Deviations and Nonconformities in Pharmaceutical Industry

“Deviation” terms used in the pharmaceutical industry, while the term “non-conformance” is classically used in the medical devices industry (ISO 13485:2016).

Nonconformity

Nonconformance means that there was an event with a process, service, or product, and the result does not match the requirements.

ISO 9000:2015 defines nonconformity as “non-fulfilment of a requirement.”

According to FDA 21 CFR part 820.3(q) Nonconformity means the “nonfulfillment” of a specified requirement.

Types of Nonconformity:

i. Major
ii. Minor

Deviation

Any unwanted event that represents a departure from approved processes or procedures or instruction or specification or established standard or from what is required. Deviations can occur during manufacturing, packing, sampling and testing of drug products.

Types of Deviation:

i. Minor
ii. Major
iii. Critical

Consequences of Deviation/Nonconformities:

The consequences of Deviation/Nonconformities depend on the possible consequences of these Deviation/Nonconformities:

Obligation to recall the drug products/devices by the manufacturer
Withdrawal of certificate
Warning letters
Criminal prosecution
Import ban
Inspection by authorities
Fines
Obligation to rectify nonconformities and their causes (corrective actions)

Causes of deviations/nonconformities:

The causes are varied. However, they can usually be traced back to one of the following reasons:

Those responsible are not aware of the legal requirements and requirements of applicable standards.
The legal and normative requirements were not correctly understood and implemented.
The legal and normative requirements were knowingly ignored.
The company’s own internal requirements are too complicated.
The management has not communicated the importance and meaning of the requirements to the employees.

Finding Deviation/Nonconformities

Manufacturers should look for nonconformities themselves by:

Carrying out internal audits (mandatory under ISO 13485)
Carrying out tests to find nonconformities, possibly also automated
Inspections and reviews of devices and documents

Prevent Deviation/Nonconformities:

Comprehensive quality management focuses not only on finding nonconformities but also on preventing them.
Conduct Regular Internal Audits
Perform Quality Checks
Provide Employee Training
Establish Clear Procedures
Improve Record-keeping
Audit Suppliers
Perform Customer Surveys
Have a Comprehensive Root Cause Analysis
Implement Risk Assessment
Enable Automated Alerts
Implement a Process to Ensure Continuous Improvement
Implement Quality Management Systems (QMS) Software