Qualification and validation

In brief

A medicinal product can only be reliably good if the premises, equipment and procedures used to manufacture and test it demonstrably do what they are supposed to do. Good Manufacturing Practice divides this evidence into two terms. Qualification refers to equipment, premises and utilities such as water, steam or compressed air: you show that they are correctly designed and installed and work reliably within the intended range. Validation refers to procedures, that is, the manufacturing process, cleaning or an analytical method, and proves that they consistently lead to the desired result.

A qualification and validation service provider helps you plan, perform and document this evidence so that it stands up to an inspection. Approval of the documents remains in your company: documents prepared by an external service provider must be checked for suitability and compliance with your procedures by the responsible persons at your site before they are approved.

Who needs this

Manufacturers with new equipment, premises or processes, after significant changes, during product transfers and after inspection findings.

Legal basis

The German manufacturing ordinance (AMWHV) and the EU GMP Guide, above all EU GMP Annex 15 in its 2015 version, supplemented by Chapter 7 for outsourcing.

Typical scope

Validation master plan, risk assessments, protocols and reports for DQ, IQ, OQ and PQ, as well as process, cleaning and method validation.

What matters

Deriving the scope and depth of testing from a documented risk assessment instead of working through a fixed list.

When you need this

The most common occasion is a project with a clear start: a new cleanroom, a new filling line, an additional site or the transfer of a product to another facility. In such phases a lot of qualification and validation work arises in a short time, which an in-house team is rarely sized for. External support is then mainly a question of capacity.

There are also occasions where expertise is needed more. These include planned changes to existing equipment or processes, whose impact on the validated state must be assessed through change control, findings from an authority inspection or a customer audit, the introduction of a new product into a multi-product facility with the question of cleaning validation, or the move to continuous process verification. Smaller companies that qualify only occasionally also like to use a service provider, because keeping their own specialists for individual projects does not pay off.

Legal basis and rules

In Germany, § 3 of the German Ordinance on the Manufacture of Medicinal Products and Active Substances (Arzneimittel- und Wirkstoffherstellungsverordnung, AMWHV) obliges manufacturers to follow Good Manufacturing Practice and refers to the EU GMP Guide for its interpretation. For this topic, the following rules are particularly important:

EU GMP Guide, Annex 15

Qualification and validation, in force since 1 October 2015: planning, qualification stages, process, cleaning and method validation, transport and packaging validation, change control and requalification.

ICH Q9(R1)

Quality risk management, applicable in the EU since 26 July 2023. Annex 15 requires the scope and depth of qualification and validation to be based on a justified and documented risk assessment.

EU GMP Guide, Chapter 7

Outsourced activities: a written contract with clearly allocated duties, prior assessment of the contract acceptor’s suitability and monitoring of its performance.

EMA guidelines on process validation

They describe which validation data are expected in the marketing authorisation application, separately for finished products and for biotechnology-derived active substances.

EMA guideline on health-based exposure limits

The basis for toxicologically justified residue limits in cleaning validation for shared facilities.

EU GMP Guide, Annex 11

Computerised systems, applicable in its 2011 version. A revised version was published as a draft in 2025.

For Annex 15 itself, the EMA and PIC/S published a concept paper in 2026 on a targeted revision, which is intended above all to include manufacturers of active substances. Until a new version enters into force, the 2015 version applies, and the following principles refer to it.

Planning and qualification stages

Annex 15 requires the key elements of a site’s qualification and validation programme to be defined in a validation master plan or an equivalent document. This includes at least the policy, the organisational structure with roles and responsibilities, an overview of equipment, systems and processes with their status, change and deviation management, guidance on setting acceptance criteria, and the strategy including requalification.

Qualification starts with the user requirement specification (URS), in which you describe what a piece of equipment must achieve. This is usually followed by design qualification (DQ), which shows that the planned design meets these requirements and Good Manufacturing Practice, installation qualification (IQ) for correct installation, operational qualification (OQ) for behaviour up to the limits of the operating range, and performance qualification (PQ) with production material or an equivalent substitute under normal operating conditions. Tests from the factory acceptance test (FAT) at the supplier need not be repeated if this is justified and it can be shown that transport and installation do not affect functionality. A site acceptance test (SAT) at the installation site may follow after delivery.

Process validation

For process validation, Annex 15 provides three approaches. In traditional validation, several batches are manufactured under routine conditions, with the number set and justified by the manufacturer on a risk basis. Continuous process verification can be used for products developed using a quality by design approach whose control strategy is scientifically established. The third approach combines both. Whichever approach is chosen, the process is then monitored over its entire life cycle through ongoing process verification, so that any departure from the state of control shows up early. Equipment and systems used for process validation must be qualified and the test methods validated.

Cleaning validation and requalification

Cleaning validation demonstrates that a cleaning procedure is effective for all product-contact parts. The limits for carry-over of product residues should be based on a toxicological evaluation, for which Annex 15 refers to the EMA guideline on health-based exposure limits. Limits must also be set for cleaning agents, and the risk from microorganisms and endotoxins must be taken into account. A visual check for cleanliness is part of the acceptance criteria but is generally not sufficient on its own.

Finally, Annex 15 requires equipment, premises and systems to be evaluated at appropriate intervals to confirm that they remain in a state of control. If this requalification is carried out at fixed intervals, the period must be justified. Planned changes are assessed through change control for their impact on the qualified state.

Important

Computerised systems are validated according to EU GMP Annex 11, in practice usually with the ISPE industry guide GAMP 5. On this website that validation is listed as a separate service. For equipment with control systems the two topics overlap, and it is worth defining the boundary early in the project.

How the work is organised

Service providers in this field essentially take on three roles, which can also be combined. Some write the documents, that is, the validation master plan, risk analyses, protocols and reports, and your team performs the tests itself. Others perform the tests, for example measurements in cleanrooms, temperature mapping studies or sampling for cleaning validation, often with their own calibrated measuring equipment. Still others provide staff who work in your organisation for the duration of a project and follow your standard operating procedures. A project usually runs through these steps:

Defining the scope

Which equipment, processes or products are affected, which schedule applies and which role the service provider is to take on.

Contract and delimitation of responsibilities

It is agreed in writing who prepares, reviews and approves documents, whose templates are used and how deviations are handled.

Planning

Risk assessment, definition of the tests and acceptance criteria, approval of the protocols by the persons responsible under your quality system.

Execution

Tests according to the approved protocol, documentation of raw data, recording and investigation of deviations.

Report and release

The report summarises and evaluates the results against the acceptance criteria. The formal release for the next stage or for routine operation is given by the responsible persons at the manufacturer.

What to look for when choosing a provider

The following questions help you compare providers and probe specific points in conversation.

Questions to ask the provider

Does the provider have experience with your type of equipment or product, for example sterile manufacturing, solid dosage forms, biologics or active substances?

Does it work with your standard operating procedures and templates or bring its own, and how do these fit your quality system?

How does it justify the scope of testing, and does it derive it from a risk assessment?

Is the measuring equipment used calibrated, and will you receive the calibration certificates?

Are the staff on site trained in GMP and in your procedures, and how is this documented?

How does it handle data integrity, that is, raw data, corrections and electronic records?

Has it already supported inspections, and can it answer the authority’s questions about its documents?

How is invoicing arranged: fixed price per package, daily rate or staff leasing?

Frequently asked questions

What is the difference between qualification and validation? +

Equipment, premises and utilities are qualified. Processes are validated, that is, manufacturing processes, cleaning procedures and analytical methods. Under Annex 15, process validation requires the equipment and systems involved to be qualified.

Do DQ, IQ, OQ and PQ always have to be performed separately? +

Not necessarily. Annex 15 allows qualification documents to be combined, for example IQ and OQ into a joint IOQ, and in some cases PQ to be performed together with OQ or process validation. What matters is that every requirement has been verifiably tested and that the approach is justified.

Who signs the documents if a service provider prepared them? +

The service provider can sign as author and as the person performing the work. Protocols and reports are approved by the persons designated for this in your quality system, and Annex 15 requires appropriate quality assurance oversight of the entire validation life cycle. Who signs what should be laid down in the contract and in your standard operating procedures.

How often must requalification take place? +

Annex 15 does not set a fixed period for all equipment. The manufacturer evaluates its equipment at appropriate intervals and justifies a fixed period if it chooses one. Regardless of this, every planned change that may affect the qualified state is assessed through change control. For individual areas, other parts of the guide set their own maximum intervals, for example EU GMP Annex 1 for cleanrooms.

Sources

Every statement in this text was checked against these primary sources (as of 10.11.2026). Laws, guidelines and authority websites, no advertising.

Company	Location	EvidenceQuote from the company’s website (German)	Credentials
A&O Pharma GmbH A&O Pharma GmbH, based in Efringen-Kirchen with sites in Itzehoe and Lörrach, provides service support to pharmaceutical companies, including batch certification by Qualified Persons, regulatory affairs, GMP consulting and GMP-certified analytics.	Efringen-Kirchen	Evidenced „Prozesse validiert, Räume und Anlagen von DQ bis PQ qualifiziert“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Amcapharm Pharmaceutical GmbH AMCAPHARM Pharmaceutical GmbH, based in Rosbach, manufactures suppositories and liquids on a contract basis, packages and labels them, and provides analytical testing, stability studies and method validation for its clients.	Rosbach Hessen	Evidenced „Auf Wunsch bieten wir Ihnen auch die Übernahme kompletter Suppositorienproduktionen inklusive Ankauf der Maschinen, Qualifizierung und Prozessvalidierung“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Ever Pharma Jena GmbH EVER Pharma Jena GmbH in Jena is a production site of the EVER Group for sterile injectable solutions. It carries out contract manufacturing and packaging of medicinal products, and offers analytical testing and stability studies.	Jena Thüringen	Evidenced „Validating manufacturing processes to ensure they consistently produce products meeting predetermined quality criteria.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
INNEXIS Marburg GmbH INNEXIS Marburg GmbH (Düsseldorf) is, according to its website, part of the INNEXIS Group, which operates pharmaceutical parks and offers engineering and logistics services. The website does not mention any contract manufacturing for third parties.	Düsseldorf Nordrhein-Westfalen	Evidenced „Wir stellen sicher, dass Herstellungsprozesse und Produkte höchsten Standards entsprechen.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
RubiePharm Arzneimittel GmbH RubiePharm Arzneimittel GmbH, based in Steinau an der Straße, carries out contract manufacturing of suppositories, ovules, ointments, creams and gels, as well as food supplements. Its services include packaging, material sourcing and stability programmes.	Steinau Hessen	Evidenced „Prozessvalidierungen“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate