Requalification to GMP Annex 1

What has changed for requalification in GMP Annex 1?

There has been a significant change to the guidance for validations and requalification in Annex 1. Previously, validation was recommended to be completed to ISO 14644-1. Now, Annex 1 details the testing that is expected in the initial qualification, then what is needed as part of the requalification.

Now the draft has become live, C2C is getting ready for implementation of Annex 1 to keep our clients compliant.

Are you ready for GMP Annex 1?

Requalification of GMP cleanrooms

The requalification of cleanrooms and clean air equipment should be carried out periodically following defined procedures. The requirement for requalification of cleanroom areas is as follows:

Minimum test requirements for the requalification of cleanrooms

GradeDetermination of the concentration of airborne non-viable particlesIntegrity Test of Terminal FiltersAirflow volume measurementVerification of air pressure difference between roomsAir Velocity test
A Yes Yes Yes Yes Yes
B Yes Yes Yes Yes *
C Yes Yes Yes Yes *
D Yes Yes Yes Yes *

* performed according to a risk assessment documented as part of the CCS. However, required for filling zones (e.g. when filling terminally sterilised products) and background to Grade A RABS.

 

 

 

Download our guide to GMP qualification and requalification

For Grade A & B areas, the maximum time interval for requalification is 6 months. For Grade C & D areas, the maximum time interval for requalification is 12 months.

Appropriate requalification consisting of at least the above tests should also be carried out following completion of remedial action implemented to rectify an out-of-compliance equipment or facility condition or after changes to equipment, facility or processes. The significance of a change should be determined through the change management process. Examples of changes to be considered include but are not limited to the following:

     i.          Change in the operational use of the cleanroom, or of the operational setting parameters of the HVAC system.

     ii.          Interruption of air movement which affects the operation of the installation.

     iii.          Special maintenance which affects the operation of the installation (e.g. change of final filters).

 Other characteristics, such as temperature and relative humidity, should be controlled within ranges that align with product/processing requirements and support maintenance of defined cleanliness standards (e.g. Grade A or B).

The requalification package can be customised to meet the exact requirements of your facility. Additional tests available are as follows:

  • Airflow direction and visualisation
  • Recovery testing
  • Containment leak testing
  • Temperature measurements
  • Relative humidity measurements
  • Lux level testing
  • Noise level testing
  • Electrostatic dissipation (ESD) testing

Full validation report provided within 10 working days.

Regulatory expertise

All validations with a requirement for GMP will have oversight from our dedicated regulatory governance team. This team has over 30 years’ combined experience in GMP & pharmaceutical industries and provides oversight on the entire validation process.

There is a live information flow between the site team and regulatory governance team, which accelerates the timeframe for report delivery. Immediate quality reviews and approvals are performed on live documentation from the engineers.

As all GMP qualification data undergoes an independent quality review, our clients don’t need an external review—saving time and money.

We will work closely with you to make sure you have everything you need for a successful audit.

Qualified and experienced engineers

Each C2C validation engineer is independently qualified to perform cleanroom qualification testing. With comprehensive training and experience, our engineers are proven to be professionally competent in their field. 

Mark

Mark

Commissioning & Validation Manager 

Mark has worked at Connect 2 Cleanrooms for almost 20 years, and has over 30 years’ industry experience in the design and build of cleanroom envelopes and HVAC systems, including commissioning, qualification and testing to the ISO 14644 suite of standards. Mark’s cleanroom training has been with professional bodies such as the Irish Cleanroom Society and S2C2, and he has held CTCB-i Professional status for over 12 years. In this time, he has gained a wealth of knowledge in both ISO and GMP environments and expectation. Mark is proactive and always focused on solutions, this and his positive attitude means he surpasses customers’ requirements and expectations.

- CTCB-i Qualified Engineer
- SMSTS Certification(site management)
- IPAF Certification
- IOSH Certification
- PASMA Certification

Alek

Alek

Validation & Commissioning Lead

Alek has worked with Connect 2 Cleanrooms since the winter of 2014 and in this time has played a key role in the build, commissioning and validation of many complex suites, working to both ISO and GMP. He specialises in validations, as well as being an experienced cleanroom maintenance engineer. A CTCB-I Professional, Alek has commissioned and validated a range of cleanroom suites including facilities for advanced manufacturing applications, medical device production, and cell and gene therapy suites, including IQ, OQ and PQ for GMP cleanrooms. Alek’s positive attitude and solutions focused approach ensures he exceeds our customer’s exacting requirements and has achieved “Legendary” status with some of our customers.

- CTCB-i Qualified Engineer
- Abrasive Wheels Training
- Ladder Safety Awareness
- Asbestos Awareness
- CITB H&S Test
- CASHH Certification
- FGAS Certification
- IPAF Certification
- PASMA Certification
- Working at Heights

Nick

Nick

Validation & Commissioning Lead 

Nick joined C2C in 2022 and has over 20 years’ experience in the healthcare sector, commissioning many projects along the way. Nick is experienced in the IQ, OQ, and PQ of a wide range of facilities, such as cleanrooms, UCV operating theatres, Cat2 and 3 labs, as well as clean air devices, such as isolators, MSCs, laminar flows and down flow booths and has held CTCB-i Professional status for 10 years and holds Authorised Person Ventilation HTM 03-01. With experience working to ISO, GMP, HTM03-01, ACDP and BS EN standards, Nick is a true clean air specialist and an extremely safe pair of hands to trust with the testing and validation of your critical environment.

- CTCB-i Qualified Engineer
- Authorised Person for Ventilation (HTM 03-01)
- Airflow measurements
- Principles of filter testing
- MSC testing
- Principle and application of particle counting
- Electrical safety certificate
- COSHH Awareness
- Fire Safety Awareness
- Asbestos Awareness
- Manual Handling
- Ladder Training
- CSCS Certification
- P601 LEV testing theoretical

Harry

Harry

Validation Engineer

Harry has worked with us since 2017 and has performed testing to countless ISO cleanrooms and GMP qualifications in a variety of sectors such as aerospace, electronics, healthcare, and pharmaceuticals. Harry takes pride in his customer service, and his numerous years of working in the service industry have created a solid foundation which is evident in his communication with customers and delivering excellent service. Harry has previous experience in the provision of cleanroom consumables and equipment services, allowing him to provide customers with a full cleanroom lifecycle solution which is C2C’s primary ethos.

- CTCB-i Qualified Engineer
- IPAF Certification
- Abrasive Wheel Certification
- COSHH Certification
- Manual Handling Certification
- Working at Heights Certification

Adam

Adam

Validation Technician 

Adam has worked at Connect 2 Cleanrooms since 2017 and in that time has validated hundreds of facilities across the UK and Europe. Leaning towards pharmaceutical and medical manufacturing applications, Adam is confident performing DOP testing on GMP facilities, validating them and also servicing HVAC systems. As a member of the installation team for a number of years, Adam has a lot of in-depth and practical knowledge on cleanrooms and loves talking to our customers about their technicalities. With vast experience in customer-facing roles, Adam is sure to bring that extra level of service to each job and as a keen photographer, he has an amazing eye for detail and brings this skill to producing evidence in validations.

- Competent person HVAC (HTM 03)
- IPAF Certification
Site Safety Plus Certification
Working at Heights Certification
COSHH Certification
HVAC
Asbestos Certification
Abrasive Wheels Certification

More about Annex 1

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