Understanding The Importance of Pharmaceutical Quality
The most important regulatory standard for ensuring pharmaceutical quality is the current provisions on Best Manufacturing Practices (CGMP) for human and pharmaceutical products. It’s important that medicinal products are manufactured under the conditions and practices required by CGMP regulation to ensure quality in the design and manufacturing process.
Compliance with CGMP rules to ensure the identity, strength, quality, and purity of medicines requires that drug manufacturers carefully monitor the manufacturing process. These controls include the introduction of a strong quality management system, the procurement of suitable quality raw materials, the introduction of robust operating procedures to detect and investigate product quality deviations, and the maintenance of reliable testing laboratories. A formal control system that pharmaceutical companies put into practice will help prevent cases of contamination, confusion, deviations, failures, and errors.
Validation is a critical part of the pharmaceutical manufacturing process and there are rules and standards to which the industry must adhere. The data that pharmaceutical manufacturers collect from their processes is crucial to ensure product quality. Pharmacists use electronic prescription protocols (EPR) to reduce medication errors, avoid drug interactions, repeat therapies, and avoid contraindications.
The use of automated drug delivery systems can help organizations drastically reduce medication errors and improve patient safety. Many automated drug delivery systems use the barcode technology described above to ensure that the correct dose, dosage, and form of medication are used.
FDA and CFR instruct pharmaceutical companies to create written procedures for production process controls. The CFR requires pharmaceutical companies to review all approved drug manufacturing and control protocols, including packaging and labeling documentation, to verify compliance with SOPs. Provisions also require that errors be investigated, which means that you must identify the reasons for the occurrence of errors.
One of the simplest methods to avoid the frequent errors described above is to assess the quality of the product. If you see a large number of deviations due to human error it is important to look at the process design and to check that your operators have the right training. If your deviations from your processes are caused by human error or contamination, faulty devices or sensors, or data out of reach, you know how to fix the problem and correct it in time to store the end product based on how you identified it and whether you have statistical data to back up your decision.
There is no acceptable level of error in the medical care system, but the goal of health organizations is to evaluate errors as they occur and make changes to the delivery process to prevent them from recurring in the future. Quality improvement programs for managed care organizations include mechanisms for reporting medication errors, investigating and evaluating the causes of errors, analyzing aggregate data to identify trends, and implementing necessary changes to their health systems to prevent errors. Despite these approaches, human error remains high in the pharmaceutical industry.
In the pharmaceutical industry, batches of processes and products that are produced in batches are common. A part of the manufacturing process of the products themselves is the packaging and labeling, disinfection, and use and control of the devices. For pharmaceutical manufacturers, a process deviation does not mean that a bad batch will affect downstream processes, but it risks rule violations, which can lead to fines and costly setbacks in the market, and it can endanger a patient’s health.
Errors in drug labeling can have dire consequences, including massive recalls. Shockingly, 50% of product recalls are due to errors in labeling. Faults in the packaging can creep in even if they are not checked for works of art during the approval process.
Substandard medicines can also be caused by contamination during the manufacturing process. If Good Manufacturing Practices (GMP) are not followed, cross-contamination between products produced at the same facility may occur resulting in dangerous FPPs for other drugs manufactured at the same facility. In LMICs, the availability of medicines that do not meet the quality standards is a major cause of treatment errors and side effects for patients and undermines public health interventions.
The vast majority of reports on flawed medicines are the result of human error, not technological failure. Problems with non-compliance can arise from interrupted workflows, problems with collaboration, or human error. This can lead to an atmosphere of blame and fear which then leads to a lack of awareness of systemic weaknesses and more mistakes.
If we can change the culture to a culture that focuses on the importance of improving reliability and consistency, rather than blaming mistakes, a more positive working environment can be created. A subtle change in perspective can help people to educate about human performance and risk management, and new tools and techniques can be implemented for understanding human failure.
A good background in quality assurance helps students develop a wide range of soft skills that are useful in evaluating and manufacturing pharmaceutical products. These skills not only facilitate work but are also a better guarantor of success by preventing human error. Compliance with technical teachings and Good Manufacturing Practices (GMP) helps many pharmaceutical workers to assure the best possible quality and to avoid unnecessary miscalculations and errors.
In practice, there are still many techniques that are not often used in the pharmaceutical industry to reduce errors. Some of these techniques will require a cultural change within individual companies to be implemented. However, there will still be cases where the behaviors of other industries can be learned to reduce the risk of errors.
Efficient IT communication enables organizations to use the data collected during manufacturing processes to influence business decisions and improve efficiency. This helps pharmaceutical companies find efficient and reliable ways to increase their productivity and product quality.
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