Everything you need to know about a GxP compliance checklist
07 May 2019
A GxP compliance checklist can have a positive impact on your organisation. However, to be effective you must first understand the term ‘GxP’ which is an abbreviation for Good Practice.
As a phrase, it's completely vague and tells businesses nothing about how they should be meeting quality guidelines and regulations. The 'x' can stand for an 'L' for laboratory, an 'A' for agricultural, a 'T' for tissue, a 'D' for distribution, and so on.
As such a broad, overarching label applicable to a string of industries, it's worth getting to the core of what GxP compliance actually means. What should a 'good' business be doing, regardless of their 'x' specifics? Which 'practices' should you even be looking at?
Find out with our GxP compliance checklist.
Getting to square one
The specific quality regulations affecting a laboratory will be very different from those of a clinic, farm or manufacturer. However, almost any organisation can work to the generic requirements of GxP compliance, no matter what industry they're in.
Ultimately, GxP's purpose is to allow businesses to guarantee the integrity, safety and quality of the products and services they provide to their customers, through traceable, accountable policies, processes and procedures. Can you completely trace the development history of the products your customers receive from you? You’ll also want to ensure you can pinpoint who contributed to their development, and how, from start to finish.
This is the 'square 1' of GxP, around which GDP, GMP, GFP and so on are built.
GxP compliance checklist
Use this GxP audit checklist below to gauge your business's ability to meet the core and generic requirements of GxP. If you can answer 'yes' to each question, your business has a firm GxP base with which you can tackle your industry-specific 'x' requirements.
Obviously, the core GxP requirements of traceability and accountability require a functional document management system. Here are the key documentation questions to ask yourself when driving a GxP operation:
- Do we have an existing documentation control system?
- Is there a dedicated physical or electronic repository for the storage of live and archived documents?
- Does that repository have controlled access?
- Is the document repository maintained, monitored and under control by dedicated personnel?
- Are all changes to documents audit-trailed, with superseded versions replaced and stored?
- Is there a Standard Operating Procedure for the storage, review, retention, and archiving of documents?
- Do we have a policy / process for guaranteeing the security of all business data and documentation?
- Is there an electronic archive / back-up system for business documentation?
Since GxP primarily concerns itself with the integrity of products reaching your customers, the equipment used to produce, store and/or move those products is particularly significant for GxP operation.
- Do we have a documented process for validating and qualifying the equipment our organisation uses?
- Do we have a central equipment and asset inventory, including instruction and operation manuals?
- Do we have established, agreed and standardised tolerance limits for equipment and asset health?
- Is there a method for continually monitoring health?
- Do we have a documented process for replacing equipment or assets whose health falls outside the agreed tolerance limits?
- Are there documented and visible calibration and maintenance schedules?
- Does each maintenance and calibration event have an accompanying log capturing the time and date, relevant personnel?
- Are the records or equipment and assets, calibration and maintenance, securely stored and traceable?
Processes & procedures
'Practice' ultimately boils down to the processes and procedures within your business. Standardised, visible, documented processes that your team understand how to follow are key for GxP.
- Do we have a central listing of all live Standard Operating Procedures (SOPs)?
- Are SOPs available in their relevant business locations?
- Do we have an overarching SOP governing how other SOPs are drafted, revised, distributed, controlled and archived?
- Is there an SOP review schedule to ensure SOPs remain up-to-date, compliant and fit for purpose?
- Is there a change control system should amendments have to be made?
- Are deviations from standard procedures fully documented?
- Are corrective and preventative actions (CAPAs) fully documented alongside their relevant SOPs?
As the old cliché goes, the most important part of an organisation.
(And of GxP compliance!)
- Are all staff properly trained to perform the functions and activities of their roles? Is training associated with the relevant SOP(s) for that employee?
- Does each employee have an associated record of their training, preferably directly accessible by that employee?
- Does each employee have a documented training matrix and plan, preferably directly accessible by that employee?
- Do we assess and document the competency of employees on a regular basis?
- Do we have an accurate organisational chart?
- Do we have a quality function/department within the business?
- Can employees quickly and easily raise issues, incidents, concerns and near misses to the quality department, should they wish to do so?
- Are our consultants, contractors, suppliers, vendors and other third parties properly certified, trained and approved for that function?
Environment, health and safety
Guaranteeing a safe, efficient working space with good EHS control is the next component of GxP.
- Is our office, warehouse, manufacturing site and general working facility clean and properly maintained?
- Do we have operational environmental controls, and are they regularly audited?
- Do all our staff have access to the correct safety equipment and PPE required for their role?
- Do we have documented cleaning, sanitation and waste disposal SOPs?
- Do we have a properly maintained space for documents, equipment and assets?
Information security and validation
Every modern business operates electronically to some extent - so GxP extends into the digital space too.
- Are our computer systems password-protected with individual user log-ins?
- Do we have a live and visible information security policy?
- Are our computer systems regularly backed up to prevent loss of data?
- Do we have a continuity plan in place for IT disruption?
- Are all computer system changes, maintenance actions, errors and repairs recorded?
- If we use software to automate and manage our operation – has that software been fully validated for use?
Q-Pulse is Ideagen’s quality management software. It provides you with a centralised system to manage every aspect of GxP compliance. It answers the requirements outlined in the checklist:
- As an electronic document control system with controlled access
- A centralised storage system for equipment records which is easily accessed and maintained
- Streamlining business practices
- Keeping all employee records and training details stored centrally
- Control EHS processes
- Ensure the safety of electronic information
Find out how Q-Pulse can help you manage your GxP compliance checklist.