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The EU Commission has published a revision of the "Compilation of Union Procedures on Inspections and Exchange of Information". This is the eighteenth revision. It mainly involves editorial changes, a few adjustments and two new documents.

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Supplier qualification, contracts and quality oversight are also important to the FDA. This is reflected in a recent Warning Letter from the authority.

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In the course of an expansion, the IRIS platform will also be used by marketing authorisation holders and applicants to communicate with the EMA about GMP inspections.

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The US FDA reports deficiencies during inspections in the so-called Form 483s. These reports are partly public, and the FDA subjects them to trending by key points. The evaluation of the last year 2020 shows a significant increase in inspection deficiencies with regard to equipment.

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The frequent occurrence of particles in sterile injection solutions and the inadequate investigation of the cause led to a Warning Letter to a sterile manufacturer in Japan. In addition, data integrity breaks and falsifications had occurred in the environmental monitoring.

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Stability studies of pharmaceuticals are a well-established discipline and, of course, an important regulatory requirement. Nevertheless, an evaluation of the last two fiscal years shows that deficiencies in the stability program are mentioned in numerous FDA 483s.

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The United States Food and Drug Administration (FDA) has recently published a Warning Letter to a manufacturer of over-the-counter (OTC) drug products. The letter summarizes significant violations of current good manufacturing practices (CGMP) concerning finished drug product testing, identity testing of active pharmaceutical ingredients (APIs), and stability testing.

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In a recent Form 483 issued as part of an FDA inspection conducted at an Indian sterile manufacturer, the FDA criticized the manual visual inspection, among other things.

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Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. An evaluation of the last two fiscal years shows that a lack of scientifically sound laboratory controls and not following/documenting laboratory controls are often mentioned in such FDA 483s.

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Sampling of materials is one of the most important processes in pharmaceutical companies. An Indian company received a so-called 483 FDA report due to inadequate sampling plans for raw materials and intermediates. Furthermore, the FDA criticises that components used in manufacturing are not tested and released prior to use.

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