Allocating Document Protocol Number for Instrument Qualification

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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