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How to perform a Facilities Qualification in 9 steps.

Facility Qualification

 

WHAT IS A FACILITY QUALIFICATION FQ?

The Facilities Qualification validates the overall manufacturing/testing/production environment and its utilities. The requirement is as usual driven from the production processes.

Where the product process calls for specific utility or room condition, then the respective facilities must be validated to accomplish the required conditions to be achieved and maintained. It includes any facility and utility system supporting: manufacturing areas, cleanrooms, laboratories, storage rooms, etc.

Some examples of these facilities and utilities are: water systems, chiller systems, AHU air handling units, electric power, compressed air, nitrogen system, reheat units, chillers, etc.

All equipment and utilities used in the process area must be listed in the Facilities Qualification, along with reference to the validation documents generated during their qualification or commissioning.

When use a Facility Qualification?

The facility qualification is performed every time a physical area, room or building shall be used for GMP manufacturing purposes.

It will guarantee that all necessary utilities and environmental conditions shall be available for the intended use.

In addition, to the structural requirements of the building with its materials as floors, ceilings, walls, windows; the facility qualification shall consider all equipment and machinery connections, supplies, air conditioning, water system, compresses air system, HVAC system, electric power capacity, city water, etc.

Typically, the facility qualification considers the commissioning or qualification of all utilities and room related to each product manufacturing operation.

How to prepare a Facility Qualification in nine (9) steps?

The facility qualification may include, but, is not limited to the following nine (9) sections and information, (as applicable)

Step 1. PURPOSE:

Define the purpose of the facility qualification in this section.

Step 2. RESPONSIBILITIES:

Define the departments and positions responsibilities in this section.

  • CONSTRUCTION (Engineering Department Responsibility)
  • UTILITIES (Engineering Department Responsibility)
  • CERTIFICATE OF CALIBRATION FOR TESTING EQUIPMENT AND PERMANENT INSTRUMENTS (Engineering Department Responsibility)
  • SAFETY (Safety Responsibility)
  • MICROBIOLOGICAL LOAD (QC Microbiology Responsibility)
  • CLEANING AND SANITIZING (QC Microbiology Responsibility)
  • Pest Control program
  • Approved cleaning procedures

Step 3. ROOM DESCRIPTION

“Include a brief description of the Room in terms of its use, utilities available, Cleanroom or Clean Zone classification and major equipment installed”.

Step 4. PROCEDURE

  • Verify the original and actual specifications of the construction materials, dimensions, floors, walls, ceiling, doors, windows, lighting, drains, transfer parts, and ground conductors as applicable. Also, comment about the actual conditions of these items by indicating any specific finding.
  • Verify actual drawings (As-Built) of room layout, utilities supplied, HVAC, structural, and/or architectural drawings. Include a copy of these drawings as part of this protocol.
  • Document any major equipment installed in the room.
  • A certified electrician will verify the electrical supply of the room.
  • If applicable, verify the utilities such as compressed air, steam, WFI, nitrogen, and purified water supplied to the room. Document results.
  • Verify that environmental conditions of Room (Temperature, Relative Humidity, and Differential Pressure) meet established requirements. Document results.
  • Verify that Room meets the requirements of the company procedures and manufacturing product specifications, “Certification Requirement for Critical and Controlled Rooms Areas”. Include a copy of the Certification Summary Report as part of the final report.
  • Verify calibration certifications of each instrument and test equipment installed permanently in Room. Document results.
  • Verify that the room is cleaned as per company procedures. Perform (QA representative) a cleaning and sanitation inspection in the room.  Document results.
  • If applicable, verify that the environmental monitoring in Room was performed according to company procedures.
  • Perform a safety audit (EHS Safety and Health representative) in Room to verify the room meets the requirements for a safe work environment.

 Step 5. ACCEPTANCE CRITERIA

  • Protocol Attachments will be documented as required in the Protocol. The attachment requirements must be found within established specifications and/or current applicable SOP’s acceptance criteria.
  • The actual room’s materials specifications must be equivalent or similar to the original room specifications or current cleanroom standards.
  • Utilities supplied to this room must meet the minimum requirements established for the processes and/or equipment operations.
  • Actual room environmental conditions must meet the requirements of SOPs.
  • Room Certification must meet the requirements of SOPs.
  • The calibration of equipment must meet the requirements of SOPs.
  • The cleaning and disinfecting of this area must meet the requirements of SOPs.
  • The environmental monitoring must meet the requirements of SOPs.
  • The room must demonstrate to be a safe workplace. Any situation that could jeopardize the safety and health of the persons working in this area must be evaluated.  If this situation is found to be critical, it must be solved in a reasonable period of time.

 Step 6. TABLE OF STANDARD ABBREVIATION (Example; not limited to the abbreviations included) 

Abbreviation Meaning
HEPA Filter High-Efficiency Particulate Air Filter with a minimum collection efficiency of 99.97% for 0.3mm of DOP particles.
HVAC Heating, Ventilating and Air Conditioning System
LEVS Local Exhaust Ventilation System
CFM Cubit Feet per Minutes
NIST National Institute of Standards and Technology
NEC National Electric Code
CCR Change Control Request
Cleanroom Is a room in which the concentration of airborne particles is controlled and which contains one or more Clean Zones.
Clean Zones Is defined as a critical area in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness as per FED-STD-209E.

 

Step 7. DISCREPANCIES

Any discrepancies observed during the Facility Qualification will be documented.

Step 8. APPLICABLE DOCUMENTS

Define any applicable document as SOP, procedures, instructions, design drawings or specifications related to he facility qualification in this section.

Step 9. APPROVALS 

Define the persons and their tiles and department that shall be approving the facility qualification.

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More details on specific FDA expectations for facility qualification can be found in the guidance document below. httpss://www.fda.gov/media/71021/download

Three (3) options to create a facility qualification protocol

Option 1. You can create a great protocol, using a template.

You can download a free sample of a validation template in .pdf format. 

To see the complete list of the most popular validation templates, click here.

In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill, and adapt to your needs.

Option 2. We can bring you a formal training on how to create your own validation protocols using our template(s).

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We can create a customized facility qualification.

One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.

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STATUTORY AND REGULATORY REQUIREMENTS

for facility qualification

Validation for drugs (finished pharmaceuticals and components) is a legally enforceable requirement under section 501(a)(2)(B) of the Act (21 U.S.C. 351(a)(2)(B)), which states the following:

“… a drug (including a drug contained in a medicated feed) shall be deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of the act as to the safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.”

Process validation for drugs (finished pharmaceuticals and components) is a legally enforceable requirement under section 501(a)(2)(B) of the Act (21 U.S.C. 351(a)(2)(B)), which states the following:

FDA regulations describing current good manufacturing practice (CGMP) for finished pharmaceuticals are provided in 21 CFR parts 210 and 211.

The CGMP regulations require that manufacturing processes be designed and controlled to assure that in-process material and the finished product meet predetermined quality requirements and do so consistently and reliably.

Process validation is required, in both general and specific terms, by the CGMP regulations in parts 210 and 211. The foundation for process validation is provided in § 211.100(a), which states that “[t]here shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess…” (emphasis added). This regulation requires manufacturers to design a process, including operations and controls, which results in a product meeting these attributes.

Other CGMP regulations define the various aspects of validation. For example, § 211.110(a), Sampling and testing of in-process materials and drug products, requires that control procedures “. . . be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product” (emphasis added).

Under this regulation, even well-designed processes must include in-process control procedures to assure final product quality. In addition, the CGMP regulations regarding sampling set forth a number of requirements for validation:

Samples must represent the batch under analysis (§ 211.160(b)(3)); the sampling plan must result in statistical confidence (§ 211.165(c) and (d)); and the batch must meet its predetermined specifications (§ 211.165(a)).

In addition to sampling requirements, the CGMP regulations also provide norms for establishing in-process specifications as an aspect of process validation. Section 211.110(b) establishes two principles to follow when establishing in-process specifications. The first principle is that

“. . . in-process specifications for such characteristics [of in-process material and the drug product] shall be consistent with drug product final specifications . . . .”

Accordingly, in-process material should be controlled to assure that the final drug product will meet its quality requirements. The second principle in this regulation further requires that in-process specifications “. . . shall be derived from previous acceptable process average and process variability estimates where possible and determined by the application of suitable statistical procedures where appropriate.”

This requirement, in part, establishes the need for manufacturers to analyze process performance and control batch-to-batch variability.

The CGMP regulations also describe and define activities connected with process design, development, and maintenance. Section 211.180(e) requires that information and data about product quality and manufacturing experience be periodically reviewed to determine whether any changes to the established process are warranted. Ongoing feedback about product quality and process performance is an essential feature of process maintenance.

In addition, the CGMP regulations require that facilities in which drugs are manufactured be of suitable size, construction, and location to facilitate proper operations (§ 211.42). Equipment must be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use (§ 211.63). Automated, mechanical, and electronic equipment must be calibrated, inspected, or checked according to a written program designed to assure proper performance (§ 211.68).

References

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://ispe.org/publications/guidance-documents/gamp-5

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://ispe.org/publications/guidance-documents/gamp-5

Related topics and resources:

Validation Plan, Installation Qualification, Operational Qualification, Performance Qualifications, Component Qualification, Traceability Matrix, Ppk, Control Charts, Cpk, User Requirements, Functional Requirement Specifications, GAMP5, risk assessment
Picture of Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!

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