Biomedical Engineering Reference
In-Depth Information
abc Pharmaceutical comPany
ANNEXURE C (FOR NONSTERILE)
MANUFACTURING FACILITY
SELF-EVALUATION QUESTIONNAIRE
6th
Calibration Control (Manufacturing/Laboratory)
Yes
No
N/A
1. Are there acceptable procedures to assure that gauges, tools, and test
equipment are maintained in proper order?
2. If the calibration is performed by the facility, are there calibration
procedures formalized?
3. Is there a system to assure that gauges and testing equipment are
calibrated on time by responsible personnel?
4. If computer software is used for scheduling preventative maintenance
and calibrations, is it validated?
Comments :
Information provided by:
Designation:
7th
Packaging/ Shipping
Yes
No
N/A
1. Are the shipping containers sufficiently marked to identify content,
storage condition, lot number, country of origin, and quantity?
2. Are shipments adequately protected from in-transit damage?
3. If drums are recycled from clients, are they cleaned via a validated
procedure?
4. Does the company include a certificate of analysis with the shipment?
5. Does the company include a packing list with the shipment?
Comments :
Information provided by:
Designation:
Page 6 of 8
 
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