Validation

Validation is the documents evidence that involves every process with validation protocols. The Page will be updated with every change in GMP, pharma guideline and
regulatory requirements.

Protocol on Hold Time Study of Machine Parts

Hold time is the period of time during which materials ( Machine Parts) may be held under specified conditions or… Read More

MACO and NOEL Calculation for cleaning Validation

MACO and NOEL Calculation for cleaning Validation

MACO and NOEL calculations have great importance in the pharmaceutical industries. NOEL( No observed effect level) and MACO is a… Read More

Difference between Validation, Calibration, and Qualification in Pharma

Many of us are having confusion between the terms validation, calibration, and qualification used in pharmaceutical industries. So let’s do… Read More

SOP on Storage and Hold time study for Products

1.0 PURPOSE: 1.1 To lay down Standard Operating Procedure for Storage and Hold Time of Starting Material, Intermediate, and bulk products. 2.0 SCOPE:… Read More

Factory Acceptance Test (FAT) in Pharmaceutical

After completion of Design Qualification, the inspection is done by the user before the delivery at the site is called the Factory… Read More

Design Qualification in Pharmaceutical industry

A Design Qualification comes to the role after the User requirements specification is finalized. Once URS is finalized, check the… Read More

Autoclave validation | study on temperature Probes

In microbiology, Autoclave validation and Sterilization are important for every Pharmaceutical to ensure good manufacturing quality. The sterility of glassware and media… Read More

Water system validation in Pharmaceutical

Water system validation is very important in pharmaceuticals. Water is used in the manufacturing process in a very large quantity during… Read More

4 types Process Validation,Pharmaceutical.FDA 2019

Validation is the established documents evidence or proof which provides a high degree of assurance that a specific method can… Read More