Seeking guidance documents for Non FDA Regulated Process Validation - New Equipment

M

mshell

#1
I am attempting to develop validation document for a new piece of production equipment. I have pulled the FDA guidance but we do not have to meet FDA requirements. Does anyone have any guidance documents for non FDA regulated companies?

Thanks,

mshell
 
Elsmar Forum Sponsor

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#2
mshell said:
I am attempting to develop validation document for a new piece of production equipment. I have pulled the FDA guidance but we do not have to meet FDA requirements. Does anyone have any guidance documents for non FDA regulated companies?

Thanks,

mshell
The principles don't change. Why not use it as a guide?
 

Statistical Steven

Statistician
Staff member
Super Moderator
#4
mshell said:
That is what we are doing at this time. I just don't want to go overboard.
Al has a point, just use the FDA guidelines as just that...a guideline.

It sounds like you are qualilfying a machine versus a process validation study. If you are just qualifying a machine, try approaching it as a capability study, and look if the machine is repeatable and reproducible.
 
Thread starter Similar threads Forum Replies Date
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
K Seeking guidance on Preliminary Steps to enable Hazard Analysis Food Safety - ISO 22000, HACCP (21 CFR 120) 1
C Process Descriptions: Seeking guidance and examples ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Seeking Guidance on the most effective items and ways to Benchmark Preventive Action and Continuous Improvement 4
M Seeking advice regarding use of off-the-shelf (OTS) batteries Other Medical Device and Orthopedic Related Topics 4
A ISMS - Seeking VAPT Consultant Food Safety - ISO 22000, HACCP (21 CFR 120) 1
M Medical Device Directive - Seeking common nonconformance write up scenarios CE Marking (Conformité Européene) / CB Scheme 2
S Seeking efficient method to manage install base data Manufacturing and Related Processes 0
K Seeking ISO 13485 Registrar Recommendations Registrars and Notified Bodies 15
R Tapping problems - 3/8" hot roll pickled & oiled steel - seeking expertise Manufacturing and Related Processes 15
S Responsibilities between government owner and private subcontractor of a power plant seeking ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Seeking for an example or a template of a Business Plan Service Industry Specific Topics 3
B Health Canada Recall Definition - Seeking Clarification Canada Medical Device Regulations 5
W Seeking Returned Merchandise Procedure Customer Complaints 1
QMMike New Trend of not seeking Official ISO 9001 Registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
R Clinical Evaluation according to MEDDEV 2.7.1 (Rev 4) - seeking template ISO 13485:2016 - Medical Device Quality Management Systems 6
T ISO 9001:2015 Training for Management Team in NM - Seeking Suggestions and Providers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Seeking Corrective Action Process Examples Nonconformance and Corrective Action 3
M AS9102 Training - Seeking third party agency that provides online AS9102 training AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
F Seeking Internship/Co-op Opportunities in Regulatory Affairs/QA/Clinical Domain (USA) Career and Occupation Discussions 4
L Seeking help in Basic Maintenance Knowledge Manufacturing and Related Processes 4
M Seeking opinion for ISO14001 team activity ISO 14001:2015 Specific Discussions 3
smryan Seeking good 2D barcode add-in for Excel Excel .xls Spreadsheet Templates and Tools 6
Sean Kelley Seeking Feedback on ASQ Guide to Failure Mode and Effect Analysis FMEA and Control Plans 2
S Seeking examples of Nonconforming Materials Nonconformance and Corrective Action 5
Sean Kelley Seeking Quality Training for Quality Technicians Training - Internal, External, Online and Distance Learning 1
P Seeking Information on ISO 15504 - Information Technology Process Assessment Other ISO and International Standards and European Regulations 3
K Seeking NDT Training and Certifications Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Chennaiite Cause Analysis for Verification/Validation Failures - Seeking Opinions Problem Solving, Root Cause Fault and Failure Analysis 3
Q Seeking Examples of current ISO/TS 16949 Training Procedures IATF 16949 - Automotive Quality Systems Standard 2
Ron Rompen Seeking Test Lab which can do 1440 Hour Accelerated Weathering Characteristics Misc. Quality Assurance and Business Systems Related Topics 1
Sean Kelley Seeking Ballooned PFMEA and Control Plans for Training FMEA and Control Plans 4
B Seeking help in answering Australia Tax Withholding Declaration Coffee Break and Water Cooler Discussions 1
H ASQ CQE Exam Review Workshop - Seeking Volunteers! September 2013 ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 7
N Seeking information on use of Byotrol Cleaning Chemicals in Pharma Industry Manufacturing and Related Processes 1
M Seeking input for a process-based quality management system training course ISO 13485:2016 - Medical Device Quality Management Systems 1
B Seeking help in writing marketing message Career and Occupation Discussions 12
B Seeking help in writing an audit report that can stand on the court Internal Auditing 6
S AAMI EC57 for ECG Medical Device - Seeking 3rd Party Test Laboratory US Food and Drug Administration (FDA) 5
W Seeking a Freelance Mechanical Inspector - Source Inspection in Bangalore, India AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
V Seeking Internal Audit Plan form or template Internal Auditing 5
W X-ray based NDT Test Equip. Mfger. seeking CE Mark - Must X-Ray Source be included? CE Marking (Conformité Européene) / CB Scheme 5
F Quality Awareness Sessions - Seeking Ideas and Presentation Material Quality Manager and Management Related Issues 4
S Seeking to learn English Video and Suggestions - I am Chinese Coffee Break and Water Cooler Discussions 9
D Seeking material on the Construction Process in IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
T I'm seeking ISO 13485:2003 Supplier Audit Checklist Supplier Quality Assurance and other Supplier Issues 1
V DIS Inspect software for our CMM Operations - Seeking Contact Information Calibration and Metrology Software and Hardware 3
R "RUO" (Research Use Only) Medical Device now seeking Clinic Use 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R Seeking Medical Device Registration Process in Korea Other Medical Device Regulations World-Wide 4
D Seeking Equipment Verification Standard Procedure books/guide/links Book, Video, Blog and Web Site Reviews and Recommendations 1
Similar threads


















































Top Bottom