Batch record supersedes all other instructions

#1
Hi all,

This is kind of an interesting question we had that got raised the other day.

Our mfg site uses area specific WIs that are not specific to a product/PN, think of area clearance or setup procedures associated with equipment. Many products' batch records call on these area specific instructions in order to help the product specific batch record make the product. I've always taken for granted that any parameters or specifics to the product that are stated in the batch record would supersede anything one of these area specific instructions states. Is this true? Is it stated in CFR somewhere that this is the default succession, if so where? Or should our firm have an SOP stating this succession hierarchy?

Any help that can be offered is greatly appreciated in advance.
 
Elsmar Forum Sponsor

pkost

Trusted Information Resource
#2
I'm not aware of anything being defined by the regulation or any standard. You would have to document it in your system otherwise you are at risk of a non conformance as it would likely be seen as a contradiction. Depending on what it is specifically then you may want to consider additional controls as the risk of people following the normal way of working instead of an exception is high
 

Ajit Basrur

Staff member
Admin
#3
Hi all,

This is kind of an interesting question we had that got raised the other day.

Our mfg site uses area specific WIs that are not specific to a product/PN, think of area clearance or setup procedures associated with equipment. Many products' batch records call on these area specific instructions in order to help the product specific batch record make the product. I've always taken for granted that any parameters or specifics to the product that are stated in the batch record would supersede anything one of these area specific instructions states. Is this true? Is it stated in CFR somewhere that this is the default succession, if so where? Or should our firm have an SOP stating this succession hierarchy?

Any help that can be offered is greatly appreciated in advance.
Instead of going into that sort of hierarchy, I would suggest to have generic WIs applicable for all products, with a NOTE to refer to product specific batch records for those specific instructions.

Having two sets of instructions may cause confusion in operators and technicians. I had similar situation in my past role, and affected the validated parameters. Therefore, as part of CAPA, we decided to have one set of requirements and identified its place in the Batch Records only.
 
Thread starter Similar threads Forum Replies Date
S How do you record your Nonconforming product? Batch production of staged processes Nonconformance and Corrective Action 2
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
M Medical Device Batch Record Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Are all In-Process Quality Records required in final QA Batch Record Review. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
V Nutraceutical Industry Master Batch Record Document Control Systems, Procedures, Forms and Templates 1
U Batch and Master Batch Record Template for Pharmaceutical Industry Document Control Systems, Procedures, Forms and Templates 9
A Batch Processing Record for Medical Devices - Disposable Plastic Syringes Other Medical Device Regulations World-Wide 1
K Batch Record Standardization Process Advice Document Control Systems, Procedures, Forms and Templates 3
C Guideline for streamlined batch record review process - cGMP compliance - Needed Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
C Need reference in order to audit batch record Quality Tools, Improvement and Analysis 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
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
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
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
I Batch Numbering for medical tape EU Medical Device Regulations 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
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
D How to measure Process Capability for Homogeneous Batch Manufacturing Capability, Accuracy and Stability - Processes, Machines, etc. 4
S Batch Traceability for Bulk Materials which are mixed in the Storage Tank IATF 16949 - Automotive Quality Systems Standard 6

Similar threads

Top Bottom