Abstract

PHARMACEUTICAL PROCESS VALIDATION OF SOLID DOSAGE FORMS: A REVIEW

Annapurna Ojha* Meenakshi Bharkatiya and Santosh Kitawat

ABSTRACT

The concept of validation was first proposed by Food and Drug Administration officials in 1970 in order to improve the quality of pharmaceuticals. Process validation is the key element in assurance of pharmaceutical product. It is the most important and recognized parameters of cGMP. This establishes the flexibility and strict quality control in the manufacturing process control in the attainment of desirable attributes in the drug products while preventing undesirable properties. Through this review the authors make an effort to explain, the overview of validation concept of conducting validation trials and provide an insight to its importance in the pharmaceutical industry.

Keywords: Validation process, cGMP, Food and Drug Administration, quality control.