We see frequently that sites share their wholesale Standard Operating Procedures aka SOPs. This can be a good thing if the wholesale SOPs are of a high quality and are tailored for the specific site, or a significant problem if they are for a different business model or out of date (not following current guidelines).
A good way to upset your regulator or 3rd party GDP auditor is to have a set of poor quality documents you have copied that are not up to date with current guidance, contain errors, lack proper pagination, version control and are not in a language understood by the staff using them… or are not followed at all.
If you are a pharmacy wholesaler with GDP SOPs that mention a warehouse (and you have three storage shelves) or a fork lift truck, you may find yourself in hot water.
The three most common deviations noted by the MHRA as of February 2015;
Failures in temperature control and monitoring
Lack of or inadequate written procedures
Failure to implement the new EU Guidelines of 7th March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) as amended.
So… two of the three most common deficiencies touch on quality documents and SOPs.
How do you create a good quality management system? How do you get some decent SOPs?
Borrow/steal some documents from someone else? This might help, if they do exactly what you do. If not, this will mean deficiencies unless you plan on adapting them to your procedures.
Google “Wholesale Standard Operating Procedures”? Ok… Are they current? Are they GDP related? Are they up to date with 2013/C 343/01? If not they are irrelevant to you.
Pay a consultant? Does your consultant know what they are doing? Are they merely tailoring something that will get you into hotter water? We have seen this happen more than once, especially when you get a GMP consultant to produce your paperwork rather than a GDP consultant.
Use common sense and the EU GDP Guidelines 2013/C 343/01? Although the guidance tells you WHAT you need to do, it lacks the support on HOW to deliver it.
Ask the MHRA? As our regulator the MHRA are here to check for compliance, not to tell us what to do. We recommend that if you have a question for your inspector that you have at least one answer for your own question, e.g. “We are thinking of doing X… we were going to use Y as a process… is this something you would be happy with?” – we definitely do not recommend stating “I don’t know how to do X.”
In many ways some or all of the above might work for you, and pass you, but frequently all you will do is put something in place without really thinking about it or understanding what is needed and this could create risks.
So… what are some staple requirement of your wholesale SOPs?
– The SOPs must be understood by all personnel. It’s a good idea to have multiple translations into different languages if it will reduce confusion/deviations.
– Layout should be appropriate and consistent. The design of your documents should be a help, not a hindrance.
– SOPs must be controlled documents. Version control is essential with a focus on ensuring that the most up to date documents are in place, and when an old SOP is decommissioned all outstanding prior versions must be removed from circulation.
It is not uncommon to find multiple copies of differing versions of wholesale SOPs in a poorly controlled sites.
– Dates should be consistent and clear. Beware of “American dates” where month and day are reversed. We recommend writing the date like this “10th April 2015” rather than “10/4/2015” which our cousins across the pond will view as October 4th.
– When SOPs are changed (using change control protocols!) the impact on any associated SOPs and forms must be considered.
– Less is more! Why write extremely wordy and descriptive SOPs when you can use a few decent bullet points?
– Follow the processes of your business and ensure that your SOPs mirror them.
– Remember that as the RP you are responsible for approving and releasing all of the SOPs, as well as any changes made to them. Don’t make yourself look foolish by issuing documents that are incorrect, out of date and irrelevant to your procedures.
Do you know what you are doing with your wholesale SOPs?
Are you up to date with the current guidance?
Need assistance or a document review?
Contact us for a free, no obligation chat.
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