SOP Writing And Reviews

Standard Operation Procedures, more commonly known as SOP's, are a crucial part of your quality system and without them you are not GDP compliant. The main purpose for an SOP is to clearly detail your procedures and should allow someone to walk onto your site and carry out all procedures in a compliant and efficient manner if they follow the document to the letter. This is often where companies receive deficiencies as their SOP's are lacking detail and are not specific to their operations. 

At Laing Pharma we can assist by writing bespoke SOP's alongside your management team. We do not sell off the shelf SOP's or even have set that we tailor to you, but each SOP is purpose-built for you and written from scratch specifically for your operation. We will work with you, going through your procedures and will draft the SOP's for your review to ensure they are exactly right. Following the EU GDP Guidelines 2013/C 343/01 and MHRA regulations, the SOP's will be the starting point for all personnel when performing their operation activity in a compliant manner. These will all be formatted specifically to how your business formats official documents and will be version controlled to sit with your previous documents. 

We are also available to review your current SOP's, ensuring they are in the correct format and look for holes that the MHRA inspector may find during an inspection. Often it is difficult to review your own documents, as you are so imersed that you need a new perspective to find missing details that won't be immediately obvious to yourself. 

Contact us to discuss your requirements and to see if this is the right service for you.