GMP News - Quality Assurance

The French Ministry of Health has published the specifications and quality requirements for medical cannabis in the pilot phase. The document covers flowers, extracts and finished products for oral, sublingual and inhalation use (including devices).

To facilitate the rapid deployment of the vaccine the European Commission (EC) recently published a document regarding labelling and packaging flexibilities for COVID-19 vaccines.

With the coming into force of the FDA Process Validation Guideline 2011 and the revision of Annex 15 (2015), the process life cycle has become state of the art in the field of validation. What does this mean in practice?

The term Design Qualification is not used in the current FDA Guidance on Process Validation. However, it is addressed that the design of a facility plays a role within the scope of a qualification. Moreover, in a current Warning Letter the FDA criticizes design deficiencies in a water system.

The British MHRA has joined an Australia-Canada-Singapore-Switzerlan Consortium to explore opportunities for information and work-sharing.

In last week's newsletter you could read about part I of Q&As on cleaning validation - asked during ECA's first Cleaning Validation Online Training Course in September. The ECA would like to share a selection of these Q&As on Cleaning Validation - now in part II.

In September the ECA offered the first Cleaning Validation Online Training Course - with many questions for the speaker. The ECA would like to share a selection of these Q&As on Cleaning Validation with the community.