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. 

More about Annex 1

Contact Us