Assure quality methods and procedures in a biomanufacturing environment
Overview
This standard covers the competences you need to assure the quality of projects and processes in a biomanufacturing environment, in accordance with approved procedures and practices. You are required to take prompt and appropriate action to rectify any quality problems. You will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Manufacturing Practice (GMP). You will also be required to present records and details of your biomanufacturing work to the appropriate people.
Your responsibilities will require you to comply with organisational policy and procedures for ensuring the successful assurance of quality, and to report any problems that you cannot personally resolve to the relevant authority.
Your underpinning knowledge will provide a good understanding of general and discipline-specific biomanufacturing principles and processes, and you will also be fully conversant with organisational procedures and systems. You will understand research planning principles and process, data analysis methods, and evaluation methods, which will enable you to assess the effectiveness of the quality assurance principles and systems, whilst ensuring compliance with your company organisational procedures and systems. You will also be conversant with organisational specifications, details and formats, and resource management principles, in sufficient depth to enable you to carry out the quality assurance activities to the required standard.
You will be fully aware of any health, safety and environmental requirements, and the appropriate legislative and regulatory frameworks, applicable to your area of responsibility. You will be required to ensure that safe working practices are maintained throughout, and will understand the responsibility you owe to yourself and others in the workplace.
This activity is likely to be undertaken by someone whose work role carries out Science/Bio manufacturing work activities. This could include individuals working in the following industries, Chemical, Pharmaceutical and Life Science industries.
Performance criteria
You must be able to:
P1 ensure that your work is carried out in accordance with standard operating procedures
P2 work safely at all times, complying with health and safety and other relevant regulations and guidelines
P3 establish clear and precise criteria for assuring the quality of biomanufacturing projects or processes
P4 identify suitable quality assurance methods and procedures
P5 ensure that the specified quality assurance methods and procedures are implemented correctly
P6 obtain accurate information from valid sources on the biomanufacturing projects or processes being quality assured
P7 specify clearly the required quality of biomanufacturing projects or processes
P8 assess accurately and realistically the quality of the biomanufacturing projects or processes
P9 ensure that information on quality is provided to the appropriate people
P10 recommend improvements to quality to the appropriate people
Knowledge and Understanding
You need to know and understand:
K1 the health and safety requirements of the area in which you are carrying out the biomanufacturing activities
K2 the implications of not taking account of legislation, regulations, standards and guidelines when conducting biomanufacturing activities
K3 the standard operating procedures, as set down in local biomanufacturing operating manuals
K4 the importance of following equipment manufacturers’ operating instructions
K5 the principles of Good Manufacturing Practice (GMP) applied in the workplace
K6 the importance of wearing protective clothing, gloves and eye protection when handling materials (including biochemical substances, biological pathogens and/or antigens), and the equipment used to contain and process them
K7 the biomanufacturing product and batch process tracking and records system
K8 the types of handling and sorting system, and the procedures used for biomanufacturing products undergoing processing in the biomanufacturing facilities
K9 the importance of correct identification, and any unique organisational or biomanufacturing numbers
K10 the organisational requirements for maintaining the security of the workplace
K11 the lines of communication and responsibilities in your department, and their links with the rest of the organisation
K12 the limits of your own authority and to whom you should report if you have problems that you cannot resolve
K13 the quality criteria that could be used for different types of biomanufacturing processes
K14 the quality assurance methods that are available
K15 statistical methods for recording and analysing biomanufacturing processes
K16 other non-statistical methods that could be used for obtaining information on biomanufacturing processes
K17 the relevant sources of valid information on biomanufacturing processes
K18 who should be involved in the biomanufacturing quality assurance process
K19 the type of impact that biomanufacturing quality assurance could have on the organisation
K20 who requires information on biomanufacturing quality assurance, and the procedures for informing them
K21 how to obtain quality information on resources used by the biomanufacturing environment
K22 how to determine the resources that are necessary to ensure that quality methods and procedures are applied
K23 how to determine the availability and suitability of resources
K24 the regulations and guidelines relevant to your area of responsibility
K25 how to obtain and interpret information on regulations and guidelines
K26 the types of recommendation that could emerge from the quality assurance process
K27 methods of presenting biomanufacturing quality assurance recommendations
Scope/range
1. carry out all of the following activities:
1.1. establish clear criteria as the basis of the quality assurance process
1.2. obtain accurate information from appropriate sources for consideration in the process
1.3. assess and specify the quality requirements for the biomanufacturing projects or processes
1.4. identify suitable quality assurance methods, techniques and procedures
1.5. assess the implications of implementing the quality assurance procedures
1.6. present recommendations for improvements to the quality assurance process to the appropriate people
develop quality assurance procedures that cover two of the following:
2.1. new project/process
2.2. revisions to existing project/process
2.3. legal/legislative requirement
2.4. international/national standards
2.5. company standard operating proceduresobtain accurate information from five of the following sources:
3.1. quality assurance department
3.2. equipment manuals/specifications
3.3. FDA/EMEA/MHRA regulations
3.4. project output specifications
3.5. other regulations and guidelines
3.6. international/national standards
3.7. legal/patented information
3.8. company standard operating procedures
3.9. customer specificationsidentify suitable quality assurance methods and procedures for four of the following:
4.1. manufacturing output specification
4.2. material specifications
4.3. patents
4.4. product quality checks
4.5. batch inspection
4.6. manufacturing methods
4.7. process parameters
4.8. technical support procedures
4.9. schedule checking
4.10. legal requirements
4.11. use of international/national standards
4.12. company standards operating procedures
4.13. other (please specify)ensure that the quality assurance methods and procedures comply with four of the following:
5.1. organisational standard operating procedures
5.2. equipment operation specification
5.3. health, safety and environmental requirements
5.4. manufacturing record keeping
5.5. recognised compliance agency/body’s standards
5.6. customer standards and requirements
5.7. aseptic/sterilisation requirements
5.8. BS and/or ISO standardsrecord details of work done, and communicate the details to the appropriate people, using:
6.1. verbal report
Plus one method from the following:
6.2. written or typed report
6.3. specific company documentation
6.4. computer-based record
6.5. electronic mail