Pharmaguideline

Design qualification is defined as a verification process on the design to meet particular requirements relating to the quality of pharmaceu...

A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specificat...

In pharmaceutical manufacturing, the product must not be contaminated by previous product as well as it should not be contaminated with the ...

The revalidation process is essential to maintain the validated status of the plant, equipment, manufacturing processes, and computer syste...

In the past, it was not important to validate the transportation of the pharmaceutical products but now it is recommended by all major re...

Cleaning of equipment was first published in the Code of Feral Regulations (CFR) as 21CFR211.67 Equipment Cleaning and Maintenance in 1978....

The Cleaning validation is performed to demonstrate the effectiveness of procedures for cleaning to remove the residue of the previous pr...

Temperature sensors are used in different processes in pharmaceuticals. Different types of temperature sensors are used in different proc...

This Quality Standard describes the requirements for the preparation, generation and approval of new or revised Packaging Masters and Batch ...

Quality of pharmaceutical products is a major concern in the pharmaceutical industry. Quality of product indicates the seriousness of the ma...

Master formula record (MFR) is a master document for any pharmaceutical product. It contains all information about the manufacturing proce...

Everything from pharmaceutical products to personal consumer products is tested in stability chambers to get an accurate reading of conditi...

Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of ...

Site Acceptance Test can determine whether or not systems are meeting the desired and required specifications. The main purpose of site acce...

Water is an essential part of manufacturing industry processes and domestic use. Water is used as a coolant, solvent or in many other chemic...

Self inspection is basically a very useful and powerful mechanism for detecting any shortcomings or faults operating within any system. It m...

Purified water in the pharmaceutical industry is a critical component because it is used at various stages of pharmaceutical manufacturing. ...

During the manufacturing process of active pharmaceutical ingredients, some unwanted substances are produced those are known as impuritie...

Data integrity is highly important in any industry, but especially so in the pharmaceutical industry where any data error could mean serious...

The purified water is prepared by purified water generation system ( Reverse Osmosis System ) and collected in purified water storage ta...

Analytical method development is considered as a critical process in pharmaceuticals. Availability of the different types of columns, opera...

Analytical methods in chemistry context entail how chemical components in natural materials or synthetic materials are identified, separated...

Cleaning Method validation is the process in which documentation of how the cleaning process of manufacturing equipment is done. Most times ...

1. Introduction Process validation is an essential part of good manufacturing practices (GMP) . It is, therefore, an element of the qu...

User Requirement Specification (URS) is a list of all requirements of buyer regarding the equipment to be purchased. URS is prepared by ...

Over the years the pharmaceutical industry has used non-temperature specific drugs as pills for most of its purposes. Cold chain pharmaceuti...

Contamination is a very serious issue in pharmaceutical manufacturing especially in sterile manufacturing. It is important to control the co...

A lot of disinfectants are used for sanitization and disinfection in pharmaceutical industries. These have different antimicrobial proper...

Compressed air is used in the different areas of the pharmaceutical manufacturing facility. Compressed air may contain contaminants those ma...

This is a common concept to validate three consecutive batches in pharmaceuticals. In process validation , initial three batches are take...