Process Validation from an FDA standpoint - The GHTF document

S

sandy3

#1
Hi, I work for a Contract Manufacturing Company and we are attempting to set up IQ for our equipment and are struggling with tyring to understand from an FDA standpoint what all we need to be looking at during our validation run for the IQ. When reading the GHTF document, it was specific to the installation of the equipment, however, we have individuals telling us that we also need to verify placement, linespeed, what size boards the machine is capable of running etc.. This does not correlate with the what the GHTF document is stating. Can anyone advise what we need to focus on during IQ? Is it all encompassing or just installation?
 
Elsmar Forum Sponsor
D

DonDuck

#2
Welcome to the wonders of validation. There are varying opinions on what must be included but genenerally validation of equipment is essentially the collection of data to prove tha the equipment is designed, installed and operates properly. In most firms this collection of data is in the florm of protocols called IQ, OQ, PQ. The sum of these will work toward a final conclusion that the equipment is ready and able to perform to meet the desired result.
Therefore in your validation plan, give an overview of what you plan to do at each stage.
IQ requires a formal and systemic check of all installed equipment against equipment suppliers specifications and additional criteria identified by the useras part of th purchase specifications.
OQ identifies the sutis to be underatken on the critical variables.
In some cases these two are combined as IQ/OQ but it is up to you.
Just remember that the validation package is to encompass all aspects of he process to meet the burden of proof that the equipment works as intended.:)
 
D

DonDuck

#4
:bonk: teach me to type things before I have my coffee.
I should have typed: OQ identifies the studies to be undertaken on the critical variables.
 

Scott Catron

True Artisan
Super Moderator
#5
sandy3 said:
Hi, I work for a Contract Manufacturing Company and we are attempting to set up IQ for our equipment and are struggling with tyring to understand from an FDA standpoint what all we need to be looking at during our validation run for the IQ. When reading the GHTF document, it was specific to the installation of the equipment,
This is my understanding.

sandy3 said:
however, we have individuals telling us that we also need to verify placement, linespeed, what size boards the machine is capable of running etc.. This does not correlate with the what the GHTF document is stating.
Placement may be a part of installation, and thus, the IQ. The rest sounds like an OQ.

sandy3 said:
Can anyone advise what we need to focus on during IQ? Is it all encompassing or just installation?
That's what I understand to be the role of IQ - the physical installation of the equipment. OQ is the generic operation of the equipment - like you mention above - operating speed, what it's capable of running - sort of a min/max determination. PQs validate that the machine can process individual products - sort of an optimization exercise.

As an aside, we had the pleasure of hosting the FDA for four days last week and they didn't look at one IQ, OQ or PQ. They did hit our cleaning validation pretty hard though.
 
Thread starter Similar threads Forum Replies Date
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
alonFAI PCBAs Process Validation Help (Regulations FDA) Manufacturing and Related Processes 2
B FDA Guidance on Metal Injection Molding process validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
E 483 Process Validation - FDA Audit Observation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D Process Validation Protocol (API) as per new FDA Guidelines Qualification and Validation (including 21 CFR Part 11) 18
Ajit Basrur New FDA Guideline on Process Validation - General Principles and Practices US Food and Drug Administration (FDA) 12
Ajit Basrur FDA releases new Draft Guidance - Process Validation - Gen Principles and Practices Qualification and Validation (including 21 CFR Part 11) 27
M Seeking guidance documents for Non FDA Regulated Process Validation - New Equipment Statistical Analysis Tools, Techniques and SPC 3
T Passivation Validation - Is passivation is considered a "special" process by the FDA? ISO 13485:2016 - Medical Device Quality Management Systems 1
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
G Devices from IQ, OQ or PQ process to be used for verification, validation and summative? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
B API Q1 5.7.1.5 Process Validation - Machining, heat treating, Manganese Phosphate and Zinc Plating Manufacturing and Related Processes 2
N Validation procedure, Major NC CAP - Equipment Validation process is not effective ISO 13485:2016 - Medical Device Quality Management Systems 5
D ISO13485:2016 7.5.6 Process Validation Responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 1
Z Who is responsible for writing the validation of a new process? Manufacturing and Related Processes 7
M Requirement for manufacturing process validation in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 8
E Sampling plan for orthopedic implant - Process Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
Z Class 2 medical device - Process Validation - Test sterile or non-sterile units? Qualification and Validation (including 21 CFR Part 11) 4
T ISO 13485:2016 - Processes exempt from process validation ISO 13485:2016 - Medical Device Quality Management Systems 12
L Injection Moulding Process (Special Process) Validation Food Safety - ISO 22000, HACCP (21 CFR 120) 2
K Is Mold qualification / process validation always required? Manufacturing and Related Processes 7
R Process Validation on CNC Lathe and Milling machining process Design and Development of Products and Processes 1
Q Release of the first batch of a cleared product before process validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Process Validation sample size selection Statistical Analysis Tools, Techniques and SPC 0
P Auditing "process validation" process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
E Cleaning Validation Process of Non-Sterile Implants and Instruments Other Medical Device Related Standards 2
W Design and Process Validation - Different? ISO 13485:2016 - Medical Device Quality Management Systems 6
A Supplier - Process Validation Manufacturing and Related Processes 3
M Medical Device Process validation, Validation of excel spreadsheets used for process Other Medical Device and Orthopedic Related Topics 4
V Tyvek packaging for Medical device process validation Qualification and Validation (including 21 CFR Part 11) 2
L Process Definition and Process Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Can we sell units that were chosen for process validation? ISO 13485:2016 - Medical Device Quality Management Systems 6
S How do I do a Process Validation for soldering process Manufacturing and Related Processes 5
S Process validation when changing location ISO 13485:2016 - Medical Device Quality Management Systems 10
A Process Validation of QMS Software ISO 13485: 2016 Cl. 4.1.6 ISO 13485:2016 - Medical Device Quality Management Systems 26
P Root Cause for a Process Validation Batch Failure 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
GoSpeedRacer Validation of Processes 7.5.6 - Do cosmetic welds need process validation? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Is Aeration Process in ETO Sterilization Validation Required? Manufacturing and Related Processes 7
C Does Japan accept the Bracketing Approach for Process Validation Japan Medical Device Regulations 1
A Robotic Sanding and Painting Process Validation Manufacturing and Related Processes 5
alonFAI Gamma Irradiation Process Validation Help Other Medical Device Related Standards 2
J Where does process validation fit within design & development? Design and Development of Products and Processes 7
O Process Mapping prior to Validation and Software to use to Map Process Maps, Process Mapping and Turtle Diagrams 12
M Justification for Not Having a Validation Plan for a Critical Process ISO 13485:2016 - Medical Device Quality Management Systems 4
M Is Validation an ongoing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K What are the minimum requirements for Process Validation (Software)? ISO 13485:2016 - Medical Device Quality Management Systems 5
Similar threads


















































Top Bottom