Batch Numbering for medical tape

I

ifserav

Involved In Discussions
#1
#1
Hi to everibody

We cut a medical tape and every time we cut a new jumbo of tape we chamge our batch number, is it right or should we stablish a batch size?, are ther any regulatory basis?

We want to certificate under ISO 13485 and GMP.

Thanks in advance

Sergio ?vila
 
Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
Ajit Basrur

Ajit Basrur

Leader
Admin
#2
#2
ifserav said:
Hi to everibody

We cut a medical tape and every time we cut a new jumbo of tape we chamge our batch number, is it right or should we stablish a batch size?, are ther any regulatory basis?

We want to certificate under ISO 13485 and GMP.

Thanks in advance

Sergio ?vila
Click to expand...
There is no one way ... you have to state (document) how a 'batch' is defined, how batch numbers are generated and applied to finished products. If you are able to demonstrate the Batch Traceability by using a jumbo, thats fine.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A Batch / Lot Numbering - Sterilization ISO 13485:2016 - Medical Device Quality Management Systems 3
E Commercial batch size Manufacturing and Related Processes 0
B EO Production Batch Failure ISO 13485:2016 - Medical Device Quality Management Systems 1
Eva lee Which is the range for the validated batch size(for example ±5%, 10%) is acceptable? Manufacturing and Related Processes 8
D Question on electronic signatures and initials on batch records ISO 13485:2016 - Medical Device Quality Management Systems 4
A % of defects on the whole batch based on result from inspection under AQL Level II Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
P How to measure DPPM in Chemical batch manufacturing Quality Tools, Improvement and Analysis 1
S Conformity of 1 batch vs other Statistical Analysis Tools, Techniques and SPC 5
P Informational SPC in Batch Processing Statistical Analysis Tools, Techniques and SPC 3
E Use of OQ cleared batch for stability and clinical study use ISO 13485:2016 - Medical Device Quality Management Systems 0
earl62 IATF 16949 Clause 9.1.1.1 - What is the batch conformance to specification method? IATF 16949 - Automotive Quality Systems Standard 3
J SPC - Stamping parts - Small batch size Statistical Analysis Tools, Techniques and SPC 6
S How do you record your Nonconforming product? Batch production of staged processes Nonconformance and Corrective Action 2
G Batch printing reports in Minitab Using Minitab Software 3
S Retained samples from each batch of spinal implant medical screws that we make ISO 13485:2016 - Medical Device Quality Management Systems 7
S Change value of target during a batch Capability, Accuracy and Stability - Processes, Machines, etc. 0
Q Release of the first batch of a cleared product before process validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
I Lot or Batch definition for IVDs Imported Legacy Blogs 0
V Paint batch approval procedure for automotive industry Manufacturing and Related Processes 6
M Batch record supersedes all other instructions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Carbon Black (Master Batch) - Basic Requirements Manufacturing and Related Processes 5
P Root Cause for a Process Validation Batch Failure 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V GRR Study on a Finished Product - Batch Manufacturing Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
S Test Method Validation or MSA for Batch Manufacturing Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
V Systems to Handle Development and Batch Analysis in same Laboratory Qualification and Validation (including 21 CFR Part 11) 3
T Policy or Good Guidance for a Traceability Decision Tree (Serial and Batch Numbers) Misc. Quality Assurance and Business Systems Related Topics 4
V Is 'Compliance' a pre-requisite or is it ok before Batch Release to Market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V Purchasing Controls - Prerequisites for Batch Release or even before Purchase Order 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Looking for templates of Master Production Record and Master Batch record Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
C Suggestions requested on handling batch record papers exposed to hormonal products Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
P "Bayer" Black Resin vs. Master Batch Manufacturing and Related Processes 1
shimonv Using sterilization data obtained from batch release for CE submission EU Medical Device Regulations 11
V Batch Chromatography API - Blending of Batches Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
I Run a batch every year to revalidate the validated condition? Qualification and Validation (including 21 CFR Part 11) 4
S Annex II List A - Notified Body Fees - Design dossier review and batch release EU Medical Device Regulations 2
S Annex II List A IVDs - Batch Verification Process EU Medical Device Regulations 2
H Extra checks to do when reviewing the batch records for release of products Records and Data - Quality, Legal and Other Evidence 2
S Requirement(s) for Fireproof Cabinets for Storing Batch Records US Food and Drug Administration (FDA) 3
D Chemical batch compounding software for lotions and solutions Manufacturing and Related Processes 1
A SPC for Single Batch Nickel Plating Process Capability, Accuracy and Stability - Processes, Machines, etc. 5
B Mix between two Tablets Batch of the same Product Manufacturing and Related Processes 7
M Medical Device Outsourcing Batch Traceability Requirements Other Medical Device and Orthopedic Related Topics 2
M Medical Device Batch Record Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K Production Batch Documentation based on Filling Manufacturing and Related Processes 5
Q Batch Tracebility for Material Certificates Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
S When to give a new Batch Number for a reworked batch ? Nonconformance and Corrective Action 3
N Statistical Quality Improvement Action for Small Batch Production Statistical Analysis Tools, Techniques and SPC 17
I Minimum and Maximum Validation Batch Size Requirements Qualification and Validation (including 21 CFR Part 11) 3
K Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and number) EU Medical Device Regulations 7
I Retention Time of Paint Batch Panels once Validation completed Document Control Systems, Procedures, Forms and Templates 4

Similar threads

Top Bottom