What is the difference between controlled copy and un-controlled copy?

Controlled copy: A controlled copy is a formal copy of the latest, correct issue of a document; an identified issue of a document to an individual or location of the record. The controlled copy is officially tracked, updated & destroyed to assure that it is current.

Uncontrolled copy: An informal copy of a document for which no attempt is made to update if after distribution; the document is marked “uncontrolled” and the user determines if the document is active prior to use. Controlled and uncontrolled copies of the documents are issued by the quality assurance department as per the official requirements. Uncontrolled copies are unofficial copies of documents generally, issued for review purpose.

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?