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GMP Audit Checklist
GMP Audit Checklist
Description
Not Applicable or Not Audited
No System
System Deficient
Improvement Needed
Acceptable
Outstanding
Full Explanation
The procedure or process is not relevant to the supplier's commodity or the particular facility audited
The procedure and process is not included in the supplier's system, but was expected to be.
The procedure or process is included in the system but planning and execution both require
substantial improvement. The system is documented but not followed.
The system is in place but it is not properly documented or executed. There is a high probability that
the system will not produce consistent results. Improvements to the process documentation are
The procedure or process is included in the supplier's system. Planning and execution meet these
requirements. There is a high probability that the supplier's system will produce consistent results.
The system can be manual or electronically automated.
The procedure or process is included in the system. Planning and execution are thorough and exceed
these requirements. It is certain that the system will produce exemplary results. Although not
required, typically electronic data management is used.
Sub-Section
1) Buildings & Facilities
2) Materials Management
3) Quality Control Systems
4) Manufacturing
5) Packaging & ID Labelling
6) Quality Management Systems
7) Personnel & Training
8) Purchasing & Customer Service
Total
Rating Scale:
Outstanding
Excellent
Good
Satisfactory
Conditional
Unsatisfactory
Score
95 to 100
90 to 94.9
80 to 89.9
70 to 79.9
50 to 69.9
Less than 50
This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement
regarding confidentiality and intellectual property. This document is not to be shared with third parties or with employees outside of normal business conduct
without prior management approval.
QFH006
1 of 1
Effective 10/01/2006
SUPPLIER
DATE
LOCATION
Points
Sub-Section
Section Score
12
15
15
11
10
15
12
10
NAp
NAp
NAp
NAp
NAp
NAp
NAp
NAp
0.00
0.0
100
Total
NAp
NAp
NAp
NAp
NAp
NAp
NAp
NAp
% of
Available
Points
NAp
NAp
NAp
NAp
NAp
NAp
NAp
NAp
0.0
NAp
Section
Points
Audit Score
Auditor's Comments
See cover letter
This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate
agreement regarding confidentiality and intellectual property. This document is not to be shared with third parties or with employees outside of normal
business conduct without prior management approval.
QHF006.1
Effective 05/26/2005
Score
Comments
NAp
This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be shared with
third parties or with employees outside of normal business conduct without prior management approval.
3 of 10
2-Materials Management
2 - MATERIALS MANAGEMENT
Score
Comments
2.2 Traceability
Lot trace system with distinctive lot number for all raw materials, in-process materials, finished goods, and packaging components.
Establish and document First-in/First out(FIFO) procedures for all materials and goods.
2.3 Storage
Materials should be handled and stored in a manner to prevent degradation, contamination, and cross-contamination.
- Temperature and humidly
- Containers designed to protect against adulteration.
- Store and/or control rejected materials in segregated facility so as to prevent usage.
- Warehouse area is clean and orderly - 18" perimeter is maintained.
- Materials should be re-evaluated, as appropriate, to determine their suitability for use (e.g., after
prolonged storage or exposure to heat or humidity).
NAp
This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be shared
with third parties or with employees outside of normal business conduct without prior management approval.
Score
Comments
NAp
This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be shared
with third parties or with employees outside of normal business conduct without prior management approval.
5 of 10
4-Manufacturing
4 - MANUFACTURING
Score
Comments
4.2 Contamination
Any material observed to have insect infestation shall be quarantined and immediately removed from premises.
Effective measures shall be taken to protect against metal and extraneous materials.
NAp
This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be shared
with third parties or with employees outside of normal business conduct without prior management approval.
Score
Comments
NAp
This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be
shared with third parties or with employees outside of normal business conduct without prior management approval.
Score
Comments
NAp
This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be shared
with third parties or with employees outside of normal business conduct without prior management approval.
8 of 10
Score
Comments
NAp
This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be shared
with third parties or with employees outside of normal business conduct without prior management approval.
9 of 10
Score
Comments
8.1 Purchasing
Is there a system to notify customers of delivery days?
How are they notified? E-mail, fax, phone, mail? Is this documented?
What systems or processes are in place for Cost of Quality (i.e. scrap, reduction, rework, commodity planning)?
An up-to-date organization chart with names/key personnel available.
8.3 General
Are there contingency plans for serious problems (fire, tornado, flood, etc.)?
Is there a system to identify facility, machine, and operational needs for the future?
An established complaint investigation and response program exists
Do you have a recall procedure?
Do you perform mock recalls? On what frequency? Have you performed one recently? What were the results?
Do you have a documented stability program?
NAp
This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be shared
with third parties or with employees outside of normal business conduct without prior management approval.