A cleaning Validation Master Plan (cVMP) is a very important document that is needed to be in place during the cleaning validation process. Below read the all content that helps to prepare a well-documented validation plan. PROTOCOL CONTENTS S. No. SECTION TITLE 1.0 APPROVAL 2.0 INTRODUCTION 3.0 PURPOSE 4.0 SCOPE 5.0 RESPONSIBILITIES 6.0 STRATEGY 6.1 … Read more
The Area Qualification Protocol plays an important role in the pharmaceutical sector, serving as a vital process that ensures compliance and upholds quality standards across various sections within a pharmaceutical facility. This protocol entails a thorough assessment and examination of the important zone including cleanrooms, manufacturing areas, storage spaces, and laboratories to validate their appropriateness … Read more
The validation Protocol for the Hold time study of Garments has been done to ensure that the suggested method of the sterile garment is capable of being free from microbial contamination for daily use in the Sterile section. Aim: To validate the Hold time study for ‘STERILE GARMENTS’ and to establish documented evidence to ensure … Read more
The objective of developing and executing this Risk Assessment Protocol is To access the Risk Associated with the Quality of the product with respect to hazards and critical point review. To evaluate the risk priority Number To identify the risk prevention steps. To identify the risk mitigation tools. 1.0 PROTOCOL APPROVAL: The Risk Assessment Protocol … Read more
Hold time is the period during which materials ( Machine Parts) may be held under specified conditions or time and remain within the stipulated requirements. At all phases of production Hold time study on machine change parts to be done on a given frequency to ensure the quality of products. Manufacturers must ensure that the … Read more