Run a batch every year to revalidate the validated condition?

ifserav

Involved In Discussions
#1
Hi to everibody

I want to knoe if you run a batch every year to revalidated the validated condition?, a consultor has told me that this is part of conserve a validated state, it is true?

Thanks in advacce

Sergio ?vila
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

Not necessarily true, it depends what the process is and what risks were identified in the initial validation.

I would say review and evaluate your situation annually. If nothing significant has changed and there are no indications of problems then just document the review and that's it. The review should include the risk management files.

Either way you should be doing what your SOPs say about it. If you change your practice, make sure to keep the SOPs aligned.

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#3
Every batch you run is a batch with your validated conditions. There is then no necessity for any annual event in the way you say. The more important aspect is to be sensitive to changes and then re-validate appropriately the changed situation at the right time. Never miss out the operator change as well.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
If the original validation already accounted for operators variability (as a process noise) then operators changes should not normally trigger re-validation. It's important to ascertain that any and all assumptions originally made regarding operators still hold, though.
 

v9991

Trusted Information Resource
#5
211.180(e) requires that information and data about product quality and manufacturing experience be periodically reviewed to determine whether
any changes to the established process are warranted...

Process variability should be periodically assessed and monitoring adjusted accordingly.

We recommend that the quality unit meet periodically with production staff to evaluate data, discuss possible trends or undesirable process variation, and coordinate any correction or follow-up actions by production.

Data gathered during this stage might suggest ways to improve and/or optimize the process by altering some aspect of the process or product, such as the operating conditions (ranges and setpoints), process controls, component, or in-process material characteristics. A description of the
planned change, a well-justified rationale for the change, an implementation plan, and quality unit approval before implementation must be documented (? 211.100). Depending on how the proposed change might affect product quality, additional process design and process qualification activities could be warranted.19

the point is, regulations expect you to assess same periodically ( the frequencyand criteria shall suit the purpose of the product - process - etc)
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
A Short Run Capability - Batch quantity is 15,000 to 20,000 Statistical Analysis Tools, Techniques and SPC 5
L Significant Production Run - How 300 was determined to be the minimum quantity APQP and PPAP 2
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
I New to LEAN but not to Quality - How to run Kaizen events Lean in Manufacturing and Service Industries 1
J Sample size definition in an Automotive SMT pilot lot run Misc. Quality Assurance and Business Systems Related Topics 1
M Has anyone heard of Run at Risk? Manufacturing and Related Processes 17
F Bayes Success run Theorem for sample size during OQ&PQ Qualification and Validation (including 21 CFR Part 11) 4
E Translating from Automotive to Medical Device industry - [email protected] Other Medical Device Related Standards 2
Q How to run a Management Review Management Review Meetings and related Processes 10
M Informational Team-NB published a press release regarding the survey run among its members to analyse the certificates being issued Medical Device and FDA Regulations and Standards News 0
M What is required to run human clinical trials in France EU Medical Device Regulations 9
M Case study - If the restaurant (ISO 9001:2015 certified) was run by 2 persons covering cooking and purchasing processes (Mother and Father) supported ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Designing the experiment with minimum run Statistical Analysis Tools, Techniques and SPC 0
S Designing the experiment with minimum run Statistical Analysis Tools, Techniques and SPC 0
U Run & rate for bulk materials IATF 16949 - Automotive Quality Systems Standard 6
N Can you use parts from Run at Rate to use in your PPAP? APQP and PPAP 4
L Formulas to be able to answer these Run Chart questions Statistical Analysis Tools, Techniques and SPC 7
R What testing would you run to determine if a device is "Clean"? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Design Control - Can Validation be based on a limited/first Production Run ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
W AS9100 Clause 8.5.1.3 Production Run Verification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
V When and How to apply the Bayes Success Run approach for Sample Size Determination Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
T Supplier Sample Run Rejection ISO 13485:2016 - Medical Device Quality Management Systems 3
P SPC Short Run Advice of a Stamping Process Statistical Analysis Tools, Techniques and SPC 3
W AS9100C registration - How long does the system have to run before initial audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
B Bayes Success-Run on Attribute Data - Determining Sample Size Statistical Analysis Tools, Techniques and SPC 2
M Standardized P Chart for Short Run Production Statistical Analysis Tools, Techniques and SPC 13
B How to Demonstrate Stability and Repeatability in very Short Run Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
Y Resin Use - Engineering Run to GMO run for the same Product US Food and Drug Administration (FDA) 1
M Setup Time vs. Economic Run Quantity Manufacturing and Related Processes 1
D What to look for in a well run Injection Molder Manufacturing and Related Processes 11
E What's the difference: AIAG-PPAP's "Significant Production Run" and "Run @ Rate"? APQP and PPAP 11
S Should PPAP Samples Come from a Production Run? APQP and PPAP 3
F Run Minitab Macro from Excel Using Minitab Software 3
E How to run an OLS or Logistic Regression when I have Panel Data in Minitab Using Minitab Software 1
W Production Trial Run in AIAG APQP and Run at Rate (GP-9) GM 1927 APQP and PPAP 2
M Average Run Length (Student Question) Statistical Analysis Tools, Techniques and SPC 3
D IMR (Individuals and Moving Range) Chart for Short-Run SPC - How much data to include Statistical Analysis Tools, Techniques and SPC 1
R What is a "DNOM Chart" in reference to Short Run SPC? Statistical Analysis Tools, Techniques and SPC 2
E Using ANOVA during the PQ Validation Run to evaluate Statistical Differences Statistical Analysis Tools, Techniques and SPC 4
CalRich Retention of First Piece from each Production Run IATF 16949 - Automotive Quality Systems Standard 11
M 7.5.1.3 Should mentioned examples such as initial run be verified or validated? IATF 16949 - Automotive Quality Systems Standard 1
J How to run a Survival Analysis in Minitab Using Minitab Software 13
V Supplier's First Run had Plating Problems - Can they Strip, Re-Plate and PPAP them? APQP and PPAP 14
O Significant Production Run - 2.1 in Section 2 of the PPAP Manual fourth edition APQP and PPAP 3
Stijloor Video clips in VIMEO do not run very well. After Work and Weekend Discussion Topics 12
G Hampel's Test for Outliers and Swed Eisenhart Run Test Capability, Accuracy and Stability - Processes, Machines, etc. 3
P Analysis of the figures from Dr Wheeler's 'Short Run SPC' Using Minitab Software 3
S Book for SPC Short Run - Recommendations Book, Video, Blog and Web Site Reviews and Recommendations 12
M Production Trial Run Checklist or PV Build Checklist wanted APQP and PPAP 3
M Type 1 Gage R&R - Analyzing Run Chart and I-mR Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12

Similar threads

Top Bottom