Facility Validation

TEMPLATES & PRESENTATIONS TEMPLATES
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Historically, the legal requirement for validation of pharmaceutical manufacturing processes originated in the U.S. with the Food and Drug Administration (FDA) promulgating the cGMP regulation in 1979. This precipitated a widespread rush by pharmaceutical manufacturers to install formalized validation programs suited to their individual needs, financial capabilities, and company philosophy. These regulations have been written in such a way as to leave the interpretation to the user. Confusion and misinterpretation by industry on the scope and extent of this requirement has led to ever increasing costs of bringing pharmaceutical facilities in compliance with these cGMPs. The cost of validating a facility is determined by time spent on documentation, development of protocols and Standard Operating Procedures (SOPs), and the time spent on actual fieldwork, data collection, and analysis.

For a new or upgraded facility, commissioning and facility validation is the foundation for assuring success in further manufacturing process validation. Before you begin validating a manufacturing process, an acceptable facility, and the utilities and equipment to support manufacturing operations must be in place. Facility qualification (a part of validation that proves and documents that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results), and validation (establishing documented evidence that provides a high degree of assurance that the manufacturing processes, including buildings, systems, and equipment consistently produce the desired results according to predetermined specifications and quality attributes) activities will establish and provide documentary evidence that:

•The premises, supporting utilities, equipment, and processes have been designed in accordance with the requirements of GMP. This constitutes Design Qualification (DQ).

•The premises, supporting utilities, and equipment have been built and installed in compliance with their design specifications. This constitutes Installation Qualification (IQ).

•The facilities, supporting utilities, and equipment operate in accordance with their design specifications. This constitutes Operational Qualification (OQ).

•The facilities, utilities, or equipment that can affect product quality, performs as intended meeting predetermined acceptance criteria. This constitutes Equipment Performance Qualification (EPQ) Once the facility has been validated (IQ + OQ + Performance Qualification [pq]), then process validation can commence

•A specific process will consistently produce a product meeting predetermined specifications and quality attributes. This constitutes Process Validation (PV) or Process Performance Qualification (PPQ).

Establishing a project team that has adequate skills that are appropriate for the size and complexity of the project is key to the project launch. Project team representation should be based on the project scope, resource requirements, and key stakeholders.

Iam enclosing a basic document about Facility validation as a PDF attachment.

Facility validation.pdf (81.2 KB)

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Dear Durga,
thank you very much for the information!
I was really handicapped on this question and now I am going to start.

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Welcome.
We are ready to help professionals like you round the clock.

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[quote=DURGA PRASAD]Historically, the legal requirement for validation of pharmaceutical manufacturing processes originated in the U.S. with the Food and Drug Administration (FDA) promulgating the cGMP regulation in 1979. This precipitated a widespread rush by pharmaceutical manufacturers to install formalized validation programs suited to their individual needs, financial capabilities, and company philosophy. These regulations have been written in such a way as to leave the interpretation to the user. Confusion and misinterpretation by industry on the scope and extent of this requirement has led to ever increasing costs of bringing pharmaceutical facilities in compliance with these cGMPs. The cost of validating a facility is determined by time spent on documentation, development of protocols and Standard Operating Procedures (SOPs), and the time spent on actual fieldwork, data collection, and analysis.

For a new or upgraded facility, commissioning and facility validation is the foundation for assuring success in further manufacturing process validation. Before you begin validating a manufacturing process, an acceptable facility, and the utilities and equipment to support manufacturing operations must be in place. Facility qualification (a part of validation that proves and documents that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results), and validation (establishing documented evidence that provides a high degree of assurance that the manufacturing processes, including buildings, systems, and equipment consistently produce the desired results according to predetermined specifications and quality attributes) activities will establish and provide documentary evidence that:

•The premises, supporting utilities, equipment, and processes have been designed in accordance with the requirements of GMP. This constitutes Design Qualification (DQ).

•The premises, supporting utilities, and equipment have been built and installed in compliance with their design specifications. This constitutes Installation Qualification (IQ).

•The facilities, supporting utilities, and equipment operate in accordance with their design specifications. This constitutes Operational Qualification (OQ).

•The facilities, utilities, or equipment that can affect product quality, performs as intended meeting predetermined acceptance criteria. This constitutes Equipment Performance Qualification (EPQ) Once the facility has been validated (IQ + OQ + Performance Qualification [pq]), then process validation can commence

•A specific process will consistently produce a product meeting predetermined specifications and quality attributes. This constitutes Process Validation (PV) or Process Performance Qualification (PPQ).

Establishing a project team that has adequate skills that are appropriate for the size and complexity of the project is key to the project launch. Project team representation should be based on the project scope, resource requirements, and key stakeholders.

Iam enclosing a basic document about Facility validation as a PDF attachment.[/quote]

Could you specify the requirement of facility validation for API manufacturing areas. ICH Q7 or 21 CFR does not recommends or specifies in the guidelines regarding facility validation. Any other guideline recommends for the same?

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I do not think there is a major difference in Guidance.
A guidance states what should be there depending up on Processes, Systems, Equipments and Contaiments.

The site survey would typically comprise a complete review of:

•Equipment, pipework, instruments and electrics
•Control and automation
•Process services
•Utilities including HVAC
•Building fabric
•Materials and personnel flows
A review of equipment pipework and E&I would address such questions as:

•is the equipment vendor still able to support the system?
•are spares still available?
•is material certification available for contact parts?
•are the existing maintenance records up to date?
•do the drawings reflect the current as built. status?
•is asbestos present?
Automation systems can present additional problems. GAMP 5 is applicable here as per trend.

The overall approach is to develop a Validation Master Plan that is prospective and incorporates the following principles:

•use of a risk Based Approach typically based on the ISPE Baseline Guide for Commissioning and Qualification.
•focus on the critical product quality attributes (CQAs) and critical process parameters (CPPs)
•development of a systems list and conduct system and Component Impact Assessments
•maximum use of Good Engineering Practices
•maximum use of existing corporate and site Validation/ Qualification Procedures and Documentation
•use of a fully integrated approach with the commissioning.

Look 3-A Industrial Dairy standrads for all Cleaning, Validation (CIP/SIP).

Dairy standrads are excellent.

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Site Operation Qualification is an important part of facility validation.This process must fulfill 2 important objectives namely:

1.Systems and subsytems are properly working as per the URS and need intended.
2.To enure that the systems personnel and Operators recieve proper and relevant training as per cGMP needs.

This whole excercise is a joint effort from Engg teams, Quality departmets, Compliance, Civil, Production and Human resources.All the groups will sit and make protocols and documents.Using such properly documented protocols all the equipments will be tested and this paves a foundation for subsequent training of all personnel involved to run and operate such equipment and facilities.

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:slight_smile: Hi Durga, Thanks for preicse information on validations…Mohammed Mustafa, Quality Manager.

[quote=DURGA PRASAD]Historically, the legal requirement for validation of pharmaceutical manufacturing processes originated in the U.S. with the Food and Drug Administration (FDA) promulgating the cGMP regulation in 1979. This precipitated a widespread rush by pharmaceutical manufacturers to install formalized validation programs suited to their individual needs, financial capabilities, and company philosophy. These regulations have been written in such a way as to leave the interpretation to the user. Confusion and misinterpretation by industry on the scope and extent of this requirement has led to ever increasing costs of bringing pharmaceutical facilities in compliance with these cGMPs. The cost of validating a facility is determined by time spent on documentation, development of protocols and Standard Operating Procedures (SOPs), and the time spent on actual fieldwork, data collection, and analysis.

For a new or upgraded facility, commissioning and facility validation is the foundation for assuring success in further manufacturing process validation. Before you begin validating a manufacturing process, an acceptable facility, and the utilities and equipment to support manufacturing operations must be in place. Facility qualification (a part of validation that proves and documents that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results), and validation (establishing documented evidence that provides a high degree of assurance that the manufacturing processes, including buildings, systems, and equipment consistently produce the desired results according to predetermined specifications and quality attributes) activities will establish and provide documentary evidence that:

•The premises, supporting utilities, equipment, and processes have been designed in accordance with the requirements of GMP. This constitutes Design Qualification (DQ).

•The premises, supporting utilities, and equipment have been built and installed in compliance with their design specifications. This constitutes Installation Qualification (IQ).

•The facilities, supporting utilities, and equipment operate in accordance with their design specifications. This constitutes Operational Qualification (OQ).

•The facilities, utilities, or equipment that can affect product quality, performs as intended meeting predetermined acceptance criteria. This constitutes Equipment Performance Qualification (EPQ) Once the facility has been validated (IQ + OQ + Performance Qualification [pq]), then process validation can commence

•A specific process will consistently produce a product meeting predetermined specifications and quality attributes. This constitutes Process Validation (PV) or Process Performance Qualification (PPQ).

Establishing a project team that has adequate skills that are appropriate for the size and complexity of the project is key to the project launch. Project team representation should be based on the project scope, resource requirements, and key stakeholders.

Iam enclosing a basic document about Facility validation as a PDF attachment.[/quote]

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Dear Forum,

I need my queries to be clarified. Requesting the forum members to help me in this regard. I am new to qualification activities.

Query is related to new pharmaceutical facility.

  1. Once after completion of civil work, do I need to qualify the facility or utility first.

Also can anyone list the qualification requirements once after completion of civil work.

Thanks in advance.