Pharmaguideline

Hazard Analysis and Critical Control Point, commonly known as HACCP, is a systematic preventive technique for identifying hazards and assuri...

When regulatory authorities make observations, it signals an indication that the company's systems, processes and controls may not compl...

The periodic review is an essential part of a suitable Pharmaceutical Quality System. It allows examining the ongoing processes and understa...

Calibration records are critical quality records kept by pharmaceutical manufacturers. A long list of measuring instruments is frequently us...

A vast volume of highly regulated data is produced by a drug-producing company on a daily basis. Various documents, such as Standard Operati...

Documentation refers to the records of various events throughout the process of pharmaceutical manufacturing. In reality, however, this term...

At any pharmaceutical production facility, training records serve as proof that an employee has attended a training program. It supports the...

The decision to outsource pharmaceutical manufacturing is an important aspect in the operations of many businesses. Contract Manufacturing O...

Imagine that a tablet compression machine is correctly functioning as highlighted in the process instruction document. The speed of compress...

The pharmaceutical industry operates on the preventative principle of failures, which means production failures are avoided before they occu...

Not every problem with quality in pharmaceutical production is an OOS situation. There are plenty of cases when testing gives results in com...

Validation tests do not finish once the testing phase has been accomplished. A good validation report proves the outcome of the validation p...

Validation documents go beyond regulatory documentation; they are written proof that the pharmaceutical premises, equipment, utilities, comp...

The core of pharmaceutical production is the concept of batch consistency. Every batch must conform with all predetermined specifications re...

When pharmaceutical specialists speak about way of manufacturing effectiveness, they usually emphasize machinery, machinery automation or im...

Validation is one of the main aspects of pharmaceutical quality assurance. It establishes documented proof that facilities, utilities, equip...

Because of the need to enhance efficiency and to minimize data errors and strengthen data integrity, the pharmaceutical sector is currently ...

The purpose of validation activities is to provide evidence that pharmaceutical processes, equipment and utilities, computerized systems and...

For any pharmaceutical manufacturer, having an open FDA 483 is one of the more difficult situations to experience. The inspection has conclu...

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