Glossary
Nonconformity
What is nonconformity?
Nonconformity in the pharmaceutical industry refers to any product, process, or activity that does not meet the specified requirements or standards. A Nonconformity Product is a product that does not fulfil its specified requirements. Nonconformity can occur in both products and processes, leading to a nonconforming product. It identifies and investigates the root cause and records the Nonconformity’s nature, date, location, personnel involved, etc.
What are the types of non-conformities?
Non-conformities in the pharmaceutical industry can be categorized into several types, including:
- Quality-related Non-Conformities: Issues affecting product quality, such as defects in manufacturing processes or documentation errors.
- Process Non-Conformities: Deviations from established procedures or protocols during production.
- Documentation Non-Conformities: Inaccuracies or missing information in required records and reports.
- Regulatory Non-Conformities: Failures to comply with regulatory standards set by agencies like the FDA or EMA.
How are non-conformities be managed?
Non-conformities are managed through a structured process that typically includes:
- Identification: Detecting non-conformities through audits, inspections, or routine testing.
- Investigation: Analyzing the root cause of the non-conformity to prevent recurrence.
- Correction: Implementing immediate corrective actions to address the non-conformity.
- Documentation: Recording the non-conformity, actions taken, and outcomes for compliance and future reference.
- Review: Evaluating the effectiveness of the corrective actions and making necessary adjustments to processes or procedures.
How can non-conformities be prevented?
Preventing non-conformities involves implementing robust quality management systems (QMS) along with regular training of employees on compliance and quality standards, clear and accessible SOPs to guide processes and reduce errors, routine audits to identify potential issues before they escalate and encouraging a culture of continuous improvement to address and mitigate risks proactively.
