Write biomanufacturing technical reports
Overview
This standard identifies the competences you need to write biomanufacturing technical reports, 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 writing biomanufacturing technical reports, 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 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. You will be expected to work to verbal/written instructions and standard operating procedures, and to report against your departmental goals set by senior management, taking personal responsibility for your own actions and for the quality and accuracy of the work that you carry out.
Your underpinning knowledge will be sufficient to provide a sound basis for your work, and will enable you to adopt an informed approach to the writing of biomanufacturing technical reports, 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 the scope and purpose of the report to be delivered
P4 determine quality, cost and delivery issues, and the resources needed to deliver the report
P5 present the report data and content in an appropriate format and structure for the reader(s)
P6 include all information that is relevant and sufficient
P7 obtain feedback on your early draft to ensure that the final report meets the stated purpose
P8 follow the appropriate procedure for authorisation and release of the report from the appropriate people
P9 ensure that the report is issued within the agreed time limits
P10 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 your organisation’s requirements for recording and archiving reports, and the use of a unique identify code
K14 the legal responsibilities for health and safety issues relevant to technical reports
K15 the requirements of any external regulatory bodies, and how they are appropriate to reports
K16 the legal consequences of breaches of quality procedures
K17 the systems used to ensure quality of reports within the organisation
K18 the methods used to monitor these quality systems
K19 the standards and standard operating procedures appropriate to reports
K20 how to establish the scope of the technical report
K21 how to establish the purpose of the technical report
K22 how to access appropriate information
K23 the range of methods used to present the data in reports
K24 how to structure the report logically, clearly and concisely
K25 the appropriate format and ‘house style’ of the report
K26 how to evaluate the information, draw logical conclusions and make subsequent recommendations from the evaluation of the information
K27 to whom to distribute the report, and the appropriate communication channels
K28 the authorisation required before the reports can be released for issue
Scope/range
1. carry out all of the following activities:
1.1. plan the report in a logical and structured way for the briefing
1.2. prepare the content to meet the needs of the target audience
1.3. invite feedback, and amend as appropriate for the required content and delivery timescale
1.4. prepare supporting materials (eg, illustrations, graphs)
1.5. use an appropriate code to create a unique identification for the report
1.6. publish and distribute in the required quantities for the target audience
write technical reports for both of the following:
2.1. internal consumption
2.2. external consumptionpublish technical reports in both of the following formats:
3.1. draft form
3.2. final versionrecord details of the work, 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