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Recommended PV SOPs

SJ Pharma Consulting has authored a complete set of drug safety, pharmacovigilance and quality SOPs that meet the requirements for a global pharmacovigilance system. These have been deployed and refined over many years. They were recently adopted by a major pharmaceutical company prior to an FDA drug safety inspection, after which the company received no safety findings.

The Complete List of SOPs is as follows:
a) Processing Adverse Events and SAEs
b) Complaint Processing
c) Literature Searches
d) Aggregate Reporting
e) Manual Procedure for Handling Adverse Events
f) Dictionary Management
g) Quality Oversight of Safety Processes
h) Training
i) Signal Detection and Risk Management
j) Escalation of Safety Issues
k) QPPV Role and Responsibilities
l) Deviation Documentation
m) Glossary of Terms
n) SOP on SOPs
o) Good Documentation Practices
p) Management of Inspections
q) Document Retention

 

Detail Discription of Safety SOPs

Number Title Scope
DS-001 Processing Adverse Events and SAEs

The scope of this SOP is 1) Processing of postmarketing adverse events from any source, including but not limited to spontaneous reporting sources, active literature surveillance, phase IV studies, patient registries, patient assistance programs, and 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 retrospective entering of cases upon 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, and 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 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 staff who are engaged in activities related to adverse event processing are 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 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