DEFINITIONS AS PER CGMP
Production/manufacturing:– All operations involved in obtaining a product from the receipt of materials through processing to packaging and labelling.
Quality Control Unit:- It is the department designated as responsible for the certification of quality of the manufactured product as per laid down specifications.
Manufacture/Processing/Packing or holding of drug Substance/drug product:- All operations, production, labelling and packing, testing, quality control, storage and distribution of product.
Active Pharmaceutical Ingredient (API):- Any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packing of a drug, becomes an active ingredient or a finished dosage form of the drug.
Drug Substance:- An active pharmaceuticals ingredient (API).
Drug Product:- A finished dosage form for example Tablet, Capsule or solution that contains an active pharmaceutical generally but not necessarily is association with inactive ingredients.
Active ingredients:- Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure mitigation, treatment or prevention of disease or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture or the drug product and be present in the drug product in a modified from intended to furnish the specified activity or effect.
Inactive ingredient:- Any component other than an active ingredient.
Packing Material:- Any material used to protect a product during storage and transport but excluding labels.
Reagent:- It is a substance other than a starting material, intermediate or solvent that is used in the manufacture of a new drug substance.
Mother Liquor:- The residual saturated liquid which remains after the crystallisation of a liquid. Mother liquor may contain undecorated products (i.e. unrelated starting materials, intermediates traces levels of the product and / or impurities).
Component:- It means any ingredient that is intended for use in the manufacture of a drug product including those that may not appear in such drug product.
Batch:- The 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.
Lot:- A batch or a specific identified portion of batch having uniform character and quality within specified limits or in the case of a drug product produced by continuous process. It is specific identified amount produced in a unit of time or quantity in a manner that assures it’s having uniform character and quality within specified limits.
Batch No. / Control No. / Lot No. / A.R. number:– The combination of letters and numbers or from which the complete history of the manufacture, processing, packing, holding and distribution of a batch drug substance can be traced.
Date of commencement of a batch for dosage form:- The date on which the raw material are dispensed for the batch manufacturing.
Date of completion for dosage form:– The date on which of the batch has been completed.
Specification:- A list of tests, references to analytical procedures and acceptance criteria (numerical limits, ranges or other criteria). It establishes the set of criteria to which a material conforms to be considered acceptable for its intended use.
Date of Manufacturing:- Month and year in which the raw material are dispensed for the batch manufacturing.
Expiry(or Expiration)Date:- The date placed on the container/labels of product designating the time during which the product is expected to remain within established shelf life specifications if stored under defined conditions, and after which it should not be used.
Retest Date:– The date when samples of the product should be re-examined to ensure that material is still suitable for further use.
Retest Period:- The period of time during which the API can be considered to remain within specifications, and therefore acceptable for use in the manufacture of a given drug product, provided that it has been stored under defined conditions. After this period, the batch should be retested for compliance with specifications and then used immediately.
Acceptance criteria:- The product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level with an associated sampling plan that is necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units).
Representative sample:- A sample that consists of a number of units that are drawn based on rational criteria such as random sampling and assures that the sample accurately portrays the material being sampled.
Process Control Parameter:- Those parameters and conditions that are associated with the manufacturing processes which have a potential for impact on the identity, strength, quality and purity of a product. Examples of parameters of concerns are process rates of flow, weights, volumes, temperature and pressure.
Critical:- A material, process step or process condition, test requirements or any other relevant parameter is considered to be critical when non-compliance with predetermined criteria directly influences the quality of the product in a detrimental manner.
In-process controls:- Testing and activities performed during production to monitor and if required adjust the process.
Quarantine:- The status of materials isolated physically or by other effective means pending a decision on their subsequent use.
Strength:- The concentration of the drug substance (for example, weight /weight, weight /volume, or unit dose /volume basis) and/or The potency, that is, the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard.
Theoretical yield:- The quantity that would be produced at any appropriate phase of manufacture, processing or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production.
Actual yield:– The quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product.
Percentage of theoretical yield:- The ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular drug product) to the theoretical yield (at same phase) stated as a percentage.
Worst Case:– A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, which pose the greatest chance of process or product failure when compared to ideal conditions. Such conditions do not necessarily include product or process failure.
Calibration:- A measuring device produces results within specified limits of those produced by a reference standard device over an appropriate range of measurements.
Alert level:- Quality levels or ranges that shows a potential difference from normal operating condition which require proper attention to the process to be in normal ranges / level.
Action level:– The quality level / range that when exceeded requires immediate following investigation and corrective action.
Environmental Control Parameter:- Those parameters and conditions that are associated with facilities and equipment utilised in the manufacturing process which have a potential for impacting on the identity, strength, quality and purity of a product. Among the parameters of concern are air flow rates and patterns, pressure differentials, materials and personnel flow, temperature and relative humidity as well as burdens of such foreign substances as non-viable and viable particulates.
Fibre:- Any particulate contaminant with a length at least three times greater than its width.
Non-fibre-releasing filter:- Any filter, which after pre-treatment such as washing or flushing will not release fibres into the component or drug substance that is being filtered.
Impurity:- Any component of the product which is not the chemical entity defined as the product.
Identified impurity:– An impurity for which a structural characterisation has been achieved.
Unidentified Impurity:- An impurity for which is defined solely by qualitative analytical properties (e.g. chromatographic retention time).
Impurity Profile:- A description of the identified and unidentified impurities present in the product.
Polymorphism:- The occurrence of different crystalline forms of the same product.
Enantiomers Compound:- They are the same molecular formula as the product, which differ in the special arrangement of atoms within the molecule and are non-super imposable mirror images.
Recovery:- Any treatment of materials by a process intended to make them suitable for further use.
Reprocessing:- Introducing an intermediate or product that does not confirm to standards or specifications, back into the process and repeating step(s) that are part of the established manufacturing process (e.g. recrystallising using the same solvent).
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 that would ensure and document that the system is maintained in a validated state.
Cleaning Validation:- It is a process, which ensures & provides the documented evidence that cleaning procedures of equipment are capable to remove the residues of drug up to the predetermined levels of acceptability and restrict the microbial growth so that it does not affect the quality and safety of next product manufactured in the same equipment.
In process Controls:- Checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms its specification. The control of the environment or equipment may also be regarded as a part of in-process control.
Reconciliation:- A comparison making due allowance for normal variation, between the amount of product or materials theoretically and actually produced or used.
Finished Product:- A medicinal product which has undergone all stages of production, including packaging in its final container.
Intermediate Product:- Partly processed material which must undergo further manufacturing steps before it becomes a bulk product.
Deviation:- Departure from an approved instruction or established standard.
Reference Standard, Primary:- A substance that has been shown by an extensive set of analytical tests to be authentic material that should be of high purity. This standard can be:
- obtained from an officially recognised source or
- Prepared by independent synthesis or
- Obtained from existing production material of high purity or
- Prepared by further purification of existing production material.
Reference Standard, Secondary:- A substance of established quality and purity, as shown by comparison to a reference standard, used as a reference standard for routine laboratory analysis.
Reworking:- Subjecting and intermediate or product that does not confirm to standards or specifications, to processing step(s) that are different from the established manufacturing process (e.g. recrystallising with a different solvent).
Protocol:- A scientific document which outlines the procedures to be followed the test acceptance criteria the process parameters and challenges to be used. The protocol should reflect the input and approval of production, quality assurance, as well as engineering.
Validation Protocol:- A written plan stating how validation will be conducted, included test parameters, product characteristics, production equipment and decision point on what constitutes acceptable test results. The protocol should reflect the input and approval of production, quality assurance, as well as engineering.
Qualification:- The action of proving that any equipment works correctly and consistently and produces the expected results. Qualification is part of, but not limited to, a validation process, i.e., installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).
Validation:- It means establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes.
Revalidation:- It is the repetition of the validation process or a specific portion of it.
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. The process validation is performed in three stages: Process Design, Process Qualification and Continuous Process Verification.
Process Design:- It is the activity of defining the commercial manufacturing process based on knowledge gained through development and scale up activities that will be reflected in planned master production and control records. The process design contains decisions for choosing the manufacturing procedure, the Critical Process Parameters (CPP) and Critical Quality Attributes (CQA). This information is necessary for process qualification.
Process Qualification:- During the process qualification stage of process validation the process design is evaluated to determine if it is capable of reproducible commercial manufacturing.
Process Performance Qualification:- In this stage the actual facility, utilities and equipment are already qualified for use, the commercial manufacturing process is to be validated.
Continuous Process Verification:- It is an on-going programme to collect and analyse product and process data that relate to product quality.
Working standard:– A product or intermediate of established quality and purity, as shown by comparison to a primary reference standard, used as a reference substance for routine laboratory analysis.
Contamination:- The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or product (API) during production, sampling, packaging or repackaging, storage or transport.
Cross Contamination:- Contamination of a material or product with another material or product.
Complaint:- Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance after it is released for distribution.
Computer System:- A group of hardware components and associated software, designated and assembled to perform a specific function or group of functions.
Contract manufacturer:- A manufacturer performing some or all aspect of manufacturing on behalf of the original manufactures.
Drug Labelling:- Use of written, printed or graphic materials upon or accompanying a drug container or wrapper. It includes contents, indications, effects, dosages, routes, methods, frequency and duration of administration, warnings, hazards, contraindications, side effects, precautions, and other relevant information.
Drug Packaging:- Containers, packaging, and packaging materials for drugs and biological products. These include those in ampule, capsule, tablet, solution or other forms. Packaging includes immediate-containers, secondary-containers, and cartons. In the United States, such packaging is controlled under the Federal Food, Drug, and Cosmetic Act which also stipulates requirements for tamper-resistance and child-resistance.
Generics:- The common name of drug not protected by trade mark.
Root cause:- The basic source or reason for nonconformity, determined through a stepwise investigation.
Corrective action:- Action (s) taken to correct the defect / problem occurred as result of non-conformity.
Preventive action:- A proactive approach takes to identify and eliminate the most likely cause of a potential nonconformity in order to prevent occurrence.
Gang-printed labelling:- It means labelling derived from a sheet of material on which more than one item of labelling is printed.
Annual Product Quality Review:- It is regular periodic quality review of each product, which is conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product to highlight any trends and to identify product and process improvements.
Biometrics:- A method of verifying an individual’s identity based on measurement of the individual physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.
Closed system:- An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
Open system:– An environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.
Electronic signature:- A computer data compilation of any symbol or series of symbols executed, adopted or authorised by an individual to be the legally binding equivalent of individual’s handwritten signature.