Planned v.s. Unplanned Deviations

Time and again, I find myself drawn into discussions about the legitimacy of the term "planned deviation." The frequency of these conversations prompts me to wonder: why do we even debate this?

A deviation, by definition, is a departure from a standard or norm. Logically, one can plan to deviate from these norms, documenting the rationale and conducting a thorough impact assessment to ensure compliance and understanding.

The distinction between "Planned Deviation" and "Unplanned Deviation" lies in their workflows – each requires a unique approach to manage effectively. Similarly, in Change Control systems, what we term a "Temporary Change" also follows a distinct procedure.

But here lies the bigger question: Why are we focusing on semantics when there are far more critical issues at hand, such as drug shortages and supply chain management challenges? These are the real pressing matters that deserve our attention.

Engaging in prolonged debates over terminology distracts from our primary goal in Good Manufacturing Practice (GMP): delivering safe, effective medicines to patients On Time In Full (OTIF).

Let's not lose sight of what truly matters. Sometimes, it's best to make a decision, move forward, and revisit less critical debates later. Our focus should always remain on enhancing product quality and ensuring patient safety.

💡 My take: Let's prioritize our discussions to reflect the real challenges we face in the pharmaceutical industry. It's time to shift our focus back to where it truly belongs.

#Pharmaceuticals #GMP #QualityAssurance #ChangeManagement #PatientSafety