Quality drugs through Regulatory compliance: Akums ensures Regulatory Compliance to Improve Drug Quality
Introduction
The pharmaceutical industry is subject to rigorous regulation globally to ensure the safety of medicines. To improve the delivery of pharmaceutical products, quality improvement measures should be applied at every level of the manufacturing process and the products should undergo comprehensive testing to confirm their safety and effectiveness.
Regulatory compliance is critical in quality management as it ensures that a company’s products comply with legal and regulatory regulations. Noncompliance can result in product recall, a tarnished brand name, and difficulties acquiring consumers. Product failures, safety difficulties, and other issues that might hurt customers or the business can be reduced through compliance. It aids in the development of consumer trust, the protection of brand reputation, and the avoidance of costly legal and commercial challenges.
Akums is a company that prioritizes quality in every step of manufacturing. Akums have implemented global standards in quality control (QC) laboratories and documentation processes ensuring that products meet the highest standards of quality and regulatory compliance. By adhering to these standards, Akums continually improve its product quality and ensure that they comply with the regulations set forth by regulatory bodies.
How Can compliance improve drug quality?
Regulatory compliance is essential in the pharmaceutical sector as it ensures that medicines are safe, effective, and of high quality. These regulations serve to reduce the hazards of medication usage while optimizing the therapeutic advantages. Pharmaceutical companies must enhance the quality of their medicines, maintain customer trust, and avoid drug recalls by conforming to regulatory guidelines.
Rigorous testing and documentation
A centralized QC lab can assist to streamline the drug testing process, decrease time, and assure drug quality uniformity. This assists pharmaceutical businesses in meeting regulatory standards, which differ by nation. Companies that adhere to global standards can avoid costly delays and drug recall as a result of noncompliance.
The QC laboratory at Akums is the largest in Asia in terms of batch and volume for assessment and is outfitted with state-of-the-art QC equipment such as an Atomic Absorption spectrometer, Raman Spectroscopy, and polarimeter, among others. Akums also has a dedicated Compliance unit solely focused on conducting quality audits.
These are a few strategies for improving pharmaceutical product quality.
Rigorous testing and documentation:
A centralized QC lab can assist to streamline the drug testing process, decrease time, and assure drug quality uniformity. This assists pharmaceutical businesses in meeting regulatory standards, which differ by nation. Companies that adhere to global standards can avoid costly delays and drug recall as a result of noncompliance.
The QC laboratory at Akums is the largest in Asia in terms of batch and volume for assessment and is outfitted with state-of-the-art QC equipment such as an Atomic Absorption spectrometer, Raman Spectroscopy, and polarimetry, among others. Akums also has a dedicated Compliance unit solely focused on conducting quality audits.
Automated compliance system:
A Compliance Management System (CMS) can streamline compliance tasks by identifying, managing, and documenting their status to meet various reporting requirements. Automated documentation eliminates human error and ensures data accuracy, reducing the risk of errors that could compromise drug quality.
Color-coding for risk mitigation:
Nowadays, it is crucial for pharmaceutical facilities to establish documented preventive measures against contamination and cross-contamination. To identify potentially dangerous drugs and materials, numerous pharmaceutical companies opt to use color coding. The effectiveness of color coding is maximized when it is done simply.
Akums enforces SAP color-coding system for all tools, including scoops and cleaning equipment, to ensure proper zoning and prevent contact with improper materials.
Compliance in storage:
Compliance with regulatory standards is crucial in handling and storing raw materials to avoid contamination and ensure quality. Regulatory agencies like the FDA have specific requirements for storage conditions, temperature, and humidity ranges. Proper handling practices also aid in regulatory compliance.
Akums maintains detailed documentation of the API from the point of unloading and the excipient to ensure precision and prevent errors. The API is put under quarantine for 14 days to undergo rigorous quality control and physical examination to detect any signs of contamination.
Akums ensures regulatory compliance and improves product quality through a strong system that includes risk assessment and measures for enhancing quality, leading to recognition for excellence in the pharmaceutical industry.