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Our quality management system

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z


  A » Top
 
Active Ingredient
ACI
Active Pharmaceutical Ingredient (API)
Analytical Methods Validation
API Starting Material

 


  B » Top
 
Batch Record
Bulk Pharmaceutical (BPs)
Bulk Pharmaceutical Chemical (BPC)

 


  C » Top
 
CAD Detection
Calibration
Calorimetric Data
Certificate of Analysis
CGG
cGMP
Clean Area
CMC File
Containment
Contamination
Cosmetic Industry
Critical Process Parameters
Critical Process Steps
Cross Contamination

 


  D » Top
 
Decox
Development Report
Drug Master File
Drug Product
Drug Substance

 


  E » Top
 
Expiry/Expiration Date

 


  F » Top
 
FDA Inspected
Final Intermediate
Final Production Stages
Finished Product

 


  G » Top
 
GMPs

 


  I » Top
 
ICH-guidelines

 


  M » Top
 
Manufacture
Manufacturing Process
Medicinal Product
Mother Liquor
Multi Step Synthesis

 


  N » Top
 
New Active Substance
New Chemical Entity

 


  O » Top
 
Organic Chemistry

 


  P » Top
 
Pharmaceutical Substances
Pilot Scale
Polymorphism
Potential Impurity
Pre-Clinical Studies
Primary Reference Standard
Procedures
Process Control
Process Development
Process Validation
Production
Prospective Validation
Purification
Pyrolysis

 


  Q » Top
 
Qualification
Quality
Quality Assurance (QA)
Quality Attribute
Quality Control (QC)
Quality Control Unit
Quality Unit(s)
Quarantine

 


  R » Top
 
Range for Critical Process Parameters
Raw Material
Reagent
Recovery
Reference Standard
Reprocessing
Retest Date
Rework

 


  S » Top
 
Secondary Reference Standard
Shelf Life
Solubility
Solvent
Specification
Stability
Standard Operating Procedures (SOPs)
Starting Material

 


  U » Top
 
Unidentified Impurity
Up Scaling

 


  V » Top
 
Validation
Validation Protocol

 


  W » Top
 
Working Standard

 



  Active Ingredient » Top
Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug 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.


  ACI » Top
Active cosmetics ingredient


  Active Pharmaceutical Ingredient (API) » Top
Active Pharmaceutical Ingredients (API) are active chemicals used in the manufacturing of drugs. Another term for Active Pharmaceutical Ingredient is Bulk Drug Substance, although API is internationally more recognised.


  Analytical Methods Validation » Top
Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice.


  API Starting Material » Top
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. API Starting Materials are normally of defined chemical properties and structure.


  Batch Record » Top
A chronological record of the production process including all materials and equipment used to produce a batch.


  Bulk Pharmaceutical (BPs) » Top
Materials (both pharmacologically active and inactive) which are intended for use as a component of a drug or biological product. These include materials manufactured by processes such as: (1) chemical synthesis; (2) fermentation; (3) recombinant DNA or other biotechnology methods; (4) isolation/recovery from natural sources, or (5) any combination of these processes.


  Bulk Pharmaceutical Chemical (BPC) » Top
Means any substance produced by chemical synthesis, fermentation, recombinant DNA processes or recovery from natural materials which is intended for use as a component in a drug product or a substance which is repackaged or labelled for drug use.


  CAD Detection » Top
Corona Charged Aerosol Detection (CAD), method for the detection of large molecules (> 10nm).


  Calibration » Top
The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a reference or traceable standard over an appropriate range of measurements.


  Calorimetric Data » Top
Calorimetric data are results of the calorimetry - the science of measuring the heat of chemical reactions or physical changes. The word calorimetry is derived from the Latin word calor, meaning heat.


  CGG » Top
Abbreviation of Central Glass Germany


  Certificate of Analysis » Top
Authenticated document, issued by an accredited firm or individual, that certifies the quality and purity of pharmaceuticals, and animal and plant products being exported.


  cGMP » Top
cGMP (i.e. current Good Manufacturing Practice) is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods, pharmaceutical products, and medical devices.


  Clean Area » Top
A clean room is a room with environmental control of particulate contamination, temperature and humidity, constructed and used in a way to minimize the introduction, generation and retention of the particles inside the room. Clean rooms are needed to reduce contaminations levels in the product or services performed.


  CMC File » Top
Chemistry, Manufacturing, Controls section of a New Drug Application.


  Containment » Top
Process by which possible release, discharge or spill of a toxic or bioactive substance during normal use or after an accident is prevented by appropriate action.


  Contamination » Top
The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API during production, sampling, packaging or repackaging, storage or transport.


  Cosmetic Industry » Top
Manufacturers of products applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions.


  Critical Process Parameters » Top
A feature or aspect of a process that requires careful control or execution to ensure that the API is of acceptable quality, with the desired end result being a safe and efficacious drug product.


  Critical Process Steps » Top
Steps in a process that requires careful control or execution to ensure that the API is of acceptable quality, with the desired end result being a safe and efficacious drug product.


  Cross Contamination » Top
Contamination of a material or product with another material or product.


  Decox » Top
European trade mark of Girindus AG for 4-Decyl-oxazolidin-2-on.


  Development Report » Top
Document describing the findings and developments regarding process development and production of a given API.


  Drug Master File (DMF) » Top
Drug Master File or DMF is a document prepared by a manufacturer in the pharmaceutical industry and submitted solely at his discretion to the Food and Drug Administration (FDA).


  Drug Product » Top
The dosage form in the final immediate packaging intended for marketing.


  Drug Substance » Top
Substance used to treat an illness, relieve a symptom or modify a chemical process in the body for a specific purpose.


  Expiry/Expiration Date » Top
The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf life specifications if stored under defined conditions, and after which it should not be used.


  FDA Inspected » Top
FDA evaluated under general principles like assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.


  Final Intermediate » Top
Key step during the manufacturing of an API, with special regulations of the FDA.


  Final Production Stages » Top
Last steps in the manufacturing of APIs.


  Finished Product » Top
The resulting material after it has been processed.


  GMPs » Top
Good manufacturing practices are a combination of manufacturing and management procedures, rules, steps or precautions that are implemented by all personnel, at all times, with the objective of ensuring that the ingredients and products are not damaged, deteriorated or contaminated, in order for the final products to be consistently manufactured to meet specifications and customer expectations that the food is safe and wholesome.


  ICH-guidelines » Top
The main focus of the ICH process is the preparation of harmonised guidelines that are adopted in the three ICH regions - EU, US and Japan. Non-ICH countries may also use the ICH guidelines within their own countries if they so wish.


  Manufacturing Process » Top
The producing of goods or wares by manual labour or machinery, often on a large scale and with division of labour.


  Manufacture » Top
Manufacture (from Latin manu factura, "making by hand") is the use of tools and labour to make things for use or sale.


  Medicinal Product » Top
A medicinal product is defined as any substance or combination of substances presented for treating or preventing disease in human beings. Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product. For further info see medication and drug.


  Mother Liquor » Top
Mother Liquor describes the solution which is separated from solid components after a crystallization step.


  Multi Step Synthesis » Top
Synthetic procedure which requires several steps to come to the final product


  New Active Substance » Top
New Active Substance (NAS) includes a chemical or biological substance not previously approved for sale as a drug.


  New Chemical Entity » Top
New chemical entity (NCE) or new molecular entity (NME) means a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.


  Organic Chemistry » Top
The chemistry of compounds containing carbon - originally defined as the chemistry of substances produced by living organisms but now extended to substances synthesized artificially.


  Pharmaceutical Substances » Top
Pharmaceutical Substances are substances that are aimed to cure, prevent, or recognize diseases and relieve pains through their application in the organism.


  Pilot Scale » Top
The size of a reaction system that is between the laboratory bench-size and a full-size system.


  Polymorphism » Top
Polymorphism in materials science is the ability of a solid material to exist in more than one form or crystal structure. Polymorphism can potentially be found in any crystalline material including polymers, minerals, and metals, and is related to allotropy, which refers to elemental solids.


  Potential Impurity » Top
A substance inside a confined amount of liquid, gas, or solid, which differs from the chemical composition of the material or compound.


  Pre-Clinical Studies » Top
Studies conducted before a drug is tested in human subjects, and which support and help establish boundaries for safe use of the drug in subsequent phase I studies.


  Primary Reference Standard » Top
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: (1) obtained from an officially recognised source, or (2) prepared by independent synthesis, or (3) obtained from existing production material of high purity, or (4) prepared by further purification of existing production material.


  Procedures » Top
A documented description of the operations to be performed, the precautions to be taken and measures to be applied directly or indirectly related to the manufacture of an intermediate or API.


  Process Control » Top
Those quality assurance actions and considerations necessary to assess production and construction processes so as to control the level of quality being produced in the end product. This includes sampling and testing to monitor the process but usually does not include acceptance sampling and testing.


  Process Development » Top
Documented program of studies which are performed to optimize synthetical procedures or scale up of chemical reactions.


  Process Development » Top
Documented evidence with a high degree of certainty that a process will consistently produce product meeting its pre-determined quality attributes.


  Production » Top
All operations involved in the preparation of an API from receipt of materials through processing and packaging of the API.


  Prospective Validation » Top
Validation conducted prior to the distribution of either a new product, or product made under a revised manufacturing process, where the revisions may have affected the product's characteristics. It is also to ensure that the finished product meets all release requirements for functionality and safety.


  Purification » Top
The act or process of purifying.


  Pyrolysis » Top
The transformation of a substance into one or more other substances by heat alone without oxidation.


  Qualification » Top
Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.


  Quality » Top
High degree of excellence.


  Quality Assurance (QA) » Top
Quality assurance represents the entirety of all measures, which have to be carried out to assure that the products display the quality required for the intended purpose.


  Quality Attribute » Top
Level of excellence.


  Quality Control (QC) » Top
Checking or testing that specifications are met.


  Quality Control Unit » Top
An organizational unit independent of production which fulfils Quality Control responsibilities.


  Quality Unit(s) » Top
An organizational unit independent of production which fulfils both Quality Assurance and Quality Control responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.


  Quarantine » Top
The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection.


  Range for Critical Process Parameters » Top
Defined range to ensure that the API is of acceptable quality, with the desired end result being a safe and efficacious drug product.


  Raw Material » Top
A general term used to denote starting materials, reagents, and solvents intended for use in the production of intermediates or APIs.


  Reagent » Top
Substance consumed during a chemical reaction.


  Recovery » Top
The retrieval of any material with the primary intention of application in another process.


  Reference Standard » Top
A substance of established quality and purity.


  Reprocessing » Top
Introducing an intermediate or API, including one that does not conform to standards or specifications, back into the process and repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distillation, filtration, chromatography, milling) that are part of the established manufacturing process. Continuation of a process step after an in-process control test has shown that the step is incomplete is considered to be part of the normal process, and not reprocessing.


  Retest Date » Top
The date when a material should be re-examined to ensure that it is still suitable for use.


  Rework » Top
Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent).


  Secondary Reference Standard » Top
A substance of established quality and purity, as shown by comparison to a primary reference standard, used as a reference standard for routine laboratory analysis.


  Shelf Life » Top
Length of time that food, drink, medicine and other perishable items are given before they are considered unsuitable for sale or consumption.


  Solubility » Top
The amount of a substance that can be dissolved in a solvent.


  Solvent » Top
An inorganic or organic liquid used as a vehicle for the preparation of solutions or suspensions in the manufacture of an intermediate or API.


  Specification » Top
A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. “Conformance to specification” means that the material, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.


  Stability » Top
The ability of a material to remain unchanged.


  Standard Operating Procedures (SOPs) » Top
Written procedures designed to ensure high quality by requiring uniform performance of specific functions.


  Starting Material » Top
Any substance used in the synthesis of chemical products.


  Unidentified Impurity » Top
Substances having an unknown or unnamed identity inside a confined amount of liquid, gas, or solid.


  Up Scaling » Top
Procedure to optimize reaction conditions from the lab scale to the production scale


  Validation » Top
A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.


  Validation Protocol » Top
A written plan stating how validation will be conducted and defining acceptance criteria. For example, the protocol for a manufacturing process identifies processing equipment, critical process parameters/operating ranges, product characteristics, sampling, test data to be collected, number of validation runs, and acceptable test results.


  Working Standard » Top
A working standard is an established norm or requirement. It is usually a formal document that establishes uniform engineering or technical criteria, methods, processes and practices.