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Article . 2026
License: CC BY
Data sources: Datacite
ZENODO
Article . 2026
License: CC BY
Data sources: Datacite
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MICROBIOLOGICAL CONTAMINATION–DRIVEN CAPA IN PHARMA PRODUCTION

Authors: Pradnya Kumbhar*; Akshay Nenade;

MICROBIOLOGICAL CONTAMINATION–DRIVEN CAPA IN PHARMA PRODUCTION

Abstract

Microbiological contamination remains one of the most critical quality risks in pharmaceutical manufacturing, particularly in sterile and non-sterile dosage forms. Such contamination can lead to product recalls, regulatory actions, and serious threats to patient safety. Corrective and Preventive Action (CAPA) systems form a fundamental component of pharmaceutical quality systems and play a vital role in identifying, investigating, and mitigating microbiological contamination events. This review provides a comprehensive overview of microbiological contamination sources in pharmaceutical production and examines CAPA strategies driven by microbial deviations. Regulatory expectations from agencies such as the US FDA, EU-GMP (Annex 1), WHO, and ICH guidelines are critically discussed. The review highlights common root causes of contamination, tools used for root cause analysis, and effective corrective and preventive measures implemented across manufacturing environments. Additionally, challenges in CAPA implementation, frequent deficiencies cited in regulatory inspections, and emerging trends such as rapid microbiological methods and data-driven contamination control strategies are explored. The review emphasizes the importance of a proactive, risk-based CAPA approach integrated with contamination control strategies to ensure sustained microbiological compliance and product quality.

Keywords

Microbiological contamination, CAPA, manufacturing environments

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
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