GMP Cleanrooms, Annex 1 & Contamination Control Strategy

cGMP Support & Annex 1

At ABN Cleanroom Technology, we understand that GMP cleanrooms are essential for industries producing sterile medicinal products. Any application that involves the production, filling, compounding or packaging of sterile medicines must comply with GMP standards. Specifically, our GMP expertise extends to cleanroom industries and applications such as:

Cell and gene therapy
Medical device manufacturing
Pharmaceutical manufacturing
Radiopharmaceutical manufacturing

We are experienced in European regulations outlined in EudraLex, Volume 4 – Good Manufacturing Practice (GMP). Annex 1, titled “Manufacture of Sterile Medicinal Products,” provides crucial guidelines for the design, control and operation of facilities, equipment and systems involved in the production of sterile products. With the recent update to Annex 1, which became effective on August 25, 2023, companies must adopt a risk-based approach to prevent contamination at every stage of the production process. To meet these stringent requirements, we offer expert guidance on the implementation of a Contamination Control Strategy (CCS), which demonstrates control over your facility’s processes to ensure the prevention of contamination.

What are GMP Standards for cleanrooms?

Good Manufacturing Practices (GMP) are the cornerstone of quality control in the medical and pharmaceutical sectors. These practices are designed to ensure that cleanroom environments remain controlled to prevent contamination during the production and sterilization of medicines or medical devices. We reduce the complexities of GMP standards, helping you implement processes that minimize the risks of microbiological, particulate and pyrogen contamination.

GMP standards ensure that products are consistently high-quality, appropriate for their intended use and compliant with regulatory specifications. We specialize in cleanroom qualification and validation, critical components of GMP standards. Our GMP services follow the four essential stages of qualification and validation:

Design Qualification (DQ)

We ensure that your GMP cleanroom design meets all regulatory and process requirements.

Installation Qualification (IQ)

Our CQV team verifies that the cleanroom installation adheres to the specified design.

Operational Qualification (OQ)

We confirm that cleanroom equipment meets operational requirements.

Performance/Process Qualification (PQ)

We validate that your cleanroom equipment operates cohesively and consistently in a controlled, repeatable state

Contamination Control Strategy & GAP Analysis

A Contamination Control Strategy (CCS) is a comprehensive plan that consolidates all controls designed to prevent contamination throughout the production process. We assist our clients in developing a robust CCS, offering a clear overview of critical process parameters supported by risk assessments and scientific justification. Our CQV experts are here to guide you through the process of implementing a Contamination Control Strategy. Conducting a gap analysis will help us assess your current practices and identify areas for improvement. Once gaps are identified, we collaborate with your team to brainstorm solutions and develop a comprehensive CCS. Our team works with you to ensure that contamination risks are minimized across all stages of production.

Onze diensten

Bij ABN Cleanroom Technology leveren we cleanroomdiensten die aan de hoogste normen voldoen. Als turnkey-provider beheren wij het hele proces van ontwerp tot installatie en ondersteuning op de lange termijn.

Bovendien omvatten onze diensten cGMP-naleving, milieubewaking en volledige validatie. Of u nu een nieuwe faciliteit opstart of een bestaande upgradet, wij leveren oplossingen op maat die aansluiten bij uw doelstellingen.

cGMP-ondersteuning

Monitoring services

Inbedrijfstelling, kwalificaties en validatie

Beheer van cleanroomfaciliteiten

Cleanroom renovatie & upgrades

Contacteer ons

Of u nu op zoek bent naar deskundig advies, een snel antwoord of een gedetailleerd gesprek, wij zijn er om u te helpen. Kies de optie die voor u het beste werkt: bel ons direct, stuur ons een e-mail of boek een vergadering van 30 minuten wanneer het u uitkomt. Laten we samen de beste cleanroomoplossing vinden!