The European GMP Auditor Association has published a revised and further improved version of its GMP Auditors Reference Handbook. It is available on the website of the association.
In the US, inspections can happen announced; companies cannot choose when these inspections happen. Now, supported by an Executive Order, foreign firms will now be treated the same.
Back in October/November 2024, the FDA carried out an inspection at a US manufacturer of OTC products and uncovered a number of GMP deficiencies, including in process validation, which has now led to a warning letter. Continue reading.
The Investigations Operations Manual (IOM) is the primary operational reference for FDA investigators. Although primarily used internally by FDA staff, it is available publicly. The Manual has now been revised.
The US FDA inspected an Indian API manufacturer from 4 to 12 September 2024 and found serious GMP violations. The deficiencies relate in particular to inadequate cleaning procedures and the associated risk of contamination, inadequate handling of quality deficiencies and violations of data integrity.
In a previous News we reported on deficiencies in media fills. The topic is a priority for the FDA! In a recent Warning Letter, media fills were criticised again, as well as deficiencies in smoke studies. What did the FDA criticise?
The US FDA inspected an Indian pharmaceutical manufacturer from 26 August to 6 September 2024 and found serious GMP violations. The deficiencies relate in particular to the cleaning and maintenance of production equipment, the structural condition of the facility and data integrity. Read more.
