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At SJ Pharma Consulting, LLC in Mendham, NJ, we have a 50-page audit checklist that includes cross-references to US, EU, and ICH drug safety laws, regulations, and guidance. We have also included the best practices for each checklist item.

Our checklist is designed to be utilized during PV audits to ensure an in-depth review of pharmacovigilance processes, staffing, tools, and organization as well as compliance with applicable regulations and guidelines.

Table of Contents

1Pharmacovigilance Strategic Intent5
2Structure Of The Phv Organization7
3Quality Management10
4Business Processes12
4.1Overall Case Processing12
4.2Receipt Of Reports14
4.3Clinical Trial Aes16
4.4Spontaneous Aes, Including Literature17
4.5Ae Assessment And Triage ? All Case Types17
4.6Ae Coding And Code Review18
4.7Data Entry Into Safety Database18
4.8Entry Of Narratives19
4.9Medical Review20
4.10Case Reports21
4.11Statistical Analysis/Signaling22
4.12Reporting (Expedited Reports, Psurs, Annual Ind, Dsur)23
5Standard Operating Procedures26
6.3Adverse Event Reporting System28
6.4Electronic Reporting29
8Appendix A: Regulations46
9Appendix B: Review Of Documentation49
Sops And Work Instructions49
3Rd Party Agreements49
Workflow Diagrams50
Organizational Charts50

Sample Page From the Checklist

4.2 Receipt of reports
1.How are AE reports received? Are back-up measures in place if technology fails? Is the fax machine “dedicated”?

Are trained health care practitioners used to query the initial reporters?

Who assesses medical inquiries to determine whether they may involve a hidden adverse event?

Is literature screening performed weekly? Does the company have provisions for screening national non-indexed journals?

Are all incoming cases checked to see if they are duplicates of existing cases or follow up to an existing case before a new record is create?

Are tracking numbers provided by other internal functions (i.e. medical information, quality, etc.)?

All those involved in classifying spontaneous reports should be trained to understand the relevant safety sections of the authorized product information and the company core safety information.

FDA recommends that sponsors make every attempt to obtain complete information during initial contacts and subsequent follow-up, and encourages sponsors to use trained health care practitioners to query the initial reporters. FDA suggests that the queries be focused on clinically relevant information associated with the product and the adverse event. Computer-assisted interview technology or other methods developed to target specific events can help focus the line of questioning. When the report is from a consumer, it is often important to obtain permission to contact the health care practitioner familiar with the patient’s adverse event to obtain further medical information and to retrieve relevant medical records, as needed.

Per GVP Module VI, the MAH is expected to maintain awareness of possible publications by accessing a widely used systematic literature review and reference database, such as Medline, Excerpta Medica or Embase, no less frequently than once a week, or by making formal contractual arrangements with a second party to perform this task; marketing authorization holders are also expected to ensure that relevant publications in each member state are appropriately reviewed.


FDA Good PhV Practices and Pharmacoepidemiologic Assessment”, March 2005 (Final)

Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products


ICH E6 (GCP) 5.5.1


21 CFR 314.80(b)
 Is appropriate case follow up performed by trained health care practitioners?FDA suggests that the intensity and method of case follow-up be driven by the seriousness of the event reported, the report’s origin (e.g., health care practitioner, patient, literature), and other factors. FDA recommends that the most aggressive follow-up efforts be directed towards serious adverse event reports, especially of adverse events not known to occur with the drug and that lack clinical information and other details important for case assessment.FDA Good PhV Practices and Pharmacoepidemiologic Assessment”, March 2005 (Final) (Section IV A)

FDA Guidance on
Postmarketing Safety Reporting for Human Drug and Biological
Products Including Vaccines (2001)

Appendix A: Regulations

This is a sample of the full set cross-references.

Approved Drugs
The basis for law for PhV of approved drugs
FDCA 505(k)
21 U.S.C. § 355(k)

Investigational Drugs
FDCA section 505(i) deals with the FDA Authority to regulate investigational drugs.
FDCA 505(i)
21 U.S.C. § 355

Biological Products
Biological products are regulated as drugs during the investigational stage.

21 U.S.C. §§ 312.2(a), 601.21

Approved Biological Products
For biological products approved under the PHSA, the FDA has been given the authority to set standards…

42 U.S.C. § 262(d), 21 U.S.C. §§ 352(a) and 352(f)(1)

Review of AEs
Investigators have no obligation to report to the FDA. Investigators must evaluate AE based on two criteria: whether the event is serious and whether it was caused by the drug.

21 CFR § 312.64(b)
Review of AEs
Sponsors report AEs to the FDA either (1) in Expedited Reports, or (2) as part of annual IND report.

21 CFR §§ 312.32-33
Expedited Telephone Reports
Sponsors must make a telephone IND safety report as soon as possible but in no event later than seven calendar days after the sponsor’s initial receipt of the reportable information.

21 CFR §§ 312.32(c)(2), 312.32(c)(1)(i)(B)

The PV AUDIT CHECKLIST is available for $500