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Q U A L I T Y A N D O P E R A T I O N S T R A C K S E S S I O N 5 - S U P P L Y C H A I N D E V E L O P M E N T .
O C T O B E R 1 , 2 0 1 6 , 1 : 4 5 P M T O 3 : 1 5 P M
Qualifying Manufacturing and Laboratory Services
Olive J Sturtevant, MHP MT(ASCP)SBB .SLS, CQA(ASQ) [email protected]
Qualifying Vendors for Manufacturing and Laboratory Services
The participants should be able to describe the regulations and standards that require programs to qualify and audit vendors / services for key raw materials including manufacturing agreements and laboratory services.
The participants should be able to evaluate the material presented and assess how it applies to their setting
The participants should be able to use the tools presented and implement changes to their program if opportunities for improvement are identified.
Vendor Qualification
All vendors, manufacturers, and contracted services that provide critical and non-critical supplies, reagents, equipment and services should be qualified through a defined process
Qualification ensures that the services being performed or the items being supplied are in compliance with:
Specifications required for a given process
Applicable laws and regulations
Applicable accreditation requirements
Services You Might Qualify and Audit
Donor assessments
Collection services
Processing / manufacturing services
Infectious disease testing laboratory
Flow cytometry lab
Other laboratory services (microbiology, immunology, HLA, ….)
Sterilization service
Contracted manufacturing for raw materials Platelet lysate, other special reagents or media
Vectors, Plasmids
Ways to Qualify
Initial
Perform an on-site audit of the provider.
Accept a review from a third party assessments by accrediting organizations such as FACT, JACIE, AABB, CAP, ASHI or others.
Perform a paper audit
On-going
Establish an ongoing relationship / discussions / meetings to look at metrics, resolution of service complaints or suggested process improvements.
Requalify at set time points
FDA Requirements for Vendor Qualifications
Qualify vendor based on written requirements and establish contract / standing order
Document what the deliverables are and how performance will be assessed
Document how recalls are handled and responsible actions
Transit tracking, monitoring, conditions
Bill of Landing FDA will look for this during an inspection
Re-Qualification
Check appropriate websites for registrations and FDA warning letters
Review deviations and recall databases
Review with lab personnel to determine if items were received in a timely manor and if any problems were encountered with availability, quality, billing, etc.
Check with vendor/manufacturer for any manufacturing changes
Product/Vendor Problems
Save device/product if possible
Submit an Occurrence Report Form
Note manufacturer and lot numbers
Report ANY defective product, no matter the cost and even if it was not used on a patient
Notify Regulatory and Administrator
Report to MedSun
MedSun
A online reporting program for medical device adverse events run by the FDA
Clinical sites report problems through MedSun where they are investigated by the FDA and shared with the clinical community
Reporting problems, concerns, and near misses can help prevent serious adverse events
http://www.fda.gov/medicaldevices/safety/medsunmedicalproductsafetynetwork/default.htm
Contracts / Agreements
Manufacturing contracts
Collection contracts
Clinical Trials Agreements
Quality Agreements
Memo of Understanding
Reference Lab Agreements
Service Agreements
Equipment
Cleaning
Supplies
Defines quality metrics, financial, contractual obligations, and legal responsibilities
Review annually
Assess performance
Review metrics
Assess access to PHI
Qualification Assessment
Risk base approach
Risk & Severity Index
GMP vs RUO
Multiple qualified manufactures vs one and only
Critical service, supply, reagent
Clinical CLIA approved lab vs a research lab
Business Assessment
How long have they been in business?
Perform a financial assessment
How many sites do they have?
How many employees do they have?
Review their organizational structure
Do they have a quality plan?
Technical / Customer Support
Laboratory
CLIA regulated analyte or RUO
Qualification / validation, Precision, accuracy, reproducibility, linearity, lot to lot comparability, PT, …
QI plan & annual report
Pre analytical – has assay been validated for the type of sample you are sending them
Post analytic – How will results, abnormal findings be reported
Accredited / Inspection
What was actually assessed / inspected?
How will they notify you if they loose accreditation?
Quality Assessment
Copy of their Quality Plan
Does the QA Unit exist as a separate organizational entity?
Are they licensed / certified / accredited Federal (FDA,..) State (NY),
Accrediting body
CLIA if applicable
ISO certified
Do a Google / LinkedIn search
(ICH Q10, 21CFR211.22)
Audit Program
How will you perform your assessment / audit
Risk based approach
Paper or On-site
Frequency
Requalification
Routine
For cause
Training Program
Review the orientation and training program
Continuing education and training
Audit the documentation of training, retraining & competency assessments
Frequency of GMP & Safety training
How are trainers qualified
How are consultants qualified
(21CFR211.25, 211.34)
Records & Document Control
Is the QA Unit charged with designing, revising, and obtaining approval for production testing procedures, forms, records?
Is there an SOP for documentation?
How are batch records / forms completed, reviewed and retained?
Instrument print outs
EM records
(21CFR211.22, 211.165)
Supplier Program
How do they qualify vendors? How do they qualify subcontractors ? Are supplies quarantined upon receipt? How are they qualified or tested? How are supplies stored and labeled ? Is there a written inventory procedure Inventory control program
Outdated material and disposition Stock rotation
(21CFR211.42,211.80-89, 211.142, 211.150, 211.184,211.160)
Equipment
Equipment control
Equipment design, placement, qualification
IQ/OQ/PQ, validations, PMs and calibrations,…
Cleaning- exam cleaning records
Can you identify what equipment is used ?
What are there plans for upgrading ?
(21CFR211.63, 211.67-68, 211.105)
*Process Control and Product Acceptance
Segregation of and control of products, supplies
Procedures for process control
Deviation / occurrence process
Qualification, control and use of equipment and supplies
QC Testing
In-process inspection, sampling and laboratory controls
(21 CFR 211.80-211.89, 21CFR211.100-110, 211.34, 21 CFR 1271.210, 21 CFR 820.50, 820.70, 820.75)
QC Testing
Preanalytic, Analytic, Post Analytic Assessments
Sample requirements,
Testing
Reporting
Regulated analytes or not
Clinical use or Research
Validation, qualification of test systems / methods
Precision, accuracy, limits of detection
Statistical assessments
Batch Release Qualification
Final testing and inspection of product
Are retention samples held ?
How long and by whom?
How does QC and/or QA review/release handled ?
Look at organizational chart for reporting conflicts
What will the final batch release record consist of?
COA or copy of entire manufacturing record
Hold long will they be retained?
Will instrument print outs and QC records also be retained?
Labeling
How will material / products be labeled?
Will they accept PHI?
For product manufacturing are they ISBT128 compliant?
How do they notify you of labeling changes?
How do they validate their labeling process and labels for the application?
HIPAA and PHI Disclosure Vendor BAA Required
Confidentiality
Agreement
Disclosure is incedential to
the service provided
Limited data
set NA Service Supplies
AccuTech Optical (Microscopes and scales) x x
Airgas USA LLC, North Division x x x
B&V Testing (BSCs and Clean room recertification) x x
BD Bioscience x* x* x
Beckman Coulter x* x* x x
Bianchi Associates (Incubators) x x
BioMerieux x* x* x
Biosafe America, INC x x
Bioscience International x x x
Caley and Whitmore (Centrifuges- tach/timer/temperature checks) x x
Charles River (Endotoxin PTS- we ship equipment offsite) x x
Crothall Healthcare (Now Eurest) X x
Cryo Associates (Controlled Rate Freezers and MVE tanks) x x
Dataworks Development x X
Digi-Trax X x
El Pro (DataLoggers) x x x
Millipore Corporation x x
Miltenyi Biotec Inc X X
Filemaker INC ? x X
Henry Troemner (Weights and thermometers – we ship offsite) x X
Lab Inc x X
Linde Gas North America x X x
Pipette Calibration Services Inc X X
REES Scientific x X x
Shon’s Scientific (Refrigerators and freezers) x x
Spectrasoft (web hosted) x x
Sysmex America Inc X X
T.E.Andresen Inc ? X X
Uniclean X X
WuxiAptech x X
If treatment related no BAA.
Storage
Who is responsible for storing the finished product?
QC samples?
Will they hold partial lots?
What happens to products not used?
How are they disposed of?
Can they supply EM data for stored items?
Access –
How do they control access?
Can they produce a record of who accessed your items ?
Shipping
Who take responsibility for shipping?
Who pays for shipping?
Do they hold the appropriate licenses for shipping if applicable?
Can they handle exporting and importing products / materials across boarders
Who is their broker for dealing with customs ?
How will goods be handled if held in customs ?
How are items replaced if lost during transit?
What is the turn-around-time to replace?
Complaints and Customer Satisfaction Program
Are complaints documented, reported and retained?
How are they dealt with? Investigated?
Examine a complaint file, How was it resolved ?
Is there are written process for handling complaints?
How do they follow-up on resolutions / CAPA?
(21CFR211.198, 21CFR820.198)
Summary
Assess each vendor (manufacturer or supplier of a service)
Perform a risk assessment
Does each lot / shipment need to be qualified
Is a site visit warranted
Obtain additional information
Send established questionnaire and ask for specific documents
Quality plan, certificates
Requalify periodically based on performance and risk
