Self-Inspection and Third-Party Audits are an important part of maintaining compliance throughout the company.
During a self-inspection you should find any deviations or failures within your operations, and from there you can start to make improvements to your procedures and take actions to correct/prevent problems.
Self-inspection is required for GDP compliance, but the MHRA inspectors often find that they are either insufficient or not carried out at all (a deficiency).
Who can perform a Self-Inspection and Third-Party Audits?
The self-inspection doesn’t have to be carried out by the RP. Another sufficiently trained member of staff may be given the duty, as long as the RP is sure that they will carry out the inspection thoroughly and impartially. The RP’s Deputy would be a good substitute. If you are breaking down the inspection into each operation, choose staff members who are ‘experts’ in each particular area as this way they can be even more thorough.
However, it is still the RP’s responsibility to ensure that the inspection is carried out effectively. They should still be involved in both self inspections and third party audits, even if it is just at a minimum level such as overseeing the process and choosing the staff member(s) who carries out the inspection.
Self inspection and third party audits should review your compliance in all of your GDP activities against the EU Guidance for Good Distribution Practice for medicines for human use, 2013/C 343/01 as this is what the MHRA will use to ‘mark’ you against during their inspections. Using the guidelines means that you will be able to check that everything required for compliance in every area/chapter is being done and that all procedures/processes are effective, helping you to reduce risks/deviations that could impact human safety as well as preparing you for an MHRA inspection.
Audits that are carried out for you by third-parties (e.g. a friendly consultancy company) cannot replace self-inspections, but they can be extremely helpful, especially with showing you how to carry out a self-inspection in a way that is effective at finding any issues or areas of improvement and making sure you’re as ready as possible for an MHRA inspection.
Further Assistance and Support
Training on these guidelines and the QMS is essential not only for the person carrying out the self-inspection, but ALL personnel. Training records/plans will need to be reviewed during a self-inspection.
If you need guidance on how to carry out an effective self-inspection or if you would like assistance with Self-Inspection and Third-Party Audits, we can help.
We also offer a range of other services that may be of help to you including: Contract RPs or RP Deputies and online courses or face-to-face training sessions. Click on the link button below to view various courses we have available.
To find out more information and have a free consultation, get in touch with us using the contact form below. Alternatively you can call us on 0330 133 0920.
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Related Courses
GDP for RPs and Management
GDP for RPs and Management covers topics that will help you with GDP compliance, such as Falsified Medicines, Deviations and Documentation. It gives more detail on what is included in the EU Guidelines 2013/C 343/01.
Good Distribution Practice: Chapters 6-10 of the EU Guidance 2013/C 343/01
Introduction to Auditing
Discover the elements and requirements of Auditing. This programme aims to focus on the critical elements of the auditing process, showing you what to look for and to identify problems in the QMS or GDP of a licensed premises.
Data Integrity
This online Data Integrity course is aimed at new starters and existing staff as part of their ongoing Data Integrity training. This course provides a practical overview of the challenges and potential areas of non-compliance that are inherit within paper-based, electronic and hybrid data systems.
Online GDP Webinar – GDP for RPs and Management
An intensive one-day webinar covering all the chapters of the EU GDP Guidelines for RPs and Management. A successful pass on the final exam (hand-marked by us) will provide a certificate as evidence of training to a current and high standard.
Good Distribution Practice Awareness – 2023/24
This training course is designed to give you a better understanding of Good Distribution Practice, covering a number of important topics such as documentation, the Quality Management System, Standard Operating Procedures, and deviations. A certificate of validation is available upon a final exam pass, which is presentable as evidence of training to the inspectorate.
