Annex 1 – Current & Future Deficiencies

Synopsis

The new Annex 1 is the ‘hottest’ regulatory topic currently. The recently introduced standard for sterile medicinal products significantly raises the regulatory requirements in a number of areas.
This presentation identifies those areas where Industry routinely failed to comply with the previous Annex 1 and looks ahead to predict the potential compliance ‘pitfalls’ within the revised guidance and how to avoid these.

This session offers a chance to consider sterile and cleanroom compliance from the perspective of a former MHRA steriles accredited inspector, before most companies will have been inspected against the new Annex 1.