As I enter my last week of work this year, all it leaves me to say is merry Christmas, I hope it is...
What GDP activities can be actioned in December?
What Good Distribution Practice (GDP) activities can be performed in December? Ideally these activities should be spaced out throughout the 12 months of the year, rather than trying to cram them in at the end. But the following are annual events that you need to complete, so it is better to get them done now, rather than miss out completely:
- Mock recall (if there hasn’t been a recall during the year)
- Management Review Meeting
- Staff training in GDP
- Self-inspections
Each of these elements plays a crucial role in ensuring Good Distribution Practice (GDP) compliance and maintaining high standards in the distribution of medicinal products. Here is why they are important:
Mock Recall
Even if there hasn't been a recall during the year, conducting mock recalls is essential. It helps identify potential weaknesses in the recall process, ensuring that the company is well-prepared to handle an actual recall efficiently and effectively. This practice helps to minimise risks and ensures regulatory compliance.
Management Review Meeting
Management review meetings are vital for continuous improvement. They provide a platform for senior management to evaluate the performance of the quality management system, identify areas for improvement, and ensure that the system aligns with the organisation's goals. Regular reviews help maintain compliance and drive operational excellence.
Staff Training in GDP
Training staff in GDP is crucial for ensuring that everyone involved in the distribution process understands the regulations and best practices. Well-trained staff are more likely to adhere to procedures, reducing the risk of errors and non-compliance. Continuous training also keeps staff updated on any changes in regulations or industry standards.
Self-Inspections
Self-inspections are an internal audit mechanism that helps identify and rectify any deviations from GDP standards before they become significant issues. Regular self-inspections promote a culture of quality and compliance within the organisation, ensuring that processes are consistently followed and maintained.
Together, these practices help create a robust quality management system that ensures the safe and effective distribution of medicinal products.
As with each month it is important to check for any regulatory updates and this month is particularly important due to the implementation of the Windsor Framework (WF) being implemented on 1st January 2025! The WF is too much to go into in this blog, but the MHRA have put out a load of information on their website – I would suggest that you review these and contact the MHRA if you think that you are going to have an issue.
Lastly, a merry Christmas to you all and a happy new year!