Identify appropriate biological routes for manufacture of existing/new products
Overview
This standard identifies the competences you need to identify appropriate biological routes for the manufacture of existing/new products, in accordance with approved procedures and practices. 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 identifying appropriate biological routes for manufacture of existing/new products, 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 biomaterial development principles and processes, and you will also be fully conversant with organisational procedures and systems. You will be required to report any problems with the biomanufacturing activities that you cannot personally resolve, or that are outside your permitted authority, to the relevant people.
Your underpinning knowledge will be sufficient to provide a sound basis for your work, and will enable you to adopt an informed approach to identifying appropriate biological routes for manufacture of existing/new products for development purposes, in accordance with approved procedures and practices. You will have an understanding of the manufacturing methods and principles used, in adequate depth to provide a sound background for carrying out the biomanufacturing activities to the required specification.
You will understand the safety precautions required when carrying out the biomanufacturing activities for scientific operations and processes. You will be required to demonstrate safe working practices throughout, and will understand your responsibility for taking the necessary safeguards to protect 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 wear the appropriate personal protection equipment (PPE) when working in the biomanufacturing environment
P3 establish that no similar activity has been carried out before by carrying out a thorough literature search
P4 identify the different potential manufacturing routes, ranking them in order of suitability against the selection
P5 evaluate other potential biological routes identified by laboratory R&D functions
P6 draw reasoned and valid conclusions from the research done
P7 make and record appropriate recommendations of your findings for future use
P8 communicate the required information about the work done, to senior management and other authorised people, in accordance with organisational procedures
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 manufactured product and batch process tracking and records system
K8 the types of handling and sorting system, and the procedures used for products undergoing processing in the manufacturing facilities
K9 the importance of correct identification, and any unique organisational or manufacturing 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 requirements of relevant quality, health, safety and environmental legislation and guidelines and your organisation’s policies and procedures
K14 sources of information (including primary literature and biological abstracts), and how to use specialist search engines appropriate to your organisation
K15 the scope of the biological manufacturing targets for quantity, quality standards, deadlines and any other special requirements
K16 the types of laboratory trial that may be used to confirm the suitability of biological materials and manufacturing processes
K17 how to apply practical techniques to your chosen experiment
K18 whom to consult, and the nature of their interest
K19 how to define manufacturing targets
K20 how to interrogate the results against the biological manufacturing process targets
K21 the effects of scale-up, and the limitations of the biological manufacturing equipment
K22 any relevant codes of best practice (such as Good Manufacturing Practice (GMP))
K23 the process that you are operating
K24 the limitations of the available equipment
K25 any budgetary flexibilities and constraints
K26 the different ways in which you might assure the quality of raw materials for biological manufacture (including maintaining a constructive dialogue with suppliers)
Scope/range
1. carry out all of the following activities:
1.1. discuss/consult with the relevant people involved in the identification of biological manufacturing routes
1.2. gather information from appropriate sources to help supervise the chosen manufacturing routes
1.3. communicate the proposed solution to the relevant people, obtaining feedback where appropriate
1.4. recommend a plan of action for implementation of the chosen manufacturing routes
1.5. ensure that the chosen solution complies with the regulatory and quality control requirements
1.6. amend the appropriate standard operating procedures for the chosen manufacturing routes
identify appropriate biological manufacturing routes in both of the following work situations:
2.1. working alone
2.2. working as part of a teamidentify appropriate biological manufacturing routes in both of the following:
3.1. test quantities
3.2. commercial quantitiesrecord details of the proposed route(s), and communicate the details to the appropriate people, using:
4.1. verbal report
Plus one method from the following:
4.2. written or typed report
4.3. specific company documentation
4.4. computer-based record
4.5. electronic mail