Operational Qualification

Operational qualification is defined as the procedure of establishing confidence that equipment and subsystems are capable of consistently operating within standard limits and tolerances.

Operational qualification in pharmaceuticals is proof that a process or system, when operated within established parameters, can perform effectively and in a reproducible manner to produce a medicinal product that provides the previously established specifications (pharmaceutical validation). Operational qualification in pharmaceuticals is part of the requirements of regulating agencies of pharmaceuticals such as FDA and their guidelines on good manufacturing practices.

All process steps, production equipment, packaging equipment, systems and environment directly relevant to the production of sterile and non-sterile products must be validated. Equipment description such as dosing, formulation, packaging, washing equipment and cleaning must also be formally confirmed. Computerized systems design, information systems, automated manufacturing equipment and electronic records are also some of the utility system designs that must be qualified in a pharmaceutical industry.

The concept of operational qualification in pharmaceuticals was proposed by some health officials to ensure that the products of pharmaceutical companies are safe and of good quality. lt is important to note that testing a sample at the end of the manufacturing process is not an assurance that all the products in that batch meet the required specification. Therefore, the main role of operational qualification in pharmaceuticals is to protect the health and safety of the population. The boundaries and scope for each process or equipment should be documented.

A risk assessment of the documented plan should be done to ensure that the equipment is able to operate in the complexity specified in the documented plan. The operational qualification of pharmaceutical industries varies by jurisdiction. In some countries, it is done at the national level by a single agency while in other countries, it is done at the state level or at both state and national levels by various bodies. Some of the examples of operational qualification in pharmaceuticals include:

1. Autoclave: The sterilization process of any laboratory must be consistent and reproducible in an efficient manner. In order to ensure this, it is important to validate the sterilization process and verify that the equipment are operational and safe. The process of operational qualification therefore ensures that the autoclave meets the desired and intended performance standards of the laboratory.
2. Radiotherapy machines: Qualification of a radiotherapy machine refers to a process of ensuring that the machine is operational and safe and that it will perform as per the intended specifications. Operational qualification tests should be performed upon receipt of the equipment, when the instrument is moved to a new location and when the equipment or software that runs the equipment is changed or modified. Operational qualification tests should also be done regularly (for instance 3 monthly) to make sure that the equipment continues to function to specifications.
3. Cold chain products: Some pharmaceutical products such as vaccines must be transported and stored in a cold chain manner. This is because they are sensitive and their quality may be altered by environmental factors such as temperature changes. Qualification of the cold chain machines such as refrigerators should be done once the machine is purchased and regularly during its use to ensure that it is operational and safe and that the vaccines are valid.

In conclusion, operational qualification in pharmaceuticals is one of the processes in pharmaceutical validation and is key to ensure that equipment and processes are as per the intended specifications.