The Art of Writing SOPs - Part 1

Writing a Standard Operating Procedure (SOP) may seem an easy work but it becomes a time consuming task if you do not choose the right people, the right structure and streamline the revision phase.

In this article we will review some of the key elements for succeeding in creating SOPs.

In particular for Pharmacovigilance, and other regulated environments, having written procedures is a legal requirement. The SOPs are a set of documents that form a key part of the Pharmacovigilance Systems and their Quality Systems [GVP Module I].

The List of SOPs governing PV processes should be summarized in the Pharmacovigilance System Master File (PSMF) as explained in the GVP Module II - PSMF and will be always visible to regulators. GVP Module I describes the required minimum set of written procedures for pharmacovigilance.

Some considerations for writing a SOP are:

• Assign SOP writing to experienced people. Choosing the right people with the hands-on experience on the subject of interest or accompanying new team members on the process will be crucial. Subject matter experts will know the insights and will definitely make the difference in the quality and usefulness of the final document.

• Use the right structure. Normally you will start from a company SOP template that will dictate the content structure of the SOP, but you will have some flexibility inside the section called 'Process'. In this section a logical structure that divides the process in different phases is very useful (e.g. creation, review, approval, implementation, updates).

• Perform a thorough and critical evaluation. Since a SOP will dictate how people in your organization will conduct their activities, a conscious review is crucial to ensure a streamlined and seaming-less process.

• Make sure the SOP it is adequate for the purpose being created. 1. Addresses the key steps of the process; 2. Mentions the right people and the right resources involved 3. Defines an streamline and efficient process, covering critical steps but avoiding unnecessary actions.

• Reflect the current company practices with considerations to best-industry practices. Writing a process that does not have any relation to the current practices at a company, does not make sense. The SOP should reflect the current practices in a department and should consider industry best practices, guidelines and regulations to adapt company processes to these standards. For big changes, a consultation process with functions involved, may be critical for a smooth implementation and to understand any particulars or impediments that difficult the roll-out in order to fix them before or change the strategy defined in the SOP.

• Choose one author and the reviewers carefully. The author will be the owner or leader of the process and a subject matter expert in the field. She/he can collect feedback from their team mates and other functions and implement them into the process as well as consider any issues that need to be fixed coming from the CAPAs, audits and inspections.

• Avoid too many functions participating in the review. Too many eyes are not necessary and will complicate the review phase with multiple rounds of comments and changes. However, make sure that one representative from each key function participating in the process is included in the review.

• Part of que company quality system. Since SOPs are part of the company quality system, it would normally be expected that Quality people participate in their review and approval.

• Inspection readiness. SOPs are one of the main documents -may be the first ones- that are queried during an audit or inspection. They will give the auditors and inspectors the first impression of your department and organization on how things are being done. A good first impression is important and things like spelling or format mistakes should be avoided. A logically structured document will also help. Common findings in audits and inspection originate from the review of the written SOPs and these findings can be easily avoided when you write a Standard Operating Procedure. For example, normally you should define timelines for the key steps of the process but consider that any deviation from what it is defined by the SOP will be highlighted if discovered during an audit or inspection.

• Good balance between detail and flexibility. A good SOP provides enough detail to understand what key tasks and how should be performed and by whom but gives enough flexibility to the team to manage these tasks. Details can be covered in a work instruction, manual or guide.

Overall, having a good set of SOPs together with good documentation practices, compliance monitoring, training programs, CAPA and Deviation Management processes and audit plans will ensure a good Quality System behind your Pharmacovigilance activities and will make the big difference during audits and inspections.

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References:

EMA/541760/2011 Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems. 22 Jun 2012. https://www.ema.europa.eu/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-i-pharmacovigilance-systems-their-quality-systems_en.pdf Accessed Jan, 2021.

EMA/816573/2011 Rev 2. Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigilance system master file (Rev 2). 28 March 2017 https://www.ema.europa.eu/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-ii-pharmacovigilance-system-master-file-rev-2_en.pdf Accessed Jan, 2021.

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Largin Pharma Consulting provides support in the development of Pharmacovigilance SOPs. Contact with us for more information at laura.larru@larginpharmaconsulting.com