1 product worth 45.55 in your cart
go to the checkout

0
shares

So your boss asks you to formulate a template to validate all of the equipment types in your organisation, where do you start? Seems like a very daunting task, how can you formulate a template that will include all the essential elements of equipment validation.

Let’s say for example you are working in the Medical Device field what regulations should you base the requirements on?

The Requirements

The main requirements that should be focussed on include:

  • (FDA) Design Control Guidance for Medical Device Manufacturers (March 11, 1997)
  • GHTF/SG3/N99-10:2004 (Edition 2) Process Validation Guidance for Medical Device Manufacturers endorsed by ICH, January, 2004
  • FDA Compliance Guidance-General Principles of Process Validation. US Food and Drug Administration Center for Drugs and Biologics and Devices and Radiological Health, May 1987

So lets break down what needs to be qualified in order to bring the equipment into a state of compliance. Remember this is just a starting point, for a full list please refer to the requirements above.

1. Documentation

a) All relevant equipment drawings are available and verified:

  • Mechanical drawings
  • Electrical schematics
  • Process & Instrument drawings
  • Pressure/Vacuum Rating ASME Code Stamp)

b) User manual

c) Spare part list

d) Software Documentation (ex. Ladder Logic) E-copy and hard copy (if applicable)

2. Equipment Design/Component Verification

a) All major Equipment/Components design verified via Design Qualification or equivalent (ex. Approved Engineering Specifications and Design Review and/or IQ verification).

b) Certification of materials of construction used, equipment finish.

c) Main components within preventive maintenance program.

d) Special cleaning and intervals established, if applicable.

3. Verification of Critical Instrument Calibration

a) Primary Instruments listed in the calibration program (i.e. control and process monitoring instruments, not backup indicators).

b) Instrument Resolution and Accuracy are identified and adequate for process control range required.

c) Traceable Standards Used.

4. Utilities Supply

a) Electricity (With all connections verified)

b) Clean steam boiler (With all connections verified)

c) Compressed air (With all connections verified)

d) Nitrogen (With all connections verified)

5. Environmental requirements

a) Temperature

b) Humidity

c) Lighting

d) Noise level

e) Electrostatic discharge isolation

6. Safety Code

a) Electrical wiring/disconnects

b) OSHA or AFS applicable standards for noise level

7. SOPs Availability

a) Operation

b) Software (PLC) Configuration Control and Disaster Recovery

c) PM

d) Cleaning

8. Validation Instrumentation

a) Validation instruments used in IQ are listed and within calibration due date.

Summary

This is not an exhaustive list but it will help anyone new to equipment validation to get a taste of what is involved when you are
developing your IQ, OQ, PQ, FAT or SAT documentation.

If you would like to learn more about equipment validation click here to post your queries.

0
shares

  • DURGA PRASAD

    Very well written.
    As the latest validation guidance is having terms like verification and testing its good to add ISO documents also in the requirements list.
    The whole article gave a clear path where and how to start.
    I thank the moderator for sharing such a good article.
    Regards

  • DURGA PRASAD

    Very well written.
    As the latest validation guidance is having terms like verification and testing its good to add ISO documents also in the requirements list.
    The whole article gave a clear path where and how to start.
    I thank the moderator for sharing such a good article.
    Regards

  • Shahid Ali

    Thanks, You have comprehensively listed out every single bit required to be covered in IQ/OQ protocol, I hope this will be a great help for those who are planning to start Equipment Qualification.

  • Shahid Ali

    Thanks, You have comprehensively listed out every single bit required to be covered in IQ/OQ protocol, I hope this will be a great help for those who are planning to start Equipment Qualification.

  • bld

    This is a great list for the IQ of the equipment. Do you have any recommendations of how to determine the OQ requirements for the equipment. What documents would you refer to for determining critical functionality that should be tested before release. Manufcturing technical specifications are a great start but are sometimes hard to get. Also how would you determine whether the OQ covers all items that would be required before releasing for manufacturing use? or whether a PQ is also required. Some items such as environmental controlled areas need PQ above operational qualification

  • bld

    This is a great list for the IQ of the equipment. Do you have any recommendations of how to determine the OQ requirements for the equipment. What documents would you refer to for determining critical functionality that should be tested before release. Manufcturing technical specifications are a great start but are sometimes hard to get. Also how would you determine whether the OQ covers all items that would be required before releasing for manufacturing use? or whether a PQ is also required. Some items such as environmental controlled areas need PQ above operational qualification

  • abu rafey khan

    Dear Sir your are really having a very nice knowledge on need based qualification.

    With regards
    abu rafey khan

  • abu rafey khan

    Dear Sir your are really having a very nice knowledge on need based qualification.

    With regards
    abu rafey khan

  • anvardeen2010

    HI ,

    I want some information on old equipment qualifications. we have purchased some equipments on 2005 , but we didn’t perform qualifications on those equipments. Now we are planning for commercial production. As per the regulatory needs we should completed the qualifications for all critical equipments.

    My question is how to do qualifications for old equipments. Whether we have to do it as retrospective method or some procedure. please guide me how to do first time qualifications for old equipments. Please suggest the me the reference guideline for this situation.

  • anvardeen2010

    HI ,

    I want some information on old equipment qualifications. we have purchased some equipments on 2005 , but we didn’t perform qualifications on those equipments. Now we are planning for commercial production. As per the regulatory needs we should completed the qualifications for all critical equipments.

    My question is how to do qualifications for old equipments. Whether we have to do it as retrospective method or some procedure. please guide me how to do first time qualifications for old equipments. Please suggest the me the reference guideline for this situation.

Similar articles:

0
shares

Training of personnel on deviation reporting and deviation handling is essential to a successful implementation of deviation management. All personnel must have a clear understanding of the deviation concept on all level of operation.

From a cleaning employee to a top level manager, everyone in the organization must apply deviation management procedure or instructions.

In order to do that, it must be mandated that all employee will attend at least once per year training on how to identify and report deviations.

 

The Three Levels

It is important to keep record of all the training’s performed in order to demonstrate to auditors that all personnel in the organization are competent and can report, handle, and/or manage deviations in a swift and accurate manner.

There are three levels of training on deviation management:

  1. Level 1: Identifying deviations and reporting them
  2. Level 2: Deviation Handling and Investigating
  3. Level 3: Deviation’s Corrective and Preventive Action

Level 1: Identifying Deviations and Reporting Them

  • This level of training should be mandated for all employees.
  • In this level, the trainee must learn how to notice and identify a course of actions or results which might indicate that something deviated from the standard and approved procedures in the quality management system.
  • This particular skill is crucial to the deviation reporting.
  • The trainer must spend considerable time developing attention to details in trainees. This particular competency forms the basis on which the trainer will build the trainees knowledge of deviation management.
  • The second obstacle to overcome is to make the employees understand that deviation reporting isn’t the equivalent of mistakes reporting.
  • In my experience, at first, many employees will see deviations as a way for the top management to record their mistakes for performance evaluation and bonus estimation.
  • The trainer must explain that it is the opposite of that concept, deviation reporting is your chance to express your interest in preserving the quality of the product or the service you provide in your organization.
  • It asserts your loyalty to the a quality based product and/or service and your devotion to the company’s standards.
  • Level 2: Deviation Handling and Investigating

    • This level of training is exclusive for management staff, including both lower and upper management.
    • In this level of training, the trainer must focus on investigational techniques and root cause analysis.
    • The basis of the training is risk analysis. The trainer must be an expert in risk identification, assessment, evaluation, reduction, and communication.
    • Other essential techniques include listening skills, communication, team work, and meeting management. These skills must be honed by the trainees during the training and during normal working hours.
    • The trainer must emphasis that this level of training is a mere introduction into deviation handling and that practice makes perfect. The reason is no one can develop all the skills necessary for investigating and solving complex deviations in one training module. The experience of the person practicing those tasks is the ammunition that would help him or her succeed at his or her job.

    Level 3: Deviation’s Corrective and Preventive Action

    • This level of training is exclusive to quality assurance personnel and upper management (including other department’s managers).
    • The aim of this training is to develop the ability of trainees to find the most efficient and effective actions to correct and prevent the deviation from reoccurring.
    • As we mentioned in 3.1.8. there are several points to consider when taking corrective and preventive actions. These points must be included in the training.
    • The trainer can be someone with experience with the applied procedure for corrective and preventive action in the organization and it would be better if he or she is experienced in risk management as mentioned in level 2 training.
    • If the training is being conducted for the first or second time, the trainer must emphasis to upper management that the trainee will need time to develop the experience necessary for them to create systematic actions with little to no side effects.
    • This training must conclude that the personnel required to decide the corrective and preventive actions must convene periodically in order to discuss the effectiveness of their actions and see what they can improve in their decision approach.

    Optional Training Sessions

    There are several competencies which are essential to successful deviation management, time management is one, communication management is also an essential feature which is greatly needed for the continuous and effective follow-up of deviations throughout the organization.

0
shares

Similar articles:

0
shares

Not all suppliers are the same, for example when you buy a car or a house, time and effort is dedicated into finding the best provider with the best product in terms of quality and reliability.

Choosing a Vendor

The same methodology needs to be dedicated when choosing a vendor for your business. Not only will you be purchasing their products or services, but you will also be dealing with them on a regular basis hence your personal relationship most also be strong.

Regulated Environment

When working in a regulated environment one of the key questions that needs to be considered is will the product of service affect your product quality. If the answer is yes then it is paramount that you can trust your supplier/vendor and the quality of their product or service

Supplier Qualification Online Course

This module is taken from our course on Supplier Qualification.

 

About Us

Learnaboutgmp is a cloud based learning management system (LMS) designed specifically for life science and regulatory organizations. Our LMS contains the courses you need to help you achieve regulatory compliance. With new courses published every month and existing courses updated in line with regulatory changes we are your true continuous learning platform.

0
shares

TOP

Similar articles: