Good Documentation Practice
Documentation such as Standard Operating Procedures (SOPs) and records, are a crucial part of an effective Quality Management System (QMS). They make up all procedures, processes and evidence required for you to ensure that you’re in compliance with Good Distribution Practice. The MHRA will look for evidence of compliance within your QMS and all of your documents, so it’s essential that you put time and effort into making them suitable and keeping them up to date. They must be tailored to your business, so copying them from another company will mean that they are not compliant or effective.
All documents must be stored securely (e.g. using passwords or locked cabinets), with back up copies in different storage systems to prevent data loss. Personal data should always be kept confidential and only authorised personnel should have access.
Failure to maintain Good Documentation Practice will inevitably result in poor or incorrect or even non-existent documentation. This will be picked up in an inspection. Poor documentation accounts for a high percentage of GDP failings.
Without Good Documentation Practice your whole system could fail. Mistakes could be made that impact the integrity of products and put the safety of patients at risk.
Training, Backup and Support
Training on Good Documentation Practice will need to be given to the relevant personnel. It is also essential that training on understanding the procedures within the company is given to every person involved in any area of wholesale distribution. The RP must have further training that enables them to confidently approve and sign off every document, as well as advise any other staff members.
To attend our one-day face-to-face training courses, take a look at our training calendar. If you would prefer online training, take a look at our course list to find which are the most suited to your needs. Use the link buttons below to access the pages.
If you need help creating compliant documentation or guidance on how to improve any existing ones, get in touch with our team via the contact form below, or phone us on 0330 133 0920 for a free consultation.
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Related Courses
GDP for RPs and Management
GDP for RPs and Management covers topics that will help you with GDP compliance, such as Falsified Medicines, Deviations and Documentation. It gives more detail on what is included in the EU Guidelines 2013/C 343/01.
Introduction to Auditing
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.
Non-Conformance And Deviation Management (GDP)
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.
Data Integrity
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.
Online GDP Webinar – GDP for RPs and Management
An intensive one-day webinar covering all the chapters of the EU GDP Guidelines for RPs and Management. A successful pass on the final exam (hand-marked by us) will provide a certificate as evidence of training to a current and high standard.
Driver Training
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.
Warehouse Operational GDP & Thermal Compliance
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).
The Global Supply Chain
Almost all of us have received medicines from the pharmacy or at the hospital at some point in our lives, more often more than once. Only around a quarter of the medicines dispensed in the UK are manufactured in the UK, which means that the other three quarters have passed through continents, climates, and cultures to get here via different modes of transport.
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.
Good Distribution Practice Awareness – 2023/24
This training course is designed to give you a better understanding of Good Distribution Practice, covering a number of important topics such as documentation, the Quality Management System, Standard Operating Procedures, and deviations. A certificate of validation is available upon a final exam pass, which is presentable as evidence of training to the inspectorate.
GDP Obligations of the Licence Holder
In order to purchase, store, import, export or supply medicinal products a company must be in possession of a Wholesaler Dealers Authorisation (WDA) issued by the HMRA. A WDA cannot be issued without a Licence Holder having been nominated by the company.
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.
By the end of the course, you will have a thorough understanding of the role and responsibilities of the Licence Holder and how you as a Licence Holder can ensure full compliance with the guidelines and regulations in your organisation.
GDP for RPs and Management – Refresher 2026
GDP for RPs and Management covers topics that will help you with GDP compliance, such as Falsified Medicines, Deviations and Documentation. It gives more detail on what is included in the EU Guidelines 2013/C 343/01.
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