As the publication for the revised Annex 1 of the GMP guidelines is fast approaching, the new guidelines add a requirement for sterile eyewear and garment change at least every work session.
The revised Annex 1 of the GMP guidelines is close to publication.
Read more to learn about the key areas affected by the new Annex 1 requirements.
Both Annex 1 and Eudralex Annex 15 require that a cleaning process should be validated to ensure the removal of residues and any subsequent consequences from them.
Cleanroom gloves are designed to protect either products from contamination or the wearer from exposure to chemicals. Glove length is a factor that is becoming increasingly important.