Lexicon
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21 CFR Part 11
Regulatory text issued by the FDA under ref. 21 CFR Part 11 - "Electronic Records; Electronic Signatures - Scope and application" to define the rules for registration and electronic signature.
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Criticality analysis
A process that determines whether the operation, contact, control, alarm or anomaly of a system or component can have a direct impact on the SQIPP (Safety, Quality, Identity, Purity, Potency) of a product.
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Risk analysis
A document that describes the regulatory, security and functional risks of a project and defines the tests to be performed to ensure that these risks are controlled.
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ANSM
Consult document
"The National Agency for the Safety of Medicines and Health Products (ANSM) was created by the law of 29 December 2011 on strengthening the health safety of medicines and health products.
On 1 May 2012, the ANSM replaced the French Agency for the Health Security of Medicines and Health Products (Afssaps), whose missions, rights and obligations took over. It has been given new responsibilities and missions, increased powers and resources. A public institution under the supervision of the Ministry of Health, the ANSM is financed by a grant for public service costs received from the State, amounting to 131 M€ for 2012."
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Detail Design
Detailed Preliminary Project
Phase 3 in the life of a project. It allows the selected solution (activities and deliverables) to be detailed to arrive at an adequate level of project definition and estimation to draft the EDA for approval.
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APS
Basic design
Phase 2 in the life of a project. It makes it possible to define the solution(s) and evaluate them. The activities and deliverables are: premises plan, detailed layout, flow diagram, preliminary criticality analysis, initialization of the Master Validation Plan and the Project Development Plan.
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Aseptic
Free from any infectious germs.
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Asepsis
A preventive method that prevents infections by preventing, by appropriate means, the introduction of microbes into the body. Absence of microbial agents.
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Biotechnology
Consult document
"The OECD defines biotechnology as "the application of scientific and engineering principles to the transformation of materials by biological agents to produce goods and services".
Biotechnology, or "bioconversion technology" as its name suggests, results from a combination of the science of living beings - biology - and a set of new techniques from other disciplines such as microbiology, biochemistry, biophysics, genetics, molecular biology, informatics...".
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GMP
Good Manufacturing Practices
French regulation (issued by the AFSSAPS) defining the quality requirements for production in the Health sector.
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GLP Good Laboratory Practices
French regulation (issued by AFSSAPS) defining quality requirements for research, development and control laboratories in the Health sector.
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cGMP
Current Good Manufacturing Practices
Regulatory text issued by the FDA under 21 CFR Parts 210 and 211 - "Current Good Manufacturing Practices".
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Commissioning
"Commissioning consists of all dynamic / energized checks, tests and trials carried out before commissioning and qualification, before production of the installations to ensure their proper functioning, particularly from a process and safety point of view."
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Containment
Means consisting of Restricting to a delimited space, enclosing, a device intended to prevent the dispersion/propagation of pathogens.
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Culture
A method of growing microorganisms in an appropriate medium; the microorganisms thus obtained.
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Cell culture
Maintaining and multiplying cells from a tissue fragment, artificially obtained on suitable nutrient media.
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Consult document
"A medical device is an instrument, apparatus, equipment or software intended by its manufacturer for use in humans for purposes such as diagnosis, prevention, control, treatment, mitigation of disease or injury. (Directive 93/42/EEC on medical devices)".
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WFI
Water for Injection Preparation defined by the pharmacopeias of each country. The main ones to remember are: US, EU, FR, JP
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Feasibility
The nature of what is achievable taking into account technical and economic possibilities.
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FDA
Food and Drug Administration
An American organization that defines the regulations applied to the food and pharmaceutical sectors and ensures that they are applied in the companies of the sectors concerned.
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Pharmaceutical industry
Consult document
"This division includes the manufacture of basic pharmaceutical products and pharmaceutical preparations. It also includes the manufacture of medicinal chemicals and herbal products."
Consult document
"The pharmaceutical industry is the economic sector that includes the research, manufacturing, and marketing of drugs for human or veterinary medicine. This activity is carried out by pharmaceutical and biotechnology companies"
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Injectable
Which must be injected, administered by injection.
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Injection
The introduction of a liquid or gas into a conduit, organic cavity or tissue using a syringe or other instrument.
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Laboratory
Premises equipped to carry out experiments, research, and scientific preparations.
A company manufacturing pharmaceutical products.
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Microbiology laboratory type BSL1, BSL2, BSL3 & BSL4
Consult document
"The laboratory is intended to provide experimenters with the containment facilities required to carry out In vitro protocols using natural and genetically modified pathogens up to risk groups 1, 2, 3 or 4."
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Microbiology
Consult document
Microorganisms are an extremely diverse group of microscopic organisms distributed in the three domains of life (eubacteria, archaea and eukaryotic). They differ from each other in shape, size, and lifestyle.
Viruses, unable to reproduce without diverting the cellular machinery of another organism, are not considered by all specialists to be alive. Microbiology sometimes studies their actions on microorganisms but is not intended to study them as entities. This study is being carried out in another discipline of biology: virology.
We are now also talking about "molecular microbiology", particularly in the field of biotechnology.
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MSFP
Pharmaceutical Forming
Production units that mix bulk products, possibly freeze-drying them and packaging them in bottles or syringes.
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CIP
Cleaning in place
The equipment is cleaned without dismantling it.
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Process
Procedure to be followed to obtain the desired result.
> Biotechnological processes, pharmaceutical processes, manufacturing processes.
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Clean
Free from all impurities.
> Cleanliness, ultra-cleanliness, clean room.
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Osmosis
Diffusion phenomenon that occurs when two liquids or two solutions of different molecular concentrations are separated by a semi-permeable membrane that allows the solvent but not the dissolved substance to pass through.
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Reverse osmosis
This is achieved by applying sufficient pressure to the most concentrated solution.
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Revamping
Consult document
A set of interventions on an existing industrial installation to modify and/or increase its production capacity or to adapt it to new technical or regulatory constraints or requirements.
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SOP
Standard Operating Procedure.
Sets of procedures called "standard operating procedures". These procedures are essential for the efficiency of any plant and are a regulatory requirement in the pharmaceutical industry.
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Sterile
Whoever does not produce anything, does not give rise to any creation, to any positive result. Free from any microbial germ.
> Sterile water production loop.
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Water treatment
Consult document
"Refers to the implementation of techniques to make water biologically, chemically or physically suitable for the uses for which it is intended."
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Ultrafiltration
Consult document
"Ultrafiltration is a technique for separating the elements contained in a liquid. It uses semi-permeable membranes with pore diameters ranging from 0.001 to 0.1 micrometers."
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Vaccine
A substance prepared from microbes, viruses or parasites (killed, inactivated or attenuated by special processes), which, when inoculated into an individual, gives him immunity against the corresponding germ.
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Veterinarian
Which has to do with animal care.
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