Standard operating procedure to allot the document number to the instrument qualification protocols describe in this post.
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1.0 OBJECTIVE:
To
provide a system for allocating document protocol number for instrument
qualification in order to have a better traceability and reference.
2.0 SCOPE:
This
SOP shall be applicable to the instrument qualification protocol such as:
2.1 User requirement specification.
2.2
Functional
requirement specification.
2.3
Design
qualification.
2.4
Installation
qualification.
2.5
Operational
qualification.
2.6
Performance
qualification.
2.7
Re-qualification.
3.0 RESPONSIBILITY:
3.1
Doing:
Quality
Control department/ Production department.
3.2
Checking:
Quality
Assurance department.
4.0 ACCOUNTABILITY:
4.1
Head of Quality
Assurance Department.
5.0 PROCEDURE:
5.1 Allot
following system for document protocol number for instrument qualification.
|
Document
protocol number |
Applicable
for |
Instrument
qualification protocol type |
|
XYZ/XXX/YY000 |
User
requirement specification |
URS |
|
XYZ/XXX/YY000 |
Functional
requirement specification |
FRS |
|
XYZ/XX/YY000 |
Design
qualification |
DQ |
|
XYZ/XX/YY000 |
Installation
qualification |
IQ |
|
XYZ/XX/YY000 |
Operational
qualification |
OQ |
|
XYZ/XX/YY000 |
Performance
qualification |
PQ |
|
XYZ/XX/YY000 |
Re-qualification |
RQ |
Where,
XYZ=
XYZ Pharmaceuticals.
XXX=
corresponds to 3 alphabets denoting the types of document protocols.
XX=
corresponds to 2 alphabets denoting the types of document protocols.
YY=
corresponds to department either QC (for quality control) or PR (for
production)
000=
corresponds to 3 numerical figure starting from 001.
5.2 Allot
following code for the protocol with respect to instrument qualification as
mentioned in 5.1.
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