Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
What is a Risk Assessment (RA) in GDP?
Risk Assessment within a Good Distribution Practice Environment.
Good Distribution Practice (GDP) is the minimum standard that a wholesale distributor must meet to ensure that the quality and integrity of medicines are maintained throughout the supply chain.
Compliance with GDP ensures that medicines are stored, transported and handled under suitable conditions, as required by the marketing authorisation or product specification, and that contamination, mix-ups, adulteration and falsification are prevented. GDP also applies to the sourcing, storage and transportation of active pharmaceutical ingredients and other ingredients used in the production of medicines.
The QRM
One of the key elements of GDP is Quality Risk Management (QRM), which is a systematic process for the assessment, control, communication and review of risks to the quality of medicines. QRM should be based on scientific knowledge, experience with the process and ultimately link to the protection of the patient. QRM should be embedded throughout the quality system and be at the forefront of the minds of all employees.
A risk assessment is a tool to identify and evaluate potential sources of harm that could affect the quality of medicines or the performance of GDP activities. A risk assessment should consider both the probability and the impact of an unwanted event, and propose appropriate measures to prevent or mitigate it. A risk assessment should be documented, justified and approved by authorised personnel. A risk assessment should be reviewed periodically or when there is a significant change in the process or the environment.
How To Do A Risk Assessment
A risk assessment can be performed at different levels and for different purposes within a GDP environment.
For example:
- A risk assessment can be part of a wholesale distribution authorisation (WDA) application, to demonstrate that the applicant has identified and addressed the potential risks associated with their intended activities and products.
- A risk assessment can be part of a qualification and validation process, to ensure that the premises, equipment, transport vehicles, computerised systems and processes used for GDP activities are fit for purpose and comply with the relevant requirements.
- A risk assessment can be part of a supplier qualification and audit programme, to verify that the suppliers and service providers involved in the supply chain meet the expected standards of quality and reliability.
- A risk assessment can be part of a change control or deviation management procedure, to evaluate the impact of a planned or unplanned change on the quality of medicines or the effectiveness of GDP activities.
- A risk assessment can be part of a recall or withdrawal procedure, to determine the scope and urgency of corrective actions in case of a quality defect or a falsified product.
There are various methods and tools available for conducting a risk assessment, such as Ishikawa diagrams. The choice of method depends on the complexity and scope of the risk assessment, as well as the availability of data and resources. The method should be consistent, transparent and reproducible.
Risk Assessment Process
A risk assessment should follow four basic steps: risk identification, risk analysis, risk evaluation and risk control. Risk identification is the process of finding, recognising and describing potential sources of harm. Risk analysis is the process of estimating the likelihood and consequences of each identified risk. Risk evaluation is the process of comparing the estimated risk against given risk criteria to determine its acceptability. Risk control is the process of reducing or eliminating unacceptable risks by implementing appropriate measures.
A risk assessment should involve all relevant parties, such as managers, RPs, employees, and in some cases customers, suppliers and regulators. A risk assessment should be communicated to all parties affected by its outcome, and its results should be incorporated into decision-making processes. It should be monitored for its effectiveness and updated as necessary to reflect new information or changes in circumstances.
A risk assessment is not a one-off exercise, but a continuous improvement process that aims to enhance the quality and safety of medicines throughout their distribution.
By applying QRM principles and practices, wholesale distributors can ensure compliance with GDP requirements, protect patients from harm and add value to their business.
Not engaging Risk Assessments where it is required could create a scenario where the products’ efficacy could be compromised, thus endangering patient safety. The fallout from this may be an expensive recall in the very least or if a patient comes to harm, a suspension of activities pending an inspection. Either way, the cost may be exponential.
Further Assistance and Support
If you feel that the Risk Assessment procedure in your business is somewhat vague, loose, or unclear to your staff, contact us for a free 5 minute consultation on 0330 133 0920, or you can email us on info@paradigmshiftconsulting.co.uk. Alternatively, use the contact form at the foot of this page.
A short list of useful links are given below concerning topics that are associated with the subject of Risk Assessment.
Sources
Guidelines on Good Distribution Practice (GDP) 2013/C 343/01.
MHRA Guidance on Quality Risk Management. WHO Guidance on Good Data Management Practices.
MHRA Guidance on Applying for a Wholesale Distribution Authorisation.
EU Guidelines on Good Manufacturing Practice (GMP) Annex 15.
EU Guidelines on Good Distribution Practice (GDP) Chapter 7.
EU Guidelines on Good Distribution Practice (GDP) Chapter 1 – Quality Management.
EU Guidelines on Good Distribution Practice (GDP) Chapter 9 – Transportation.
ICH Q9.
ISO 31000.
EMA Reflection Paper on Quality Risk Management.
Gov.UK
MHRA