PHARMACOVIGILANCE AUDIT CHECKLIST

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.

1	Pharmacovigilance Strategic Intent	5
2	Structure Of The Phv Organization	7
3	Quality Management	10
4	Business Processes	12
4.1	Overall Case Processing	12
4.2	Receipt Of Reports	14
4.3	Clinical Trial Aes	16
4.4	Spontaneous Aes, Including Literature	17
4.5	Ae Assessment And Triage ? All Case Types	17
4.6	Ae Coding And Code Review	18
4.7	Data Entry Into Safety Database	18
4.8	Entry Of Narratives	19
4.9	Medical Review	20
4.10	Case Reports	21
4.11	Statistical Analysis/Signaling	22
4.12	Reporting (Expedited Reports, Psurs, Annual Ind, Dsur)	23
4.13	Labeling	24
4.14	Archiving	25
5	Standard Operating Procedures	26
6	Systems	27
6.1	Cdms	27
6.2	Ctms	27
6.3	Adverse Event Reporting System	28
6.4	Electronic Reporting	29
7	Surveillance	30
8	Appendix A: Regulations	46
9	Appendix B: Review Of Documentation	49
	Sops And Work Instructions	49
	3Rd Party Agreements	49
	Workflow Diagrams	50
	Organizational Charts	50

Sample Page From the Checklist

	AREA OF ASSESSMENT	BEST PRACTICES	REGULATIONS
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 E2D ICH E6 (GCP) 5.5.1 CIOMS VI 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.

#	Topic	Notes	FDCA	U.S.C.	CFR
1	Approved Drugs	The basis for law for PhV of approved drugs	FDCA 505(k)	21 U.S.C. § 355(k)
2	Investigational Drugs	FDCA section 505(i) deals with the FDA Authority to regulate investigational drugs.	FDCA 505(i)	21 U.S.C. § 355
3	Biological Products	Biological products are regulated as drugs during the investigational stage.		21 U.S.C. §§ 312.2(a), 601.21
4	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)
5	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)
6	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
7	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)

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PHARMACOVIGILANCE AUDIT CHECKLIST

Table of Contents

Sample Page From the Checklist

Appendix A: Regulations