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ולידציה – 3 Validation case study – part

Posted on by אביב צברי

ולידציה – 3 Validation case study – part

 This article was written by Iian Shaya, validation,automation and control expert

אילן שעיה Ilan Shaya
Ilan Shaya CEO , control and automation specialist and designer

Documentation for IQ and OQ – to be checked at PDI/FAT

Welding reports

Surfaces finishing test reports

PDI and FAT results

As-built drawings, 3 sets in nominated project language, plus 1 set in English

As-installed versions of all documentation submitted for design review

Back-up software on diskette/CD-ROM, as appropriate, ready for re-installment

Machine configuration/start up, set-up and commissioning data, including tabulation of all change parts and identifications

Full machine parts list

Complete documentation (protocols and method statements) required for equipment DQ, calibration, IQ and OQ specified for manual and automatic operations

Calibration certificates for all required instruments to NIST

Specification for all parts manufactured by sub-contractors

Full identification of all parts according to the P&ID, including valves, regulators, instruments, pipes, media and flow direction arrows

Tags for electrical and pneumatic wiring

Documentation to ensure qualification in compliance with FDA and EMEA, as outlined above

DQ Protocols Including PC/PLC

Approval

Statement of purpose

System description

Traceability matrix

IQ Protocols Including PC/PLC

Approval

Statement of purpose

System description

Specifications

Materials in product contact

Engineering drawings

Subsystem inspection

Components

Piping

Valves

Instrumentation and calibrations

PC/PLC requirement definition

Software development documentation

Manual / technical literature

Test equipment data sheet

Component data sheets

Utility requirements

Exceptional conditions, if required

Summary

OQ Protocols Including PC/PLC

Statement of purpose

System description

Manual and automatic control over all modules through HMI

PC/PLC validation protocols

Step-by-step checking of schedule of system operation – SSO

Alarm and message reaction

HMI synoptic screen vs. P&ID

System operation tests

Operation tests for HMI to ensure compliance with 21 CFR part 11

Application software certification

HW documentation

SW code

SW components data sheets

HW components data sheets

PLC configuration

Graph printout

Synoptic screen list and printout

Operation screen list and printout

Parameters list screen

Messages and alarms list, and printout

HW inspections

SW inspections and application

Approved schematic description

Ladder diagram validation

PLC capabilities

PLC accuracy

SW development documentation

List of control devices

Exceptional conditions

Reports – verification of authorization inspection

PQ Protocols Including PC/PLC

Statement of purpose

Analysis procedures

Staff instruction

Plan for sampling

Criteria for acceptance

 This article was written by Iian Shaya, validation,automation and control expert

ולדיציה – Validation case study – part 1

Posted on by אביב צברי

ולדיציה -1 Validation Requirements – case study- part

 This article was written by Iian Shaya, validation,automation and control expert

Validation Requirements is a document which may be part of the validation documentation that describes the validation strategy for a system or subsystem. This document is generic; the system or subsystem may include a PC with Human/Machine Interface (HMI), a Programmable Logic Controller (PLC), virtual hardware (HW), software (SW), and other components designed to maintain the user's facility in proper conditions specified by the user.

Validation Requirements Document Contents

This document is structured in a relatively standard fashion, with predetermined chapters and sections, where the final contents are tailored according to the type and size of the system under validation.

The main chapters and sections of a Validation Requirements document are:

Responsibility

Validation Requirements

Documentation for Initial Tender

Documentation for Design Review

Documentation Prior to Factory Acceptance Test (FAT) or Pre-Delivery Inspection – PDI

Commissioning

Documentation For Installation and Operational Qualification (IQ and OQ) – to be checked at PDI/FAT

Design Qualification (DQ) Protocols (Including PC/PLC) Architecture

Installation Qualification (IQ) Protocols (Including PC/PLC

Operational Qualification (OQ) Protocols (Including PC/PLC

Performance Qualification (PQ) Protocols

Computerized System Validation

Responsibility

This section lists the responsibilities of contractor, the user, and the required contents of the documents composing the validation file

The contractor is responsible for creation and performing the DQ, Design Review, Commissioning, IQ and OQ validation protocols

The user is responsible for creation and performing the PQ validation protocols

Design Qualification (DQ) – The design of the system will be documented and checked in the Design Specification. This specification will include details of the system and must be traceable to the URS and BOD documents

Mechanical Completion Check Report (MCCR) of the system will be documented and checked only by the contractor. This document will check system readiness for the IQ

Commissioning Execution (CE) of the system will be documented and checked only by the contractor. This document will check system readiness for  OQ

Installation Qualification –IQ

IQ will establish documented evidence that the system is installed according to the manufacturers’ specifications and user requirements, and assure that the environment is appropriate for its intended purpose

Each IQ protocol will include an appendix of deviation report, which describes the deviations (if they existent) of the specific system, and the contractor will be responsible to correct them

Operational Qualification – OQ

OQ will establish documented evidence that the system is operated according to manufacturers’ specifications and user requirements, and assure that the environment is appropriate for its intended purpose

OQ will establish documented evidence that the system is operated according to manufacturers’ specifications

.Each OQ protocol will include an appendix of deviation report, which describes the deviations (if they existent) of the specific system, and the contractor will be responsible to correct them

Performance Qualification- PQ

PQ will establish documented evidence that the system performs according to manufacturers’ specifications and user requirements, and assure that the environment is appropriate for its intended purpose

The PQ protocols are user's responsibility

 This article was written by Iian Shaya, validation,automation and control expert

ולידציה – DQ – Design Review

Posted on by אביב צברי

 ולידציה – DQ – Design Qualification / Design Review

DQ  – Design Qualification is for Design Review by verifying that the system has been designed as specified in the URS (User Requirements Specification), FDS (Functional Design Specification), and relevant equipment specifications satisfying all GMP requirements. The Process User Requirements in the URS have been identified by the Quality Risk Assessment. Since the Quality Risk Assessment is an iterative process, it may be performed again, whenever necessary, during the DQ and subsequent lifecycle qualifications.  For  hardware and software of the control system, verification data will be collected to prove that the system has been designed in accordance with the URS and FDS including the requirements of 21 CFR Part 11. As DQ is the final step to formally review and document the proper design of the system, the protocol must enable the reviewers to verify that all quality-critical attributes and essential technical attributes of the system have been incorporated in the design. When the DQ report is approved, the system is ready for fabrication and construction.

DQ PROTOCOLS
PROCESS EQUIPMENT AND SYSTEMS
Media Preparation and Hold Tanks
Buffer Preparation and Hold Tanks
Process Tanks
Reactors – Organic Synthesis
Bioreactors
Evaporator Systems
Distillation Tower Systems

CLEAN UTILITY SYSTEMS
USP Purified Water Storage and Distribution Systems
WFI Storage and Distribution Systems
Clean Steam Generation and Distribution Systems
Process Air Systems
Nitrogen Gas Systems

SUPPORT SYSTEMS
CIP Systems
Biowaste Kill Systems – Continuous
Biowaste Kill Systems – Batch
Autoclaves

HVAC SYSTEMS AND CLEANROOMS
HVAC Systems
Cleanrooms – Aseptic
Air Locks – Gowning

LABORATORY EQUIPMENT
Incubators
CO2 Incubators
Water Bath Incubators
Ultra-Low Temperature Freezers
Refrigerators