Could the Microbiology Laboratory Audit be done based on Documentation?

v9991

Trusted Information Resource
#1
how far is it advisable/dependable/recommendable to solely to base the microbiology audit based on documentations (systems-SOPs & activities-documentations)

what will we miss if we miss the laboratory round.?

if there is any point by which we can avoid/miss the laboratory round, then is it applicable to facility inspection of sterile manufacturing area as well?

counter point is , if its ok to miss lab-round, then is it acceptable to do a postal/online audit(i.e., all sops and documentation are available online for review, remotely)?
 
Elsmar Forum Sponsor

Ajit Basrur

Staff member
Admin
#2
Re: Could the Microbiology laboratory audit be done based on documentation ?

how far is it advisable/dependable/recommendable to solely to base the microbiology audit based on documentations (systems-SOPs & activities-documentations)

what will we miss if we miss the laboratory round.?

if there is any point by which we can avoid/miss the laboratory round, then is it applicable to facility inspection of sterile manufacturing area as well?

counter point is , if its ok to miss lab-round, then is it acceptable to do a postal/online audit(i.e., all sops and documentation are available online for review, remotely)?
Could you provide more info -

is this is part of the internal (first party) or supplier (second party) audit ?

what is the nature of business - sterile pharmaceuticals / non sterile pharmaceuticals ?
 

v9991

Trusted Information Resource
#3
Re: Could the Microbiology laboratory audit be done based on documentation ?

Could you provide more info -

is this is part of the internal (first party) or supplier (second party) audit ?

what is the nature of business - sterile pharmaceuticals / non sterile pharmaceuticals ?
my query was originally for a supplier audit. and now, i would like to extend same to the internal audit as well. and scope & nature of business being certain microbial limit tests and validation as well.

my second query was for sterile processes ;
 

somashekar

Staff member
Super Moderator
#4
Re: Could the Microbiology laboratory audit be done based on documentation ?

my query was originally for a supplier audit. and now, i would like to extend same to the internal audit as well. and scope & nature of business being certain microbial limit tests and validation as well.

my second query was for sterile processes ;
Be careful that it could turnout to be no Lab set up at all or just a board outside a room...... Neat documentation is no big deal.
I would look at personnel qualification and experience / training records as well more in depth.
 

v9991

Trusted Information Resource
#5
Re: Could the Microbiology laboratory audit be done based on documentation ?

Be careful that it could turnout to be no Lab set up at all or just a board outside a room...... Neat documentation is no big deal.
I would look at personnel qualification and experience / training records as well more in depth.
true, that is a frighfull end; but given it is not a case, nothing beats inperson interaction to gauge the expertize/alignment with systems.

what is the downside of doing a document-paper-online audit>? especially in microbiology lab or parenteral facility?
 

Ajit Basrur

Staff member
Admin
#6
Re: Could the Microbiology laboratory audit be done based on documentation ?

true, that is a frighfull end; but given it is not a case, nothing beats inperson interaction to gauge the expertize/alignment with systems.

what is the downside of doing a document-paper-online audit>? especially in microbiology lab or parenteral facility?
For a supplier audit, I would definitely have an actual lab involved as part of the audit just to be sure that all controls are in place. The very purpose of the audit is to ensure compliance ... the supplier can have the very best procedures written aka boiler plate documentation but with failed execution, it could turn out to be a disaster.

The same could be held valid for Internal audit but the severity is much lesser than a second party audit. Yet, I would recommend a lesser audit frequency if the past audit results have been satisfactory.

For Sterile preparations, Microbiology lab is an integral and a critical area and definitely covered in a field audit.

Could you pls tell why the organization want to proceed with a paper audit and not a field audit ?
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#7
A micro-bio lab should certainly consider accreditation under ISO/IEC 17025 in order for customers to have confidence all applicable criteria have been met.

Given you are in India, you should contact NABL.

If I were the customer, and only a paperwork audit done on efforts that critical, I would likely consider going elsewhere in order to have confidence in the results. As Somashekar correctly points out, neat paperwork - for a lab - may not tell you much.
 

v9991

Trusted Information Resource
#8
Re: Could the Microbiology laboratory audit be done based on documentation ?

Could you pls tell why the organization want to proceed with a paper audit and not a field audit ?
we were discussing about areas where a online/remote audit can be applicable in various scenario of customer/supplier audit.

thank you for all the inputs and your recommendations.
 
Thread starter Similar threads Forum Replies Date
P Can a 2 Person Microbiology Laboratory get ISO 17025 Accreditation ISO 17025 related Discussions 10
B Is a certified microbiology test laboratory required? Milk and Cheese Processing Food Safety - ISO 22000, HACCP (21 CFR 120) 5
Ajit Basrur Lean / Six Sigma Technical or Administrative Projects for Microbiology Laboratory Lean in Manufacturing and Service Industries 7
J Microbiology Testing - Managing a Microbiology Process Hospitals, Clinics & other Health Care Providers 2
S Do Microbiology Testing Labs need to use ISO 17025 accredited vendors? ISO 17025 related Discussions 2
R Microbiology Testing Outsourcing - Transport Qualification and Risk Assesssment Qualification and Validation (including 21 CFR Part 11) 2
H Microbiology Criteria for Food Packing Material Food Safety - ISO 22000, HACCP (21 CFR 120) 5
R Determining Sample Sizes for Testing (Chemistry or Microbiology) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
S ISO 19036 - Measurement Uncertainty for Microbiology Measurement Uncertainty (MU) 7
AnaMariaVR2 QbD, PAT, and the Future of Microbiology Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
Q Measurement Uncertainty Calculations and Microbiology - ISO 8199 or ISO 19036 Measurement Uncertainty (MU) 5
D Definition of "Critical Laboratory Equipment"? General Measurement Device and Calibration Topics 1
S Internal calibrations - Part of an ISO 17025 accredited testing laboratory (Automotive) ISO 17025 related Discussions 3
DMLqms Material for laboratory use or Medical Device? EU Medical Device Regulations 2
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 1
A Single use non-sterile syringe used in the oral cavity - Laboratory test advice US Food and Drug Administration (FDA) 7
B Accredited laboratory or not under MDD 93/42/EEC IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
D Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed? ISO 13485:2016 - Medical Device Quality Management Systems 1
Casana IATF 16949 7.1.5.3.2 External Laboratory - On Site Calibration IATF 16949 - Automotive Quality Systems Standard 8
A Information on good laboratory practices (GLP) for the non-medical or food industry wanted Manufacturing and Related Processes 1
D Internal audit forms or checklists for a medical/veterinary laboratory General Auditing Discussions 5
N IATF 16949 7.1.5.3.2 External Laboratory - Calibration of Nikon machine in factory IATF 16949 - Automotive Quality Systems Standard 24
Q Calibration laboratory scope - Include software such as Gagetrak or Mini tab used? General Measurement Device and Calibration Topics 3
B IATF 16949 7.1.5.3.2 FAQ #7 Audit Finding - External Calibration Laboratory IATF 16949 - Automotive Quality Systems Standard 7
P Procedure for maintaining Confidentiality And Impartiality in a Laboratory Quality Management System (QMS) Manuals 2
sswaim IATF 16949 7.1.5.3.2 External Calibration Laboratory Requirelents IATF 16949 - Automotive Quality Systems Standard 15
J Good Laboratory Practice: online training course recommendations? US Food and Drug Administration (FDA) 0
E 2 participants in inter-laboratory comparison tests ISO 17025 related Discussions 3
T MDR on Good Laboratory Practice (GLP) - Pg 110, section 6.1 (b) EU Medical Device Regulations 1
D Laboratory Manual ISO/IEC 17025 Example wanted ISO 17025 related Discussions 2
D Help identify a Nationally Recognized Testing Laboratory (NRTL) (UL) certified lab General Measurement Device and Calibration Topics 3
L How to manage a Metrology Department or Calibration Laboratory General Measurement Device and Calibration Topics 3
J IATF 16949 Calibration Laboratory Scope IATF 16949 - Automotive Quality Systems Standard 20
H Internal laboratory scope requirements - IATF 16949 Cl. 7.1.5.3.1 IATF 16949 - Automotive Quality Systems Standard 1
S RSL (Remote Site Location) Laboratory - Does it need to be ISO 17025 IATF 16949 - Automotive Quality Systems Standard 5
S Jewelry vs. Normal Laboratory Balances - Accuracy and calibration General Measurement Device and Calibration Topics 2
rob73 Requirement for independent certification of device using an ISO 17025 laboratory EU Medical Device Regulations 2
G Calibration Laboratory Dimensional Temperature Question General Measurement Device and Calibration Topics 2
G ISO 17025 Calibration Laboratory Assessor's Common Questions and Procedures ISO 17025 related Discussions 11
H Need to Start an R&D Laboratory, what to do? Design and Development of Products and Processes 6
B IATF 16949 - 7.1.5.3.1 Internal calibration laboratory requirements IATF 16949 - Automotive Quality Systems Standard 9
A Pharmaceutical Manufacturer's obligations - Laboratory Test instruments General Measurement Device and Calibration Topics 0
S HVAC Thermostat for Calibration Laboratory General Measurement Device and Calibration Topics 8
V Temperature/humidity requirements in internal metrology laboratory General Measurement Device and Calibration Topics 3
C Looking for Testing Laboratory for Aluminum Products - CE Marking General Measurement Device and Calibration Topics 5
S Looking for a Threaded Ring Gage Calibration Laboratory General Measurement Device and Calibration Topics 13
J Internal Laboratory Scope and Measurement Uncertainty (MU) IATF 16949 - Automotive Quality Systems Standard 1
B IATF 16949 Cl. 7.1.5.3.2 - External Laboratory Sub-Supplier Requirements IATF 16949 - Automotive Quality Systems Standard 2
J Is a Laboratory Scope Necessary if... IATF 16949 - Automotive Quality Systems Standard 15
V One Pager on Applications used in a Laboratory Qualification and Validation (including 21 CFR Part 11) 2
Similar threads


















































Top Bottom