Common mistakes in validating package systems
Installation Qualification (IQ):- Installation qualification should be carried out on new or modified facilities, systems and equipment. Food and Drug Administration (FDA) has proposed guidelines with the following definition for process validation: Process validation is establishing documented evidence which provides a high degree of assurance that a specific process (such as the manufacture of pharmaceutical dosage forms) will consistently produce a product meeting its predetermined specifications and quality characteristics.
Mechanical drawings and design features provided by the manufacturer of the equipment should be examined.2.
In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000, it had proven to be an important tool for quality management of pharmaceuticals.
The concept of validation was first proposed by two Food and Drug Administration (FDA) officials, Ted Byers and Bud Loftus, in the mid 1970’s in order to improve the quality of pharmaceuticals. Validation - the Essential Quality Assurance Tool for Pharma Industries.
The working party would usually include the following staff members, preferably those with a good insight into the company's operation.1.
Design Qualification (DQ):- In this qualification, compliance of design with GMP should be demonstrated.
Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance.