Pharmaguideline

Regulatory inspections are a fundamental part of the pharmaceutical manufacturing process. They allow a company to verify compliance with Cu...

The foundation of quality systems in the manufacturing and distribution of pharmaceuticals is based upon the documentation of work performed...

Energy usage is one of the biggest business costs in pharmaceutical manufacturing facilities. Modern pharmaceutical factories have complex f...

Stability studies are extremely important scientific and regulatory functions in the pharmaceutical industry because they define your produc...

Fire safety plays an important role within pharmaceutical manufacturing as many hazards are associated with fires and explosions from solven...

Sterilization is an essential operation in pharmaceutical manufacturing, particularly when it comes to sterile products. Impacting directly ...

The pharmaceutical market is a heavily regulated, highly competitive environment where a small drop in manufacturing cost can mean the diffe...

Stability testing represents one of the most critical components of the pharmaceutical industry as it establishes how long a drug product ca...

An essential document for pharmaceutical manufacturing is the Batch Manufacturing Record (BMR). The BMR contains all the details on how to m...

Cleaning validation is one of the most critical components of pharmaceutical production due to its role in ensuring that all equipment used ...

Validating a pharmaceutical manufacturing operation is an essential aspect of the production of quality pharmaceutical products in accordanc...

In the production of pharmaceuticals, there are many steps that must be completed consistently. A small issue with a piece of equipment or t...

One of the strictest levels of environmental control is needed to produce sterile pharmaceuticals in a manufacturing facility. The following...

Validation is among those activities that ensure the quality of pharmaceuticals during their manufacture. Validation guarantees that all equ...

One of the most important processes in the manufacture of pharmaceuticals is sterilization, especially for products intended to be sterile. ...

In manufacturing pharmaceuticals, controlling contamination is vital in clean rooms and sterile areas. To do this, we rely heavily on HEPA f...

Clean air is primary fundamentals for a pharmaceutical factory. Airborne residue and micro-organisms can influence quality and patient’s hea...

Pharmaceutical manufacturing relies heavily on pure steam, particularly in sterile pharmaceutical manufacturing. Pure steam is largely used ...

Pharmaceutical manufacturers must validate their manufacturing processes. It is going to provide proof that a pharmaceutical company's e...

One of the most commonly used utilities in the manufacturing of pharmaceuticals is water. Both Purified Water and Water for Injection are re...

In order to preserve the cleanliness and avoid contamination in Pharmaceutical Manufacturing, cleanliness will be a significant factor. A cl...

One of the important parts of solid dosage form manufacturing is the compression stage of tablets. During this time, the granules or powder ...

A Form 483 observation can be detrimental to any pharmaceutical organization. This can indicate to an inspector that there are conditions wh...

Validation is an important part of pharmaceutical manufacturing, as it confirms the processes, equipment and systems used to manufacture pro...

The process of transitioning into digital transformation continues for the pharmaceutical industry, replacing the use of conventional paper ...

Within the validation processes of the pharmaceutical industry, a considerable amount of data is created through activities such as equipmen...

In pharmaceutical labs, having an accurate measurement is one of the key requirements to ensure that the different tasks required to correct...

In the production of drugs, the validated state is important to ensure that products produced are of high quality, safe to use and in compli...

Pharmaceutical products that are sensitive to temperature - including vaccines, biologics, insulin and certain injectable medications - requ...

The measurement of pH is critical analytical measurement in the pharma industry. Drug stability, solubility, bioavailability and therefore, ...