What are Standard Operating Procedures?
Standard Operating Procedures (SOPs) are the documents that will set out all of the procedures used by your company, meaning they should mirror these processes. They are the backbone of your company’s Quality Management System (QMS).
If they aren’t clear, complete, correct and up to date the whole system could fail, risking your licence being suspended as deficiencies will be found during an MHRA inspection.
When creating them you should use the EU GDP Guidelines 2013/C 343/01 to guide you on what you need to do, however, it does not give guidance on HOW to do it which means that you must make sure that you are researching and getting training/advice to ensure full Good Distribution Practice compliance.
All SOPs must be tailored to your company’s activities meaning that they can’t be taken from another company or the internet, especially if you don’t plan on adapting them. This may seem like a quick and easy trick to creating your QMS but in reality it could cause deficiencies which will each create further problems and take more time to fix. It can take a while to create good quality SOPs but it will become easier with time and experience, and there’s nothing stopping you getting advice from those platforms (or a friendly consultancy company).
Every SOP should be in language that is understood by all personnel with no complex words/jargon used if it is not necessary to do so. If needed, copies of all documents should be translated into different languages as this will ensure there is no confusion, and all members of staff will have access to SOPs that they can easily understand.
To ensure that the correct most up to date version of an SOP is being used, you must use a version control system. It should be made clear that if changes are made to an SOP and the version is subsequently updated (and before the change can be approved), change control procedures should be carried out to assess any impacts it may have.
All members of staff will need to be trained on the company’s SOPs, particularly the ones that apply to their job role/tasks, as this will ensure that they are understood and followed correctly. Training will help to prevent deviations occurring and protect patient safety. If new SOPs are introduced or major changes are made, re-training will be needed for all personnel it will affect.
The RP will be responsible for approving and signing all new SOPs and any changes to existing ones, so they must understand the SOPs and the process of creating/adapting them. They need to be able to identify if they are incorrect or need adapting. Training on SOPs is crucial.
Further Assistance and Support
If you need help creating or reviewing your Standard Operating Procedures, or you need Good Distribution Practice training, contact us using the form below to arrange a consultation. Also, visit our online training courses selection via the link button.
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Related Courses
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In this training course we will cover the obligations of a Licence Holder with regards to EU Good Distribution Practice (GDP) Guidelines and Human Medicines Regulations 2012.
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The pharmaceutical global supply chain sees the flow of medicinal products around the globe, from API’s (active pharmaceutical ingredients) imported from one country, packaged in another, and re-exported world-wide, or simple business to business transactions of a finished product.
This course will help you fully understand the distribution process, attain the level of quality risk management that meets GDP regulatory requirements, and thus ensure the lowest possible risk to patient safety.
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Warehouse Operational GDP & Thermal Compliance is of critical important to the quality, efficacy and safety of the product and consequently, to the patient - the end user. For any warehouse to meet the standards of compliance expected, it is essential that all areas of operation are engaged correctly, fully and in accord with the established SOP's and QMS (Standard Operational Procedures and Quality Management System).
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The Driver Training Course is for all drivers, logistics personnel and transport/shipping supervisors involved in the vehicular transportation of medicinal products, and will help you attain GDP awareness and compliance observance.
It is during the transportation of medicines that the products are at highest risk. This course provides tuition on how to minimise risk to the products when in transit, and how it should be handled.
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This online Data Integrity course is aimed at new starters and existing staff as part of their ongoing Data Integrity training. This course provides a practical overview of the challenges and potential areas of non-compliance that are inherit within paper-based, electronic and hybrid data systems.
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Discover the elements and requirements of a compliant Non-Conformance and Deviation management system. This programme aims to focus on the critical elements of the Non-Conformance and Deviation process and on implementation, correct procedure, where it could go wrong, risks and correct documentation.
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Discover the elements and requirements of Auditing. This programme aims to focus on the critical elements of the auditing process, showing you what to look for and to identify problems in the QMS or GDP of a licensed premises.
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