Our Services

GMP Consultancy Services

At Angstrom Technology, we understand that maintaining the highest standards of patient safety and regulatory compliance is paramount for pharmaceutical cleanroom operations. Our GMP Consultancy Services are designed to support cleanroom users in navigating the complexities of Good Manufacturing Practice (GMP) requirements. Our team of experienced consultants bring in-depth knowledge and practical expertise to ensure your cleanroom meets the necessary regulatory standards, meets your process requirements and guarantees product quality and safety.

Partner with us to achieve excellence in your GMP cleanroom environments, fostering innovation and reliability in your critical processes.


Why do you need GMP Consultancy?

Here are just some of the reasons why GMP Consultancy is crucial for cleanroom users:

Compliance with
Regulatory Standards

GMP consultancy supports companies in understanding and adhering to the regulatory requirements set by competent authorities such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, the European Medicines Agency (EMA) in the EU and the FDA in the US. Compliance is essential to evidence patient safety and to avoid delays to your manufacturing programme.

Ensuring Product
Quality & Safety

Consultants provide expertise in establishing and maintaining practices that guarantee the highest levels of product quality and patient safety. They help design processes that minimize contamination risks and ensure the consistent production of Medicinal Product with consistent quality.

Cleanroom Operations

GMP consultants offer specialist knowledge to optimise cleanroom design, layout, and operational protocols. This optimisation ensures that the cleanroom environment supports efficient, effective, and compliant manufacturing processes.


A consultant can help identify potential risks within cleanroom design and operations and then develop strategies to mitigate these. Effective risk management ensures that cleanroom users can pre-emptively address issues that could compromise product quality or patient safety. Gap analysis is an important part of risk management and this can be addressed with an independent audit by a consultant.


GMP Consultancy can supports continuous improvement by regular review and update of cleanroom practices and supporting documentation. This ongoing process ensures that cleanroom operations evolve with emerging technologies and changing regulatory landscapes, maintaining the highest standards of compliance and efficiency.

and Education

Initial and regular Training & Education is crucial for cleanroom users, due to both regulatory requirements and the critical nature of the industries that rely on cleanroom environments. Well-trained cleanroom users can operate equipment and follow protocols more efficiently, reducing errors and increasing productivity.

Our GMP Consultancy Services

GMP/cGMP Audit

Our EU GMP/cGMP audits are comprehensive evaluations of your facility’s compliance with Good Manufacturing Practices (GMP) or current Good Manufacturing Practices (cGMP) regulations.

These audits meticulously examine your processes, systems, and documentation to ensure they meet both process needs and regulatory requirements set by Competent Authorities. By conducting thorough assessments, we help you identify areas of non-compliance and offer advice on how to implement corrective actions to bring your operations in line with regulatory requirements, ultimately ensuring patient safety and product quality.

GMP Consultancy - GMP Audit

Gap Analysis Audit

Gap analysis audits are strategic assessments designed to identify ‘gaps’ between your facility and/or processes and the required regulatory standard.

Our experienced consultants meticulously analyse your facility, processes, and documentation to pinpoint areas where improvements are needed. By highlighting these gaps, we provide valuable insights that enable you to develop a targeted action plan to meet the necessary requirements.

GMP consultancy - Gap Analysis Audit

Mock Inspection

Mock inspections simulate regulatory inspections conducted by authorities such as the MHRA or other regulatory bodies. A simulated inspection allows you to assess your readiness for actual regulatory scrutiny and also identify potential compliance gaps and/or areas for improvement.

Our regulatory governance team can conduct mock inspections using industry-recognised methodologies and criteria, providing detailed feedback and recommendations to help you strengthen your compliance and mitigate the risks of regulatory non-compliance.

GMP mock inspection

Documentation Required For A New Cleanroom Facility

When establishing a new cleanroom facility, EU GMP Annex 15 defines the essential documentation to ensure regulatory compliance. Our consulants can assist you in preparing comprehensive documentation, including User Requirement Specification (URS), Site Master File (SMF), Validation Master Plan (VMP) and, for facilities performing Sterile Manufacture, a Contamination Control Strategy (CCS).

The URS outlines your facility’s functional and operational requirements, while the SMF provides a detailed overview of your facility’s design, construction, and operational controls.
The VMP outlines the validation strategy and protocols necessary to demonstrate that your cleanroom facility meets regulatory requirements and operational objectives.

A requirement of EU GMP Annex 1 is a CCS, which defines all critical control points and assesses the effectiveness of all the controls and monitoring measures employed to manage risks to product quality and safety.

GMP Documentation Required For A New Cleanroom Facility

Preparation of Pharmaceutical Quality System (PQS) Documentation

A robust Pharmaceutical Quality System (PQS), often known as a Quality Management System (QMS), is essential for maintaining patient safety, product quality, and regulatory compliance within your cleanroom facility. Our consultants will assist you in developing comprehensive PQS documentation, including for example Quality Manual, Environmental Monitoring Plan, Policies, Standard Operating Procedures (SOPs) and supporting documents.

PQS documents establish clear procedures and controls for managing quality-related processes, ensuring consistency, traceability and compliance throughout your operations. By implementing a well-defined PQS, you can enhance patient safety and product quality, as well as minimising risks and demonstrating your commitment to regulatory compliance.

GMP Consultancy - Documentation

Which Service Do I Need?

Why not let us support you with our consultancy service. By leveraging the knowledge and experience of our GMP consultants, you can enhance your operational efficiency, minimise compliance risks, and ensure that your processes meet the regulatory requirements outlined by GMP.

Our Regulatory Governance Team

Over 30 years' combined GMP experience

All Angstrom Technology cleanroom projects with a requirement for GMP will have oversight from our dedicated Regulatory Governance team.

With over 30 years’ combined experience in GMP & pharmaceutical industries, this level of in-house expertise sets us apart from other cleanroom companies.

GMP Consultancy Team
Cleanroom Design


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.