INTERNAL AUDIT CHECK LIST – FACILITIES AND EQUIPMENT SYSTEM

INTERNAL AUDIT CHECK LIST

FACILITIES & EQUIPMENT SYSTEM

LOCATION

DATE OF AUDIT

AUDITOR(S)

AUDIT No.

FORMAT No.:

EFFECTIVE DATE

Oct. 2010 Page 1 of 5

 INTERNAL AUDIT CHECK LIST – FACILITIES AND EQUIPMENT SYSTEM

INTERNAL AUDIT CHECKLIST

No. Question Observations
1 Buildings and Facilities
1.1 Design and Construction
1.1.1 Cleaning and maintenance easily to
be carried out?
1.1.2 Adequate space for placement of
equipment available?
1.1.3 Outdoors equipment raise no
concerns for contamination
1.1.4 Flow of materials and personnel
raise no concerns for contamination
1.1.5 Is the existing facility separated
from beta-lactams manufacturing
facility?
1.1.6 Is facility lay out designed to
prevent cross contamination?
1.1.7 Is Air handling systems in place?

1.1.8 Are Air handling systems designed

to prevent cross contamination?
1.1.9 Defined areas for the following
activities available:
- receipt, identification,
sampling of incoming
materials
- quarantine before
release/reject
- handling of rejected materials
1.1.1 Is there control systems available
0 for implementing changes in the
building?
1.1.11 Washing facilities and toilets
available for personnel?
1.1.7 Laboratory areas separated from
production?
1.2 Utilities
1.2.1 All utilities qualified?
1.2.2 Adequate ventilation, air filtration
and exhaust systems in place?
1.2.3 Control of re-circulated air
sufficient to avoid contamination?
1.2.4 Permanently installed pipework
appropriately identified?
1.2.5 Drains designed to prevent back-
siphonage?

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 INTERNAL AUDIT CHECK LIST – FACILITIES AND EQUIPMENT SYSTEM
No. Question Observations
1.3 Lighting & Sanitation
1.3.1 Is there any measures to prevent
process contamination?
1.3.2 Is there dedicated production
facilities are available for highly
sensitizing materials?
1.3.3 Adequate lighting facilities are
available for cleaning and
maintenance?
1.3.4 Buildings are maintained, repaired
and cleaned properly?
1.3.5 Written procedures for cleaning for
equipment and facilities in place?
1.3.6 Procedures for pest control in place?
2.0 Process Equipment
2.1 Design and Construction
2.1.1 Is the equipments are suitably
located, easy to clean and
maintenance?
2.1.2 Are Equipment Installation &
Operational Qualification
performed?
2.1.3 Are the equipment surfaces do not
alter product quality?
2.1.4 Are the equipment surfaces are not :
- Reactive
- Additive
- Absorptive
2.1.5 Are the equipment used only within
the qualified operation range.
2.1.6 Are the major equipment and
permanently installed pipework
identified
2.1.7 Are the Lubricants can have contact
with Intermediate and APIs?
Are food grade lubricants used?
2.1.8 Any Precautions (measures) taken
where equipment is opened?
2.1.9 Is there procedure available for
Qualification, Calibration and
maintenance of storage equipment,
such as refrigerators and freezers for
ensuring that standards, raw
materials, reagents etc. are stored at
the proper temperatures?
2.1.1 Are control system for
0 implementing changes in the
equipment available?
Oct. 2010 Page 3 of 5
 INTERNAL AUDIT CHECK LIST – FACILITIES AND EQUIPMENT SYSTEM

2.2 Equipment Maintenance and Cleaning

2.2.1 Preventive maintenance programme
in place?
Schedule followed?
2.2.2 Written procedures for the cleaning
of equipment in place?
2.2.3 Continuous production or dedicated
production:
Cleaned at appropriate intervals
(frequency)?
2.2.4 Is equipment cleaned between
production of different products?
2.2.5 Acceptance criteria for residues
determined?
2.2.6 Equipment identified as to its
content and cleanliness status?
2.2.7 Appropriate rodenticides, fingicides,
insecticides, cleaning and sanitizing
agents identified for sanitization of
the building?

3.0 Calibration
3.1 Instruments critical for
Intermediate/or API quality are
calibrated?
3.2 How is critical defined?

3.3 Written procedure in place?

3.4 Is there equipment identification

practices?
3.5 Calibration schedule followed?

3.6 Calibration done with standards that

are traceable to certified standards?
3.7 Records of calibration maintained?

3.8 Calibration status of instrument

known?
3.9 How is ensured that instruments out
of calibration are not used?
3.10 If instruments have been shown out
of calibration, are investigations
performed to determine if this fact
has an influence on the release of the
IM/API?
3.11 Any unexpected discrepancy
documented?
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 INTERNAL AUDIT CHECK LIST – FACILITIES AND EQUIPMENT SYSTEM

4.0 Computerised systems

4.1 Are GMP related computer systems
validated?
4.2 IQ,OQ for Hard-and Software
available?
4.3 Retrospective validation for existing
systems if not validated at time of
installation
4.4 What controls are in place to prevent
unauthorized access?
4.5 What controls are in place to prevent
omissions in data?
4.6 Is there a document where changes to
data are recorded, who made the
change, when the change was made
and of the previous entry?
4.7 Written procedures for the operation
and maintenance of computerized
systems available?
4.8 Is the entry of critical data checked
by additional means (second operator
or system itself)?
4.9 Incidents of computerized systems
recorded and investigated?
4.10 Changes to the computerized system
are made according to a defined
procedure?
4.11 How are data protected in cases of
system breakdowns?
Back-up system provided?
5 Equipment Cleaning and Use Records
5.1 Are there records for the major
equipment used, cleaning and
maintenance showing the following:
- date & time
- product and batch number of
each batch
- person who performed
cleaning & maintenance

Oct. 2010 Page 5 of 5