Stem Cell Product Batch Production
/ Lot Release Record Review
A Registry’s Perspective
Elizabeth A. Crews
Quality and Regulatory Compliance
21 CFR Part 211
Current Good Manufacturing Practice
• 211.188 – Batch Production and Control Records
▫ Batch Production and Control Records shall be
prepared for each batch of drug product produced.
 Each donation = one batch
 Donor Chart = Batch Production Record
• 211.192 - Production Record Review
▫ All drug product production and control records,
including those for packaging and labeling, shall be
reviewed and approved by the quality control unit to
determine compliance with all established , approved
written procedures before a batch is released or
distributed.
 WU Checklist / Product Labeling Checklist
Our approach to ensure compliance
…WU Process Flow Checklists
• One for each product
▫ HPC, Marrow
▫ HPC, Apheresis
▫ MNC, Apheresis
• Provides:
▫ Instructional steps for advancing the donor from
“match” notification through the 1 week post
donation follow-up
▫ Documentation that each step in the process is
completed
 Steps are not sequential due to the dynamic nature
of the process.
WU Checklist Sections
• Divided into 8 parts
 All parts provide a list of forms required for each task
▫ Part 1 - Start Workup Chart
 Administrative tasks required to initiate the Workup
process
▫ Part 2 - Information Session
 Communication tasks with the donor and TC
 Critical Control Point 1
▫ Part 3 - Arrange the Physical Exam
 Communication tasks with the CC and tracking of blood
sample kits to and from testing facilities as well as
confirming receipt and review of all required documents
 Critical Control Point 2
WU Checklist Sections cont.
▫ Part 4 - Once Donor Clearance Arrives
 Communication tasks with the TC and tracking of donor
eligibility time frames in relation to the date of the
donation:
 30 days for IDM testing
 12 weeks for Health History Questionnaire
 6 months for Physical Examination
▫ Part 5 - Donor Tasks After Clearance
 Tasks for:
 Arranging donor travel for the collection
 Arranging the Courier
 Tracking of sample kits for day of collection
 Pregnancy testing for female donors
 Filgrastim administration if PBSC donation
 Critical Control Point 3 – Batch Release Review
WU Checklist Sections cont.
▫ Part 6 - Tasks for Day of Collection
 Administrative Tasks for Coordinators in office
 Communications between Day of Collection Coordinators
▫ Day of Collection Checklist - for Coordinators accompanying
donor to collection
 Begin short term follow-up
 Critical Control Point 4 – Product Labeling and
Packaging
▫ Part 7 - Begin Long Term Follow-up Process
 Administrative tasks for hand off to Donor Follow-up
Coordinator
 Chart submitted to QA for final review
▫ Part 8 - Final QA Review – Production Chart Quality
Audit
 Entire chart review using separate QA Audit Checklist
Critical Control Point 1
 Donor Services Management
 HHQ administered following the Donor Information
Session
 Consent to Donate
 Medical records available at Gift of Life
Critical Control Point 2
 Donor Services Management
 Physical Examination – including all source documents
 Medical clearance information
▫ Donor Suitability and Eligibility
Critical Control Point 3
 Donor Services Management and Quality Assurance
 Entire chart up to day of Collection
 Start Quality Audit Checklist
Critical Control Point 4
▫ AC / CC Personnel:
 Label and verify according to their internal
procedures, package product (according to transport
container instructions) and complete the Labeling
Checklist
▫ Donor Services Management:
 Photo of product label prior to transfer to courier for
packaging.
Production Chart Quality Audit
▫ Complete the Quality Audit Checklist (Started at
Critical Control Point 3)
 Ensure forms are present
 Required signatures present
 Required source documents present
▫ Identified issues are referred back to Donor
Services for correction.
Critical Control
Point 1
Critical Control
Point 3 –
Batch Release