We see frequently that sites share their wholesale Standard Operating Procedures aka SOPs, which in some cases 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tailored for the specific site… or a significant problem if they are wholesale SOPs for a different business model, or out of date.
A good way to upset your regulator or 3rd party GDP auditor is to have a set of poor quality documents that you have copied and 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.
Google “Wholesale Standard Operating Procedures”? Ok… are they current? Are they GDP related? The first search result will only get you into a pickle… these are old documents, and not up to date with 2013/C 343/01. Most of the other results are irrelevant.
Pay a consultant? Does your consultant know what they are doing? Really? 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.
So… what are some staple requirement of your wholesale SOPs?
The SOPs must be in a language that is understood by the staff… plain English. It is reasonable to have multiple translations into different languages.
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, and a focus on ensuring that the most up to date documents are in place are essential, and when an old SOP is decommissioned that any and all outstanding prior versions are removed from circulation.
Dates should be consistent and clear… beware of “American dates” where month and day are reversed. We recommend writing a date this way “10th April 2015″ rather than “10/4/2015″ which our cousins across the pond will view as October 4th.
It is not uncommon to find multiple copies of differing versions of wholesale SOPs in a poorly controlled sites.
When SOPs are changed (under change control protocols!) the impact on 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 these processes.
Remember that as a responsible person YOU are responsible for approving and releasing all of your SOPs. Don’t make yourself look foolish by issuing rubbish.
Do you know what you are doing with your wholesaler SOPs?
Are you up to date with current guidance?
Need assistance or a document review?
Contact us for a free, no obligation chat.
Welcome to a new Paradigm!