Main description:

This pioneering handbook serves as an essential tool for any biobanking entity to create, implement and continuously improve their Quality Management System (QMS). Written in a concise and highly readable manner all biobanking related QMS aspects, ranging from legal aspects to safety matters, are addressed according to the best knowledge in compliance with the dedicated Biobanks ISO standards. Following a practical approach by making use of FAQ and common practice sections this book guides the readers through this complex field in an easy-to understand way.The guidelines are convergent not only with ISO 20387:2018 Biotechnology - Biobanking - General requirements for biobanking but also with ISO 9001:2015, ISO 19011:2018, ISO 27000:2014, and ISO 27002:2013. Furthermore, they are compatible, among others with the recommendations of the Organization for Economic Cooperation and Development (OECD), IARC, and ISBER Best Practices.

Aimed at both biobank employees and other stakeholders (e.g. public bodies, political bodies, hospitals, pharmaceutical industry, funders) at any level of experience the book serves as valuable source for self-education and teaching. The manual complies to the principles of responsibility, openness, and transparency and can be used by any biobanking unit regardless of the biological material the biobank operates with and independent of their associated biobank network.

On behalf of a group of specialists and experts in the area of biobanking, regarding Quality Management Systems (QMS), Ethical, Legal and Societal Issues (ELSI) and IT solutions, the authors present with this book a significant achievement based on activities within the project, European Research Infrastructure BBMRI-ERIC "Quality Standards for Polish Biobanks" Handbook (QSPB).

Contents:

Dictionary

1. Management of Biobanks

1.1. Organization

1.1.1. Organizational structure of the organization/institution under which the biobank operates

1.1.2. Organizational chart of the biobank

1.2. Biobank's mission and scope of activity

1.3. Biobank's objectives and their monitoring

1.4. Communication

1.4.1. External communication

1.4.2. Internal communication

2. Quality Management

2.1. General requirements

2.2. Quality policy

2.3. Setting objectives

2.4. Risk and opportunity management

2.4.1. Identification of risk and

2.4.2. Risk and opportunities assessment (evaluation and analysis)

2.4.3. Reaction to risk and opportunities

2.4.4. Monitoring of risk and opportunities

3. Documentation and Records

3.1. General requirements

3.1.1. Traceability of documentation

3.1.2. Readability of documentation

3.1.3. Availability of documentation for biobank employees

3.1.4. Confidentiality

3.1.5. Supervision of changes in documentation

3.1.6. Backup / safety copies of documentation

3.2. Implementing documentation

3.2.1. Responsibility for dealing with documentation

3.2.2. Update and withdrawal of documentation

3.2.3. Training after documentation updates

3.2.4. Documentation distribution

3.3. Storage of QMS documentation

3.3.1. Records

3.4. Verification of documentation

3.4.1. Periodic and incidental verification of documentation

4. Human Resources Management

4.1. Human resources management policy

4.2. Biobank employee identification

4.3. Admission of an employee to the biobank

4.3.1. Scope of initial training

4.3.2. On-the-job training

4.4. Responsibility and permissions of key personnel

4.5. Biobank personnel training (improvement training)

4.6. Verification of biobank employees' knowledge

4.7. Training documentation

4.8. Termination of employment

5. Ethical and Legal Aspects

5.1. Compliance with ethical and legal requirements

5.2. Ethical advice and approval

5.3. Impartiality

5.3.1. Impartiality safeguarding

5.3.2. Risks to impartiality

5.3.3. Transparency and documentation

5.3.4. Responsible supervision

5.3.5. Communication

5.4. Confidentiality and privacy

5.5. Respect for autonomy

5.5.1. General requirements

5.5.2. Informed consent

5.5.3. Re-contacting with participants

5.5.4. Right to refuse consent and right to withdraw consent

5.5.5. The right to know and not to know the results

5.5.6. Consent from participants who are not capable to give a consent

5.6. Sharing material and data

5.7. Proprietary rights and commercialization

6. Supplies, Materials Management

6.1. Materials receipt rules

6.2. Reception, qualification and acceptance of materials

6.3. Qualification of suppliers

6.4. Handling of materials stored in storage space

6.5. Handling of materials used in daily work

7. Equipment

7.1. Acceptance of the equipment

7.1.1. Device acceptance criteria

7.1.2. Acceptance or rejection of the equipment

7.1.2.1. Installation qualification (IQ)

7.1.2.2. Operational qualification (OQ)

7.1.2.3. Performance qualification (PQ)

7.1.3. Final qualification report (IQ, OQ, PQ)

7.2. Rules for supervision over equipment

7.3. Recordings of equipment operation

7.3.1. Key parameters defined internally

7.3.2. Parameters verified/actions performed directly by the user (user maintenance)

7.3.3. Parameters verified/actions performed by an external company

7.3.4. Recordings from maintenance, cleaning of the equipment

7.4. Work with equipment outside the supervision

7.5. Requalification of critical equipment

8. Traceability

8.1. Traceability system

8.2. Unique identification of biological material

9. Environmental and Staff Hygiene

9.1. Personnel hygiene and safety

9.1.1. Occupational health and safety

9.1.1.1. Occupational risk

9.1.1.2. Periodic examinations

9.1.1.3. Personal protective equipment

9.1.1.4. Handling of clothing and protective equipment

9.1.2. Chemical and hazardous substances

9.1.3. Work with potentially infectious material derived from humans

9.1.3.1. The list of employees exposed to biological agents

9.1.3.2. Occupational exposure

9.1.3.3. Disinfection

9.2. Process environment

9.2.1. Environmental conditions and staff hygiene

9.3. Waste management

10. Biobanking Processes and Quality Control

10.1. The life cycle of biological material and critical processes

10.1.1. Acquisition of the biological material and related data

10.1.2. Transport of biological materials and associated data

10.1.2.1. Transport from and to the biobank (shipping)

10.1.2.2. Transport within the biobank

10.1.3. Reception, qualification and acceptance of biological material and associated data for inventory

10.1.4. The process of handling of biological material and associated data

10.1.4.1. Processing of material and data

10.1.4.2. Storage of material and data

10.1.5. Transport of material and data within the biobank

10.1.6. Process of withdrawing biological material and associated data

10.2. Quality control

11. Deviations, Nonconforming Product/Data or Service

11.1. Deviations/Nonconformities

11.2. Corrective and correction actions

11.3. Complaints

11.4. Nonconforming output/service

11.4.1. Identification of nonconforming products/services and accompanying documentation

11.4.2. Rejection of nonconforming product/service

12. Audits

12.1. Internal audit

12.2. Auditor's competences and qualifications

13. Improvement

13.1. Tools for improving the effectiveness of biobank

13.2. Management review

13.2.1. Conducting a management review

14. Biobank Cooperation in the Scientific, Research and Development Area

14.1 General requirements

14.2 Sharing of biological material and data for research

14.3. Cooperation agreements

14.4. Communication during scientific cooperation

14.4.1. Informing about irregularities in the course of research

15. Safety & Security

15.1. Security procedures

15.2. Biological material safety

15.3. Information security

15.4. Basic methods of securing it infrastructure and data processing

15.4.1. Awareness of the functioning the biobank in the organization

15.4.2. General principles for the secure exchange of information

15.4.3. Security of processed data

15.4.4. Basic methods of securing access to the premises

15.4.5. Operating systems and software

15.4.6. Anti-virus software

15.4.7. User and password management

15.4.8. Lan network

15.4.9. Emergency power supply

15.4.10. Basic features of the biobank it system

15.4.11. Backups

15.4.12. External services including cloud services

15.4.13. Personnel