Deviation or non-conformance management and Quality Risk Management (QRM)

Deviation management or non-conformance management system plays a very vital role in the pharmaceutical and biopharmaceutical quality system.

Process for deviation management remains same irrespective of industry and organizations. However, customization may require depending on individual organization’s need, regulatory requirements and types of business models.

It is very important to document and investigate deviation to the written procedure or unexpected discrepancy noted during GMP operations. Deviation process helps to identify potential risk to the product quality and patient safety and to identify root cause of the event. Upon identification of root cause, appropriate corrective action and preventive action can be implemented to prevent re-occurrence.

Definition of deviation

Deviation is an occurrence of unexpected event, departure from procedures or specifications in the GMP environment.

The occurrence may or may not have potential risk to the identity, strength, quality, purity, safety, efficacy, performance, reliability or durability of the drug substance/ drug product. However, any departure from the procedure must have to be documented and investigated.

The unexpected events which may have potential impact on validation status of the process, equipment, utility, facility, software or impact on regulatory filings should also be handled through deviation management process.

Example of deviations

• Departure from the approved specifications or procedure
• Failure to meet in-process control (IPC) specifications of drug products
• Failure to meet requirement of approved dossier or filing (ANDA, NDA…)
• Equipment, instruments, or systems breakdown during batch production
• Loss of data or documents
• Malfunctioning of computerized system where product or GMP relevant data are lost
• Unauthorized changes in the facility, document, software or utility without change management system
• Non-compliance to regulatory requirements
• Failure in utility system resulting in environmental excursions in the facility

To read more in detail about deviation management, deviation classification, deviation trending, and GMP guidelines applicable for deviation managements, click here.