What each credential actually guarantees you
Cleanroom Quality and Certifications
A page of logos tells you very little. What matters is which credential proves what, and which one proves nothing on its own. And what evidence you should hold at the end of a cleanroom project.
Credential record
ISO 9001- Certification held
- ISO 9001, quality management system
- Issuing body
- Named on the certificate, sent on request
- Rooms engineered to
- ISO 14644-1, ISO Class 5 to 8
- Filters specified to
- EN 1822, H13 and H14 at MPPS
- Built for inspection under
- EU-GMP Annex 1, WHO, cGMP, Schedule M
- Handover evidence
- DQ, IQ, OQ and PQ, signed
What Fabtech holds, and what Fabtech builds to
Fabtech holds one certification as a company: ISO 9001, which covers how we work. Everything else on this page is a standard a room is tested against, or a rulebook an inspector uses. None of it is a badge a builder can wear. So we have written the limits of each credential as plainly as the strengths.
Two different things, kept deliberately apart:
- CertifiedISO 9001 quality management. This is the one certificate Fabtech holds as a company. It governs how projects and manufacturing are specified, documented, inspected and signed off. The certificate names an issuing body, a number, a scope, the sites covered and a validity period.
- Engineered toISO Class 5 through 8, under the international room-classification standard. The class is demonstrated by particle counts on site, room by room.
- Built for inspection underEU-GMP, including the revised Annex 1. Also WHO-GMP and cGMP. And India's revised Schedule M.
- Specified toEN 1822, the standard our HEPA filters are graded against. Most rooms run H13 or H14. ULPA grades are used where a process calls for them.
- Delivered withA signed qualification dossier for the room itself, including filter integrity tests and particle counts. The four stages of that file are unpacked further down this page.
- Further credentialsAnything else the company holds or is working toward is available on request.
Only the first is a certification. The rest are standards we engineer to, and frameworks your facility is inspected under. Keeping those two ideas apart is the point of this page.
What ISO 9001 actually means on a cleanroom project
ISO 9001 says nothing about how clean your air will be. It says something quieter, and just as useful. The company you are buying from has a written, audited way of working, checked by an outside auditor rather than taken on trust.
On a project, that becomes a set of unglamorous habits. Those habits decide whether a room qualifies first time. The requirement is captured in writing before anything is designed. The design is formally reviewed, on the record. Materials are verified when they arrive. Work is inspected on the factory floor. Failures are logged, then closed with a corrective action. When a specification is questioned in an audit two years later, that trail is the answer.
In the standard's own terms, the 2015 revision covers requirements capture, design control, control of externally provided processes and of production, control of nonconforming outputs, internal audit and corrective action.
Certification is issued against a defined scope and named sites. It is then maintained through surveillance audits, with recertification on a three-year cycle.
How that runs on our floor is on the In-house cleanroom manufacturing page.
FIG. 01A certificate is not a permanent badge. It is issued against a named scope, held open by surveillance audits, and re-earned on a three year cycle, which is why the validity period printed on the document matters as much as the standard printed on it.
The vocabulary
Three words, three mechanisms, and only one of them is a credential.
Certified, accredited, inspected. They are used as if they mean the same thing, and the difference is the whole of this page. Two sections from here, the same four questions run down all three so you can settle it by reading across.
The four questions
Answered in section 05- 01Who issues it
- 02What it applies to
- 03What it actually guarantees
- 04What it does not mean
ISO 14644 classifies the room, it does not certify the company
ISO 14644-1 classifies. ISO 14644-2 says how often you re-demonstrate it. Neither part issues anything to a company.
There is no such thing as an ISO 14644 certified cleanroom company. Strictly speaking, there is no permanently certified cleanroom either. The standard classifies one specific room by counting the particles in its air. The count happens at defined sample locations, on a particular day, in a particular occupancy state. The classification belongs to the room. And it has a shelf life.
FIG. 02A classification statement is only complete when all three parts are present. Drop the occupancy state and the same room can be quoted at two different numbers, both of them true. Any one of the three missing, and what you are holding is not a classification. It is a number without a question.
The detail sits in two parts. ISO 14644-1 sets the class by the particle concentration allowed at a given particle size. That gives ISO Class 1 to 9, and in practice ISO Class 5 to 8 in most pharmaceutical and industrial work. ISO 14644-2 covers monitoring. Its 2015 revision replaced fixed retest intervals with a risk-based plan, so how often your room is re-demonstrated is something your quality system justifies.
A complete specification names three things: the class, the particle sizes counted and the occupancy state. That last one matters. A room measured empty and the same room with people and process running are two different numbers.
The class-by-class picture is on our ISO classification of cleanrooms reference.
Certification, accreditation and inspection are three different things
These three words get used as if they mean the same thing. They do not, and the confusion is where most overclaiming starts.
A certification is issued to a company by an independent body, after an audit against a published standard. ISO 9001 certifies how a company works. It does not certify a product, and it does not certify a room. An accreditation sits one level above. It vets the certification body itself, or the testing laboratory, and it is what makes anyone's certificate worth reading. An inspection is different again. It is what a medicines regulator carries out on a licensed facility.
In India, the bodies that issue ISO 9001 are themselves accredited by the National Accreditation Board for Certification Bodies (NABCB). Some are recognised through the International Accreditation Forum instead. The laboratories that count the particles in your finished room are accredited by NABL.
Pharmaceutical facilities are inspected by the Central Drugs Standard Control Organisation and the state drug authorities. Where a site exports, the US-FDA, the European inspectorates or the WHO prequalification team inspect as well. Every one of those bodies acts on the facility and its licence holder. Not one of them acts on the company that built the room.
- 01
Certified
A certificate, issued to a company.
Who acts on whom
- Who issues it
- An independent certification body, after an audit against a published standard such as ISO 9001.
- What it applies to
- An organisation, and only the activities and sites named in the certificate's scope.
- What it actually guarantees
- That the company works to a documented, externally audited system: requirements written down, designs reviewed, materials verified, work inspected, failures closed with a corrective action.
- What it does not mean
- Nothing about the cleanliness of a finished room. ISO 9001 is not a performance rating, and it says nothing about the air in your facility.
- 02
Accredited
One level above the certificate.
Who acts on whom
- Who issues it
- An accreditation body. In India, NABCB for certification bodies and NABL for testing laboratories, or recognition through the International Accreditation Forum.
- What it applies to
- The certification body itself, or the laboratory that counts the particles in your finished room.
- What it actually guarantees
- That whoever issued your supplier's certificate, or measured your room, was itself vetted against published criteria by somebody else.
- What it does not mean
- It is not a credential your supplier holds. It is the thing that makes your supplier's certificate worth reading in the first place.
- 03
Inspected
What a regulator does, and only to a facility.
Who acts on whom
- Who issues it
- A medicines regulator. In India the Central Drugs Standard Control Organisation and the state drug authorities. Where a site exports, the US FDA, the European inspectorates or the WHO prequalification team.
- What it applies to
- A licensed manufacturing facility, and the licence holder who runs it. Never the company that engineered or built the room.
- What it actually guarantees
- That the site, its systems, its records and its people were examined, and that findings, observations or an approval to manufacture were recorded against the licence.
- What it does not mean
- No regulator certifies a cleanroom builder. There is no EU-GMP certified supplier, and there is no FDA approved cleanroom builder.
FIG. 03The same four questions, answered by all three mechanisms. The bottom row is the one nobody publishes about their own credentials, and it is where every misunderstanding on this page lives.
What each credential certifies, and what it does not
The right question about any credential is not “do you have it”. The right question is “what does it prove”. This table is the honest version of the answer, limits included.
| Credential or standard | Applies to | What it does prove | What it does not proveTHIS PAGE |
|---|---|---|---|
| ISO 9001 | the organisation | an audited quality management system: documented requirements, design review, inspection records, corrective action, external audit | nothing about the cleanliness of a finished room. It is not a performance rating |
| ISO 14644-1 classification | one room, one occupancy state | that this room, on the day it was tested, met the particle limits for its ISO class in the state tested | it is not a certificate a company holds, and it does not carry to the next room, or the same room next year, without retesting |
| EN 1822 H13 / H14 | one individual filter | efficiency at the most penetrating particle size: H13 at 99.95 percent or better, H14 at 99.995 percent or better | that the filter is still intact after transport and installation. On-site HEPA integrity testing with PAO or DOP proves that |
| EU-GMP Annex 1 | the licence holder's sterile operation | a design and control framework: a written contamination control strategy, Grades A to D, at-rest and in-operation limits | nobody is “Annex 1 certified”. It is a guideline a facility is designed to and inspected against |
| India's Schedule M | the drug manufacturing licence | the statutory good manufacturing practice baseline an Indian pharmaceutical facility must meet to hold its licence | it is not something a builder can hold. The licence, and the inspection, sit with the manufacturer |
| US-FDA cGMP | a site shipping product to the US | that the site was inspected and the findings recorded against current good manufacturing practice expectations | there is no such thing as an FDA approved cleanroom builder. The agency inspects facilities and approves products |
| WHO-GMP | a facility supplying markets that rely on WHO guidance | that the facility was inspected against the WHO's good manufacturing practice guidance, with the findings recorded | it is not a certificate for the company that engineered or built the room. The inspection sits with the facility and its licence holder |
| DQ / IQ / OQ / PQ dossier | this specific installation | signed evidence that this room was designed, installed, operated and performed against predetermined acceptance criteria | it is only as strong as the criteria it was written against, which is why those are agreed at design stage |
| Factory Acceptance Test | one piece of equipment, before dispatch | that the unit met its specification in the factory, witnessed and recorded | it does not replace on-site qualification. Equipment behaves differently once integrated |
FIG. 04Fourth column is the one this page publishes and most suppliers do not.
Every credential is narrow, and each is honest only when it is described narrowly.
EU-GMP Annex 1 and Schedule M: the frameworks a room is designed for
If you make medicines, two rulebooks decide most of what your room has to do. Neither is a certificate. Both are design briefs your builder has to know cold.
EU-GMP Annex 1
The first is the revised Annex 1, Europe's guidance for sterile medicinal products. Its central idea is simple to state. Contamination control has to be planned and written down as one strategy for the whole facility, not assembled from individual precautions. It sets the EU-GMP Grade A to D scheme, with limits the room must meet both at rest and in operation.
- Grade A to D
- Contamination control strategy
- At rest and in operation
Schedule M, revised
The second is India's revised Schedule M, notified in December 2023 and phased into effect through 2024 to 25. It moves Indian expectations toward the same discipline. It is the statutory baseline an Indian pharmaceutical facility must meet in order to hold its manufacturing licence, which is why an Indian project is designed against it and Annex 1 together rather than against either one alone.
- Notified December 2023
- Phased 2024 to 25
- Statutory GMP baseline
Neither rulebook is issued to a builder, and neither can be. They are design inputs, and we treat them exactly that way. The target grade and class are fixed at the user requirement stage. The air change rates, pressure cascade, filtration and finishes are then engineered to hold them. The acceptance criteria the tests will use are written at design stage, not invented at test stage.
The pharmaceutical requirement in full is on the pharmaceutical cleanrooms page. There is a wider walkthrough in our cleanroom compliance and standards guide (page in preparation).
That is what “built to withstand inspection” means.
Regulators inspect facilities, they do not certify cleanroom builders
This is the most misused idea in the industry, so it is worth stating without hedging. The US-FDA, the WHO, the European inspectorates and India's drug authorities inspect manufacturing facilities. They examine the site, the systems, the records and the people. They issue findings, observations or an approval to manufacture. Every one of those outcomes attaches to the licence holder. Not one of them is a certificate for the company that engineered or installed the cleanroom.
So if you are ever told that a supplier is itself EU-GMP certified or WHO-GMP certified, look twice. The same goes for “FDA approved”. No regulator issues that credential, to us or to anyone else.
What a cleanroom company can honestly promise is narrower, and more useful. Fabtech designs, builds and documents facilities to withstand inspection under EU-GMP and US-FDA cGMP expectations. The same discipline holds under WHO-GMP and India's revised Schedule M. The credit for passing belongs to the manufacturer who runs the facility. Our job is to make sure nothing in the room, and nothing missing from the paperwork, is what costs them.
The DQ, IQ, OQ and PQ validation package is the evidence that counts
Four documents, four questions
- DQ
- Is the design capable?
- IQ
- Was it installed as designed?
- OQ
- Does it work across its range?
- PQ
- Does it keep performing?
One signature each, and none of them ours alone.
When someone asks whether a cleanroom is compliant, the answer is not a certificate. It is a stack of signed documents. Each of the four qualification stages answers a different question, and the table below gives you all four.
| Document | The question it answers | What is in it |
|---|---|---|
| DQ, Design Qualification | Is the design capable of meeting the requirement? | the user requirement specification traced to the design, class and grade targets, the airflow and pressure scheme, and the acceptance criteria everything later is tested against |
| IQ, Installation Qualification | Was it installed as designed? | as-built documentation, equipment and filter identification records, material and calibration certificates, utilities verified against the design |
| OQ, Operational Qualification | Does it work across its operating range? | airflow volumes and velocities, air change rates, pressure cascade, HEPA integrity testing with PAO or DOP, particle counts to ISO 14644-1, recovery testing |
| PQ, Performance Qualification | Does it keep performing in operation? | performance with people and process running, in-operation particle counts, and the environmental monitoring baseline, including microbial monitoring where the grade requires it |
FIG. 05Stage-by-stage test scope lives on the cleanroom validation page.
These documents matter more than any badge, because they are specific to your room and traceable to a signature. A certificate says an organisation was audited. A dossier says this filter and this pressure differential were tested on this date, by this person, against a criterion agreed before anyone started.
The full test scope is on our cleanroom validation page, which sets out the stage-by-stage evidence chain rather than repeating it here.
How this works on a Fabtech project
Quality on a cleanroom is decided long before test day. So the quality management system is aimed at the places projects usually go wrong. Requirements are written down before design starts. Designs are reviewed on the record, not in passing.
The core of the room is engineered and manufactured in our own facility: the modular wall and ceiling panels in PUF and in Rockwool, the air handling units, the HEPA housings and terminal boxes, the fan filter units, the cleanroom doors, the laminar airflow units, the pass boxes, the air showers and the biosafety cabinets. That means a specification is inspected in process, on our floor, rather than argued about after it reaches your site. Where it applies, equipment is Factory Acceptance Tested before dispatch. The room is then handed over with the dossier that proves all of it.
One more form of verification costs you nothing. Your procurement team can run its own diligence on the company before anyone signs. The filings are in the investor relations (page in preparation) section.
- Ajanta PharmaAurangabad
- DesanoPharmaceuticals
- PGICH NoidaBSL-3 containment
- ASMC ShahjahanpurBSL-3 containment
Fabtech has designed, built and validated cleanrooms and GMP facilities across India. The list includes Ajanta Pharma (Aurangabad), Desano and German Remedies in pharmaceuticals, and BSL-3 containment facilities at PGICH Noida and ASMC Shahjahanpur. Class, area and scope are available on request.
The one project documented in full is the Ajanta Pharma cleanroom case study .
Ask for our ISO 9001 certificate and a redacted sample protocol.
Talk to an engineerFive checks that verify any certification claim
Use these on us, and on anyone else you shortlist. They take about twenty minutes, and they separate a real credential from a logo.
- 01
Ask for the certificate, not the logo.
A real certificate names the issuing body, a unique number, the standard and its revision, a scope of activities, the sites covered and a validity period.
- 02
Check who issued it, and whether they are accredited.
In India, look for a certification body accredited by NABCB, or recognised through the International Accreditation Forum. Most accreditation bodies publish a register you can search yourself.
- 03
Read the scope, not just the standard.
ISO 9001 is issued against named activities at named sites. A scope covering the design and manufacture of cleanroom panels and equipment tells you something about the room you are buying. A scope covering trading does not.
- 04
Ask what the credential does not cover.
For any GMP claim, ask which facilities have been inspected, by which authority, and what the supplier's role in them was.
- 05
Ask to see a redacted qualification protocol.
This is the strongest check of the five. A completed, client-redacted IQ or OQ protocol shows the acceptance criteria, the test methods, the results and the signatures. That is the evidence you will actually receive at handover.
Who signs what at handover
Reading the chips
- FabtechThe one signature that is ours. We sign as the executing party.
- Everyone elseThe specification, the approvals, the tests and the release for use.
Documents are only as good as the signatures on them. So it is worth knowing who owns each one before a project starts.
- 01Your team
The user requirement specification is yours.
Your process and quality teams define what the room must do. Everything downstream is tested against it.
- 02Your quality unit
The design qualification is approved by your quality unit, before construction proceeds.
That is the cheapest possible point to catch a mismatch.
- 03Both, in advance
Protocols are approved before execution, not after.
Results recorded against a protocol written afterwards carry very little weight in an audit.
- 04The testing party
Test results are signed by whoever performed the test.
Where an independent laboratory does the particle counts or the filter integrity testing, that laboratory's own accreditation is what makes its numbers stand up.
- 05Fabtech
Fabtech signs as the executing party.
We hand over the as-built documentation, the manuals, the material and calibration certificates and the executed protocol set.
- 06You, and only you
The release for use is yours, and only yours.
A cleanroom company never releases a room for regulated manufacture. The licence holder does, on the strength of the dossier.
FIG. 06Ownership of the handover record. Five of the six signatures are not ours, and that is the point: a builder executes and evidences, the licence holder releases.
After handover, the facility is operated and maintained by your team. Annual maintenance contracts from Fabtech cover equipment rather than the running of the room.
- Certification held as a companyISO 9001
- 1
- Qualification stages signed at handoverDQ, IQ, OQ and PQ
- 4
- Checks that verify any certification claimAbout twenty minutes each
- 5
- Regulators that certify a cleanroom builderThey inspect facilities instead
- 0
This page in four numbers. Every one of them is a limit rather than a boast, which is the only honest way to write about a credential.
Frequently asked questions
Fabtech holds one management-system certification: ISO 9001, covering its quality management system. Its cleanrooms are engineered for classification to ISO 14644. They are built to withstand inspection under EU-GMP, cGMP and WHO expectations. Also under India's revised Schedule M. Any further certifications are available on request.
Yes. Fabtech's quality management system is certified to ISO 9001. The certificate names its issuing body, certificate number, scope of activities, sites covered and validity period, and we send it on request. Read the scope line closely, because that is where a certificate tells you what it really covers.
ISO 9001 says nothing about how clean your air will be. It means the company works to a documented, externally audited system. Requirements are written down, designs reviewed, materials verified, work inspected, failures closed with corrective action. The trail shows who approved what, ready for any audit.
No. EU-GMP, including the revised Annex 1, is a guideline that a licensed manufacturing facility is designed to and inspected against. No regulator issues that certificate to a cleanroom builder. What a builder can honestly say is that it builds facilities to withstand inspection under it.
Not in the way the phrase suggests. ISO 14644 classifies one specific room by counting particles at defined sample points, on a given day, in a given occupancy state. The result is a report for that room. It does not transfer to another room, and it expires without retesting.
A certification is issued to a company by an independent body, after an audit against a standard such as ISO 9001. An accreditation vets the certifier, or a test laboratory, and makes their results credible. An inspection is a regulator's examination of a licensed facility, producing findings, not a certificate.
Yes. Fabtech designs, builds and documents cleanrooms to withstand inspection under US-FDA cGMP expectations. The same holds under WHO-GMP and EU-GMP. And under India's revised Schedule M. Regulators inspect facilities rather than certify builders. So the deliverable is the room plus its full qualification dossier.
Ask for the certificate document, not a logo. It should name an issuing body, a certificate number, a scope and a validity period. Check the issuer is accredited, in India by NABCB or another recognised body. Read which activities and sites the scope covers. Then ask to see a redacted qualification protocol.
Tell us the standard your facility answers to
Give us the grade or class you need to hold. We come back with the design, the acceptance criteria and the qualification plan in one proposal, and we send the ISO 9001 certificate with it.