Some Glossary of Terms Used in Pharmaceutical Manufacturing

A List of Pharmaceutical Terminology:

Absolute Advantage

is the ability of a country, individual, company or region to produce a good or service at a lower cost per unit than the cost at which any other entity produces that same good or service.

Absolute Bioavailability

is determined by comparing the blood (plasma) concentration-time-curves (usually as area under the curve) of a compound after application (usually orally) of that compound to that after intravenous application of the identical compound (e.g. tablet vs. i.v. or capsule vs. i.v. or from a food vs. i.v.). So, i.v. application is used as the reference form of application.

Active Ingredient

An active ingredient (AI) is the ingredient in a pharmaceutical formulation that is biologically and therapeutically active.

ANDA

Abbreviated New Drug Application contains data that, when submitted to FDA's center for drug evaluation and research, review and ultimate approval of generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American people.

Annual Product Quality Review (APQR)

APQR is overall review of the product manufactured during the whole calendar year, for all the parameters including critical parameters and trend of the batches .

APQP

Advanced product quality planning (or APQP) is a framework of procedures and techniques used to develop products in industry, particularly the automotive industry. It is quite similar to the concept of Design for Six Sigma.

Asepsis

Asepsis is the state of being free from disease-causing micro-organisms (such as pathogenic bacteria, viruses, pathogenic fungi, and parasites).

Aseptic Area

The areas in which aseptic processing operations are performed, including both the classified and controlled areas.

Bioassay

is an analytical method to determine the concentration or potency of a substance by its effect on living cells or tissues.

Bioavailability

is the rate and extent of substances that reaches the systemic circulation. Bioavailability is one of the principal pharmacokinetic properties of drugs.

Bioburden

The number of bacteria living on a surface that has not been sterilized. This level and type (e.g. objectionable or not) of micro-organisms that can be present in raw materials, API starting materials, intermediates or APIs. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected.

Bioequivalence

A high degree of similarity in the bioavailabilities of two pharmaceutical products (of the same dosage form) from the same strength, that are unlikely to produce clinically relevant differences in therapeutic effects, or adverse effects, or both.

Biological Indicator

is a test system containing viable microorganism providing a defined resistance to a specified sterilization process.

Bioinformatics

is defined as the science of using computer technology to gather, store, analyze and merge biological data.

Biomarker

is defined as a measurable indicator that can be used to a particular disease state or some other biological state of an organism.

Biopharmaceutical Classification System (BCS)

A system of classification of drugs based on their solubility and their permeability through the gut wall. The solubility classification is based on a United States Pharmacopoeia aperture.

Biosimilar

is a biologic product that is demonstrating highly similar to an already approved biologic product. Which has a demonstrable similarity in physicochemical, biological and immunological characteristics, efficacy and safety, based on comprehensive comparability studies.

Biowaiver

means in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval).Biowaivers are possible in the USA, in Europe and in Japan, but the requirements for achieving a biowaiver differ in these countries. In the USA and Europe the biowaiver is potentially available for rapidly dissolving formulations of BCS class 1 drugs.

Calibration

is the system performance checking, in where the known (standard) compare with unknown.

Cell Culture

refers the technique or processby which cells are grown under controlled conditions.

Cell Lines

are defined as a developed or permanently established cell that will proliferate indefinitely given appropriate fresh medium and space.

Change Management

A systematic approach to proposing, evaluating, approving, implementing and reviewing changes (ICH Q10).

Cleanroom

is defined as a controlled environment, typically used in manufacturing or scientific research that has a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors etc.

Comparative Bioavailability

is determined by comparing the plasma concentration-time-curves (usually as area under the curve) after administration of two different formulations of the same compound (e.g. capsule vs. tablet vs. dissolved in water etc.). It’s also called Relative bioavailability.

Conjugated Product

is made up of an active ingredient (for example, peptide, carbohydrate) bound covalently or noncovalently to a carrier (for example, protein, peptide, inorganic mineral) with the objective of improving the efficacy or stability of the product.

Control Strategy

A planned set of controls, derived from current product and process understanding that ensures process performance and product quality.

Corrective Action

Action to eliminate the cause of a detected non-conformity or other undesirable situation. It's taken to prevent recurrence.

Critical Process Parameter (CPP)

A process parameter whose variability has an impact on a critical quality attribute.

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.

Cytotoxicity

is the quality of being toxic to cells.The cells may undergo necrosis, in which they lose membrane integrity and die rapidly as a result of cell lysis.

Design qualification (DQ)

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

Design Space

The multidimensional combination and interaction of input variables (e.g., materialattributes) and process parameters that have been demonstrated to provide assuranceof quality.

Drug Master File (DMF)

is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form.It’s may be used to provide confidential detailed information about facilities, processes, or sources used in the manufacturing, processing, packaging, and storing of one or more human drugs.It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States respectively.

Innovation

The introduction of new technologies or methodologies (ICH Q10).

In-vitro in-vivo correlation (IVIVC)

A predictive mathematical model describing the relationship between an in-vitro property of a dosage form and an in-vivo response

Lifecycle

All phases in the life of a product from the initial development through marketing until the product's discontinuation (ICH Q8)

Lyophilization

is a process in which water is removed from a productfor rapidly frozen and dehydrated under high vacuum.

Marketing authorization application (MAA)

is an application submitted by a drug manufacturerto the relevant authority; typically: the UK’s MHRA or the European Commission’s Committee for Medicinal Products for Human Use (CHMP) to market a drug or medicine. The U.S. Food and Drug Administration equivalent of Marketing authorization application (MAA) is a New Drug Application (NDA).

Operational Qualification (OQ)

The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated (expected) operating ranges.

Out of specification (OOS)

is defined as those results of in process or finished product testing that does not comply with the pre-determined acceptance established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer.

Out of trend (OOT)

result that does not follow the expected trend, either in comparison with previous results with other stability batches or with respect to previous results collected during a stability study.

Performance Indicators

Measurable values used to quantify quality objectives to reflect the performance of an organisation, process or system (ICH Q10).

Performance Qualification (PQ)

The documented verification that the facilities, systems and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.The performance qualification tests requirements defined in the User Requirements Specification (URS).

Pharmaceutical Quality System (PQS)

Management system to direct and control a pharmaceutical company with regard to quality (ICH Q10).

PIC/S

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use.

Precision

The precision of an analytical procedure refers to the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions.

Predictive Dissolution Study

Predictive dissolution study means in-vitro dissolution study to assume or predict the in-vivo dissolution rate.

Preventive Action

Action to eliminate the cause of a potential non-conformity or other undesirable potential situation. It's taken to prevent occurrence.

Probiotics

Probiotics are live microorganisms or microbial mixtures (bacteria, moulds or yeast)administered to improve the patient's microbial balance, especially the digestive systemand the vagina.Probiotics have demonstrated an ability to prevent and treat some infections.

Process Analytical Technology (PAT)

A system for designing, analyzing and controlling manufacturing through timely measurements of critical quality and performance attributes.

Process Validation

is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the processoperated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.

Product Realisation

Achievement of a product with the quality attributes appropriate to meet the needs of patients, health care professionals and regulatory authorities (ICH Q10).

QMS

A quality management system is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.

Quality

The suitability of either a drug substance or a drug product for its intended use. This term includes such attributes as the identity, strength and purity (ICH Q6A).

Quality by Design (QbD)

A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.

Quality Risk Management

A systematic process for the assessment, control, communication and review of risks to the quality of the drug products across the product lifecycle (ICH Q9).

Quality Target Product Profile (QTPP)

A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, safety and efficacy of the drug product.

Reference Listed Drug (RLD)

RLD is an approved drug product to which new generic versions are compared to show that they are bioequivalent.

Rheology

is the study of the flow of matter, primarily in a liquid state. It describes the interrelation between force, deformation and time.

Robustness

refer to the ability of an analytical method to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.

State of Control

A condition in which the set of controls consistently provides assurance of continued process performance and product quality (ICH Q10).

The Center for Drug Evaluation and Research (CDER)

performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.

Therapeutic Equivalence (TE)

Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product.

TOC

Total organic carbon (TOC) is a measure of the total amount is of carbon bound in an organic compound and is often used as a non-specific indicator of water quality or cleanliness of pharmaceutical manufacturing equipment.

Validation

is the method of analysis or process performance checking to ensure the operational activity is correctly performed.

Viscosity

The measurement of a materials resistance to flow.Viscosity can determine using a viscometer.

Zeta Potential

is defined as the potential difference between the dispersion medium and the stationary layer of fluid attached to the dispersed particle. The significance of zeta potential is that its value can be related to the stability of colloidal dispersions (e.g., a multivitamin syrup).

2 comments:

  1. Very helpful terminology in pharma field. Thanks a lot...

    ReplyDelete
  2. Very nice collection of pharmaceutical terminology!

    ReplyDelete

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