Good Laboratory Practice
It's a profession that provides opportunities to:
Influence working practices to improve standards of quality
The main purpose of the role of the Good Laboratory Practice (GLP) Quality Assurance (QA) professional is to assure management of the compliance with the GLP regulations within their departments. GLP is the quality system applied to non-clinical safety and environmental studies during the development of new products such as medicines, industrial chemicals and pesticides. GLP gives assurance that study data submitted to government assessors is accurate, valid and of sound integrity. Monitoring for GLP compliance by the QA Professional involves conducting audits of the facilities, of ongoing work in the facilities and of various documents.
The GLP regulations require that QA conduct audits of the following types
- Facility audits – to assure the facility is fit for purpose and documents to support processes are in place
- Process and Study audits – observing personnel in the laboratory to assure they are following relevant procedures and working in compliance with GLP
- Study Plan reviews – review of the document which outlines the work to be conducted
- Study Report reviews – review of the report to check it accurately reflects the data generated during the study and contains everything required under GLP
- Computerised Systems used to generate and/or manipulate study data and facility GLP records– review of documents associated with validation of new systems plus audits of ongoing maintenance and validation status of the system
The role also involves proactive input into changes in policies and working practices within the departments. As a QA professional, you will be asked for suggestions on how to improve processes and policies within the department with a view to improving the quality of the work.
Work with a variety of internal and external companies
A GLP QA professional typically works with many parts of the organisation. It really is a cross departmental role. Additionally your organisation may be involved in contracting out work or in collaborations with other organisations. You may be involved in auditing quality systems within these external organisations as well as auditing other parts of your own organisation.
Share knowledge through consultancy and training
You may be expected to deliver training in the basic principles of GLP to new staff within your organisation as well as training for staff taking on particular GLP roles in what their responsibilities are (for example, computer system owners, Study Directors). It is also expected that all staff working in GLP areas receive periodic refresher training so you may be involved in putting together material for this as well as running training workshops. All of this training needs to be organised and documented so organisation skills are also key.
Provide opportunities for personal and professional development
A career as a GLP QA professional will mean that you will be constantly developing your knowledge and skills. In order to perform audits, you will need a good understanding of the science behind the work being conducted. Therefore as scientific techniques evolve and develop, you will be aware of this and learn about these exciting developments.
You will also get opportunities to gain a broad understanding of the pharmaceutical or agrochemical industry and the drug development process to understand how your role fits in.
You will also get the opportunity to attend professional development courses such as auditing skills, observation and report writing, risk management and process mapping, and you may get the opportunity to study for a MSc in Quality Management.
Travel
Many organisations that are involved in GLP work are large global companies that have sites on many locations. You may be required to travel to other locations in order to participate in joint audits or attend meetings.
You may also be required to be involved in due diligence activities at a location of another company of which your organisation is considering a buy out or buying a drug in mid development.
The laboratory within your organisation may decide to contract some work to other organisations. You may be required to audit these 3rd party organisations, which could be located anywhere in the UK or abroad. The purpose of these audits will be to assess the standards that they are working to and whether this is acceptable to your organisation.
Additionally you may be required to audit supplier companies who provide materials and/or services that are key to the work being conducted in your organisation. This is to ensure that the systems in the supplier company are adequate to ensure quality of those products that are being supplied.
Enjoy a variety of roles through involvement in a number of different projects, processes and locations
You could be involved in auditing a wide variety of study types ranging from animal toxicity studies designed to provide a safe dose for dosing to man to soil sediment studies looking at how an agrochemical would behave in the environment.
Additionally as you hold a unique role within the organisation that encompasses many departments, you will probably also get involved in improvement projects both in QA and in the scientific functions, as well as computer validation projects.
You may be involved in hosting inspections of your organisation from regulatory authority inspectors. This will include helping to prepare for the inspection as well as answering questions and supporting scientific staff throughout the inspection.
Raise your profile within your organisation
Working in QA means that you will never be stuck in an office all day not being able to meet people in other parts of your organisation. Your role means that you will be liasing with people from all parts of your organisation at all levels. You will meet people through auditing them in the laboratory and meet with management to discuss corrective actions. Working in QA is an excellent way to get to know all parts of the organisation and raise your profile.
Plan and organise your own workload and schedule
You will be required to plan audits and maintain schedules, which will be scrutinised by the regulatory authorities. The ability to prioritise your workload is very important, as you are likely to be involved in different projects and audits at the same time.
Acquire an in-depth understanding of how complex organisations work
Due to the unique position that QA hold with their 'umbrella' view, you will gain an understanding of many different areas and processes within your organisation and gain an understanding of how different parts of your organisation liase with each other.