Recommended PV SOPs


SJ Pharma Consulting, LLC in Mendham, NJ has created a full set of standard operating procedures for drug safety, pharmacovigilance, and quality. Our SOPs satisfy the requirements of a global pharmacovigilance system.

This set has been utilized and adjusted over many years. It has also been updated to comply with the requirements of the recent EU PV legislation.

Numerous pharmaceutical companies are using what we have authored. It has also passed regulatory inspections in the US and EU.
 

The Complete List of SOPs

 
  • Processing Adverse Events and SAEs
  • Complaint Processing
  • Literature Searches
  • Aggregate Reporting
  • Manual Procedure for Handling Adverse Events
  • Dictionary Management
  • Quality Oversight of Safety Processes
  • Training
  • Signal Detection and Risk Management
  • Escalation of Safety Issues
 
  • QPPV Role and Responsibilities
  • Deviation Documentation
  • Glossary of Terms
  • SOP on SOPs
  • Good Documentation Practices
  • Management of Inspections
  • Document Retention
  • CAPA Processes for PV
  • Regulatory Intelligence
 
 

Detailed Descriptions of Safety SOPs

 
Number
Title
Scope
DS-001
Processing Adverse Events and SAEs
The scope of this SOP:
1. Processing of post-marketing adverse events from any source, including but not limited to spontaneous reporting sources, active literature surveillance, phase IV studies, patient registries, and patient assistance programs
2. Processing of serious adverse event reports from client-sponsored phase I, II, and III studies
This SOP begins with the receipt of a potentially valid adverse event report and ends with the appropriate reporting of the adverse event information to stakeholders.

Processing of non-serious adverse event reports from company-sponsored phase I, II, and III studies is out of the scope of this SOP.
DS-002
Complaint Processing
The scope of this SOP is the intake and appropriate management of product-related information received from any source (including call center, phone, fax, email, etc.). The information received may involve product complaints, adverse events, medical inquiries, or other subjects.
This SOP begins with the receipt by the company of product-related information and ends with the routing of the information to the appropriate parties either within the company or to a designee.
DS-003
Literature Searches
The scope of this SOP is routine surveillance of scientific and medical literature in accordance with applicable laws to detect adverse event case reports and other relevant drug safety information.
This SOP begins with the establishment of search parameters and ends with the receipt of an article or abstract that is ready to be processed.
DS-004
Aggregate Reporting
The scope of this SOP is the preparation and management of US periodic reports, PSURs, IND Annual reports, and DSURs.
DS-005
Manual Procedure for Handling Reported Adverse Health Events
The scope of this SOP is manual processing of adverse event cases when the safety database is unavailable.
This SOP begins with the determination that manual case processing should begin and ends with the retrospective entering of cases upon the availability of the safety database.
DS-006
MedDRA Coding Conventions and Dictionary Management
The scope of this SOP is the consistent application of medically accurate terms when using MedDRA to assign codes to adverse events. The scope also includes the management and administration of medical terminology lists used to classify adverse event information.
DS-007
Quality Oversight of Safety Processes
The scope of this SOP is periodic reviews to ensure that the processes related to patient safety and compliance with all applicable regulations are satisfactorily performed. This SOP also ensures that findings noted during reviews are satisfactorily addressed.
DS-008
Training
The scope of this SOP is the establishment and execution of training requirements to ensure that the staff engaged in activities related to adverse event processing is adequately trained.
DS-009
Signal Detection and Risk Management
The scope of this SOP is the assessment of and update to the risk-benefit profile for company products both on the market and in clinical development.
DS-010
Escalation of Safety Issues
The scope of this SOP is the management of the escalation of safety issues both within the company and beyond to all affected stakeholders.
DS-011
QPPV Role and Responsibilities
This SOP describes the role and responsibilities of the QPPV and Deputy for marketed products.
QA-001
Deviation Documentation
The scope of this SOP is the management, processing, review, approval, and closeout of SOP deviations, planned or otherwise.
QA-002
Glossary of Terms
The scope of this SOP is a global list and associated meaning for commonly used terms and acronyms.
QA-003
SOP on SOPs
The scope of this SOP is the format, responsibilities, approval, periodic review, obsolescence, maintenance, and usage of controlled documents.
QA-004
Good Documentation Practices
The scope of this SOP lists the minimum standards for good documentation practices and ensures that errors are properly corrected and noted as to their nature.
QA-005
Management of Inspections
The scope of this SOP includes the responsibilities, conduct, and activities during the US and European regulatory inspections and post-inspection responses to findings and observations.
QA-006
Document Retention
The scope of this SOP is the retention of Product Safety Records.
QA-007
CAPA Processes
for PV
This SOP describes the Corrective and Preventive Action System (CAPA) as it applies specifically to the Quality Assurance (QA) Department audit findings that involve deficiencies or deviations found regarding regulations or established practices and procedures of the pharmacovigilance system activities or any external vendors and/or contractors responsible for outsourced pharmacovigilance activities.
QA-008
Regulatory Intelligence
This SOP describes the process to screen and assess new or updated Pharmacovigilance (PV), Clinical, and Regulatory Affairs (RA) regulatory policy documents on a regular basis for potential impact on company procedures, the documentation of the impact analysis, and the monitoring and completion of required implementation activities by the business units involved.