Self-inspections in sterile pharmaceutical manufacturing: a critical review of the literature and of recurrent inspection deficiencies
1 Department of Health Management and Healthcare Economics, Faculty of Public Health "Prof. Dr. Tzekomir Vodenicharov, MD, DSc", Medical University of Sofia, Sofia, Bulgaria
2 Department of Social and Preventive Medicine and Disaster Medicine, Faculty of Public Health "Prof. Dr. Tzekomir Vodenicharov, MD, DSc", Medical University of Sofia, Sofia, Bulgaria
* Corresponding Author
ORCID Details
Kostadinka Ivanova Tsvetkova 1: 0009-0007-5311-1715
Asena Hristova Serbezova: 0000-0002-1949-1212
Angelika Spasova Velkova: 0000-0003-4594-9845
Review
World Journal of Advanced Pharmaceutical and Life Sciences, 2026, 11(02), 001–010.
Article DOI: 10.53346/wjapls.2026.11.2.0019
Publication history:
Received on 17 August 2026; revised on 24 September 2026; accepted on 26 September 2026
Abstract:
Self-inspections, also termed internal audits, are a mandatory element of the pharmaceutical quality system under Chapter 9 of the EU Guidelines to Good Manufacturing Practice, under ICH Q10 and under equivalent international frameworks. In sterile manufacturing the instrument carries particular weight, because the revised Annex 1 requires a formalised contamination control strategy whose effectiveness has to be periodically reviewed, and because published inspection data place sterile operations among the areas generating the highest share of critical findings. Our aim here is twofold: to review what has been published on self-inspection practice in sterile manufacturing, and to ask, against the deficiency data that inspectorates and analysts have put into the public domain, which non-compliances keep recurring at sterile sites and why internal audits so seldom catch them first. PubMed, Embase and Google Scholar were searched purposively for the period 2015 to 2025, together with regulatory and industry sources. Deficiency data were taken from the published MHRA inspection deficiency datasets, from non-compliance reports in the EudraGMDP database and from published analyses of warning letters and inspection observations of the United States Food and Drug Administration. Six recurrent clusters were identified: environmental monitoring design and excursion investigation; contamination control strategy and aseptic practice; cleaning, disinfection and cleaning validation; premises, equipment and utilities; investigations, root-cause analysis and corrective and preventive action; and the integrity of monitoring records. Almost all of these clusters fall within the documented scope of a routine self-inspection, yet they continue to be reported by inspectorates in stable proportions. We argue that what limits these programmes is how deeply they look rather than how widely.
Keywords:
Self-inspection; Internal audit; Sterile manufacturing; Annex 1; Contamination control strategy; Environmental monitoring
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