It is very challenging to evaluate the quality of a custom manufacturing system. There are already hundreds of thousands of pharmaceuticals on the market, according to pharmaceutical companies. Different approaches are suggested for ensuring quality while minimizing costs. Thus, all aspects of Quality Assurance (QA) may affect the quality of prescription pharmaceuticals.
The A&C group is a pharmaceutical company that specializes in custom manufacturing. To provide their clients with high-quality products, they develop everything they produce to fit their needs.
In quality assurance, the aim is to ensure that the prescribed medicine can achieve the desired effect on the patient to ensure patients are not given the wrong medication and to meet regulatory standards.
Controlling the quality of products is a key process and should be applied at all manufacturing stages. Starting with the design, continuing with raw materials, in-process, post-process, and eventually finishing with stability testing. Therefore, Quality Control is frequently described as being the most appropriate concept of Total Quality Control.
It would be impossible to talk about high-quality finished pharmaceuticals without mentioning Good Manufacturing Practices (GMP) and Validation. In Quality Management, GMP ensures reliable production and quality control of products according to the standards required by regulations and product specifications.
It also ensures that the end-users expectations are met in terms of the safety, quality, and efficacy of the manufactured products. During the GMP process, pharmaceutical companies monitor the processes, the equipment, the personnel, and the environment.
In a manufacturing validation, other aspects of higher-end quality include the probability of consistency in manufacturing, as well as the consequences of inconsistency. Pilot trials are also used to pinpoint an area of ‘weakness’ within a manufacturing process where attention is required.
Pharmaceutical companies must have a system in place for implementing corrective and preventive actions resulting from complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and process performance metrics. During the investigation process, a structured approach should be used to determine the root cause of the problem.
In a Quality Risk Management system, the effectiveness of the system or procedure is monitored and assessed. An analysis of deviations occurring throughout the manufacturing process or identifying faulty raw materials, devices, or equipment is central to this. A root cause analysis is conducted, documented, and a recommendation is made. The evaluation confirms that quality objectives were met and the quality of the product was not compromised.
Several areas of business, including pharmaceuticals, utilize risk management principles. Manufacturing and using medicines, including their components, involves some risk, while the quality risk is a small part of the overall risk. An investor group that communicates effectively can achieve far more than just routine improvements.
Additionally, A&C’s Canadian facility is FDA-registered. CDER reviewed the data on a drug’s effects and determined that benefits outweigh its potential and known risks for the intended population. The FDA has therefore approved the drug.
For a drug, it must meet several criteria, including:
- A review of available treatments
- Assessment of risks and benefits based on clinical data.
- A risk management strategy
By implementing standard operating procedures and implementing a Quality Management System (QMS), we ensure our products are compliant with Good Manufacturing facilities and Good Distribution Practices (GDP).
A&C continuously looks into opportunities of improving data integrity management using validated automated systems such as supply chain transparency to continually meets the standards of quality, purity, safety, and suitability for their manufacturing application, up-gradation in ISO certification for facilitating through international trade, EXCiPACT Certification to regulate quality management in the production and marketing of pharmaceutical excipients and many other systems.