Change control is mandatory to maintain the validated state also for computerised systems and is subject to inspections. What are the regulatory requirements and what is the inspection practice?
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.
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.
Thermal sanitization is still the most common method for keeping pharmaceutical water plants under microbiological control. Some systems are stored at high temperatures - but often water systems are heated up cyclically to an elevated, germicidal temperature. Here, the question of optimal temperature often arises.
The FDA has published a draft Guidance for Industry with the title "Selected Update for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices". What will come?
More than a year after the publication of the draft of Chapter <1220> on Life Cycle Management of Analytical Procedures, the USP has announced the final version for 01 November.
Marketing authorisation holders of chemically-synthesized or biologic medicinal products are required to perform confirmatory testing after identifying a potential risk of nitrosamine contamination and report the results using specified templates. One of these reporting templates has been recently revised. Read more here about the updates to be considered in the nitrosamine contamination reporting template.
The PIC/S has developed a stand-alone Aide-Memoire (PI 038-2) on Quality Risk Management (QRM) for GMP inspectors. The aim of the document is to provide guidance to GMP inspectors on the inspection of QRM systems in the pursuit of harmonisation.
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.
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.