What do you mean by re-validation?

A repeat of the process validation to provide an assurance that changes in the process/ equipment introduced in accordance with change control procedures do not adversely affect process characteristics & product quality.

 Revalidation is to validate any process or equipment again after the maintenance or change that can affect the quality of the product. It ensures that the system or equipment is working as per the standards.

What are the possible causes for “Out of Specification”?

 Out of specification is the deviation of the product from the pre-determined specification.

The following are the possible causes for out of specification:

• ·         Test analysis error in QC Lab.
• ·          Lab equipment malfunctioning or off-calibrated
• ·         Production equipment malfunctioning or off-calibrated
• ·         Operator/human errors

What is the difference between specification and Limit?

Specification: A document giving a description of a starting material, packaging material, intermediate, bulk or finished product in terms of its chemical, physical & possibly biological characteristics. A specification normally includes description clauses & numerical clauses, the latter stating standards & permitted tolerances.

Or

 It is the type of standard which is often referenced by a contract or procurement document. It provides the necessary details about the specific requirements.

 Or

 Lists of detailed requirements with which the products/ materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation.

Limit: The point, edge or line beyond which something cannot or may not be proceeding. The boundary surrounding a specific area, bounds.

Describe about swab and rinse sampling?

What do you mean by “performance qualification