QMS 080 GMP Audit Procedure Sample
QMS 080 GMP Audit Procedure Sample
QMS 080 GMP Audit Procedure Sample
EHS Statement
Audits must be conducted with due concern for employee safety and environmental protection.
Table of Contents
Overview ............................................................................................................................................................ 2
Procedure........................................................................................................................................................... 3
1. Internal Quality Audit............................................................................................................................... 3
2. Vendor Audit ........................................................................................................................................... 5
3. Environmental, Health and Safety (EHS) Audit ...................................................................................... 6
4. Environmental, Health and Safety (EHS) workplace Inspection............................................................. 6
5. Housekeeping Audits .............................................................................................................................. 7
6. Regulatory inspection.............................................................................................................................. 8
7. Summary of Changes ............................................................................................................................. 9
End of Procedure ............................................................................................................................................... 9
Overview
An audit is a systematic and independent review to verify compliance, suitability and/or data integrity.
Audits may assess: systems, processes, procedures, facilities, products, records and/or data for compliance
with policies, standards, procedures, guidelines, regulations or regulatory submissions.
2. Vendor Audit
2.1. Schedule
An audit schedule is to be established commencing in the beginning of the year with a 12-36 month
period. All audits are to be entered in the Documentation Database with the schedule date reflective
of the schedule.
2.2. Preparation
The Vendor Questionnaire (Form-385) may be sent out to the vendor. This will become part of the
preparation for the audit.
2.4. Reporting
Vendor Audit reports, written using template TEM-120 should be issued within 30 calendar days
after the audit, indicating the audit team’s observations and recommended status of the Vendor.
The Vendor should be requested to provide a formal response to the audit report within 30 working
days of its receipt.
6. Regulatory inspection
6.1. Schedule
Regulatory Agency inspections may be announced or unannounced. The Quality Assurance
Manager is the primary contact for Regulatory Agency Inspections. Should the Quality Assurance
Manager not be available on site, this responsibility will be defined in the letter of delegation issued
prior to planned absences.
6.2. Planning
For Regulatory inspections, either announced or unannounced, the following should be identified
and made available in a timely manner to facilitate the auditing process.
An inspection team with specific roles such as runners, scribes and subject experts to be
able to quickly respond to the needs of the auditor.
An appropriate individual to assist the auditor in conducting the audit and be available at all
times to the auditor to facilitate the timely gathering of information.
A conference room or office available to the auditor for the purpose of reviewing notes,
inspection of company documents and /or use of telephone to contact his/her office.
The auditor should be made aware that the taking of photographs, use of tape recorders or
other electronic equipment, the listening to, reading and signing of affidavits, the review of
internal audit reports and the allowing of access to computer databases is NOT ALLOWED
and requires consultation with the Quality Assurance Manager.
Management Responsibility
Is an organization chart available? If yes, please enclose a copy. Yes No N/A
Are there any written job descriptions defining each individuals responsibilities Yes No N/A
How many shifts of operation are there in the Production Area?
How many shifts of operation are there in QC Laboratory?
Approximately how many employees do you have?
- Site total
- QA/QC
- Production
To whom does the QA/QC Manager report?
Does the company have a policy on EHS (Environmental, Health & Safety)? Yes No N/A
Does the company have a policy on Quality? Yes No N/A
Who is responsible for contacts with Sydco with regards to the following areas:
Quality:
Technical:
Commercial:
All information contained within this document will be treated as confidential between the Supplier and Buyer.
Warehouse
Are storage facilities/equipment/ rented or personnel contracted? Yes No N/A
If “Yes”, please provide details.
Comments:
Production
Is there more than one site or plant used for the manufacture
Yes No N/A
of the specified material(s)?
If “Yes”, please provide details.
All information contained within this document will be treated as confidential between the Supplier and Buyer.
Material Release
Is the decision to release/reject product made by a person or function
Yes No N/A
independent from production?
Is the final status recorded? Yes No N/A
Are certificates issued for each batch? Yes No N/A
Are certificates signed by QA/QC? Yes No N/A
If not, who signs certificates?
Transport
Is a list of approved hauliers in use? Yes No N/A
Is temperature controlled transports used? Yes No N/A
If “Yes”, are temperature records reviewed and retained? Yes No N/A
If bulk tankers are used, is a cleaning certificate required? Yes No N/A
If bulk tankers are used, are they dedicated? Yes No N/A
If not, what other substances could be transported in the tankers?
All information contained within this document will be treated as confidential between the Supplier and Buyer.
Area Manager:
Area Inspected:
General
This EHS Workplace Inspection was conducted by:
Inspection Observations:
(Write the inspection observations and recommendations here)
Your comments and suggestions regarding improvements to the above areas or the inspection process
would also be much appreciated.
_______________ ____________________
Inspector (s) EHS Manager
All information contained within this document will be treated as confidential between the Supplier and Buyer.
LIGHTING HAZARDS
Item Code Comments
Is there adequate illumination for tasks?
Is there direct or reflected glare?
Are light fittings clean and in good condition?
All light switches working correctly and positioned
appropriately?
Are there energy saving practices / equipment in place?
Other Comments
HAZARDOUS SUBSTANCES
Item Code Comments
Do employees know where to access MSDS?
Do employees know how to dispose of used chemicals and
containers?
Are there sharps / appropriate disposal containers readily
available?
Are all containers clearly labelled?
Is storage suitable for different chemical types?
Are chemicals of incompatible classes stored separately?
Are cabinets located more than 3 metres from ignition
sources?
All information contained within this document will be treated as confidential between the Supplier and Buyer.
For each hazard, think How severely could it hurt someone or harm the environment?
about:
kill or disable / several days first aid /
major irrevesible off work / excess
environmental significant resource use
How likely is it to hurt someone
harm or environmental or minor
or harm the environment?
pollution incident pollution
1
very likely
2 3
LIKELIHOOD
likely
could happen occasionally
+
2 3 4
unlikely
-Could happen, but only rarely
3 4 5
very unlikely
Could happen, but probably never
--
will
4 5 6
The numbers show how important it is to do
1 do something immediately
something:
6 do something when possible.
All information contained within this document will be treated as confidential between the Supplier and Buyer.