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| Change, planned or unplanned, is imperative in pharma manufacturing. |
by Peter Murray,
Consultant
1. The concept of change
Within the pharmaceutical industry, the concepts of validation, change, change control, deviation and out of specification (OOS) are often treated as distinct activities which operate with a significant degree of independence.
All these activities are related to change, whether that change is planned or unplanned. While separate terms can usefully serve to focus attention on detail in particular activities when dealing with the consequences of change, treating them as isolated activities can lead to confusion and inconsistency of approach to what are logically very similar and/or closely related processes.
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