Broad Spectrum for Non conformance

Non-Conformance and types of Non-conformances in Pharmaceutical and Medical device industries.

Non-conformance refers to any deviation from established quality standards and procedures in the pharmaceutical industry. Here are some common types of non-conformances that can occur in the industry:

• Process NCs: This occurs when a deviation from a defined manufacturing or testing process is identified. It can happen due to various reasons such as equipment malfunction, human error, or incorrect procedures being followed.
• Product NCs: This occurs when the product fails to meet the specifications or quality standards, either during manufacturing or after release to the market. It may include issues such as use of incorrect or outdated components/material, wrong quantity, or inadequate storage conditions.
• Documentation NCs: This occurs when documentation such as batch records, analytical data, and other relevant documents are not complete, inaccurate, outdated, lack of adherence to established procedures, or incorrect labeling of components/materials.
• Equipment NCs: These are deviations from the established procedures for maintaining, calibrating, or validating the equipment used in the manufacturing, testing, packaging, labeling or distribution of products. It may include issues such as inaccurate temperature control, improper machine settings, or malfunctioning of sensors etc.
• Environmental NCs: This occurs when the environment in which the product is being manufactured or stored does not meet the required standards, such as temperature, humidity or lighting.
• Facility NCs: This occurs when the facility does not meet the required standards for manufacturing or testing of products, such as cleanliness or maintenance issues, Structural defects and Improper storage of hazardous materials etc.

It is important to identify and address non-conformance issues as soon as possible to prevent further problems and ensure the safety and efficacy of the products.