Test 1 2020 Flashcards
Several declarations and protocols that are concerned with ethics influence on quality
assurance have been introduced. They serve to protect subjects-of-trials’ safety and
integrity as well as serve to disseminate results in an honest, reliable and
comprehensive manner.
Name at least three of them and give a comprehensive description of purpose and
meaning of such declarations or protocols.
World Medical Association Declaration of Helsinki:
Purpose: Regulate the use and abuse of human subjects in medical research.
Description: The Declaration of Helsinki emphasizes the ethical obligation of physicians to prioritize patients’ welfare and rights. It underlines the importance of careful assessment of risks and benefits in medical research involving human subjects. Additionally, it addresses the use of placebos and emphasizes the necessity of testing new interventions against proven ones, except under specific circumstances where it’s ethically justifiable. The Declaration of Helsinki serves as a guiding document for ethical conduct in medical research involving human subjects.
Basel Declaration:
Purpose: Advocate for trust, transparency, and communication in animal research.
Description: The Basel Declaration focuses on ethical considerations in animal research. It highlights the importance of protecting animals used in research through various protocols, such as the Convention for the Protection of Animals and other specific protocols for different contexts involving animal research. It emphasizes the ethical responsibility of researchers to ensure the well-being and ethical treatment of animals involved in research activities.
Vancouver Declaration:
Purpose: Define research misconduct and promote ethics in scientific publishing.
Description: The Vancouver Declaration, established by the International Committee of Medical Journal Editors (ICMJE), addresses ethical issues in scientific publishing. It defines research misconduct and emphasizes the importance of integrity and transparency in research publication. The declaration aims to prevent tampering with scientific data and promotes ethical conduct among researchers. It provides guidelines for writing manuscripts and encourages researchers to disclose conflicts of interest to maintain the integrity of scientific literature. Additionally, it recognizes the evolving nature of ethics and emphasizes the need for continuous updates to ensure relevance and effectiveness.
In principle, all methods should be validated before they can be used for chemical
analysis.
3A. Explain the two main purposes of conducting the method validation
- Certify that the method is fit for purpose
- Make sure that the measurements are performed outside the noise range of
the method.
Explain the difference between verification and validation
2.44
verification
provision of objective evidence that a given item fulfils specified requirements
2.45
validation
verification, where the specified requirements are adequate for an intended use
. Give a comprehensive description of the activities that are associated with a
full method validation
Method validation involves a comprehensive set of activities outlined in the ICH guide Q2(R1) to ensure the reliability and accuracy of analytical procedures. These activities include identification tests, quantitative tests for impurities, limit tests, and assay procedures. Identification tests confirm the identity of an analyte by comparing it to a reference standard, while impurity testing involves quantitative or limit tests to assess purity characteristics. Validation characteristics such as fit for purpose, accuracy, precision, specificity, detection limit, quantitation limit, linearity, range, and robustness are determined through various analytical procedures. Variations in analytical conditions, such as stability of solutions or chromatographic conditions, are also considered. Method validation concludes with the validation of results, the creation of a Standard Operating Procedure (SOP), the establishment of an uncertainty budget, and calibration of the method to ensure accuracy and reliability.
Many documents are required to fulfil the requirements of the QMS. One of these
documents is the quality policy that is mediated to all potential customers and to the
public.
What is the purpose of the quality policy?
Guidance for Employees: The quality policy provides clear direction on the activities and behaviors expected from employees to ensure the highest possible quality of products or services. It outlines each employee’s responsibility in maintaining and enhancing quality standards.
Alignment with Organizational Strategy: A well-crafted quality policy aligns with the overall strategy of the organization, ensuring that quality objectives are integrated seamlessly into the broader organizational goals and vision.
Top Management Review and Maintenance: The quality policy is reviewed and maintained by top management, underscoring its importance and ensuring its relevance in the evolving organizational context. This ongoing review process helps to keep the policy current and aligned with organizational objectives.
Integration of Quality Principles: The quality policy embodies the organization’s overall intentions and direction concerning quality, reflecting its commitment to continuous improvement and adherence to quality principles. It serves as a cornerstone for professional quality integration within the organization.
Tangible Implementation: A well-written quality policy translates the organization’s quality intentions into tangible activities and practices. It provides employees with a clear understanding of how their work directly impacts the quality of products and services.
Managerial Tool: While the genuine quality policy is reflected in the awareness and actions of individuals rather than just in documents, the documented quality policy statement issued and signed by top management serves as a useful managerial tool. It helps to communicate the organization’s commitment to quality both internally and externally.
. Where would you find the quality policy in the laboratory?
Quality Manual
Prepare 8 points of contributions to a quality policy that could be used at the
analytical laboratory of BIUST
High level of laboratory safety
2. High level of research ethics
3. Access to state-of-the art technology
4. Apparatuses well maintained
5. Comply with principles of scientific methodology in our research
6. Effectively communicate the quality objectives of the department
7. Work closely with external partners at BIUST and in the community
8. Effective support to teaching and operation of apparatuses
9. Adequate funding of research
10. Effective teaching and support to projects
