Notes from MHRA GDP symposium 2009

The Medicines and Healthcare products Regulatory Agency (MHRA) organised a symposium regarding Good Distribution Practice on November 18th 2009. Isard Haasakker has attended that event in Manchester.

Topics discussed were:

  • Counterfeit awareness
  • Quality management systems
  • Developments in Europe
  • Risk based inspections
  • Temperature Control during storage and distribution

There were several workshops during the day and the input from the people at my table was very valuable for my focus on developing the Foxy Cola prototype system.

Most memorable quote of the day was “whatever you do, avoid any suspicion by asking the obvious questions”.

Regarding goods receipt, inspections are important in order to avoid accepting counterfeit medicine. Checks are related to the received documentation during the purchase process and the labels on the packages. Attention for detail regarding the name of the product, the strength, batch number, batch expiry dates and certificates.
Verifying the condition on arrival focuses on the fact whether the packages are still unopened. Another check will be to verify whether contamination could have been possible with other products that accompanies the transport.
The storage condition is vital, as cold chain medicine need to be processed with priority to ensure that the temperature restrictions are not violated and it is  expected to receive a temperature record during transport.

Regarding sales, checking the validity of the licence of the customer is vital. Although it is rare that licences are revoked, it could happen and you need to know. Of course you need to deliver the quantities that have been ordered, preferably in full and on time. Also it needs to be avoided to have large deviations between ordered and delivered quantities; especially avoiding to exceed the overdelivery tolerance is important. When sent medicine needs the sign-off of the Qualified Person, then supply that information to your customer along with the actual release data.

Regarding the returns process, it should also be able to cope with a recall. Also it is highly recommended to make a distinction between ambient and refrigerated products because the allowed customer return period differs. For ambient products customer can return within 3 days, whereas refrigerated products have a much shorter deadline being 24 hours.
Staff needs to be well trained when handling returns and recalls. It is advised to record that they have been trained for these disciplines.
By default returned medicine needs to be quarantined and inspected before deciding whether to bring the products back into saleable stock.
Regarding recalls, an annual dummy run is important; approach it like a fire drill you regularly have at your premises.
Traceability is of the utmost importance. You need to know the transactions linked to the range of batches that need a recall and you need to be able to report the percentage of products you were able to get back into your warehouse. So the reconciliation of units sold and units returned will decide the severity of the penalty by the MHRA.

Finally, irrespective you are dealing with vendors or customers, you need to ensure that they are bona fide.

What else was interesting to note?

  • Apart from vendors and customers, also consultants should expect rigorous checks. Therefore it makes sense that every consultant is able to supply a criminal record check.
  • Future white paper topics: insight on the terms ‘bona fide’ and ‘due diligence’
  • Quality Management Systems (QMS) focuses on effectiveness; so when a company uses spreadsheets to make business decisions, then it makes sense to check whether it can be replaced by functionality offered by ERP systems such as SAP.
  • Basic requirements of Standard Operating Procedures (SOP); for example structure the document to answer the following in sequence: who, what, where, when and why. Also a SOP is necessary regarding creating, issuing, releasing and withdrawing SOP’s.

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