RECOMMENDED PV SOPS

SJ Pharma Consulting, LLC 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.

The SOPs have been utilized and adjusted over many years. They have been updated to comply with all the requirements of US, EU and UK PV legislation.

Numerous pharmaceutical companies are using what we have authored. The SOPs have passed regulatory inspections in the US, EU and UK.

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
Product Quality Complaints
Medical Information Enquiries
PSMF Development

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
Safety Data Exchange Agreements
Unblinding
Labeling Updates
Social Media
Business Continuity

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.
DS-012	PSMF Development	This SOP describes the activities and responsibilities required for the preparation, review, approval and maintenance of the Pharmacovigilance System Master File (PSMF)
DS-013	Safety Data Exchange Agreements	The scope of this SOP is the preparation and revision of Safety Data Exchange Agreements with business partners and subcontractors of the company.
DS-014	Unblinding	This SOP describes the steps for code breaking (revealing treatment assignment), distribution and reporting SUSARs.
DS-015	Product Quality Complaints	The SOP describes the handling of written and oral product quality complaints after the product has been released for distribution.
DS-016	Medical Information Enquiries	This SOP describes the process for documenting, processing and responding to medical information enquiries regarding the company’s medicinal products.
DS-017	Labeling Updates	This SOP describes the process for the receipt and maintenance of new or revised package inserts/labeling for approved products.
DS-018	Safety Data from Social Media	This SOP describes the process for handling safety data from company-owned social media.
DS-019	Pharmacovigilance Business Continuity Plan	This SOP describes the process that drug safety & pharmacovigilance will follow in the event of a facilities disruption or a disaster.
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.

The SOPS are available for $500 per SOP

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