Pharmaguideline

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 failures are usually due to improper testing, equipment failure, or mistakes made by the operator. One of the most common causes ...

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...

During an inspection by regulatory authorities, various documentation reveal the working of a pharmaceutical facility. Although inspectors s...

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

An inspection carried out according to regulations is one of the major moments in the life of a pharmaceutical production plant. Regardless ...

One of the hardest experiences that any pharmaceutical company could encounter is the failure of the cleaning validation process. There are ...

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

Cleaning validation is one of the most studied and analyzed processes during the pharmaceutical inspections since it demonstrates that the c...

Verification tools are always limited although many pharmaceutical manufacturing sites manufacture various products utilizing the same machi...

Each pharmaceutical producer hopes to successfully emerge from a regulatory inspection, which is not possible just because it wishes to do s...

When raw materials are delivered to a manufacturing plant, they pose a threat to the quality of finished goods. The quality department canno...

The piping systems and water systems are made to carry vital services like PW, WFI, pure steam, process gases and CIP solutions without comp...

Dissolution testing is recognized as one of the primary quality control tests for solid dosage forms. It shows how quickly and how much of t...

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 ...

Cleaning validation plays a vital role in manufacturing as it ensures that all manufacturing equipment is being cleaned according to the set...

Analytical method validation establishes documentation for how an analytical test procedure is adequate for meeting its intended use. When t...

One of the most important utility systems at any manufacturing site is the pharmaceutical water system. Depending on whether purified water,...

One of the most essential qualifications performed within sterile pharmaceutical manufacturing facilities is the execution of smoke studies ...

Validation of cleaning processes is an essential function in the pharmaceutical industry by providing documented proof that manufacturing eq...

The validation of processes is one of the major cornerstones of manufacturing in the pharmaceutical industry. The process of Validation prov...

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...

Manufacturing pharmaceuticals entails many processes and systems, equipment and personnel activities that can impact the quality of the prod...

The Corrective and Preventive Actions (CAPA) System is a critical aspect of managing the quality of pharmaceuticals. At the same time, CAPA ...