Deviation Management Posts

Deviation Management: Taking GMP Compliance to the Next Level

Deviation Management: Taking GMP Compliance to the Next Level

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Despite the best efforts of industry and regulators alike, quality issues are on the rise. Product complaints are up, along with product recalls, drug shortages, product bans, plant shutdowns, and enforcement actions. This means that industry and regulators alike are looking for answers.

It happens that many of these answers lie within your existing deviation management processes and data. The key to addressing these increasingly common issues is understanding the true driver behind Good Manufacturing Practices (GMP), and then structuring your deviation and quality management processes accordingly. (more…)

A Deviation by Any Other Name

A Deviation by Any Other Name

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. (more…)

Deviation Management and the Next Level of GMP Compliance

Deviation Management and the Next Level of GMP Compliance

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions

Despite the best efforts of industry and regulators alike, quality issues are on the rise. Product complaints are up, along with product recalls, drug shortages, product bans, plant shutdowns, and enforcement actions. This means that industry and regulators alike are looking for answers.

Fortunately, many of these answers lie within your existing deviation management processes and data. The key is understanding the true driver behind Good Manufacturing Practices (GMP), and then structuring your deviation and quality management processes accordingly.
(more…)