The COVID-19 global pandemic has made the installation qualification (IQ) and quality assurance process for pharmaceutical companies more important than ever. The nature of the virus and how it transmits has caused these companies to introduce new policies to protect workers and prevent the spread of the illness.
The development, shipment, and storage of COVID-19 vaccines forced healthcare professionals to discern the best ways to handle these sensitive medical products. Healthcare centers have also had to adopt pandemic-related policies and procedures in order to prevent transmission of the virus
Since installation qualification is so important for pharmaceutical companies to maintain the quality of their products, let’s explore each step of the qualification process and how it has changed since the pandemic.
Installation Qualification and IQ OQ PQ Plans
Pharmaceutical companies and manufacturers must abide by installation (IQ), operation (OQ), and performance(PQ) qualification standards, as described by the FDA. Data loggers can play an important role in making sure that companies are complying with these standards, thus limiting their potential legal liability if something goes wrong. Data loggers themselves should also undergo this IQ OQ PQ process to ensure they are functioning as they should.
The FDA defines qualification as the “activities undertaken to demonstrate that utilities and equipment are suitable for their intended use and perform properly. These activities necessarily precede manufacturing products at the commercial scale.”
Qualification can be broken down into three categories. The first category, installation qualification (IQ), refers to the steps a manufacturer takes to analyze any equipment used as part of a supply chain to make sure it functions as desired before it is installed. Refrigeration and transportation equipment, for example, should be examined to confirm that they are capable of performing their role in the supply chain.
According to Dickson Data, a fundamental part of installation qualification is verifying that proper equipment is paid for, available, and functional according to expected specifications. In order to confirm this, pharmaceutical companies must cross-verify purchase orders, packing lists, and receipts with their equipment inventory. This way, they can make sure that the correct equipment has been ordered and delivered.
Many pieces of equipment will include a nameplate that lists information about the equipment. If so, this information, including the supplier’s part numbers, and configurations listed on the nameplate should be verified. Some examples of these verifiable configurations include the electrical power and equipment capacity capabilities of the equipment.
Companies should verify that the equipment will be installed in a place that meets the requirements set forth by the manufacturer so the equipment will function as it should. Pharmaceutical companies must also verify that hardware meets the system requirements for all software that will be used. All hardware used must also be placed in a location in which adequate ventilation and air flow is available.
The next category is operational qualification (OQ), which refers to the process of running and testing equipment to document that it is operating properly. Failure modes, meaning the response that should take place if equipment malfunctions, should also be defined and tested.
Companies must turn on and run the equipment to verify that it is operating properly at each step of the manufacturing process. They should also do the same with any utilities, including water, gases, and power, that are being used so the testers are confident that everything is correctly connected and functional.
Next, pharmaceutical companies must define statistical process controls. Statistical process controls are baseline conditions that represent the environment in which equipment functions properly. These conditions can include specific temperature, humidity, and pressure ranges.
Statistical process control can also include qualities of materials used in the manufacturing process such as color, viscosity or other characteristics. After defining statistical process controls, companies should standardize how and when equipment will be reassessed in the future. They should also make sure that their operational policies incorporate how workplaces are changing as a result of COVID-19.
The last category is performance qualification (PQ) which entails proving that equipment can continue to perform in the long-term in a repeatable, stable manner. Companies will also test that the equipment can function in conjunction with the personnel, procedures, and company policies set forth by management.
An important part of performance qualification is to challenge equipment by testing whether it can function in a range of different environmental conditions set forth in the operation qualification process. Companies must also test equipment by scaling up production and monitoring its performance. This step will reveal if the equipment could be prone to failure when reaching capacity limits during full-scale operations.
It is also important to examine the end product produced by manufacturing processes to assess products’ variability. Any changes or variability in the end product must be accounted for and explained by specific manufacturing processes to address any potential quality assurance concerns. Product variability that could affect its use or safety must be accounted and controlled for.
How the Pandemic Has Affected Installation Qualification
The COVID-19 global pandemic has represented a danger to workers and consumers alike. As a result, pharmaceutical companies must adapt their practices to protect both workers and products.
Pharmacies and manufacturers have begun to adhere to social distancing guidelines. Many pharmacies limit the number of customers in the store at any one period of time and make use of lines and signs to encourage social distancing, or physical distancing.
Some pharmacies and retailers even make use of physical barriers such as plexiglass dividers to further promote social distancing indoors. Pharmacies have also been making use of personal protective equipment (PPE) to attempt to prevent transmission of COVID-19 and protect workers and customers. Many have also implemented training and practices to ensure proper disposal of masks so as to limit their effect on the environment.
Finally, some pharmacies and retailers have established limited or adjusted store hours to protect elderly or vulnerable individuals.
Many of these precautions were introduced as part of robust quality assurance and qualification practices for pharmacies and manufacturers.
We’ve seen that the qualification process is made up of several different components including IQ, OQ, and PQ, and that COVID-19 has put many of these qualification standards to the test. As manufacturers rush to create and distribute pharmaceutical products in response to the pandemic, they must also introduce practices that curb the spread of the illness within the organization. Similarly, pharmacies that distribute these products have introduced policies including PPE, social distancing, and adjusted hours in an attempt to prevent the spread of COVID-19.