The U.S. Food and Drug Administration (FDA) has published the final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate ProductCompliance Policies".
MHRA has issued/ updated a set of guidance documents for UK companies, which will also have impact on EU companies supplying medicines into UK.
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.
When complying with the requirements of the Anti-Counterfeiting Directive, the status message "recall" for recalled batches is of great relevance for the entire supply chain. What has to be considered here?
The requirement for a "written GACP declaration" is contained in the current draft of the EMA HMPC Guidance Document "Quality of Herbal Medicinal Products". However, some questions remain: Who creates the declaration and what does it look like?
Due to the deficiencies identified during an inspection that the FDA had already conducted in February 2020, an Indian pharmaceutical manufacturer has now received a Warning Letter. The main reasons for this were deficiencies in equipment design, validation and incoming goods inspection. Read more here.
The British MHRA has joined an Australia-Canada-Singapore-Switzerlan Consortium to explore opportunities for information and work-sharing.
In addition to the new USP Chapter <1567> Pyrrolizidine Alkaloids announced recently, the USP is proposing a new chapter entitled <567> Analysis of Contaminant Pyrrolizidine Alkaloids (PAs).
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.
A repacker in the US has recently received a Warning Letter from the FDA. The described deficiencies are repackaging of products in non-equivalent primary packaging, the lack of cleaning validation and the establishment of a suitable quality unit.