The Pharmacovigilance function is required to have a robust Quality Management System (QMS) and for this, one needs to have efficient standard operating procedures or SOPs. Apart from the SOPs, one can consider other documents, such as working practices (work instructions) or guidelines/guidance documents, as recommended in the QMS of the organization.

The list of SOPs required would depend on the scope of activities managed by the unit. Besides, this would also depend on the type of business entity, namely:

1. Marketing authorization holder
2. Wholesalers, licensing partners and Distributors
3. Service Provider
4. Regulatory Agency
5. Others

Following is the laundry list of SOPs that may be maintained by any of the above entities or units.

Case Management, Systems, and Benefit-Risk Management

1. Case Processing – Triage, Data Entry, Quality Review, Medical Review
2. Safety Submissions
3. Literature Management
4. Social Media Management
5. Aggregate Safety Management
6. Signal Management
7. Risk Management – RMP, REMS, RMM
8. PSMF Management
9. Safety Data Exchange Agreements

Local SOPs

1. Qualified Person for Pharmacovigilance
2. Website Management
3. Medical Information
4. Local Risk Management Measures

IT SOPs

1. Safety Database Management
2. Management of IT Systems used in Pharmacovigilance (in line with the PSMF Annex E)

Safety Labeling

1. Safety Variations
2. Urgent Safety Restrictions
3. Management of Safety information in product labels
4. Black triangle products and those with black box warnings

Oversight Related

1. Regulatory Intelligence
2. Website Management
3. Vendor Management
4. Self-Inspections

QMS SOPs

The following SOPs may not be specific to the Pharmacovigilance system but must be maintained.

1. SOP on SOP
2. Training Management
3. Management of Change Controls
4. Management of Incidents/Deviations
5. Corrective Actions and Preventative Actions
6. Management of Inspections
7. Internal Audits
8. Archival and Records Management
9. Data Integrity in Pharmacovigilance
10. Computer System Validation

Core SOPs

These SOPs are required for every Pharmacovigilance system, irrespective of the scope of its activities.