Quality Management System and Standard Operating Procedures

Quality Management System

A Quality Management System (QMS) is defined as:

“The organisational structure, procedures, processes and resources needed to implement quality management.”

The backbone of the QMS is your Standard Operating Procedures (SOPs), which will we go over later.

Include an organisational chart listing the roles, responsibilities and duties of all personnel. It should be clear what department each person works in and who they report to.

Have quality and improvement meetings every month to review your Quality Management System, going over any changes, deviations, complaints, CAPAs, etc. This will help you to maintain compliance with GDP within your QMS and keep it updated. Manage and monitor any changes made, planning them before they are implemented, assessing the effectiveness and any impact on other areas.

Your personnel need to be competent and confident with their tasks and have a high standard of knowledge and understanding of GDP. The facilities will need to be suitable for the activities being carried out and the medicinal products stored them. Make sure equipment is serviced, maintained, calibrated and validated as required, and that they work effectively for the functions they are needed for.

Store all documents safely and accessibly, making sure they are available for at least 5 years. Have a backup system to prevent the risk of losing all records. The most up to date copies of each document must be used.

Remember if you haven’t documented it, you haven’t done it – evidence is crucial!

Wholesale Standard Operating Procedures

It is crucial that your SOPs are representative of your business’s processes and operations. We have seen companies sharing their SOPs! When the SOPs are of a high quality and are tailored to each company this will not be an issue, e.g; when templates for SOPs are shared. If they have not been changed to reflect your procedures and/or are of a poor quality this could cause serious issues, risking product quality and patient safety. Having SOPs that have been directly taken from another company will be easily picked up on during an MHRA inspection, and will be a serious deficiency.

Personnel must be able to easily understand the SOPs, so training on them is essential. To aid understanding and reduce the risk of deviations, make sure that you have copies printed in different formats (e.g. larger fonts) and languages where required. You will need to have a consistent, easy to read layout across your SOPs (with a template so new ones can easily be created). To ensure they are deemed complete, paginate each document using the ‘page x of y’ technique.

Use clear bullet points to describe each procedure and how it is carried out; there’s no need to go into too much depth on each one, using jargon that the personnel performing the tasks won’t be able to understand easily. The SOPs are there to ensure that all activities are carried out correctly and compliantly, so they need to be easy to follow.

SOPs are controlled documents. Use version control to ensure that the most current version of each document is used by the whole company. Decommission and archive the old version as well as any SOPs not in use anymore. We often find that in poorly compliant companies, they are using multiple versions of SOPs.

Every SOP needs to include the date it was created (along with the date of any updates), as well as when it should be reviewed, and that all dates should be clear. We recommend using this date format “10th Feb 2021”, as this “10/02/2020” could mean 2nd October in America causing confusion on when activities should be carried out which could lead to risks, deficiencies, and deviations.

When making changes to an SOP (following the change control procedure) you must consider/review the impact this could have on SOPs and forms relating to the one being updated – these must also be changed accordingly when required.

Your RP has the responsibility of approving, signing and releasing all new SOPs and any changes that are made to existing ones. Each will need to be checked over carefully, ensuring that the information within is correct, up-to-date and reflective of the company’s activities.

 

If you need help creating or reviewing your Quality Management System and/or SOPs, we can help! Use the contact form at the foot of this page to get in touch with your requirements and business model to arrange a free consultation to discuss our services.

Do you or your staff need GDP training? Take a look at our online training site.