ANALYSIS OF OUT OF SPECIFICATION CAUSES IN INDIAN PHARMA
Keywords:
Corrective and Preventive Actions, Good Manufacturing Practice (GMP), Out of Specification, Quality Control, Standard Operating Procedure, United States Food and Drug Administration (USFDA)Abstract
Objectives: This research explores the underlying reasons behind Out of Specification (OOS) findings in Indian pharmaceutical companies by reviewing the responses gathered through a planned questionnaire.
Methodology: The responses summarized in Tables 1a, 1b, and 1c revealed recurring challenges such as inconsistent manufacturing practices, inadequate process control, insufficient analytical verification, and limited workforce expertise. A mixed-method approach was used, combining qualitative feedback with descriptive analysis. Data were collected using a Google Forms questionnaire shared with professionals from manufacturing and quality functions. All responses were organized and examined through a comparative thematic analysis to identify trends and contributing causes.
Results: Findings showed that pressure to meet production timelines sometimes resulted in shortcuts, leading to product quality failures. Several respondents acknowledged weaknesses in investigation practices, including incomplete assessments and failure to appropriately justify or record failing results. Limited training and unclear procedural guidance were also identified as significant barriers to effective OOS management.
Conclusion: The study highlights the need for structured procedures, preventive controls, trained personnel, and strong documentation to ensure consistent compliance. A systematic approach supported by continuous monitoring and accountability may significantly reduce OOS occurrences and enhance regulatory alignment.
