User Requirement Specifications

Tetra Pak Stainless Equipment

Agus Rascana

Tangerang, September 15th, 2015

URS-User Requirement Spesifications

AR/2015-09-15

Flowchart of Buying Process

Preliminary
Study

Product
Capacity
Market Size
Validation
master Plan

Rooms Layout, Personal

& Material Flow, Plant
Layout, Utilities , HVAC,
VMP, URS, Process

Feasibility
Study

Engineering
Conceptual

DQ, Plant Layout,

Architecture, Cost of
Budget Investment,
VMP, URS

Detailed
Engineering

Basic Design
/Engineering

VMP, URS

BPOM
Approval

VMP
New Product
Formulation

Note :
: Consultant or supplier roles
: Done by Customer

Bidding Detail:
Engineering
& Cost Approval

Compile All Designs

Plant Design,
Automation and
Plant
Integration,
Building

HVAC
Electrical
B Automation
Waste

Processing
P Automation
Plant Integration

Civil Architecture

Commercial
Product

BPOM
Approval for
production

R
I
S
K

IMB,
AMDAL,
BKPM
Approvals

BPOM &
Headquarter
Approvals

Stability Test
Result
Facility
Improvement

A
N
A
L
Y
S
I
S

Tender

DQ
Detailed
Engineering
& Approval

Construction
Installation completed
IQ, OQ, PQ
Process Validation
Stability
Test
BPOM
Approval
for use of
facility

URS-User Requirement Spesifications

AR/2015-09-15

Illustration of the validation and

qualification principles in GMP.

Ref. ISPE

URS-User Requirement Spesifications

AR/2015-09-15

Main Propose and Validation

URS-User Requirement Spesifications

AR/2015-09-15

The Risk - Based Verification Process

Ref. ASTM

URS-User Requirement Spesifications

AR/2015-09-15

Scope and Approach

Requirements

URS-User Requirement Spesifications

AR/2015-09-15

Scope

New commercial manufacturing and modification to

existing regulated manufacturing facilities
Planning, specification, design, and delivery
(harmonized) with GAMP 5
Addresses the verification (or qualification) portion
of the validation life cycle on which process
validation is built

URS-User Requirement Spesifications

AR/2015-09-15

Approach and Method Validation

Traditional & RBA Based on ASTM E 2500

(Product) User Requirements not

Formally Documented

Process Requirements Documented,

Approved

Protocols Developed from

Templates IQ/OQ Protocols

Risk Assessments Determine Critical

Aspects of Design

Preapproved Commissioning not

Leveraged

Engineering Testing (Commissioning)

Verification

Engineering And Validation

Personnel Often Distinct

All Documents with Technical Merit

Used as Evidence of Fitness or Use

Emphasis on Documents Not

System Performance

Emphasis on Meeting Process

Requirements

URS-User Requirement Spesifications

AR/2015-09-15

Summaries of requirement

1. Introduction
2. Overview Of The
Lifecycle
3. Requirements
4. Specification & Design
5. Verification, Acceptance
and Release
6. Continual Improvement
7. Quality Risk
Management

8. Good Engineering
Practice
9 . Design Review
10. Change Management
11--15.

Appendices
16. Appendix 6 Glossary
and Acronyms
17. Appendix 7
References
Note : Automation dealt
with throughout each
chapter

URS-User Requirement Spesifications

AR/2015-09-15

ASTM- Risk Based Approach

ASTM Process

Supporting
activities

Ref. ISPE

URS-User Requirement Spesifications

AR/2015-09-15

Production Functionality Review

Objective

To evaluate the ability of the functional design documents to

meet production related requirements in contract and to
identify deviations (if any) and agree necessary actions.

Requirements
As per the Contract
Exhibits:
Design Requirements
Technical Description and Drawing list
Specification of Equipment and Services
Commissioning Criteria and Performance Targets

URS-User Requirement Spesifications

AR/2015-09-15

Production Functionality Review

Scope

The works or agreed sections thereof as per documents

listed below.
Process Technology Diagram
Mass balance
Production Time Schedule or manufacturing,
characteristics
Production Block Diagram
Functional Diagram
Automation System Configuration
Machinery layout
Single Line Diagram

URS-User Requirement Spesifications

AR/2015-09-15

Next

Next and detail

See

file P0031-033_QualityAssurancePlan.doc

Risk based approach

AR/2015-09-15

Validation Master Plan

URS-User Requirement Spesifications

AR/2015-09-15

Validation Master Plan

Key Elements of validation Programme

The validation master plan (VMP) should reflect

the key elements of the validation programme.
It should be concise and clear and contain at
least the following:
a validation policy
organizational structure of validation activities
summary of facilities, systems, equipment and processes
validated and to be validated
documentation format (e.g. protocol and report format)
planning and scheduling
change control
references to existing documents.

URS-User Requirement Spesifications

AR/2015-09-15

Validation Master Plan

Typical VMP Contents

1. Introduction
2. Scope
3. Facility Description
4. Commissioning
5. Qualification
6. Process Validation
7. Computer System
Validation
8. List of Required
Protocols and
Procedures

9. List of Required
Standard Operating
Procedures
10. Equipment and
Utility System
Descriptions
11. Computer System
Description
12. Other cGMP
Programs
13. References

URS-User Requirement Spesifications

AR/2015-09-15

Validation Master Plan

Validation references

World Health Organization, WHO Technical Report

Series, No. 937, 2006, Annex 4, Supplementary
guidelines on good manufacturing practices:
Validation
World Health Organization, WHO Technical Report
Series, No. 937, 2006, Annex 4, Supplementary
guidelines on good manufacturing practices:
Validation, Appendix 7, Non-sterile process
validation
WHO good manufacturing practices: water for
pharmaceutical use. Geneva, World, Health
Organization 2005 (WHO Technical Report Series,
No. 929), Annex 3.
URS-User Requirement Spesifications
AR/2015-09-15

Quality Assurance &

Scope of Supply

URS-User Requirement Spesifications

AR/2015-09-15

Productions solutions for Oral products

Vacuum Mixing
Module

CIP Module

PW Generator

PW tank
and Loop module
Holding Module
URS-User Requirement Spesifications
AR/2015-09-15

Production solutions for Parenteral

products

LVP Module

PSG and
WFI Loop
LVP Filling
Machine

SVP Module

CIP SIP Module

SVP Filling
Machine
URS-User Requirement Spesifications
AR/2015-09-15

Complete

line solutions
Integrated automation
Traceability

URS-User Requirement Spesifications

AR/2015-09-15

User Requirement
Specification

URS-User Requirement Spesifications

AR/2015-09-15

Equipment or systems is suitable for the

intended purpose
Product or application

General requirements for pharmaceutical water

systems
Water quality specifications
Drinking-water
Purified water
Highly purified water
Water for injections
Other grades of water

Application of specific water to processes and

dosage forms

URS-User Requirement Spesifications

AR/2015-09-15

Equipment or systems is suitable for the

intended purpose
Product or application

Water purification methods

General considerations
Production of drinking-water
Production of purified water
Production of highly purified water
Production of water for injections

URS-User Requirement Spesifications

AR/2015-09-15

The Risk - Based Verification Process

Ref. ASTM

URS-User Requirement Spesifications

AR/2015-09-15

Quality Assurance
Plan

URS-User Requirement Spesifications

AR/2015-09-15

Project Quality Assurance Plan

Design Review and Risk Assessments

Review of Production Solution Functionality

Production Functionality review
Operation Functionality review
Review of Technical Design
Hygienic Risk Assessment
Health & Safety Risk Assessment

URS-User Requirement Spesifications

AR/2015-09-15

Project Quality Assurance Plan

Implementation

Supplier selection
Procedure, Facility
Certification, etc.
Testing
Third party inspections
Factory Acceptance Test FAT - Dry
Factory Acceptance Test FAT Wet
Factory Acceptance Test FAT Product Test
Waste handling
Etc.
URS-User Requirement Spesifications
AR/2015-09-15

Project Quality Assurance Plan

Installation Completion

Pre-delivery Inspections
Factory Acceptance Test (FAT)
Box Opening Inspection
Health & Safety Risk Validation
Completed Installation Inspection

URS-User Requirement Spesifications

AR/2015-09-15

Project Quality Assurance Plan

Commissioning

Commissioning Test
Performance Test

URS-User Requirement Spesifications

AR/2015-09-15

Project Quality Assurance Plan

Performance Validation

Performance Test

URS-User Requirement Spesifications

AR/2015-09-15

Thank you

URS-User Requirement Spesifications

AR/2015-09-15