2018-2019 paper Flashcards
bioanalytical device which parameters
Specificity/ Selectivity/Accuracy Sensitivity Robustness Sample handling Stability
Which is the most relevant analytical procedure for protein analysis? Please, describe the process and name two parameters which makes protein analysis difficult?
Sandwich assay, Surface Plasmon Resonance
Parameters: Protein assay relevant parameters
- protein size
- protein complex
- pH
- physisorption
- assay buffer
- k d value binding affinity
- nativity of the analytes
- incubation time
- quantification
two parameters that make protein analysis difficult:
-small sample size
-binding affinity or protein-matrix/ protein-protein interactions
-unknown conditions for the nativity of analyte
Name the current EU medical device regulation. How many classes for medical devices are defined within this regulation? Describe these classes.
Medical Device Directive (MDD) 93/42/EEC
Active Implantable Medical Device (AIMD) 90/385/EEC
In Vitro Medical Device Directive (IVDD) 98/79/EC
1&2 REG 2017/745 MDR
3 REG 2017/746
Basic Class I
Devices that are non-sterile or have no measuring function (low risk)
Wheelchair, plaster, hospital bed, bedpan
Class Is
Devices that are placed on the market in a sterile condition
Personal protection kits
Class Im
Devices with a measuring function
Stethoscope, thermometer, weighing scale
Class Ir A new subclass for products that are reprocessed or re-used Surgical instruments and endoscope
Define an IVD for MDs. What is conformity assessment? Please describe it
- concerning a physiological or pathological state,
- concerning a congenital abnormality,
- to determine the safety and compatibility with potential recipients,
- to monitor therapeutic measures.
Conformity assessment involves a set of processes that shows your product, service or system meets the requirements of a standard. Undergoing conformity assessment access has a number of benefits: It provides consumers and other stakeholders with added confidence. It gives your company a competitive edge.
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.
GMP (Quality)
GLP (Safety)
GCP (Efficacy)
Def of Medicinal Product (DRUGS)
“key features” of the GMP Pharmaceutical Quality Management System.
Validation Verification Charge Control Deviation Investigation CAPA Vendor Management Quality Control Facilities/Utilities/Equipment PQR/APR recall Complaints/Incidents Destruction
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?
is a set of specifications for a dossier for the registration of medicines.
Module 1: Administrative Information and Prescribing Information (Specific to the region)
Module 2: the pharmaceutical, including its pharmacologic class, mode of action, and proposed clinical use.
Module 3: Quality info
Module 4: Non-clinical study reports
Module 5: Clinical study reports
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. 6 P
MDD 93/42/EC: This Directive shall apply to medicine devices and their accessor for the purpose of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereafter be termed devices.
90/385/EEC (AIMDD) : gives manufacturers the opportunity to develop their own compliance program.
(IVDD) 98/79/EC : provides regulatory requirements that facilitate the free trade within the European Economic Area (EEA)
The IVDD specifically addresses the safety, quality and performance of In Vitro Diagnostic medical devices (IVDs).
Two types:
REG 2017/746 : - Stringent requirements for Technical documentation(TDI)
- Includes Medical and Non medical devices
- (UDI)Unique product number for every medical device
- Notified bodies are stricter
REG 2017/746 (IVDR) Changes compared to the IVDD include changes in device classification, stricter oversight of manufacturers by Notified Bodies, introduction of the “Person Responsible for Regulatory Compliance” (PRRC), the requirement of UDI marking for devices, common specifications, Eudamed registration, and increased post-market surveillance activities.
Define within each sentence, what is biosafety, what is biosecurity? 2P.
Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health.[1] 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. Failures to follow such protocols can lead to increased risk of exposure to biohazards or pathogens. Human error and poor technique contribute to unnecessary exposure and compromise the best safeguards set into place for protection.
What is biosecurity?
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 minimise the risk of transmission of infectious disease. The term includes biological threats to people, including those from pandemic diseases and bioterrorism. The definition has sometimes been broadened to embrace other concepts, and it is used for different purposes in different contexts.
The COVID-19 pandemic is a recent example of a threat for which biosecurity measures have been needed in all countries of the world.
Please name and describe at least two technical and two administrative arrangements for a biosafety lab. 6P.
Technical Arrangements: Room (Washable lab surfaces, Division of lab and office) Handling waste Equipments (working bench, hood, autoclave) Administrative arrangements: Labelling of the working area Access only for authorised lab members Operation instructions Arrangements for accidents Regular biosafety lectures for lab members Documentation of all the lab work Hygiene plan
Biosafety labs with levels 1 and 2 are the most common ones. Please name the differences for technical and administrative arrangements. 4P.
Biosafety level 1 (BSL-1)
BSL-1 is the lowest security level for handling biological material.
This kind of material poses no or only a low risk to healthy adult humans and presents minimal potential hazard to laboratory personnel and the environment.
BSL-1 laboratories do not have to be separated from the rest of a building.
Laboratory workers can do their work on open bench tops, and there is no need to use special equipment.
Standard microbiology practises usually suffice to protect laboratory workers and other employees in the building.
This means, for example, that no mouth pipetting is allowed and splashes and aerosol formation should be avoided.
Spills have to be cleaned up immediately and all work surfaces should be decontaminated each time work is finished.
Eating, drinking, and smoking are not allowed in the lab.
To protect themselves, workers generally wear eye protection, gloves, and a lab coat.
It is recommended that access to the laboratory be limited.
In general, an autoclave is only required when working with genetically modified organisms or modified genetic elements (e.g., plasmid vectors). Biohazard signs are posted whenever infectious agents are present.
Biosafety level 2 (BSL-2)
All activities in a BSL-2 laboratory require higher security standards than in a BSL-1 laboratory.
The biological material used in a BSL-2 laboratory consists of bacteria, viruses, and organisms associated with human diseases.
The potential pathogenic or infectious organisms subject to BSL-2 standards pose a moderate hazard to healthy adult humans.
However, because of their potential to cause human disease, great care must be taken to prevent percutaneous injury, and employees are subject to regular medical surveillance if necessary.
The main difference in the work procedures followed in a BSL-1 laboratory and a BSL-2 laboratory is that employees in a BSL-2 laboratory will use a BSC as a primary barrier for potentially hazardous aerosols.
These aerosols are generally formed during standard work procedures like mixing, pipetting, and centrifuging, so these activities should be carried out under a BSC.
At a minimum, an autoclave has to be present in the lab as a second barrier. Windows open to the outside are not recommended.
A sink for washing hands must be placed in direct proximity to the exit door. The laboratory should be easy to clean and decontaminate.
Inside the laboratory, special lab coats, gloves, and face and eye protection should be worn.
Special precaution must be taken with sharps that can cause injury.
Access to BSL-2 laboratories must be restricted.
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. 6P.
Check whatsapp
Quality control is part of QMS. Please name at least 4 arrangements for quality control in the field of Life sciences. 4P.
There are 3 main objectives of quality control: enhance product quality and reduce risks, gain production efficiencies, and garner customer loyalty. These 3 objectives will be evident in any manufacturer with a robust and functional quality control program.
What are the four types of quality control? GLP GMP GMaP QC(Calibration, documentation, SOP)
Name the current ISO for QMS. What is a notified body? 4P.
13485 ISO
A notified body, in the European Union, is an organisation 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 which is entitled by an authorised 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.
Which ISO describes and defines risk assessment? Which modules are part of the risk assessment? Please describe them? 6P.
OR
Risk assessment and risk minimization play also in the area of biosafety a crucial role. There is from the scientific point of view a highly effective tool for risk minimization. Please describe this procedure addressing the biosafety level and give one example for it. 6P.
ISO 27001 requires you to document the whole process of risk assessment (clause 6.1.2), and this is usually done in the document called Risk assessment methodology.
The 3 Steps of Risk Management
The risk management process consists of three parts: risk assessment and analysis, risk evaluation and risk treatment. Below, we delve further into the three components of risk management and explain what you can do to simplify the process.
1. Risk Assessment & Analysis
The first step of the risk management process is called the risk assessment and analysis stage. A risk assessment evaluates an organisation’s exposure to uncertain events that could impact its day-to-day operations and estimates the damage those events could have on an organisation’s revenue and reputation.
Effectively assessing and analysing an organisation’s risks helps protect assets, improve decision making and optimise operational efficiency across the board to save money, time, and resources.
2. Risk Evaluation
After the risk assessment/analysis has been completed, a risk evaluation should take place. A risk evaluation compares estimated risks against risk criteria that the organisation has already established. Risk criteria can include associated costs and benefits, socio-economic factors, legal requirements, and system malfunctions.
3. Risk Treatment & Response
The last step in the risk management process is risk treatment and response. Risk treatment is the implementation of policies and procedures that will help avoid or minimise risks. Risk treatment also extends to risk transfer and risk financing.
It is important to note that risk management is an ongoing process and does not end once risks have been identified and mitigated. An organisation’s risk management policies should be revisited every year to ensure policies are up-to-date and relevant.
