The below HTML version provides a quick overview.

The GMP guidance for sterile manufacture was revised in 2003 to accommodate changes from various cleanroom standards and create a single unified cleanroom standard, ISO4644-1. The introduction to ISO 14644-1 states this as:

Annex 1 of the EC Guide to Good Manufacturing Practice (GMP) provides supplementary guidance on the application of the principles and guidelines of GMP to sterile medicinal products. The guidance includes recommendations on standards of environmental cleanliness for clean rooms. The guidance has been reviewed in the light of the international standard EN/ISO 14644-1 and amended in the interests of harmonisation but taking into account specific concerns unique to the production of sterile medicinal products.

The method to certify a cleanroom must comply with the rules and format of ISO14644-1 guidance. This new Annex includes a modified ISO standard which addresses sterile medicinal products. To support this, a table of cleanroom certification values that roughly translated to ISO 14644-1 was defined. For clarity, a series of notes appended the table. Unfortunately, the first, “Note a”, caused certain confusion.

This confusion has been remedied in the 2008 release of the EU GMP Annex 1 which clearly outlines three phases that need to be performed:

1. Certification: Each cleanroom and clean air device should first be classified
2. Monitoring: the cleanroom should then be monitored to verify that conditions are being maintained relative to product quality
3. Data Review: Ensure that the data accrued from the monitoring be reviewed in the light of risk to finished product quality.

Click here to download the full paper: Click here to signup and download files (Technical Review: Particle Counting to Meet European GMP Annex 1, 2008 edition)