Adverse Events

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1.0 Purpose 
 
 The purpose of this procedure is to define the requirements for Adverse Event reporting. It is
 intended to ensure compliance to FDA Dietary Supplement and Nonprescription Drug
 
 Consumer Protection Act as it applies to 21 CFR 111 (Subpart O) and 21CFR Part 211 and
 
 establish and implement a system for reporting adverse incidents as a basis for effective
 identification and evaluation of adverse events, and timely submissions of Forms to the FDA
 
 and/or Canadian Authorities. 
 
 2.0 Scope 
 
 This procedure pertains to all dietary supplements (human and pet), or OTC products that are
 
 produced by Ion Labs, Inc. as a contract manufacturer on behalf of a customer. The customer
 is responsible for adverse event reporting unless a specific agreement has been signed by both
 
 parties, transferring responsibility to Ion Labs, Inc. Regarding reporting, Ion Labs will
 collaborate with the customer, when necessary. 
 
 3.0 Responsibility 
 
 3.1 ‘It is the responsibility of Quality Management to implement, maintain and enforce this
 procedure. Quality Management is also responsible for determining if event reporting
 
 is warranted. 
 
 3.2 It is the responsibility of Production Management to assist with the investigation
 
 associated with any Adverse/Serious/Unexpected Adverse Event. 
 
 4.0 Definitions 
 
 4.1 Dietary Supplement — A product intended for ingestion that contains a dietary
 
 
 

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 ingredient intended to add further nutritional value to supplement the diet
 
 4.2 OTC — Over-the-Counter Drug; drugs that have been found to be safe and appropriate
 
 for use without the supervision of a health care professional such as a physician, and
 can be purchased by consumers without a prescription. 
 
 4.3 Disability — A substantial disruption of a person’s ability to conduct normal life
 functions. 
 
 4.4 Initial Reporter — The person who first notifies the responsible person about the
 serious adverse event and can be the injured person, a family member, or some other
 
 person (e.g., doctor, pharmacist). 
 
 4.5 Life-Threatening Adverse Event — Adverse events that place the person, in the view
 of the initial reporter at immediate risk of death from the serious adverse event as it
 
 occurred. Drug Related: Life-threatening Adverse Drug Experience: Any adverse
 drug experience that places the patient, in the view of the initial reporter, at immediate
 
 risk of death from the adverse drug experience as it occurred, i.e., it does not include an
 adverse drug experience that, had it occurred in a more severe form, might have caused
 
 death. 
 
 4.6 Non-serious — Drug Related: Any Adverse Experience that is not fatal or life
 threatening that does not require inpatient hospitalization or prolonged hospitalization
 
 or is not permanently or severely disabling, or is not a congenital anomaly or does not
 jeopardize the patient/subject and/or is not an overdose. 
 
 4.7 Responsible Person — The manufacturer, packer, or distributor whose name appears on
 the label of a dietary supplement, or OTC marketed in the US and who is required to
 
 submit to FDA all serious adverse event reports associated with use of the dietary
 
 supplement in the US. 
 
 4.8 Adverse Event — Any health-related event associated with the use of a dietary
 
 supplement, or OTC that is adverse. 
 
 4.9 Serious Adverse Event — Results in death, a life-threatening experience, inpatient
 
 

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 hospitalization, a persistent or significant disability or incapacity, or a congenital
 
 anomaly/birth defect or one that requires medical or surgical intervention to prevent
 
 such serious outcomes. 
 
 4.10 Serious Adverse Drug Experience — Any adverse drug experience occurring at any
 
 dose that results in any of the following outcomes: death, a life-threatening adverse
 drug experience, inpatient hospitalization or prolongation of existing hospitalization, a
 
 persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
 
 Important medical events that may not result in death, be life-threatening, or require
 hospitalization may be considered a serious adverse drug experience when, based upon
 
 appropriate medical judgment, this may jeopardize the patient or subject and may
 require medical or surgical intervention to prevent one of the outcomes listed in this
 
 definition. 
 
 4.11 Unexpected Adverse Event or Unexpected Suspected Adverse Reaction — An
 adverse reaction, the nature or severity of which is not consistent with the applicable
 
 product information and is not consistent with the risk information described in the
 general investigational plan or elsewhere in the current application. Drug Related:
 
 Unexpected Adverse Drug Experience: Any adverse drug experience that is not listed
 in the current approved labeling for the drug product. This includes events that may be
 
 symptomatically and pathophysiologically related to an event listed in the labeling but
 
 differs from the event because of greater severity or specificity.
 
 5.0 References 
 
 5.1 QS-101, SOP, Complaints 
 
 ew QS-101-F1, Form, Complaint Report Form 
 
 5.3 QS-112, SOP, Core Quality Systems and Quality Events 
 
 5.4 C-502, SOP, Record Storage, Retention, and Destruction 
 
 5.5 FDA SRP — Safety Reporting Portal 
 
 

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 5.6 FDA Guidance for Industry, Questions and Answers Regarding Adverse Event
 
 Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary
 
 Supplement and Nonprescription Drug Consumer Protection Act. 
 
 Information can be found at: 
 
 5.6.1 http://www.fda.gov/food/ guidanceregulation/guidancedocumentsregulatoryinfor
 mation/ucm171383.htm 
 
 5.7 Adverse Event Reporting Guidance, American Herbal Products Association (AHPA)
 
 5.8 The US FDA CFSAN (Center for Food Safety and Applied Nutrition) -Adverse Event
 
 Reporting System supports information regarding adverse events and complaints for
 
 Dietary Supplement. 
 
 39 Health Canada Adverse Reaction Reporting System - MedEffect Canada/Canada
 
 Vigilance Program (Reference Guidance Document for Reporting Adverse Events for
 Marketed Products via the Marketed Health Products Directorate). 
 
 5.10 MedWatch -FDA Safety Information and Adverse Event Reporting Program for drug,
 device, food and cosmetics. MedWatch Form FDA 3500A is used by Facilities,
 
 Importers, Distributors and Manufacturers for Mandatory Reporting.
 
 6.0 Procedure 
 
 6.1 Reference FDA’s Guidance for Industry “Questions and Answers Regarding Adverse
 
 Event Reporting and Recordkeeping for Dietary Supplements as Required by the
 Dietary Supplement and Nonprescription Drug Consumer Protection Act” and AHPA’s
 
 “Adverse Event Reporting Guidance” for assistance in assessing adverse events for
 
 FDA reportability. 
 
 6.2 The VP of Quality and Regulatory Affairs or designee reviews the adverse event
 
 information obtained to verify that minimum information was documented and reflected
 in the Complaint Report, Form QS-101-F1 (for completing corresponding sections of
 
 FDA MedWatch Form 3500A). 
 
 

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 6.3 Adverse Events are governed by the SOP QS-112 (Core Quality Systems and Quality
 
 Events) and may be documented and investigated under the Complaint Handling
 
 System. Complete all applicable sections of the FDA MedWatch Form 3500A
 electronically on the FDA.gov web site. Reference “FDA-3500A General Instruction
 
 (Excluding Device Sections). 
 
 6.4 If the required information is incomplete, at least three attempts to collect the
 
 information must be made and documented on the Complaint Report. 
 
 6.5 A decision must be made as to whether the event meets the definition of a Serious
 Adverse Event. A licensed physician may be contacted for consult to assess the
 
 seriousness. 
 
 6.6 Serious Adverse Events must be reported to FDA no later than 15 business days after
 
 the report is received by the responsible person. 
 
 6.6.1 Note per FDA: A report of each adverse drug experience that is both serious and
 
 unexpected must be made to FDA as soon as possible, but no later than 15 days
 after receiving information about the event. Persons required to file such 15-day
 
 Alert reports are also required to investigate and submit any new information to
 
 FDA. 
 
 6.7 A serious adverse event report must be submitted to FDA using one of the following
 
 electronic methods: 
 
 ® Preferred: Electronic reporting, www.safetyreporting.hhs.gov, or
 
 % MedWatch Form 3500A Mandatory Reporting, 
 
 http://www.fda.gov/Safety/Med Watch/. 
 
 6.7.1. A copy of the label on or within the retail packaging of the dietary supplement
 
 or OTC must be included with the serious adverse event report to FDA.
 
 

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 6.7.2 As part of the serious adverse event report, attach the following as appropriate:
 (1) hospital discharge summaries, (2) autopsy reports, (3) relevant laboratory
 
 data, and (4) other critical clinical data. 
 
 6.7.3. Any new medical information, related to a submitted serious adverse event
 
 report that is received within one year of the initial report shall be submitted to
 
 FDA no later than 15 business days after the new information is received by the
 responsible person. 
 
 6.8 For electronic submission, using the FDA SRP -Safety Reporting Portal, a confirmation
 email is sent to the responsible person containing a time stamped copy of their report
 
 upon its submission. This copy also contains an Individual Case Safety Report number
 to identify the report in any subsequent communications. The email is attached to the
 
 Complaint Report. 
 
 6.9 If a paper form is submitted (electronic is preferred), a serious adverse event report,
 
 along with a copy of the dietary supplement label and any other attachments must be
 
 mailed to FDA, Center for Food Safety and Applied Nutrition, Office of Food Defense,
 Communication and Emergency Response, CAERS Team, HFS-11, 5001 Campus
 
 Drive, College Park, MD 20740. A copy of the entire submission is attached to the
 Complaint Report. 
 
 6.10 Voluntary Adverse Event Reporting Contact Information is as follows:
 
 For Special Nutritional Products (Dietary Supplements, Infant Formulas, Medical
 
 Foods), Cosmetics and Foods/Beverages — 
 
 E-mail: Consumer@fda.gov 
 
 E-mail: DSRSupport@fda.hhs.gov 
 
 Phone: 888-723-3366 
 
 7.0 Records 
 
 7.1 Complaint and Adverse Reporting documentation is maintained according to SOP
 
 

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 Standard Operating Procedure SOP No Rev 
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 Adverse Events 
 
 C-502 Record Storage, Retention and Destruction. Records will be scanned and
 retained, as appropriate. 
 
 8.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 01/23/14 | New procedure. | 14-0034 | L. Derrick |
| 1 | 09/01/16 | Biennial review: Update to be in compliance with MedWatch guidelines. Reference assistance from production and operations for ati tiynpvees otifgaadtvieonr saes seovceinattse. dR weiftehr eandcvee rHseea letvehn Ctsa.n aRdefae Ardevnecer saen dE vleisntt Mipreee paa; r | 16-0788 | S. Millar |

 Reporting System. Revise titles. 
 Change to add reference to SOP QS-112. Remove reference to 
 3 04/22/20 | products where Ion Labs, Inc. appears on the label of the dietary 19-0604 S. Millar
 supplement, cosmetic, OTC. 
 4 08/05/22 | Remove reference to Cosmetics. Update regulation reference. CC-22-0338 S. Millar