What is an SOP?
SOP is the acronym for Standard Operating Procedure.
For those of you in pharmacy you will be familiar with SOPs, which are the backbone of your business.
Wholesale SOPs are much the same, and are the backbone of your Quality Management System (QMS).
So… what makes a good set of Wholesale SOPs?
The MHRA have high expectations of your Wholesale SOPs and will look for the following;
• Pagination – each page should be numbered “X of Y”, and include the SOP number somewhere on each page. Without this the SOP cannot be deemed “complete” and if a file is dropped it is possible to re-order and replace them in the right places.
• Easy to read – The SOPs must be in a language easily understood by your team members – whether this is English or not, Wholesale SOPs should be clear and unambiguous, and reflective of actual working practice.
• Wholesale SOPs must also be personalised to the operation. Commercially sourced wholesale SOPs are not acceptable and could give you a critical failure to comply with Good Distribution Practice.
• Version controlled – each Wholesale SOP should be controlled. First draft Wholesale SOPs generally start as v1.0 and evolve as the Wholesale SOPs are edited. Master copies should be kept by the RP/Management and when new Wholesale SOPs are issued the old ones should be decommissioned and stored for five years (as with any other records).
• Associated documents – should be mentioned, including any forms or appendices, or additional “guides” that relate to process described in the Wholesale SOPs.
• Definitions/glossary – potentially ambiguous terms or acronyms used (like GDP/Good Distribution Practice) should be explained.
• Process – the process should be explained as simply as possible… whilst giving the desired results every time “Less is more.” If you can describe your process in six lines it is better than sixty lines.
• Unambiguous dates – We often see Word documents that are written in American English and this can cause problems with dates. For example, writing 10/11/2014 would be read by an American as October 11th 2014, whereas in the UK we would read it as 10th November 2014. Try writing 10th Nov 2014 or 10th November 2014, to ensure your records are correct and there is no confusion.
This is just the tip of the iceberg.
Want to know more?
Need help with updating, or even creating, your Wholesale SOPs?
Contact us for a no obligation chat, and we can help review or fully draft your procedures, based on your working practices.
10 Mar 2020
2 Apr 2019
2 Apr 2019
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