Pharmaguideline

The validation process does not guarantee the continued qualification of pharmaceutical equipment, systems, cleaning methods, or processes. ...

The efficacy of validation denotes the extent to which an approved process, system, method, equipment, or cleaning practice – that has alrea...

It is expected that sterilization validation will show that a particular sterilization process will be able to ensure the sterility in its i...

Carrying out validation in Contract Manufacturing Organizations (CMOs) is more complicated than doing validation in a single-site pharmaceut...

Process validation is commonly considered a technical activity involving qualification of instruments, key process characteristics, inspecti...

The cleaning validation report must not stop at declaring equipment cleaned. It must also show a crystal clear, traceable and scientifically...

An HVAC system used in pharmaceuticals might work properly on a normal day, but if the weather conditions become more difficult, it will cau...

Validation processes produce some of the key GMP evidence in a pharmaceutical plant. Qualification procedures, performed reports, raw data, ...

Validation deviation does not only mean a deviation in the steps of its realization. Refer to such deviations as events that can influence t...

Prior to the regulatory inspection, one of the first documents to be put under scrutiny is the validation document and the teams prepare by ...

While utilities are typically viewed as engineering systems, they can have a direct impact on product quality, contamination control, proces...

HVAC qualification has become one of the fields of the pharmaceutical validation protocol that can generate a great number of deviations. Te...

Cleaning validation in the manufacturing of ointments poses some challenges that differ from those that come with many traditional solid ora...

The classification of sterile areas indicates how clean the surrounding area must be with regard to the condition of the environment in ques...

The occurrence of failures in GMP compliance is often linked to a contribution of multiple weak links rather than being a result of a single...

The term critical quality attributes (CQAs) refers to the objectives established for some of the relevant physical, chemical, biological, or...

It is rare for a regulatory inspection to be problematic because one of the inspectors may ask a surprise question. Problems are usually cau...

An analytical result does not necessarily have to exceed the specification limit in order to warrant concern regarding product quality. In t...

The occurrence of regulatory action is one of the most severe consequences that can befall a pharmaceutical company as a result of a regulat...

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...

Validation can be defined as written proof showing that a process system or equipment is working as it was meant to be. In reality, however,...

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

Pharmaceutical manufacturing has aseptic production as one of its toughest processes because the end product has to stay sterile without the...

In a sterile manufacturing environment, personnel represent one of the greatest possible causes of contamination. A cleanroom can have a sui...

Continuous manufacturing affects the way processes are developed, certified and validated in the pharmaceutical industry. Instead of manufac...