Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
What’s in a name? Depending on industry, a word can have very precise meaning. Look up the word “deviation” on the internet and the first definition to appear reads: noun, The action of departing from an established course or accepted standard. Statisticians use the term to define “The act of deviating” or “Deviation from a norm”.
If you search for the definition of “deviation” as applied in the Pharmaceutical industry, you’ll find some variation of “Unexpected departure from an approved instruction, procedure, established standard or specification.” In other words, “deviation” is not a desirable term in the Quality lexicon.
Unscheduled Departures from Pharmaceutical Quality
Deviations can occur during manufacturing, sampling and testing, even finished pharmaceutical product acceptance. They can occur anywhere within the organization and during any process. Examples of deviations include, but are not limited to, the following:
- Unapproved steps added to the process
- Steps omitted from the process
- Operating steps not correctly followed/executed
- Unapproved changes to the ingredients
- Incorrect issuance of raw materials
- Activity performed without proper training
- Equipment out of calibration
- Production lines running outside of in-process controls
- Alternate production equipment used unexpectedly
- Failure to follow written SOPs or approved Batch instructions
- Significant variance in expected yield
When these types of departures occur, deviation best practices and industry regulations dictate the following:
- The deviation must be reported in real time.
- The deviation must be thoroughly investigated, and the investigation should be timely — typically, within 30 days.
- Corrective actions are to be proposed and initiated and completion should be tracked. Immediate actions taken must also be recorded.
- All implicated batches should be assessed, and dispositioned (i.e. released, rejected, re-worked).
- Preventive actions, if appropriate, should be taken to ensure prevent reoccurrence of the deviation.
The various Good Manufacturing Practice (GMP) standards, whether the International Conference on Harmonization (ICH), the FDA, or the EU GMP standard, requires the documentation and investigation (based on severity), of any deviation.
Historically, the Pharmaceutical industry has called a “deviation” by two other names: either unplanned deviations or planned deviations. However, the regulators are asking industry to move away from that nomenclature as a best practice. But why?
By nature, a deviation is unexpected and uncontrolled, so calling it an unplanned deviation is redundant at the very least. During the September 25th Parenteral Drug Association/FDA conference in Washington D.C., Douglas Campbell a former FDA investigator, noted that “there’s some pushback against this idea of having a planned deviation. Its kind of an oxymoron.” The term planned deviation is often used for short-term deviations or changes in processes that are pre-planned and executed for a defined period, in a controlled manner.
The FDA’s Rick Freidman said, “I would use the Change Management program in the Quality system and not use peculiar terminology.” In other words, Freidman agreed with other FDA panelists at the conference that it makes sense to drop the word “planned” from the term for deviations, even when it’s known that the deviation is coming versus something that occurred unexpectedly. Further, Friedman argued that change control systems should handle such changes.
Change control systems should indeed handle temporary changes, and temporary changes should be easily segregated from permanent changes. Additionally, temporary change records should vary in complexity based on the whether the temporary change is minor or major in nature.
Deviations happen; the regulators recognize this. In fact, deviations (a.k.a. unplanned deviations) records are one of the most common areas inspected during a visit from regulatory authorities. Temporary changes (a.k.a. planned deviations) can also raise a red flag for investigators when they may indicate a process problem that is being worked around rather than corrected.
Clearer Skies Ahead
Regardless of the name, although there are benefits to considering the current thoughts of the regulators, the bottom line is this: when it comes to managing deviations and temporary changes, it’s all about managing risk. It’s about demonstrating control even when things unexpectedly go wrong, or the need to take a temporary adjustment arises. Proper deviation management and temporary change control will provide your organization with the tools needed to detect reoccurring issues and will support continuous improvement to ensure product efficacy and patient safety.
SmartSolve® Change Management
Product Showcase Video
This video helps you create a standard process to record, review, approve, and implement change.