What is GMP Cleanroom Consultancy?
Whether you’re new to, or an expert in the world of GMP, ensuring you are operating to the correct standards and your cleanroom is qualified and maintained appropriately can be a difficult, ongoing task for anyone!
In this blog, we’ll explain what GMP means, what GMP consultancy actually is, who needs it, and the services we offer here at Angstrom Technology, to ensure you remain compliant.
What does GMP Stand For?
The European Medicines Agency (EMA) states:
Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP.
GMP requires that medicines:
- Are of consistent high quality
- Are appropriate for their intended use
- Meet the requirements of the marketing authorisation or clinical trial authorisation.
You may also see the term cGMP used by the US Food & Drug Administration (FDA) which refers to current GMP).
The highly regulated cleanroom industry and the products manufactured in controlled environments means GMP compliance is a critical factor to consider when managing, operating and maintaining a cleanroom.
All Angstrom Technology cleanroom projects with a requirement for GMP have oversight from our dedicated Regulatory Governance team, and with over 30 years’ combined experience, this in-house knowledge and expertise sets us apart.
Who needs GMP Consultancy?
GMP cleanroom consultancy can be useful for those planning a new GMP facility, or currently operating a GMP cleanroom. It can be essential for a wide range of sectors and organisations where contamination control and regulatory compliance are of paramount priority.
By leveraging expert consultancy services, companies can ensure that their operations are fully compliant with GMP standards, safeguarding product quality, protecting patient’s safety, and maintaining regulatory compliance.
Why Utilise GMP Consultancy Services?
There are many reasons why GMP Consultancy is key to you and your GMP facility.
GMP Consultancy ensures that you are fully supported in understanding and adhering to regulatory requirements set by authorities such as the MHRA in the UK, EMA in Europe and FDA in America.
Consultants provide expertise in establishing and maintaining practices that guarantee the highest levels of product quality and patient safety.
GMP Consultants offer specialist knowledge to optimise cleanroom design, layout and operational protocols.
A consultant can help identify potential risks within cleanroom design and operations, and then develop strategies to mitigate these. Gap analysis is an important part of risk management, and this can be addressed with an independent audit by a consultant.
GMP Consultancy can support continuous improvement by regular review and update of cleanroom practices and supporting documentation.
Initial and regular training and education is crucial for cleanroom users, due to both regulatory requirements and the critical nature of the industries that rely on cleanroom environments.
Our GMP Consultancy Services
We offer a range of GMP Consultancy services, including:
- GMP/cGMP Audit
- Gap Analysis Audit
- Mock Inspection pre regulatory visit, e.g. MHRA or HTA
- Documentation Required for a new Cleanroom Facility e.g. User Requirement Specification (URS) or Validation Master Plan (VMP)
- Preparation of Pharmaceutical Quality System (PQS) Documentation
To find out more about the services we offer, click here.
REQUEST A CONSULTATION
We are committed to supporting you through successful audits and inspections, now and in the years to come. To learn more about our GMP consultation services or GMP cleanroom design-build assistance, please contact us by clicking the button below.
CONTACT US