21 CFR 58 GLP Periodic Study Phase Inspection Report

#1
Hello,

I'm looking to get some clarity on the documentation that needs to be generated to document the "phase" inspections required for nonclinical lab studies.

Sec. 58.35 Quality assurance unit.

b.(3) Inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for reinspection. Any problems found during the course of an inspection which are likely to affect study integrity shall be brought to the attention of the study director and management immediately.


The only documentation guidance I can see is on Sec. 58.35.b.(7) but it only refers to information from these inspections that must be included in the final study report. Does a separate inspection report need to be generated beyond this?

Does anyone have a template they can share that they use for these inspections?

Thank you!
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
P Controls over Systems Documentation in 21 CFR Part 11 Qualification and Validation (including 21 CFR Part 11) 1
E The FDA regulations (21 CFR 312.3): Is it allowable that IND sponsor involves more than one individual or organization? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
K 13485 do e-signatures have to be 21 CFR Part 11 compliant? ISO 13485:2016 - Medical Device Quality Management Systems 8
D Audit Report details when ISO 13485:2016 and cGMP 21 CFR 820 are applicable ISO 13485:2016 - Medical Device Quality Management Systems 6
I 21 CFR 806 Corrections and Removals Other US Medical Device Regulations 2
C 21 CFR 820.90 - Documenting rework and reevaluation in DHR 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
Sam Lazzara Record signature requirements in proposed FDA 21 CFR 820 QMS Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
William55401 21 CFR 11 Password Aging - What does "periodically" revised mean in your org? Qualification and Validation (including 21 CFR Part 11) 3
D 21 CFR Part 11 Assessment (Fully Compliant or Not) Qualification and Validation (including 21 CFR Part 11) 9
JesseE Electronic signatures FDA CFR 820 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Validation of Data verification tool per 21 CFR 820 Quality Assurance and Compliance Software Tools and Solutions 1
Anonymous16-2 Sinks and Sanitation - 21 CFR Part 111 Miscellaneous Environmental Standards and EMS Related Discussions 4
S 21 CFR part 11 version differences Qualification and Validation (including 21 CFR Part 11) 1
L FDA & 21 CFR Part 11 Medical Device and FDA Regulations and Standards News 19
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A TUV Audits - 21 CFR 820 General Auditing Discussions 6
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
T 21 CFR 820.20 - Quality Planning Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S ISO 9001:2015 vs 21 CFR Part 211 matrix Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
D CFR Title 14: Aeronautics and Space PART 120—DRUG AND ALCOHOL TESTING PROGRAM Federal Aviation Administration (FAA) Standards and Requirements 3
M 21 CFR 820 vs 21CFR820 vs 21 CFR Part 820 Document Control Systems, Procedures, Forms and Templates 3
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
C 21 CFR 803 malfunction detected during packaging - report? Other US Medical Device Regulations 1
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
Anonymous16-2 21 CFR Part 11 - Steps to take if we want to validate an electronic system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
A 21 CFR part 11 - section 11.100 - Electronic Signature Certification Other US Medical Device Regulations 6
E 21 CFR 211.103 Calculation of Yield Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
Q 21 CFR 821 Medical Device Tracking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L Wearables 21 CFR Part 11 compliance Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J Mislabeling - Consider this an FDA notified recall? CFR 806.10 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
P 21 CFR 807.81 When a premarket notification submission is required Other US Medical Device Regulations 0
F 21 CFR Part 11 - Implicit requirements - Validation plan for a Software as a Service Other US Medical Device Regulations 1
C 21 CFR Part 11- What about handwritten signatures? Other US Medical Device Regulations 1
Z 21 CFR and Annex 11 mapping document Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Ed Panek Do Cloud services require 21 CFR Part 11 compliance? Qualification and Validation (including 21 CFR Part 11) 7
QIE FDA 21 CFR Part 11 "Meaning of Signature" Other US Medical Device Regulations 6
J Business Intelligence and 21 CFR Part 11 Compliance Qualification and Validation (including 21 CFR Part 11) 1
R Addressing training requirements - 21 CFR Part 820.25 (1) & (2) Other US Medical Device Regulations 4
R How to improve a Validation program and procedures to FDA (21 CFR part 820) & ISO13485 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Marc Problem with 21 CFR Part 820 - US FDA Quality System Regulations (QSR) sub-forum link - 2 May 2019 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
R 21 CFR Part 820 Contract Manufacturer of Medical Device Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S 21 CFR 810 - Medical Device Recall Authority - Contract Manufacturing Other US Medical Device Regulations 1
S Is Adobe Sign - E-signature for QMS documents - 21 cfr part 11 compliant? ISO 13485:2016 - Medical Device Quality Management Systems 2
D Design developer - 21 CFR 807 - do we need to register? Other US Medical Device Regulations 0
C Signature manifestations - 21 CFR Part 11 Qualification and Validation (including 21 CFR Part 11) 4
C Informational CFR 21 Definition for Data or Raw Data Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5

Similar threads

Top Bottom