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Types of Deviations in Pharma

What is Deviations and What are the Types of Deviations

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30 views1 page

Types of Deviations in Pharma

What is Deviations and What are the Types of Deviations

Uploaded by

srinivasa
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

Deviations

A Deviation is an unplanned departure from an approved instruction, standard procedure,


specification, or established practice in the manufacturing, testing, or documentation
process. It may affect product quality, process reliability, or regulatory compliance and
must be investigated and documented.

Purpose:
• To identify and document unplanned events that deviate from standard procedures.

• To evaluate the impact of deviations on product quality and compliance.

• To implement corrective and preventive actions to prevent recurrence.

Scope:
Deviation management applies to all operations affecting:

• Manufacturing processes

• Analytical testing and QC procedures

• Standard Operating Procedures (SOPs)

• Equipment and utilities

• Raw and packaging materials

• Documentation and records

• Facility operations and environmental conditions

Types of Deviations:
• Critical Deviation – May impact patient safety or product quality significantly.

• Major Deviation – May affect product quality or compliance but not directly endanger
patient safety.

• Minor Deviation – Has minimal impact on product quality or regulatory compliance.

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