Decision Rule ISO 17025

Decision Rule ISO 17025: Understanding Its Role in Pharmaceutical and DTL Laboratories

Introduction A decision rule tells you how to decide pass or fail while accounting for measurement uncertainty. In ISO/IEC 17025 laboratories — including pharmaceutical and DTL testing labs — you must define and document a decision rule when you state conformity (pass/fail) to a specification. Decision rules are critical because ignoring uncertainty can lead to […]

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Automated optical inspection machine

1. Purpose To lay down a procedure for cleaning, equipment line clearance & Operation of the Automated optical inspection machine. 2. Scope It is applicable for cleaning, equipment line clearance & Operation of the Automated optical inspection machine. 3. Responsibility Automated optical inspection machine Operator, Production Officer Production manager Quality assurance officer 4. Cleaning Procedure […]

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Double Jacketed Liquid Manufacturing Vessel

1. Purpose To lay down a procedure for cleaning, equipment line clearance & Operation of the double jacketed liquid manufacturing vessel. 2. Scope It is applicable for cleaning, calibration, equipment line clearance & Operation of the double jacketed liquid manufacturing vessel. 3. Responsibility Double jacketed Vessel Operator Production Officer Production manager Quality assurance officer 4. […]

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Standing Operating Procedure Of Q Mixer Of Powder Formulation

1.    Purpose To lay down a procedure for cleaning, equipment line clearance & Operation of the Q  mixer 2.    Scope It is applicable for cleaning, calibration, equipment line clearance & Operation of the Q  mixer. 3.    Responsibility Operator, Production Officer Production manager Quality assurance officer 4.    Cleaning Procedure Cleaning Materials Cleaning agents: Purified  water Cleaning […]

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