In November 2017, the MHRA released a document that contained deficiency data from inspections carried out in 2016. It included the most common areas of deficiencies found during inspections in relation to the GDP EU Guidance 2013/C 343/01, as well as examples of deficiencies from each chapter.
The data showed that the top deficiency areas were:
–Quality Systems (1.2) at 22%
–Transportation (9.2) at 13%
–Responsible Person (2.2) at 12%
This was the largest deficiency area that the inspectors found, and it is probably the most crucial part to get right as it incorporates all of your operations, procedures, personnel and equipment. This means that it’s quite worrying that the Quality System is where the highest percentage of deficiencies are found.
Some examples of the deficiencies found in this area included:
– Contracts for third-party services being out of date.
– Some written procedures and processes were missing.
– Not enough detail included in some procedures/records.
– There was no formal review of any outsourced activities, including the contracts.
– Little to no evidence of implementation of some procedures (e.g. change control and risk assessments) – incomplete or no records.
Your quality system is the backbone of the company, so ensuring it is fully compliant is essential. Regular reviews of your system will help you to find if there is anything that is missing or out of date – the examples above should give you an idea of some of the deficiencies you should be checking for.
The next area where a lot of deficiencies were found was in Transportation, which relates to how the medicinal products are transported to and from the company, and includes any procedures/documents relating to it.
Some examples included:
– Within the contracts there were no descriptions of the responsibilities of each party or if there were they are not clearly defined.
– Uncalibrated equipment was being used for temperature monitoring.
– There was no evidence that the products were being transported at the correct temperatures (could have been deviations that impact the quality).
– Risk assessments for temperature controls were lacking in details and included assumptions about the UK climate.
– Ambient transportation was used that had no risk assessments performed or definition of responsibilities.
If the transportation is not properly risk assessed or monitored it will not only be a deficiency but could lead to a deviation in the conditions the products is kept in (e.g. temperature) which could mean that the integrity of the medicinal product is negatively impacted, making it a potential risk to patient safety.
Contracts must be in place that clearly define the responsibilities of each party when using a third-party for transport. The storage conditions of the products should be made clear and the vehicle must be assessed for suitability with calibrated equipment used for monitoring the conditions.
There must be evidence that there were no deviations during the whole of the transport process (e.g. temperature logs). You must always check for this before accepting any products.
The third largest area is Responsible Person (RP). Again, this is a very important area to be compliant in as the RP is responsible for the whole system so for it to be successful they must have a high standard of knowledge and understanding of GDP. Deficiencies in this area can cause high risks to patient safety and lead to your licence being suspended/revoked.
Some of the examples were:
– The RP was unable to show sufficient knowledge of the company’s GDP activities and procedures.
– The RP had not fulfilled their responsibilities meaning that the conditions of the licence were not complied with.
– A formal training record was not in place for the RP – no evidence of continuous training to gain further knowledge and competence in GDP.
These deficiencies will have a huge impact on the compliance of the company as the RP is responsible for everything within your QMS so it will start to fail if they’re incompetent in their role. It may put you on a path to losing your licence, particularly if there are no improvements when an inspector returns to check your progress after the initial inspection.
Through the tasks they perform the RP should be preventing deficiencies within all operations, as well as ensuring that any risks/deviations are identified so that they can be corrected/prevented quickly, which means that having an effective RP and QMS is crucial for compliance.
Initial and continuous training will be required to ensure that the RP has sufficient and updated knowledge of GDP which will enable them to successfully fulfil their responsibilities – they must keep track of any updates to the regulations/guidelines. A record of all past and future training will need to be kept and there must be evidence that they passed the training (e.g. a certificate).
If you are worried about deficiencies or are struggling with compliance, we can help. We can audit your site to find any problems and give advice on how to correct them. Our compliance support memberships allow you to benefit from a number of the services we offer, one of which is a Deputy RP that can guide you through GDP compliance.
We also run monthly two-day training courses on the GDP EU Guidance, which is required for RPs and useful for staff members to help with compliance.
Contact us at firstname.lastname@example.org for more information on the services we offer.
10 Mar 2020
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