Pharma industry and NCs

In the pharmaceutical industry, non-conformance refers to any deviation or failure to meet regulatory requirements, quality standards, or established procedures.

The following are some common types of non-conformances that can occur in the pharmaceutical industry:

• Deviation: Any departure from standard operating procedures, including manufacturing, testing, packaging, or labeling processes, which may affect product quality such as equipment malfunction, change in approved vendor for API/excipients, change in BOM or equipment list used for an approved batch.
• Out of Specification (OOS): OOS refers to results that fall outside the predefined specifications or acceptance criteria for a product, process, or test method such as variability in the physical or chemical properties of the drug substance or drug product, Inconsistency in the potency, desired drug release profile, impurities etc.
• Out of Trend (OOT): OOT refers to a trend of results that are moving away from the expected range or historical data, indicating a potential problem in the process or product quality.
• Market Complaints: Any reported issue related to a product quality, efficacy, or safety by a customer, patient, or healthcare professional such as such as broken tablets, missing or incorrect labels, or incorrect dosing instructions or problems with the drug delivery device (Combination drugs).
• Product Recalls: A product recall is initiated when a potential quality issue is identified that could pose a risk to patient safety, health, or welfare.
• Adverse events: Any unwanted or unexpected medical occurrence associated with the use of a product, including side effects, reactions, and allergies.
• Audit Observations: Any observations or non-compliance identified during an internal or external audit, inspection, or regulatory assessment.

It is crucial for pharmaceutical companies to have a robust non-conformance management system in place to identify, investigate, and correct any deviations from quality standards, regulatory requirements, or established procedures to ensure patient safety and product quality.