A systematic process for organizing information to support a risk decision that is made within a risk management process.

or the values represented by a material measure. Calibration (new) The set of operations that establish. followed by line clearance and application of the label.A person providing pharmaceutical products and materials on request. employed in the packaging of a pharmaceutical product. labelling and relabelling. Retest date . weight. recording.Any material. storage and distribution of finished products. Pharmaceutical product . Packaging material . Manufacture . Material . Supplier . intermediates. Computer validation www. quality control.The action involving the selection of the correct label.A general term used to denote starting materials (active pharmaceutical ingredients and excipients). if stored correctly.g. production. reagents.All operations involved in the preparation of a pharmaceutical product. Expiry date .The storing of pharmaceutical products and materials up to their point of use.— assist in product identification.The date given on the individual container (usually on the label) of a drug product up to and including which the product is expected to remain within specifications. It is established for each batch by adding the shelf-life to the date of manufacture. Storage .com . packaging and repackaging. pH) used in a manufacturing process or analytical procedure (in production or quality control) gives measurements that are correct within established limits. Calibration (old) The performance of tests and retests to ensure that measuring equipment (e. Labelling . to completion of the finished product. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product. distributors. including printed material. solvents. and the corresponding known values of a reference standard. under specified conditions. Production .pharmatechbd. the relationship between values indicated by an instrument or system for measuring (especially weighing). Where possible. and controlling. from receipt of materials.The date when a material should be re-examined to ensure that it is still suitable for use.blogspot. but excluding any outer packaging used for transportation or shipment. and the related controls. brokers. that is subject to control by pharmaceutical legislation in both the exporting state and the importing state. with the required information. for temperature. or — enhance any other attribute of the overall safety and effectiveness of the drug during storage or use. release. suppliers should be authorized by a competent authority. manufacturers or traders. process aids. packaging materials and labelling materials.Any medicine intended for human use or veterinary product administered to food-producing animals.All operations of purchase of materials and products. presented in its finished dosage form or as a starting material for use in such a dosage form. Limits for acceptance of the results of measuring should be established. Suppliers may be agents. through processing.

pharmatechbd. cost-effective . Working document QAS/03.e. Performance Qualification (PQ) PQ is the documentary evidence. Qualification (new) www.blogspot. dosing. Operational Qualification (OQ)(new) Documented verification that the system or subsystem performs as intended over all anticipated operating ranges. Installation Qualification (IQ)(new) The performance of tests to ensure that the installations (such as machines. which is broken down into individual steps. batch size. predetermined specifications. equipment and processes have been designed in accordance with the requirements of GMP. Good Engineering Practices Established engineering methods and standards that are applied throughout the project lifecycle to deliver appropriate. utilities. (The term “process validation” may also be used.Documented evidence. these are then evaluated on the basis of past experience to determine whether they may lead to critical situations. supporting utilities. which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.2 Operational Qualification (OQ)(old) OQ is the documentary evidence to verify that the equipment operates in accordance with its design specifications in its normal operating range and performs as intended throughout all anticipated operating ranges. which verifies that the equipment or system operates consistently and gives reproducibility within defined specifications and parameters for prolonged periods. Cleaning validation Documented evidence to ensure that cleaning procedures are removing residues to predetermined levels of acceptability. manufacturing areas) used in a manufacturing process are appropriately selected and correctly installed and operate in accordance with established specifications. equipment size. Installation Qualification (IQ)(old) IQ is the documentary evidence to verify that the equipment has been built and installed in compliance with design specifications. etc. which provides a high degree of assurance that a computerized system records data correctly and that data processing complies with. Design Qualification (DQ) Documented evidence that the premises.) Process validation (See Validation) Documented evidence. Prospective validation Validation carried out during the development stage by means of a risk analysis of the production process.055/Rev. toxicology. measuring devices. Concurrent validation Validation carried out during routine production of products intended for sale. taking into consideration i.

whether intentional or unintentional. Revalidation (old) Involves the repeat of the initial process validation to provide assurance that changes in the process and/or in the process environment. www. production equipment and decision points on what constitutes acceptable test results. but the individual qualification steps alone do not constitute process validation. Validation Report (VR)(old) The VR is a written report on the validation activities. It provides information on the manufacturer’s validation work programmed and defines details of and time-scales for the validation work to be performed. Validation (new) Validation is a documented evidence which provides a high degree of assurance that a specific process. Validation Protocol (VP)(old) The VP is a written plan stating how validation will be conducted. It may also contain proposals for the improvement of processes and/or equipment. Validation Master Plan (VMP) VMP is a high level document that establishes an umbrella validation plan for the entire project and summarizes the manufacturer’s overall philosophy and approach.blogspot.055/Rev. procedures. Retrospective validation Involves the examination of past experience of production on the assumption that composition. validation. product characteristics. Revalidation (new) Repeated validation of an approved process (or a part thereof) to ensure continued compliance with established requirements. results and evaluation of a completed validation programmed is assembled.or a part thereof .for routine use. Validation Report (VR)(new) A document in which the records. including stating the responsibilities relating to the plan. Qualification is often a part (Initial stage) of Validation. including test parameters. do not adversely affect process characteristics and product quality. and/or work correctly and lead to the expected . equipment Working document QAS/03. and equipment remain unchanged. maintenance and cleaning. method or system will consistently produce to the required specification in accordance with accepted standards of cGMP. Certain SOPs may be used to supplement product-specific master and batch production documentation.Action of proving and documenting that any premises.g. Validation Protocol (or plan) (VP)(new) A document describing the activities to be performed in a validation. the validation data and the conclusions drawn. Standard operating procedure (SOP) An authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material but of a more general nature [new] (e. cleaning of premises and environmental control. sampling and inspection). including the acceptance criteria for the approval of a manufacturing process .2 operation.pharmatechbd. systems and equipment are properly installed. to be used for establishing performance adequacy.

Aseptic Processing RoomA room in which one or more aseptic activities or processes is performed. which pose the greatest chance of product or process failure when compared to ideal conditions. tests and other evaluations. to determine compliance with the GMP principles. this term is synonymous with “aseptic processing facility” as used in the segregated segment context.pharmatechbd. in addition to monitoring. Aseptic Manufacturing AreaThe classified part of a facility that includes the aseptic processing room and ancillary clean rooms. materials. and equipment are regulated to control microbial and particle contamination. The intent of an aseptic processing airlock is to preclude ingress of particulate matter and microorganism contamination from a lesser-controlled . Air lockA small room with interlocked doors. constructed to maintain air pressure control between adjoining rooms (generally with different air cleanliness standards). The challenge microorganism is selected based upon www. Such conditions do not necessarily include product or process failure. Alert levels are always lower than action levels.. should trigger appropriate investigation and corrective action based on the investigation. within SOPs. procedures. Biological Indicator (BI)A population of microorganisms inoculated onto a suitable medium (e. BioburdenThe total number of microorganisms associated with a specific item prior to sterilization. Action LevelAn established microbial or airborne particle level that.Verification The application of methods. or segregated segment of it. For purposes of this document. Aseptic Processing FacilityA building. Worst case A condition or set of conditions encompassing upper and lower processing limits and circumstances.g. when exceeded. BarrierA physical partition that affords aseptic processing area (ISO 5) protection by partially separating it from the surrounding area. Alert LevelAn established microbial or airborne particle level giving early warning of potential drift from normal operating conditions and triggers appropriate scrutiny and follow-up to address the potential problem.blogspot. AsepsisA state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product. solution. containing clean rooms in which air supply. container or closure) and placed within appropriate sterilizer load locations to determine the sterilization cycle efficacy of a physical or chemical process.

closures. Clean ZoneSee Clean Area. DepyrogenationA process used to destroy or remove pyrogens (e.. Clean AreaAn area with defined particle and microbiological cleanliness standards. DecontaminationA process that eliminates viable Bioburden via use of sporicidal chemical agents. ComponentAny ingredient intended for use in the manufacture of a drug product.pharmatechbd. Endotoxin can lead to reactions in patients receiving injections ranging from fever to death. endotoxin). and sterility is maintained throughout processing. and controlled to prevent particle and microbiological contamination of drug products. maintained. including those that may not appear in the final drug product.A Pyrogenic product (e. and equipment may be exposed in critical areas. Sterilized product.g. Endotoxin. while others possess additional capability to effectively kill bacterial and fungal spores. Critical Area – An area designed to maintain sterility of sterile materials. Some Disinfection agents are effective only against vegetative microbes. Clean room- A room designed. DisinfectionProcess by which surface Bioburden is reduced to a safe level or eliminated. DynamicConditions relating to clean area classification under conditions of normal production. . Critical surfaces are rendered sterile prior to the start of the manufacturing operation. Critical surfacesSurfaces that may come into contact with or directly affect a sterilized product or its containers or closures. lipopolysaccharide) present in the bacterial cell wall.g. One colonyforming unit is expressed as 1 CFU. Incoming lot D-value and microbiological count define the quality of the BI..its resistance to the given process. www. Colony Forming Unit (CFU)A microbiological term that describes the formation of a single macroscopic colony after the introduction of one or more microorganisms to microbiological growth media. Such a room is assigned and reproducibly meets an appropriate air cleanliness classification. D valueThe time (in minutes) of exposure at a given temperature that causes a one-log or 90 percent reduction in the population of a specific microorganism.blogspot.

.97 percent. when appropriately validated.g.A process that is sufficient to provide at least a 12 log reduction of microorganisms having a minimum D value of 1 minute. Sterilizing grade filterA filter that. surrounding cleanroom air and personnel). filler.. rather than use of openings to the surrounding environment.blogspot. supplied with Class 100 (ISO 5) or higher air quality. There are two major types of isolators: Closed isolator systems exclude external contamination from the isolator’s interior by accomplishing material transfer via aseptic connection to auxiliary equipment.A decontaminated unit. Closed systems remain sealed throughout operations. the capability of an individual to don the complete sterile gown in an aseptic manner. HVACHeating. producing a sterile effluent. Open isolator systems are designed to allow for the continuous or semi-continuous ingress and/or egress of materials during operations through one or more openings. sterile product refers to one or more of the elements exposed to aseptic conditions and ultimately making up the sterile finished drug product. These elements include the containers.Any individual participating in the aseptic processing operation.pharmatechbd. including line set-up. and components of the finished drug product. and at sufficient speed to reproducibly sweep particles away from the critical processing or testing area. InterventionAn aseptic manipulation or activity that occurs at the critical area. Unidirectional flowAn airflow moving in a single direction.g. Operator. continuous isolation of its interior from the external environment (e. using continuous overpressure) to exclude the entry of external contamination into the isolator. that provides uncompromised.Gowning Qualification. Laminar flowAn airflow moving in a single direction and in parallel layers at constant velocity from the beginning to the end of a straight-line vector. or other personnel associated with aseptic line activities. in a robust and uniform manner. Terminal sterilizationwww. Quality Control UnitAn organizational element with authority and responsibility as defined by 211.A program that . and air conditioning. Sterile Product. maintenance. HEPA filterHigh efficiency particulate air filters with minimum 0. both initially and on a periodic basis. ventilation. PyrogensA substance that induces a febrile reaction in a patient. Isolator. Openings are engineered (e.3 µm particle retaining efficiency of 99. closures. Overkill sterilization process.22.For purposes of this guidance. will remove all microorganisms from a fluid stream.

or Validation is a documented evidence which provides a high degree of assurance that a specific process. finished drug products for the purpose of achieving a predetermined sterility assurance level (SAL) of usually less than 10-6 (i.e.. 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. a probability of a no sterile unit of greater than one in a million).pharmatechbd. ULPA filterUltra-low penetration air filter with minimum 0. method or system will consistently produce to the required specification in accordance with accepted standards of cGMP.blogspot. www.999 percent.3 µm particle retaining efficiency of 99.The application of a lethal agent to .