InfoCard #: COMM-QA-040 Rev.

06 Effective Date: 15 Jul 2019

DUKE

DOCUMENTNUMBER: COMM-QA-040

DOCUMENT TITLE:
Inspections by Outside Agencies

DOCUMENTNOTES:

Document Information

Revision: 06 Vault: COMM-QA-rel

Status: Release Document Type: COMM-QA

Date Information

Creation Date: 26 Feb 2019 Release Date: 15Jul2019

Effective Date: 15 Jul 2019 Expiration Date:

Control Information

Author: RB232 Owner: AKB8

Previous Number: COMM-QA-040Rev 05 Change Number: COMM-CCR-098

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 InfoCard #: COMM-QA-040 Rev. 06 Effective Date: 15 Jul 2019

COMM-QA-040
INSPECTIONS BY OUTSIDE AGENCIES

1 PURPOSE
1.1 To describethe policies applicableto conductinginspections, assessments, and
audits ofCarolinas Cord Blood Bank (CCBB), Stem Cell Laboratory(STCL),
Robertson GMP Laboratory, Adult and Pediatric Blood and Marrow Transplant
Programs (APBMT) and other Programs, hereafter referred to as "the
Organization",by external agencies. Throughoutthis policy, the term inspection
will be used to describe any inspection, assessment, or audit activity.
INTRODUCTION
2.1 Recognizingthe importance ofbuildingquality into our products, the
Organizationwants all staffto feel comfortable, be knowledgeable, and be
hospitable during inspections.
2.2 FDA inspections are occasionally scheduled in advance and may be conducted
any time the facility conducts operations unless it is a for-cause audit.
2. 2. 1 21 CFR, Part 600, Subpart C. and 21 CFR, Part 1270, Subpart D
establishesthe authorizationandprocedures for FDA inspections.
2. 2. 2 Section 351(c) ofthe Public Health Service Act and Sections 702 and
704 ofthe Federal Food, Drug, and Cosmetic Act provide authority for
FDA inspectors to conduct inspections.
2. 2. 3 Purpose of Inspection
2.2. 3. 1 To ensure that establishments distributingblood, human
cells, tissues, and cellular and tissue based products are in
compliance with the relevant sections of Title 21 ofthe
CFR.
2.2.3.2 To ensurethe safety, quality, identity, purity, efficacy, and
potency ofblood, human cells, tissues, and cellular and
tissue based products.
2. 2. 3. 3 To prevent the distribution ofmisbranded or adulterated
products.
2. 2.4 FDA inspectors are not permitted to accept free meals, incentives, etc.,
andthese should not be offered. It is acceptableto offer drinks such as
coffee, juice, water, etc.
2.3 Inspections that are usually unannounced include:
2. 3. 1 AABB
2. 3. 2 CAP

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2.4 Inspectionsthat are usually scheduled in advance include:

2. 4. 1 FACT
2. 4. 2 EU
2. 4. 3 Customers for which Duke Facilities perform contract work or services.
2.5 Organization Employee Conduct During an Inspection:
2. 5. 1 All employees must demonstrate professional conduct as official
representatives of the Organization.
2. 5.2 Employees are obligated to give the inspection a top priority.
2. 5.3 Employees must cooperate with the inspector.
2. 5.4 Employees must answer truthfully the questions asked, being as specific
as possible.
2. 5.5 Employees must not sign any affidavit presented to them by an
inspector without prior review and approval ofthe Program/Medical
Director or designee.
2. 5.6 Employees must not discuss work-related matters with an inspector
outside ofthe inspection environment.

SCOPE AND RESPONSIBILITIES

3. 1 All members ofthe Duke Organization need to beawareoftheprocess andthe
guidelines for inspections.
3.2 The QSU is responsible for ensuring that all staffthat may interact with an
inspector are fully trained in their roles and understand the importance of
inspections.
3.3 Duke Office of Regulatory Affairs and Quality (ORAQ) is available to serve as
part of the inspection team.
3.4 Inspection Coordinator
3. 4. 1 QSU Director/designee will act as the Inspection Coordinator.
3. 4.2 IfaQSUrepresentative isnot available, the highest-ranking employee
or their designee will serve as Inspection Coordinator.
3. 4.3 The responsibilities of the Inspection Coordinator (and team) include,
but are not limited to:

3. 4. 3. 1 Asking for and reviewing the inspector's credentials.

3.4. 3. 2 Reserving a private space in which the inspectors can work.
3.4.3.3 Creatingan inspection file.
3. 4. 3. 4 Acting as an escort throughout the inspection, unless the
inspector is in the reserved private spaceor restroom
facilities.

3. 4. 3. 5 Providing personal protective equipment, as needed.

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3.4. 3. 6 Being knowledgeable in the procedures on handling any

external audits.

4 DEFINITIONS/ACRONYMS
4. 1 Affidavit - A voluntary sworn statement offacts, made in writing, before an
authorized official, such as an inspector from the Food and Drug Administration
(PDA). Affidavits may be prepared by PDA inspectors to document events,
occurrences, or statements made by the Organizationemployees and presented for
signature by these employees during the inspection process.
4. 2 AABB - This organization performs accrediting inspections to ensure compliance
with the:
4. 2. 1 Standards for Blood Banks and Transfusion Services

4.2.2 Standardsfor ImmunohematologyReferenceLaboratories

4. 2. 3 Standards for Hematopoietic Progenitor Cells
4. 3 Center for Biologies Evaluation and Research (CBER) - The branch ofthe FDA
responsible for the regulation ofbiological and related products including blood,
vaccines, allergenics, tissues, and cellular and gene therapies.
4. 4 CAP - College of American Pathologists - Performs accrediting inspections of
the STCL and CCBB Laboratories.
4. 5 Code of Federal Regulations (CFR)
4. 6 Current Good Manufacturing Practices (cGMPs) - Regulations found within the
Code of Federal Regulations (CFR) governing the manufacture of blood and
blood components (600 series), drugs and biologies (200 series), and medical
devices (800 series).
4. 7 Current Good Tissue Practices (cGTPs) - Regulations found within the CFR
governing manufacture of human cells, tissues, and cellular and tissue based
products (1271 series).
4. 8 EstablishmentInspection (El) - A careful, critical official examinationof a
facility to determine its compliance with the laws enforced by PDA.
4. 9 Establishment Inspection Report (EIR) - A detailed description ofthe FDA
inspection, includingthe circumstances surroundingobservations cited on PDA
Form 483.
4. 10 European Union (EU)
4. 11 Freedom of Information Act (FOI) - An act that allows public access to
documents such as the FDA Form 483 and EIR.

4. 12 FDA Form 482, Notice ofInspection - The form presented by FDA inspectors
upon arrival, announcing the intent to inspect. FDA Form 482 also provides a
written explanation ofthe authority ofthe inspectors and the rights ofthe
establishmentbeing inspected.
4. 13 FDA Form 483, Inspectional Observations - The form on which the FDA records
observations noted during an inspection, when the inspector believes that there are
processesthat are not in compliancewith regulations.
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4. 14 Foodand Drug Administration (FDA) - An executive branch ofthe United States

government, within the Department of Health and Human Services, charged with
the enforcement ofthe Federal Food, Drug, and Cosmetic Act of 1938 and the
Public Health Service Act of 1944.

4. 15 Inspection Coordinator - The individual within an organization assigned to

facilitate an inspection, assessment, or audit.
4. 16 ISO - International Organization for Standardization - Defines and publishes
quality management system and numerous other standards for many industries.
4. 17 Most Responsible Individual (MRI) - The person designated to represent the
facility being inspected.
4. 18 Nonconformance- A term used by the American Association ofBlood Banks
(AABB) to describean areaofnoncompliancewith standards. A nonconformance
may be classified as Major or Minor, depending on the impact ofthe
noncompliance and the number oftimes similar non-compliances occur.
4. 19 Observation - Verifiable qualitative or quantitative observation, information,
record, or statement of failure to conform to a regulation, accreditation
requirement, standard, SOP, or policy.
4. 20 Office of Regulatory Affairs and Quality (ORAQ) - The office within Duke
responsible for providing regulatory and GMP quality assurance support to the
facilities for which this procedure applies.
4. 21 Quality Systems Unit (QSU) - The term used to refer to quality staffproviding
support to GMP facilitiesper 21 CFRparts 210 and 211.
5 MATERIALS
5. 1 N/A

6 EQUIPMENT
6. 1 N/A

7 SAFETY
7. 1 Inspection personnel are provided personal protective equipment if applicable and
are to observe all laboratory safetypolicies.
8 PROCEDURE
8. 1 General Inspection Process
8. 1. 1 When advanced notification and scheduling of an inspection occurs, the
Inspection Coordinator will communicate the proposed inspection plans
to appropriatepersonnel. Referto COMM-QA-040JA1 Inspection
Notification List.
8. 1. 1. 1 Documents can be provided to the inspection team in
advancewith QSUDirectorapproval.

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8. 1.2 Upon arrival ofthe inspector, if not alreadyperformed, the Inspection

Coordinatorwill coordinatenotificationto appropriate personnel. Refer
to COMM-QA-040 JA1 Inspection Notification List.
8. 1.3 The InspectionCoordinatorwill ensurethatthe inspector is
credentialed,as applicable, and then escort them to the reserved private
area.

8. 1.4 Ifthe inspection is beingconducted by FDA, an FDAForm 482, Notice

ofInspection, must be issuedto the InspectionCoordinator,
Program/MedicalDirector, or designatedresponsible individual.
8. 1.5 An openingmeeting is typically held to establishthe purpose ofthe
inspection andto create a tentative agenda. The Inspection Coordinator
or designee should request that the inspector(s) completes COMM-QA-
040 FRM4 Auditor Attendee Signature Log.
8. 1.6 The Inspection Coordinator and QSU will work with the inspector to
ensure that the appropriate Organizationemployees are availablewhen
needed to gather data and answer questions. The Inspection Coordinator
or designee should request that Organization employees attending
opening meeting complete COMM-QA-040 FRM3 Audit Attendee
Signature Log.
8. 1.7 The Inspection Coordinator must offer the inspector personal protective
equipment, such as a lab coat, prior to entering production areas.
All Organization staffmust be attentive to the inspection process and be
prepared to respond to the questions or requests in a timely manner.
8. 1.9 A closing meeting will be held.
8. 1.9.1 The Inspection Coordinator will request that the inspector
provide as much notice as possible so that the
Program/Medical Director/designee, the QSU
Director/designee.and other appropriate staffmay attend.
8. 1.9.2 The inspectorwill be askedto summarizethe inspection,
listing any formal citations and other observations or

8. 1. 9. 3 Participants at the closing meeting may ask the inspector for

clarifications or explanations as necessary.
8. 1. 9. 4 The Inspection Coordinator or designee should request that
the Organization employees attending the closing meeting
complete COMM-QA-040FRM3 Audit Attendee Signature
Log.
.
2 Retrieving Information and Documents for Review
8. 2. 1 The Inspection Coordinator evaluates the appropriateness ofproviding
the requested information.
8. 2. 2 All records, policies, and procedures related to GMP manufacturing,
collection, procurement, processing, testing, and distribution ofproducts
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as well as documentation regarding the Organization's Quality Program

should be available for review, if requested.
8. 2. 3 Requests from the inspectors once onsite can be tracked and
documented on COMM-QA-040 FRM2 Document Request Form,
8. 2. 4 Financial and personnel/HR information/documentation should not be
sharedwith the inspector. Redaction ofdocuments is allowed if these
documents are requested.
8.2. 5 MakingCopies ofRequested Documents
8. 2. 5. 1 Ensure that each "COPY" is labeled and/or stamped as such,
if applicable.
8. 2. 5. 2 Each document given to the inspector should be captured
either by making a copy or by noting simply which version
ofan SOP was requested. Refer to COMM-QA-040 FRM1
Audit Records Log.
8. 2. 6 Making Copies of Redacted Documents
8.2.6. 1 Ifthe documents requested contain confidential information,
the confidential information must be redacted.

8.2. 6. 2 Redaction is performed by copying the document,

obliterating the confidential information with a thick black
marker, and then copying the redacted document.
8.2. 6. 3 If the inspector requests that un-redacted copy is needed, the
QSU Director, Risk Managementor the Program/Medical
Director must give approval. These copies must be stamped
"CONFIDENTIAL."
8. 2. 7 Photography is allowed.
8.2. 7. 1 If the inspector takes a photograph, notify the QSU Director
or designeeand the Program/MedicalDirector.
8. 2. 7. 2 If photographs are taken, the Inspection Coordinator or
designee will take photographs as close as possible to those
taken by the inspector.
Ifthe inspectorrequests a sample, the Inspection Coordinatormust
ensure that:

8. 2. 8.1 Collection occurs in a manner that maintains the integrity of

the sample.
8. 2. 8.2 The sample is properly labeled.
8. 2. 8.3 A duplicate sample is maintained by the Organization,
whenever possible.
8.2. 8.4 The Organization obtains a receipt for the sample from the
inspector.
8.2. 8.5 The Organization obtains a copy ofany tests performed on
the sample by the auditingagency.
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8. 3 Content for Note Taking During the Inspection

8. 3. 1 Personnel associated with the inspection should strive to take
comprehensive notes that capture information discussedbetweenthe
inspector and the Organization. Notes reflecting these exchanges may
include, but are not limited to, the following:
8. 3. 1. 1 Key questions that were asked and the answers given.
8. 3. 1. 2 Employees interviewed.
8. 3. 1. 3 Topics discussed.
8. 3. 1.4 References to the inadequacy of a process/procedure.
8. 3. 1. 5 List ofnames ofkey staffpresent at opening and closing
meetings

8.4 Inspection Follow-Up

8.4. 1 The Inspection Coordinator or designee will work to address any
observations or action items following the audit. One method for
completion of this task includes the creation ofan inspection summary
report that will minimally include:
8. 4. 1. 1 Observations/recommendations presented by the inspector.
8.4. 1. 2 Observations made by the Organization staffduring the
inspection.

8. 4. 1. 3 Identification ofthe responsible department and any

corrective actions required.
8. 4.2 Obtain and place the original formal inspection report (e. g., EIR), or a
copy, fi-omthe inspection agencyon the shareddrive.
8. 4.3 Formal responses are usually due within 30 days ofthe conclusionof
the inspection or within 30 days ofthe receipt ofthe written report;
however, this timeframe may vary.
8. 4.4 The QSU Du-ector/designee will prepare formal inspection responses,
with input from the applicabledepartments.
8. 4.5 Inspection responses should be reviewed by the QSU Director/designee,
the Program/Medical Director/designee, and Regulatory Affairs, as
applicable, prior to sendingthe response.
8. 4.6 A copy ofthe final response, includingcover letter, should be
maintained in the QSU inspection file.
8. 4.7 Corrective actions will be tracked by the QSU, as applicable.

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9 RELATEDDOCUMENTS/FORMS
9. 1 COMM-QA-040 JA1 Inspection Notification List
9. 2 COMM-QA-040 FRM 1 Audit Records Log
9. 3 COMM-QA-040 FRM2 Document Request Form
9. 4 COMM-QA-040 FRM3 Audit Attendee Signature Log
9. 5 COMM-QA-040 FRM4 Auditor Attendee Signature Log
10 REFERENCES
10. 1 Code ofFederal Regulations, current edition, Title 21, Parts 200, 201, 210, 211,
300, 600, 601, 606, 610, 640,660, 680, 1270and 1271.
10. 2 Federal Food, Drug, and Cosmetic Act, Sections 702 and 704, 18 U. S. C.,
Section 1114.

10. 3 Public Health Services Act, Section 351(c), 42 U. S. C., Section 262.
11 REVISION HISTORY
Revision No. Author Description of Change(s)
06 R. Bryant Update facility names and clarify processes.

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Signature nflanifest
Document Number: COMM-QA-040 Revision: 06
Title: Inspections by OutsideAgencies
All dates and times are in Eastern Time.

COMM-QA-040 Inspections by Outside Agencies

Author

Name/Signature Title Date Meaning/Reason

Richard Bryant (RB232) 08 Jul 2019, 08:15:27AM Approved

Medical Director

[Name/Signature Title Date j Meaning/Reason

Joanne Kurtzberg
(KURTZ001) 08 Jul 2019, 08:18:56 AM Approved

Quality

Name/Signature ^^......l
Title Date [ Meaning/Reason
Richard Bryant (RB232) 08 Jul 2019, 10:21:32AM Approved

Document Release

Name/Signature Title Date Meaning/Reason

Sandy Mulligan (MULL1026) 10 Jul 2019, 09:18:19AM Approved

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