VALIDATION PROJECT PLAN FOR THE

ZETASIZER NANO ZSP

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TABLE OF CONTENTS
1.

INTRODUCTION..................................................................................................................2

2.

ACRONYMS, TERMS AND DEFINITIONS.....................................................................3

3.

REFERENCES.......................................................................................................................4

4.

RESPONSIBILITIES............................................................................................................5

5.

VALIDATION STRATEGY..................................................................................................6

6.

DELIVERABLES, RESPONSIBILITIES AND APPROVAL MATRIX........................10

7.

DEPENDENCIES.................................................................................................................13

8.

PROJECT COMPLETION AND CLOSURE...................................................................13

1. INTRODUCTION
1.1.

Purpose

1.1.1. The purpose of this Validation Project Plan (VPP) is to outline the validation
approach, strategy, and deliverables required for the validation of Zetasizer Nano
ZSP model ZEN 5600).
1.1.2.
1.2.

The Zetasizer Nano ZSP will be validated in accordance with SOP, Analytical
Instrument Qualification Procedure( USP1058)
Scope

1.2.1. The scope of validation will be limited to the one (1) Zetasizer nano ZSP (System
ID: ZEN 5600) at XYZs Quality Control (QC) laboratory located at 300 XYZ
Way, Lexington MA.

2. ACRONYMS, TERMS AND DEFINITIONS

Acronym/Term

Definition

CFR

Code for Federal Regulations

IOQ

Installation and Operational Qualification

IOQR

Installation and Operational Qualification Report

IT

Information Technology

Living Document

A document that should be assessed for changes when specification,

design, or testing documents are created or revised or when business
processes and practices change.

N/A

Not Applicable

Project document

A document written to support validation project activities that a

typically not revised after the system is released to production use.

QA

Quality Assurance

QC

Quality Control

RTM

Requirements Traceability Matrix

SDCS

System Design and Configuration Specification

SOP

Standard Operating Procedure

URS

User Requirements Specification

VPP

Validation Project Plan

VPR

Validation Project Report

3. REFERENCES
Document #

Title

MAN0486 issue1.0

Zetasizer Nano Basic Guide

MAN0485 issue 1.1

Zetasizer Nano User Manual

4. RESPONSIBILITIES
4.1.

Information Technology (IT)

4.1.1. Assist with the drafting of the GAP IOQ, primarily the sections on installation
qualification, configuration verification.
4.1.2. Develop, review and approve documents listed in section 6.
4.1.3. Assist in sorting out discrepancies found during the execution of GAP IOQ
protocols.
4.1.4. Provide IT impact assessment details in the change control and complete any
change action items.
4.2.

Quality Control (QC)

4.2.1. Develop, review and approve documents listed in section 6.

4.2.2. Assisting and collaborating with QC validation in the development of GAP IOQ
protocols.
4.2.3. Assist in the execution of GAP IOQ protocols.
4.2.4. Assist in sorting out discrepancies found during the execution of GAP IOQ
protocols.
4.3.

Validation

4.3.1. Develop, review and approve documents listed in section 6.

4.4.

Quality Assurance (QA)

4.4.1. Reviewing and approving of applicable discrepancies observed during the

execution of this protocol.
4.4.2. Review and approve documents listed in section 6.
4.4.3. Ensure all activities are being performed in a manner consistent with applicable
regulatory guidance documents and XYZ policies and procedures.
5. VALIDATION STRATEGY
5.1.

System Description

This system consists of optical unit, sample dispersion units like MPT-2 Titrator,
vacuum degasser and a computer with zetasizer software installed. The software
controls the system during the measurement and then analyses the data from the
instrument to give particle size, molecular weight or zeta potential for the sample
measure. The system also has the ability to perform Trend (tendency) measurements
and enables in determination of microrheology of protein and polymer solutions,
Protein melting point etc.
The system incorporates a two angle particle and molecular size
analyzer for the enhanced detection of aggregates and measurement of samples at
very low or high concentration using dynamic light scattering with NIBS (NonInvasive backscatter optics) technique. The ZSP also incorporates a zeta potential
analyzer that uses electrophoretic light scattering for particle and a molecular weight
analyzer using static light scattering for the measurement of Zeta potential and
molecular weight respectively. In addition, the system can also be used in a flow
configuration to operate as a size detector for Size Exclusion Chromatography (SEC)
or Field Flow Fractionation (FFF). The instrument also measures the electrophoretic
mobility of the proteins using a improvised laser Doppler velocimetry method (M3)
with Phase Ananysis Light Scattering (PALS).
The sample is prepared, filled in appropriate cells and placed in the cell chamber area.
Then a light source like laser beam is used to illuminate the particles within the sample.
Most of the laser beam passes straight through the sample cell but some is scattered by
the particles in all directions. An Avalanche photodiode acts as detector that measures the
intensity of this scattered light and passes it to a digital signal processing board called
correlator. This information from correlator is then passed to computer where a
specialized Zetasizer software will analyse the data and derive the required results.
The system incorporates a two angle particle and molecular size
analyzer for the enhanced detection of aggregates and
measurement of samples at very low or high concentration using

dynamic light scattering with NIBS (Non-Invasive backscatter

optics). The ZSP also incorporates a zeta potential analyzer that
uses electrophoretic light scattering for particles, molecules and
surfaces, and a molecular weight analyzer using static light
scattering. In addition, the system can also be used in a flow
configuration to operate as a size detector for Size Exclusion
Chromatography (SEC) or Field Flow Fractionation (FFF). The
instrument also measures the electrophoretic mobility of the
proteins using a improvised laser Doppler velocimetry method (M3)
with Phase Ananysis Light Scattering (PALS).
5.2 Current State- N/A
Future State
The intent of this validation effort is to ensure the continuous support of the system.
ZEN5600 will be Validated as per Analytical Instrument Qualification Procedure.)
USP 1058).

5.2.

Planning Stage

Planning stage include the following deliverables URS assessment form, , Equipment
Classification form, Design Qualification, Vendor IOQ, Vendor Protocol Assessment
form,
URS assessment for the system ZEN5600 will be completed.

Equipment classification forms for system ZEN5600 was approved on 21MAR2016.

Design Qualification document for the system ZEN 5600 was approved on
DDMONYEAR

User Requirements Specification for the system ZEN 5600 was approved on
29MAR2016. This document includes the system requirements.

AGMP Computerized System Categorization, form was approved on

29MAR2016.

The vendor documentation (IOQ) will be performed by vendor and then reviewed by
Business.

Vendor Protocol Assessment will be completed as per SOP.

5.3. Specification and Configuration Stage

System Design and Configuration Specifications (SDCS) was approved on
DDMONYEAR.
5.4.

Qualification Stage

Qualification stage includes the following deliverables:

As per SOP, a GAP IOQ will be drafted and executed for the system. The GAP IOQ
will be pre-approved and executed on the system. Any discrepancies observed during
the execution of the GAP IOQ will be initiated, investigated and resolved as per
SOP Validation Discrepancy Handling. The Requirement Traceability Matrix for
the system will be drafted and approved. The intent of this effort is to test all the
requirements listed in URS

The Installation Qualification will be performed by XYZs IT department. XYZ IT is

responsible for installing all the IT infrastructure components that are required to
support the system. The components shall be installed according to the
specifications defined in the SDCS. The intent of this effort is to test all the
requirements listed in URS.

5.5.

Reporting and Release Stage

Reporting and release stage include the following:

The systems will be released pending successful completion of all deliverables

identified in this VPP, resolution to any discrepancies (if any had occurred), and
approval of the following deliverables, per SOP:
Installation and Operation Qualification Report (IOQR)
Equipment Release Form per, Release of Analytical Equipment for GMP Use at XYZ
will be approved after successful approval of IOQR and effective SOPs (Operation and
Maintenance SOP and System Administrator SOP).One (1) VPR shall be generated
summarizing this validation effort. Any departures from this plan will be captured in the
VPR. The document ID, name, location shall be detailed in the VPR.

VALIDATION PROJECT PLAN FOR ZETASIZER NANO ZSP (ZEN 5600)

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6. DELIVERABLES, RESPONSIBILITIES AND APPROVAL MATRIX

Deliverables Responsibilities and Approval Matrix
Deliverables
Document
URS Assessment Forms

Responsibilities
Document
Author
Type
Project
QC Validation

System
Owner(QC)

Approvals
Information
Validation
Technology

N/A

Quality
Assurance

Validation Project Plan

Project

Validation

User Requirement Specification for Zetasizer

Nano ZSP in XYZs Quality Control Laboratories

Living

QC

System Design and Configuration Specification

Living

IT

Attachment 1: Equipment Classification Form

Living

QC

Design Qualification Document

Living

QC

Attachment 1: GMP Computerized System

Categorization for. Zetasizer Nano ZSP

Living

Validation

GAP Installation and Operational Qualification

(IOQ) Zetasizer Nano ZSP ( ZEN 5600)

Project

Validation

Requirement Traceability Matrix (RTM) for the

Zetasizer Nano ZSP ( ZEN 5600)

Living

Validation

N/A

Installation and Operational Qualification Report

(IOQR) for Zetasizer Nano ZSP ( ZEN 5600)

Living

Validation

Equipment Release Form for Zetasizer Nano ZSP

( ZEN 5600)

Project

QC Validation

Operation and Maintenance of Malvern

ZETASIZER NANO ZSP ( ZEN 5600)

Living

QC

N/A

N/A

Validation Project Report (VPR)

Project

Validation

VALIDATION PROJECT PLAN FOR THE

ZETASIZER NANO ZSP (ZEN 5600)
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7. DEPENDENCIES
7.1.

The URS, SDCS must be approved prior to execution of the GAP IOQ.

7.2. The Equipment release form must be approved after the approvals of IOQR,
RTM, and SOPs becoming effective.
8. PROJECT COMPLETION AND CLOSURE
8.1. All documentation listed in section 6 (Deliverables Responsibilities and Approval
Matrix) must be completed, approved and/or closed.
8.2. All discrepancies must be resolved successfully and closed prior to release of the
respective system.
8.3. The Validation Project Report (VPR) will be created to summarize completion
and approval of all deliverables and that all discrepancies were successfully closed out.