Year: 2024
Type: article
Abstract: The Role of Current Good Manufacturing Practices (cGMP) in the manufacturing unit of a pharmaceutical industry is pivotal for ensuring the quality, safety, and efficacy of pharmaceutical products. cGMP regulations, enforced by regulatory agencies like the FDA, outline stringent requirements for the design, monitoring, and control of manufacturing processes and facilities. These practices encompass various aspects, including the validation of manufacturing equipment, proper documentation, employee training, and robust quality control systems. In the manufacturing unit, adherence to cGMP ensures that products are consistently produced and controlled according to quality standards. It involves meticulous documentation of every step in the manufacturing process, from raw material procurement to final product release. cGMP also mandates regular audits and inspections to identify and rectify any deviations or non-compliance issues promptly. Implementing cGMP minimizes the risk of contamination, mix-ups, and errors, thereby safeguarding public health. It fosters a culture of continuous improvement, where feedback and corrective actions are integral to the manufacturing process. Moreover, compliance with cGMP enhances the credibility and marketability of pharmaceutical products globally, as it aligns with international quality standards. Thus, cGMP is essential for maintaining the integrity of the pharmaceutical manufacturing process, ensuring that the end products are safe, effective, and of high quality.
Author: Rashed Ahmed
Institution: North South University
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4405947656