Pharmacovigilance Standard Operating Procedure Audits

Standard Operating Procedures (SOPs) are the individual quality control documents at the heart of your company’s operational policy and are reflective of your company’s structure and individual working practices.

However, when was the last time you thoroughly reviewed your SOPs or had them audited?

• Are you sure your processes are compliant with the current Pharmacovigilance regulations?
• Do you know if your company Standard Operating Procedures are being adhered to?
• Do you want to be inspection ready?

If you answered ‘Yes’ to any of the above questions, then Pure Drug Safety can help you with our comprehensive Standard Operating Procedures Audits.

We understand that face to face audits are difficult in the current climate, but to ensure the Pharmacovigilance regulations are being followed to the letter, our Standard Operating Procedures Audits are an excellent remote vigilance process to put in place to give you peace of mind.

Pharmacovigilance Standard Operating Procedure Audits from PDS

PDS will thoroughly examine your Pharmacovigilance SOP, comparing the content to the relevant good pharmacovigilance practices (GVPs) and any applicable local legislation.

Over several days, PDS will request internal documents from your staff as evidence to ensure that your SOP is being adhered to.

We will then provide you with a full report, reviewing each section of the SOP, referencing any regulatory deficiencies, any internal process errors and our recommendations for areas of improvement to ensure your SOPs are controlled, comprehensive and specific to your company’s drug safety system.

PDS is here to help you. Call us today on 01476 512395 or email: carol@puredrugsafety.com for a confidential discussion about your SOP Audit needs.