Standard Operating Procedure

Title: GMP Audit Procedure

____________________________________________________________________________________________________________
Related Documents
TEM-080 Internal Audit Report Template
TEM-120 Vendor Audit Report Template
Form-385 Vendor Audit Questionnaire
Form-445 EHS Workplace Instruction Checklist
QMS-010 All Documents - Classification, Definition and Approval Matrix
EHS-010 Environmental, Health and Safety - Risk Management
QMS-015 Quality Documentation Management and Change Control
QMS-030 Preparation, Maintenance and Change Control of Master Documents
QMS-025 Quality Documentation - Control, Tracking and Distribution
QMS-035 Deviation Report System
QMS-105 House Keeping Audit Procedure
QMS-045 Vendor Selection and Evaluation

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.

The Documentation Database:

The Documentation Database is used to facilitate creation, control, maintenance and tracking of Quality,
External and Master file documents. These are also referred to as “Controlled Documents. The
Documentation Database is divided into three (3) of areas of control:

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Standard Operating Procedure
Title: GMP Audit Procedure
____________________________________________________________________________________________________________
Observations of a less serious or isolated nature that are not deemed Critical or
Major, but require correction, or suggestions given on how to improve systems or
procedures that may be compliant, but would benefit from improvement (e.g. Good
Practice seen elsewhere).
These are to be considered as a Deviation and raised as a DR.
Standard Observation is the first text to be written in the “description” long text of the DR.
A response indicating responsibilities and timescales of corrective actions is required.
All tasks in the audit Deviation Report are to be reviewed and approved by QA/auditor. Any
problems relating to agreement of corrective action are to be reported to the Quality
Assurance Manager, EHS Manager or Production Manager for resolution.
A copy of the draft report is to be forwarded to QA for review. After the debrief meeting, and
agreement is reached between the auditor and auditee, a signed copy is to be forwarded to
QA.
The report is to be issued as per SOP QMS-015 in the Quality Audit area in the
Documentation Database as a confidential document to management of the audited area
and Manufacturing Management Team.
(The content of internal audit reports are confidential and will not be shared with any
external regulatory agency, unless approved by Quality Assurance Manager, however
audit schedules/logs may be reviewed).

1.5.4. Audit Outcome Review

All Observations are to be raised as Deviation Report. Auditors are to record all audit DRs in
a Tracking Spreadsheet, so tracking and trending of topics of DR can take place. The
spreadsheet will be reviewed by QA department on a quarterly basis. Any significant
observations or trends should be referred to QA Management and together with corrective
actions will be considered, implemented and follow up.

1.5.5. Archiving of Documentation

Master copies of audit reports and related documentation are to be filed in a satellite file
location for QA and retained as listed in the document Retention time section of SOP QMS-
010. Soft copies of the report are to be stored in the document database by report number.

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.

2.3. Performing the audit

The audit is to be lead by a qualified QA auditor with assistance from Technical, Manufacturing,
Engineering, EHS or a relevant staff member, reflecting the audit needs. A maximum of two people
should facilitate 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.

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Standard Operating Procedure
Title: GMP Audit Procedure
____________________________________________________________________________________________________________
The auditors should use the Housekeeping checklist for area audited. Non-conformances made
during the inspection should be discussed with personnel at the time they are observed, so that
observations are clearly understood by all involved. Non-conformances should be resolved as soon
as possible, and are to be documented in the housekeeping checklist. Non-conformances are also
captured using the Deviation Report system and are to be raised by the designated Housekeeping
Auditor or Process Manager. DR number must be recorded on the Housekeeping Checklist.

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.

6.3. Audit Performance

Once the Regulatory Inspection has commenced, the following process should be followed:

Senior management should be present at the opening and closing meeting of a regulatory
inspection. It is suggested that the senior management give a brief introductory
presentation to the Regulatory Authorities (with their agreement) covering the department,
function or site being audited.

Auditors should be accompanied at all times to meet the organization’s EHS requirements
and to facilitate the provision of documents, information and movement through the facility.

Auditor’s questions must be answered truthfully and honestly, in the most direct manner to
ensure prompt provision of information and adherence to the audit schedule timeliness.

Auditors must go through proper Induction Training Programs for areas audited should they
request entrance into restricted areas of facility.

Inspection team members should keep accurate detailed notes on issues, products,
operations, documents reviewed and samples taken during the audit, to facilitate timely
clarification and resolution of issues arising during the audit.

Documents or copies of documents provided to the auditor should be stamped as
“CONFIDENTIAL” to ensure company confidentiality and a duplicate copy of these
documents must be included as part of the inspection file at QA Office to facilitate the timely
resolution of any future queries from the Regulatory Agency relating to the audit, should they
arise.

Daily summary sessions (daily wrap-up meetings) with the auditors at the end of each day’s
activities should be requested for the purpose of clarifying any issues that may have been

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 Form-385
Issue date:
Vendor Audit Questionnaire
(Ref. SOP QMS-045; QMS-080)
____________________________________________________________________________________________________________

For “Yes” / “No” answers;

Please tick the box for the one which applies, or select “N/A” (Not Applicable)

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:

Are subcontractors (if used), used for significant steps or components in

Preparation of Sydco’s products? No N/A
Yes
The term subcontractors includes both contracted operations within Production
and the Laboratory
If “Yes”, please list and explain:

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 Form-385
Issue date:
Vendor Audit Questionnaire
(Ref. SOP QMS-045; QMS-080)
____________________________________________________________________________________________________________

Warehouse
Are storage facilities/equipment/ rented or personnel contracted? Yes No N/A
If “Yes”, please provide details.

Are receipt and release procedures documented? Yes No N/A

Is the supply chain documented? Yes No N/A

How is material status controlled? (i.e. Physical, system or labelling)

How is rejected material controlled? (i.e. Physical, system or labelling)

Is there an identified sampling area? Yes No N/A
Are all containers identified? Yes No N/A
Is a First-In-First-Out or First-Expiry-First-Out system in use? (Identify) Yes No N/A
Are shelf life/expiration dates used? Yes No N/A
Is Temperature (T°°), controlled and documented? Yes No N/A

Comments:

Is Relative humidity (RH%), controlled and documented? Yes No N/A

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.

Is plant equipment labelled as to its status and contents? Yes No N/A

Is Pipe work labelled? Yes No N/A
Are critical processes validated? Yes No N/A
Does process documentation include:
Yes No N/A
Process instructions
Cleaning instructions Yes No N/A
Cleaning records Yes No N/A
Area clearance Yes No N/A
Are cleaning processes validated? Yes No N/A

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 Form-385
Issue date:
Vendor Audit Questionnaire
(Ref. SOP QMS-045; QMS-080)
____________________________________________________________________________________________________________

Investigation of rejected material Yes No N/A

Product complaints Yes No N/A
Handling out of specification results Yes No N/A
Are manual calculations checked by a second person? Yes No N/A
Are data transcriptions checked by a second person? Yes No N/A
Is all raw-data retained? Yes No N/A
Are all standards traceable to their preparation and the reagents used? Yes No N/A
Are analytical methods validated? Yes No N/A
Do you perform stability testing on materials and/or products? Yes No N/A
If so, what shelf life / retest dates are available for the referenced product(s)?

Do you perform annual product reviews or campaign reviews on

Yes No N/A
products?

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?

Is shelf life or retest dates or expiry date provided on the “C of A “ OR

Yes No N/A
“C of C’s”
Is there a documented recall procedure? Yes No N/A

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.

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 Form-445
Issue Date:
EHS Workplace Inspection Checklist
(Ref. SOP QMS-080)
____________________________________________________________________________________________________________

Inspected by: Date of inspection Date of Report Report # Pages

Area Manager:
Area Inspected:

General
This EHS Workplace Inspection was conducted by:

Scope of the Inspection:

Write what is covered and what’s not.

Inspection Observations:
(Write the inspection observations and recommendations here)

Summary / Inspectors' Comments

Your comments and suggestions regarding improvements to the above areas or the inspection process
would also be much appreciated.

_______________ ____________________
Inspector (s) EHS Manager

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 Form-445
Issue Date:
EHS Workplace Inspection Checklist
(Ref. SOP QMS-080)
____________________________________________________________________________________________________________
Are all hot machine surfaces guarded & identified through
signage?
Other Comments

ERGONOMIC AND MANUAL HANDLING

Item Code Comments
Are controls easily accessible?
Is adequate lifting equipment available if required and staff
trained in correct use?
Are no static / awkward positions required or maintained for
prolonged periods?
Have seating / displays / ergonomics been designed to
accommodate different demographics and minimise stress /
error?
Are there repetitive body movements required?
Is there no repetitive reaching / pushing / pulling / bending /
twisting / reaching over or arm raising required?
There is no excessive vibration / friction?
Do working positions appear comfortable?
Other Comments

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?

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 Form-445
Issue Date:
EHS Workplace Inspection Checklist
(Ref. SOP QMS-080)
____________________________________________________________________________________________________________

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

could happen regularly

++

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.

HAZARD IDENTIFIED LIKELIHOOD SEVERITY Risk Risk Controls

Level
Very likely Kill or disable
Likely Several days off 1-6
Unlikely First aid
Very Unlikely

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