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, and have been updated to comply with the requirements
of the recent EU PV legislation. They have been adopted by several pharmaceutical companies,
and have passed regulatory inspections in both the US and EU.

The Complete List of SOPs is as follows:

1 Processing Adverse Events and SAEs
2 Complaint Processing
3 Literature Searches
4 Aggregate Reporting
5 Manual Procedure for Handling Adverse Events
6 Dictionary Management
7 Quality Oversight of Safety Processes
8 Training
9 Signal Detection and Risk Management
10 Escalation of Safety Issues
11 QPPV Role and Responsibilities
12 Deviation Documentation
Numbe
Title 13 Glossary of Terms
Scope
r
14 SOP on SOPs
Processing Adverse
15 GoodThe
Documentation
scope of thisPractices
SOP is 1) Processing of postmarketing adverse events
Events and SAEs
from anyofsource,
including but not limited to spontaneous reporting
16 Management
Inspections
sources,
active literature surveillance, phase IV studies, patient registries,
17 Document
Retention
assistance
18 CAPApatient
processes
for PV programs, and 2) Processing of serious adverse event
reports from client-sponsored phase I, II, and III studies.
19 Regulatory Intelligence
DS-001

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

DS-003

Literature Searches

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.
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

The scope of this SOP is the consistent application of medically accurate

MedDRA Coding
terms when using MedDRA to assign codes to adverse events, and the
Conventions and
management and administration of medical terminology lists used to
Dictionary Management
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

CAPA processes
for PV

This SOP describes the Corrective and Preventive Action System (CAPA) as
it applies specifically to Quality Assurance (QA) Department audit findings
involving 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-007

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, documentation of the impact analysis, and the monitoring and
completion of required implementation activities by the business units

involved.