Equipment Installation Protocol - We Need Your Input

GOOD DOCUMENTATION PRACTICE (GDocP) IQ (INSTALLATION QUALIFICATION)
1

Hello All,

I am currently working on a project where I need to develop an Equipment IQ Protocol Template for use on a manufacturing line, that has various pieces of equipment working together.

I thought it would be a good idea to open this up to discussion and get peoples experience’s to date on what they have included into their protocols.

At the end of this exercise we will generate “The Ultimate Equipment Installation Protocol”

We need your help with this guys so please add any comments of opinions to the list below.

Documentation:
• All relevant drawings are available including: Mechanical Drawings, Electrical Schematics, Process and Instrument Drawings;
• User Manual;
• Spare Parts Listing;
• Software Documentation (Ladder Logic, Version Control Documentation for Source Software) .

Equipment Design / Component Verification:
• All major Equipment/Components design verified via Design Qualification or equivalent (ex.

Approved Engineering Specifications and Design Review and/or IQ verification)
• Certification of Materials of Construction used, equipment finish;
• Main Components of Preventative Maintenance Program;
• Special Cleaning Intervals Established.

Verification of Critical Instrument Calibration:
• Primary Instruments Listed in the Calibration Program;
• Instrument Resolution and Accuracy are identified and adequate for Process Control Range;
• Traceable Standards Used.

Utilities Supplied:
• Electrical;
• Compressed Air;
• All Connections to be Verified;

Environmental Requirements:
• Temperature;
• Humidity;
• Lighting;
• Noise Level;
• Electrostatic Discharge Isolation.

Safety Code:
• Electrical Wiring/Disconnects;
• Noise Level Standards.

SOP Availability:
• Operation;
• Software/PLC Configuration Control;
• Disaster Recovery;
• Preventative/Maintenance;
• Cleaning Routines.

Adequate Acceptance Criteria:
• All Acceptance Criteria to be Supported by Engineering/Quality and any other Stakeholders.

Validation Instruments:
• Validation instruments used in IQ are listed and within calibration due dates.

Good Documentation Practices
• Clear statement of Purpose, Results and Conclusions;
• Raw Data Available;
• Use of Permanent Ink;
• Non-Adulterated Records;
• Proper Correction of Data Entries.

Please leave your comments below

2

Quite a list!

One situation I ran into once was the quality of utilities; e.g., in this case, compressed air. The process that built the part blew some compressed air on a membrane. I think they couldn’t use just any compressed air and had to install some filters to eliminate oil (vapor). Maybe water has to be a specific type / quality.

The list doesn’t explicitly state a PM and/or a cleaning schedule - implied? Is calibration check / re-calibration considered part of PM? Maybe all this would be covered in the associated SOPs? Might not hurt to be explicit.

I presume the “Software Documentation” would include identification of software revision. We always require and an archived copy of the software (e.g., CD / DVD). This has been invaluable in the past. Ensuring the software is under change control is also a pretty good idea.

What is the ‘acceptance criteria’ item? On the surface, I’m not sure this is appropriate for an IQ. If you’re saying that this is just part of constructing an IQ, then probably ok.

How about scope? What if there is more than 1 machine to be qualified? What if there’s a desire to show equivalence?

How about a thorough description of the operations to be performed (i.e., how it will be used for its intended purposes)?

Training of operators? Training requirements?

Just thinking out loud. Hopefully some of it is helpful. I look forward to the Golden Protocol set!

3

Good point I will alter the list to include those

Absolutely agree, change control is essential.

Yes, it was just a general statement really, that acceptance criteria should be very clear upfront

[quote=yodon]
How about a thorough description of the operations to be performed (i.e., how it will be used for its intended purposes)?

Training of operators? Training requirements?

Just thinking out loud. Hopefully some of it is helpful. I look forward to the Golden Protocol set![/quote]

Yes I didn’t add the normal heading for an IQ, I will add them

4

Table of Content

Scope

Purpose

System Description

Training Requirements

Intended Use of Equipment

Documentation:
• All relevant drawings are available including: Mechanical Drawings, Electrical Schematics, Process and Instrument Drawings;
• User Manual;
• Spare Parts Listing;
• Software Documentation (Ladder Logic, Version Control Documentation for Source Software) .

Equipment Design / Component Verification:
• All major Equipment/Components design verified via Design Qualification or equivalent (ex.

Approved Engineering Specifications and Design Review and/or IQ verification)
• Certification of Materials of Construction used, equipment finish;
• Main Components of Preventative Maintenance Program;
• Special Cleaning Intervals Established.

Verification of Critical Instrument Calibration:
• Primary Instruments Listed in the Calibration Program;
• Instrument Resolution and Accuracy are identified and adequate for Process Control Range;
• Traceable Standards Used.

Utilities Supplied:
• Electrical;
• Compressed Air;
• All Connections to be Verified;

Environmental Requirements:
• Temperature;
• Humidity;
• Lighting;
• Noise Level;
• Electrostatic Discharge Isolation.

Safety Code:
• Electrical Wiring/Disconnects;
• Noise Level Standards.

SOP Availability:
• Operation;
• Software/PLC Configuration Control;
• Disaster Recovery;
• Preventative/Maintenance;
• Cleaning Routines.

Adequate Acceptance Criteria:
• All Acceptance Criteria to be Supported by Engineering/Quality and any other Stakeholders.

Validation Instruments:
• Validation instruments used in IQ are listed and within calibration due dates.

Good Documentation Practices
• Clear statement of Purpose, Results and Conclusions;
• Raw Data Available;
• Use of Permanent Ink;
• Non-Adulterated Records;
• Proper Correction of Data Entries.

5

In some casses they are taking the Equipment Drwaings and architectural (Room Drawings) and looking into alignment of equipments into the rooms.(Pre IQ Inspection)

Operation Manual
Maintenance Manual
Product specifications
Product Cut sheets
Containment or class in which the Equipment is housed or Installed.
Weld Documentation
Air Balancing Reports
Passivation Reports
Walk down Reports

Regards

6

[quote=DURGA PRASAD]In some casses they are taking the Equipment Drwaings and architectural (Room Drawings) and looking into alignment of equipments into the rooms.(Pre IQ Inspection)

Operation Manual
Maintenance Manual
Product specifications
Product Cut sheets
Containment or class in which the Equipment is housed or Installed.
Weld Documentation
Air Balancing Reports
Passivation Reports
Walk down Reports

Regards[/quote]

Hi Durga,

Yes I agree I think this could go under the heading of:
Equipment Design / Component Verification:

7

Some other considerations int he upfront section (before the meat of the IQ):

Responsibilities: Define who is responsible for what in regards to protocol preparation, review, pre-approval and execution. (Engineering, QA, QC, Manufacturing, etc.)

General procedures for protocol execution: how to execute, method of recording results (color of pen, no pencils, etc), how to address a deviation, how to handle protocol attactments (label with protocol number, number of pages, initial, date, etc)

I would also break out several things from the documentation section and have a separate sections drawings and software as there could be pretty specific acceptance criteria for those items that would not apply necessarily to an equipment manual or a purchase order. I WOULD include such things as functional requirements and design specifications in that section.

We also perform I/O testing in the IQ for PLC systems.

8

Hi Graham,

The template looks good so far.

As you’ve stated that its a mfg line project you’re working on, I can’t see the room/area classification in the template. If its an aseptic line, then that opens a whole new chapter and series of other validations.

Other points you may mention are;

Rated Capacity
Certificates of calibration
Ergonomic design
Lubricants used and their grade/types

Regards,

9

Its good.
But I think you need to mention about the verification of the receiving specification of the equipment. And how you handled it and and how you transfer to its intended location, what care you have taken, who did this will represent the exact installation.
Enjoy the assignment

10

Hi…

Please add follwoing information aslo.

Change Control Procedure
Requalification Procedure
Deviation Record

Thanks

11

Hi::::

The Installation Qualification Protocol must fullfill all the primary requirements which the equipment need for proper functioning. Therefore it is better to prepare separate Installation Qualification Protocol for each equipment not just fill the Generalize Protocol.

Syed Ali Mesum Rizvi
Senior Executive Validation
Kaizen Pharmaceuticals Pvt. Ltd.
Pakistan
Mobile # 092-0300-8905340

1 Like