Limit of Detection in Analytical Method Validation

What are Analytical Method Validation Parameters?

Robustness in Analytical Method Validation

Ruggedness in Analytical Method Validation

Steps in Analytical Method Validation

Analytical Method Validation

Quality Audit Frequency and Audit Schedule

Depth And Duration Of Quality Audit: It usually depends on the following parameters.

• Objectives status and history of organization.
• Complexity and size of organization.
• Number of audit criteria.
• Amount of human and financial resources.
• Amount of time and expertise of auditors.

Frequency of Quality audit:

• To optimize the control of significant quality aspects.
• High risk areas are audited more frequently.

Quality Audit Schedule:

• It clearly identifies objectives, criteria, scope etc.
• It contains audit details, site information, date and duration of audit, proposed activities documents required etc.
• Resulting in greater chances of audit to become more valuable and cost effective.

Notification of Audit:

• Announcement encourages the organizational units to correct many things in advance on their and set their house in order. Units are noticed in advance so that it may be likely that performance of the audit smoother and fruitful.