Can procedures impact the number of deviations?
Deviations arise when unforeseen events or problems deviate from an approved GMP process and/or from what is required/accepted in the GMP area.
One of the reasons why people deviate from a GMP process is that it is not effectively and clearly explained in the SOP . This can cause lack of understanding on the part of staff and misinterpretation of the process, which can then result in deviations.
How do we write efficient procedures?
We have identified 6 useful tips.
Say what you do. When writing the SOP, describe what you do and outline the steps taken to achieve compliance with a regulatory requirement.
Do what you say This is equivalent to following the standard procedure.
Prove it. This means collecting and being able to present data demonstrating that you have followed the instructions in the procedure and have investigated any incidents in which you have deviated from those instructions.
Improve it. Once you have mastered the first three concepts, you can start working on the concept of “improvement” by reviewing and updating your procedures to reflect current practices and process refinements.
Writing an SOP with the correct amount of information, neither too restrictive nor too ambiguous, is not an easy task. It takes time and effort to create an SOP with the right balance of information.
Procedures should have the correct amount of information for keeping the process under control and reducing deviations. An example of an SOP with too much information would be one that lists the serial number of a piece of equipment. If the equipment has to be changed for any reason, this will result in a deviation. An example of ambiguous information is not indicating the specific order in which reagents must be added to generate a reaction. If it is important to add the reagents in a certain order, this information must be specified in the SOP.
When writing an SOP, it is a good idea to keep in mind the target audience and adapt the language to the intended audience. In any event, we should avoid overly technical language in favour of clarity and precision. We should also aim for concise and action-oriented sentences.
This links back to point 3, namely keeping the audience in mind and checking whether they actually understand the SOP. How do we do this? For instance, by involving the end user in the review phase and then analysing quantitative and qualitative data, such as the number and type of wrong answers during training, the implementation of the process described in the SOP on a target group and the number and type of deviations related to the SOP.
Paragraphs that contain too much information are difficult to read. One suggestion is to add an extra paragraph to make the information more user-friendly and to use bullet points, images and graphics to make it even clearer.
Keep track of the revision history and ensure that the current version of the SOP is available to everyone involved. Obsolete procedures represent a very serious error, which can be particularly common in companies that use a paper SOP system. A digital system, on the other hand, automatically blocks the obsolete version, making only the current version available centrally to all staff involved.
References: S. Schniepp, “Writing Effective SOPs,” Pharmaceutical Technology 44 (10) 2020, https://www.pharmtech.com/view/writing-effective-sops
PRAGMA4U is a modular and scalable Workflow Management System platform that digitises work processes in compliance with FDA and cGxP guidelines.
It enables companies to: have documentation that is protected, always up-to-date, organised and linked to the source processes; assign and implement workactivities directly on the platform; easily share information between departments; keep processes under control using KPIs; and compile reports and dossiers that will be useful for inspections.
The platform can contain multiple processes, creating a true digital map of the company. It also integrates with other systems, such as ERP, simplifying the compilation and updating of data.
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Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.
The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.
PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.
During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes
It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.
The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.
PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.
Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes