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0 Exakte Antworten 89 Text Antworten 46 Multiple Choice Antworten
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1. Concerning Biotechnologies, for a bioanalytical device which parameters must be defined/characterized? Name at least 4 parameters.

  • Specificity

  • Sensitivity

  • Robustness

  • Simple handling

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2. Which is the most relevant analytical procedure for protein analysis? Please, describe the process and name two parameters that make protein analysis difficult?

- the procedure: Immunoassay

- the process: measures the presence or concentration of a macromolecule or a small molecule in a solution through the use of an antibody (usually) or an antigen (sometimes).

- the parameters that make protein analysis difficult: binding affinity of the antibody, structure of the protein, function of the protein. In addition the absorbance depends on the type of protein analyzed (different proteins have different amino acid sequences).

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4.b What is conformity assessment?

Conformity assessment is the process used to show that a product, service, or system meets specified requirements. These requirements are likely to be contained in an ISO standard.

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What is an in vitro diagnostic medical device (IVDMD)?

Directive 98/79/EC, Article 1, defines IVDMDs as follows: “in vitro diagnostic medical device”: any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

- concerning a physiological or pathological state,

- concerning a congenital abnormality,

- to determine the safety and compatibility with potential recipients,

- to monitor therapeutic measures.

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3. Name the current EU medical device regulation. How many classes for medical devices are defined within this regulation? Describe these classes.

ISO 13485

4 classes (I, IIa, IIb, III):
I. Lowest risk classification. Non-sterile and/or non-measuring function; No notified Body involvement.
IIa. Manufacturing systems audit
IIb. Manufacturing & product design audit (Technical File)
III. Highest risk classification. Manufacturing & Design Dossier audit   

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Directive 98/79/EC, Article 1, defines IVDMDs ... for the purpose of providing information on...

concerning a physiological or pathological state

concerning a congenital abnormality

determining the safety and compatibility with potential recipients

monitoring therapeutic measures

concerning the safety and congenital ability

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6. Please provide four examples of "key features" of the GMP Pharmaceutical Quality Management System.

Validation, Verification, Compliance, Recall, Quality Control

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7. The CTD, The Common Technical Specification is the regulatory required format for submission of data in drug development. What parts in drug development does the CTD address/ require the information to be provided?

Validation, Verification, Vendor Management, Quality Control

Change Control, Deviation Investigation, Quality Control, CAPA

Change Investigation, Deviation Control, Quality Management, PCR

Facilities/ Utilities/ Equipment, CAPA, PQR/ APR, Complaints

Recall, Destruction, Change Control, Incidence

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What is the CTD?

The Common Technical Document (CTD) is a set of specifications for a dossier for the registration of medicines. The CTD was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and adopted by the Therapeutic Goods Administration (TGA) in 2004.

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What is the organisation of the common technical document?

The Common Technical Document is organised into five modules. Module 1 is region specific. Modules 2, 3, 4, and 5 are intended to be common for all regions. Conformance with this guideline should ensure that these four modules are provided in a format acceptable to the regulatory authorities.

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5. What are the pertinent Quality Management Systems required in the production of medicinal products (drugs) with the intention to authorize the medicinal product (drug)? Please name three regulatory controlled Quality Management Systems and allocate the required QMS to the phase in medicinal product (drug) development.

 

Good Laboratory Practice (GLP) for early-stage drug development, the pre-clinical studies, Good Manufacturing Practice (GMP) for the manufacture of medicinal product throughout the medicinal product (drug) production, and Good Clinical Practice during the clinical trials. 

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What does DIR stand for?

= DIRECTIVE (GMP/GLP/GCP)

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What does REG stand for?

REG = REGULATION (GMP/GCP)

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What does ICH stand for?

= international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (GMP/GLP/GCP/CTD)

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What does OECD stand for?

= The Organisation for Economic Cooperation and Development (GLP)

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8. The currently applicable three medical device directives have been revised and in the near future two regulations will come into effect to regulate the medical devices. Name/number the three medical device directives and explain what medical products are regulated and also name/number the new two Regulations and explain which directives are covered in which regulation.

 

Directive 98/79/EC for In Vitro diagnostic medical devices, will become the Regulation 2017/746 for In Vitro diagnostic medical devices. The directive 93/42/EC for medical devices and the directive 90/385/EEC for active implantable medical devices will become the regulation 2017/745 for medical devices.

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What is PQR and what APR?

Product Quality Review

Annual Product Review

Annual Price Review

Product Quality Revenue

Annual Price Revenue

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What is CAPA?

Corrective and Preventive Action (CAPA) is a Quality Management System (QMS) process

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9. Define within each sentence, what is biosafety, what is biosecurity?

Biosafety is the prevention of large-scale loss of biological integrity, focusing on ecology, and human health. These prevention mechanisms include conduction of regular reviews of the biosafety in laboratory settings, as well as strict guidelines to follow. Biosafety is used to protect from harmful incidents. Many laboratories handling biohazards employ an ongoing risk management assessment and enforcement process for biosafety.

Biosecurity refers to measures aimed at preventing the introduction and/or spread of harmful organisms (e.g. viruses, bacteria, etc.) to animals and plants in order to minimize the risk of transmission of infectious disease.

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12.  Wildtype E.coli is a widely spread bacterium for life science applications. Unfortunately, it is indicated with biosafety level 2. Please describe the procedure for risk assessment and an alternative in practice for level 1.

First stage: Definition of context: Legal framework, Protection goals, Project Objectives, Biology of Bacterium, Receiving medium, Track record of safe use

Second stage: Formulation of the problem and hazards list

Third stage: Risk characterization

Fourth stage: Risk estimation (also: Disposal method)


Pro-Tip: Work with a bacterial strain of lower biosafety level.

Risk group 2: E. coli Wildtyp

E.g. E. coli K-12: common laboratory strain e.g. used for cloning experiments.
No pathogenic factors.
Risk assessment: S1 (same for E. coli XL-1 blue)

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12.b Wildtype E.coli is (...) indicated with biosafety level 2. Please describe the alternative in practice for level 1.

What he said: planning to work with a bacterial strain within the lowest biosafety level.
E.g. E. coli Wildtyp to E. coli XL-1 blue or E. coli K-12.

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13. Quality control is part of QMS. Please name at least 4 arrangements for quality control in the field of Life sciences.

GMP, GLP

GMaP, GLP

QC (e.g. calibration, document)

QC (e.g. SOP)

GMP, GLaP

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14.  Name the current ISO for QMS. What is a notified body?

ISO 13485

A notified body, in the European Union, is an organization that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are published in European directives or regulations.
More generally, a notified body is an independent, accredited body that is entitled to an authorized accrediting body. Upon definition of standards and regulations, the accrediting body may allow a notified body to provide verification and certification services. These services are meant to ensure and assess compliance to the previously defined standards and regulations, but also to provide an official certification mark or a declaration of conformity

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10b. Benches and autoclaves are the most relevant equipment in labs within the biosafety label. Please describe the technical and administrative arrangements, which must be under attendance that you are allowed to work with?

Technical: 
Annual check of the filters 
Label, Benches with class 2 
Autoclave with spore tests.  

Administrative: 
labeling of the working area
access only for authorized lab members
operation instructions
arrangements for accidents
regular biosafety lectures for the lab members
documentation of all the lab work
Hygiene plan

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Which is the current ISO for QMS?

13485

98/79/EC

17025

90/385/EEC

10125

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Which is the current ISO for Life Science Products?

17025

13484

90/385/EEC

98/79/EC

10125

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Which is the current regulation for IVD medical devices?

17025

98/79/EC

90/385/EEC

134845

2017/746

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Which was the former directive for IVD medical devices?

17025

2017/746

98/79/EC

90/385/EEC

134845

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Which was the former directive for active implantable medical devices?

17025

2017/746

98/79/EC

90/385/EEC

134845

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Which was the former directive for medical devices?

17025

2017/746

93/42/EC

90/385/EEC

134845