All companies in the manufacturing and innovation business need to pay attention to quality control, but few face a quality control burden as high as pharmaceutical companies.
Consumers depend upon pharmaceuticals to successfully alleviate pain, quell inflammation, maintain a safe blood pressure reading, balance their thyroid, shrink dangerous tumors, and produce many more effects to safeguard life and quality of life. Put simply, these products have to work or else people suffer.
For this reason, pharma remains one of the most regulated industries in the world, all over the world, as a matter of public safety. It’s also a lucrative and groundbreaking industry, on the cutting edge of cures, vaccines, and treatments for conditions that have bedeviled the human race for months, years, or even centuries.
We all need pharma to keep succeeding, which is why the quality control practices that enable them to succeed should be demystified and enabled.
Quality control (QC) is the process of finding and correcting problems that undermine the quality of the product, executed by the implementation of a quality management system (QMS) to produce a record of quality assurance (QA) that regulators regard as proof of compliant practices.
In the interest of demystifying pharma QC and helping aspiring pharmaceutical entrepreneurs meet their QA needs while trying to alleviate human suffering, here are three quality control processes that help pharma companies.
GxP is an acronym for good practices. You might wonder where the “x” came from, but the x acts as a placeholder for various industries that must pay attention to good practices. For example, good manufacturing practices becomes GMP. Good agricultural practices becomes GAP.
“Good practices” is a vague and understated term. When it comes to quality control, GxP is not optional. Pharma companies need to consider several GXP to maintain quality assurance:
- GMP—Good Manufacturing Practices
- GDP—Good Distribution Practices
- GCP—Good Clinical Practices
- GLP—Good Laboratory Practices
As Dickson notes in this guide, GxP covers an array of different guidelines that regulated industries must abide by in order to remain in good regulatory standing. Each GxP is a complicated topic in its own right, but GxP in pharma is often broken down to “5 Ps”:
- People—Do employees and stakeholders have clear responsibilities, adequate training, and do they follow all procedures?
- Procedures—Are all procedures recorded and documented, with all critical processes included and any deviations reported and investigated?
- Products—Are all specifications in order, all methods for manufacturing, packing, and testing sound?
- Premises—Are premises clean and well maintained, all equipment calibrated and validated? (More on this when we discuss IQ OQ PQ.)
- Processes—Are all processes documented and clearly defined, critical steps in place with change control procedures implemented?
Every pharmaceutical company must carefully implement GxP in order to maintain quality assurance and comply with relevant regulations.
2. IQ OQ PQ
As mentioned above, part of GxP for pharmaceutical premises involves making sure all equipment is calibrated and validated. The pharmaceutical industry relies on sophisticated equipment for testing and manufacturing, so this aspect of GxP can’t be skipped.
The QC process to ensure proper equipment calibration and validation is known as IQ OQ PQ. This acronym defines a three-step validation process that breaks down as follows:
- IQ—Installation Qualification. This is the process of documenting and ensuring that a piece of equipment was delivered and installed according to manufacturer recommendations. This includes confirming that the facility can supply the equipment with adequate energy, as well as optimal operating conditions. IQ also includes confirming that all items on the packing list were delivered, any software was installed properly, and verifying peripheral connections.
- OQ—Operational Qualification. This is the process of validating the equipment for operational effectiveness before it is put into production mode. OQ involves checking that certain functions fall within manufacturer-specified parameters, including repeatability, leveling, fluctuation, and keyboard controls. It also includes the collecting of calibration and performance reports.
- PQ—Performance Qualification. The final stage of the equipment validation process involves testing the equipment in actual production mode. PQ checks to make sure that the equipment functions as specified when it is in operation under real conditions. Validators test for the machine to meet manufacturer specifications and produce repeatable results.
Any pharmaceutical industry procedure that requires equipment must perform IQ OQ PQ validation on the equipment before it can operate in a compliant manner. Since nearly all pharma production is equipment-intensive, that means that every pharma company must pay attention to IQ OQ PQ.
3. Cold Chain Monitoring
A “cold chain” is a supply chain that is maintained at refrigerated temperatures to maintain the quality and safety of temperature-sensitive materials.
Many pharma materials, including raw materials, vaccine cultures, and medications, are sensitive to heat and become useless if overheated. For this reason, cold-chain monitoring is essential to the operation of many pharma companies as a function of quality assurance. The company has to be able to document that the materials were maintained at compliant temperatures.
Steps in the cold chain include:
- Shipping of materials.
- Storage of materials.
- Laboratories and manufacturing facilities.
- Shipping distribution and warehouse storage.
Cold chain monitoring involves confirming compliant refrigeration at every step of the way. The easiest way to do this is to arm all storage and shipping containers with digital data loggers, which automatically record the ambient temperature with time stamps to record the hour and duration of any deviations.
Data loggers keep their temperature record on a digital data drive. Some even use wireless communicativity to push the data directly to the cloud. These kinds of IoT data loggers can even alert responsible parties of possibly dangerous temperature conditions, possibly in time to correct the temperature and prevent a loss of materials or inventory.
Heavy regulatory burdens may intimidate entrepreneurs who want to make an impact in the pharmaceutical industry. Considering the way miracle drugs have lengthened and improved our lives, however, we need brilliant pharma minds to continue fighting the good fight against disease and debilitation. Rising to the task of making quality control and compliance more manageable is part of that good fight.