Pharmaguideline

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

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

An organogram is a diagrammatic representation of any organization or company. It contains all the positions of all departments in the co...

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

Pathogens are the microorganisms which are capable the cause disease. All of these microorganisms are harmful to human. Those can survive...

When we are sick, we always trust the medical product believing that they will certainly provide relief. We get assured that the medical c...

Accidents happen. Even with a range of measures in place, we’ll likely always see drug recalls that cost companies a lot of money. However, ...

Data integrity in microbial analysis refers to the maintaining and assuring the accuracy of the data that is being obtained from the raw inf...

Heating, ventilation and air conditioning (HVAC) is the key to ensuring that the pharmaceutical products manufactured by an industry are of ...

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

HPLC, also known as High-Performance Liquid Chromatography system , is one of the most crucial analytical methods in pharmaceuticals. The pu...

Computer validation planning consists of a Computer Validation Plan (approach), specific activities required to carry out the plan, and a Co...

Pharmaceutical manufacturing industry is a highly regulated industry that is regulated by different regulatory agencies from drug developmen...

Lubricants are added to solid tablets and capsules to prevent the sticking of material to the punch, dies and compression machine during man...

FDA inspects pharmaceutical manufacturing facilities to find cGMP violations. The observations are documented in form 483. If these observat...

All pharmaceutical companies have established strict guidelines and regulations according to current good manufacturing (cGMP) guidelines. T...

1. Meaning of a Drug Master File DMF stands for Drug Master File which is a voluntarily submission at the holder’s discretion to help the c...

It is the responsibility of the FDA to ensure that pharmaceutical products are safe and effective. To ensure this, the FDA inspects the phar...

Indian government published the latest guidelines to prevent unethical pharmaceutical industry practices that can influence healthcare profe...

The risk assessment is the process that helps to identify the risks associated with the process or system. Risk assessment is important for ...

The pharmaceutical industry is the most impactful industry for human beings because it has direct impact on people’s lives. But the pharmace...

Event tree analysis (ETA) is a risk assessment technique that is used to sequence of events in a variety of industries. In pharmaceutical in...

Defected tablets are the most common problem in pharmaceutical manufacturing. These defects may occur in any stage of manufacturing from raw...

Pharmaceutical manufacturing is a perfectly systematic process that primarily relies on quality control to produce quality products. The goa...

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

New Drug Application (NDA) are the documents about the product you want to manufacture and those are submitted to the government to detail t...

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

The clean-in-place cleaning method is used to clean equipment that can not be disassembled or displaced like pipelines, tanks and large vess...

Cleaning validation is an important part of pharmaceutical manufacturing and regulatory agencies take it very seriously. FDA issues many war...

In pharmaceutical manufacturing product quality, efficiency and regulatory compliance have important roles. To maintain product quality and ...