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ComplianceQuest is the #1 AI-powered Quality, Risk, and Compliance (QRC) platform that connects Product, Quality, Manufacturing, People, Suppliers and Customers in a single system.
Built on Salesforce, the platform delivers end-to-end visibility, AI-driven intelligence, and enterprise-scale execution, enabling organizations to manage risk, ensure regulatory compliance, and turn quality into a driver of growth.
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cGMP (Current Good Manufacturing Practices)
cGMP stands for Current Good Manufacturing Practices. It is established by the U.S. Food and Drug Administration (FDA). cGMP is a set of quality assurance guidelines and regulations that ensure the safety, quality, and consistency of pharmaceutical, biotechnology, and food products. cGMP must be followed by manufacturers throughout the production process, from the design of facilities and equipment to the testing, storage, and distribution of products.
Complying with cGMP is essential for regulatory compliance and delivering safe, effective, and reliable products.
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The FDA ensures that the quality of drugs manufactured at the facility is in compliance with cGMP regulation. cGMP compliance includes the implementation of modern quality systems and a robust risk approach that meets the 21 CFR part 210 and 211 of cGMP regulations. The primary goal is to encourage the adoption of modern manufacturing technologies. For cGMP compliance implementation, the manufacturer must focus on the following steps:
Current Good Manufacturing Practice (cGMP) regulations are enforced by the FDA that assure systems have the proper design, monitoring, and control of manufacturing processes and facilities. FDA assessors and investigators determine if a firm has the necessary equipment, facilities, and ability to manufacture the drug to sell in the market. By adhering to the CGMP compliance regulations, a manufacturer assures the identity, strength, quality, and purity of drug products through controlled manufacturing operations.
To remain cGMP compliant, organizations must incorporate a Quality Management System. A robust QMS helps improve quality within the organization. To meet many of cGMP compliance and regulatory requirements, follow these steps:
Ensure data is complete with controls
Document activities at the time of performance
Assign ownership of activities to a specific individual
Authorize only individuals to make changes to the recordsa
Establish a record to identify a change in data
Review records for accuracy, completeness, and compliance with established standards
Maintain data security right from data creation through disposition after the record’s retention period
Adhering to cGMP compliance regulations focuses on:
Customer Success
To implement a functioning and compliant quality system that supports cGMP regulations, the company’s management must focus on the following parameters:
ComplianceQuest pairs the user-friendly tools of SalesForce with a very capable and responsive development / support team resulting in a full QMS application that was adapted to our processes and very easy to implement. Our large, global organization is not an easy group to please. From their patient participation in our configuration workshops to their quick responses to every email and crazy request, the CQ team has proven to be a true partner in our implementation. Their website and demos show how user-friendly and well integrated the modules are. The REAL win is getting this functionality with a team who is truly invested and has gone over and above to make our implementation a success!
Melanie Lees,Quality Director
There is a significant overlap between QMS and cGMP regulations. As both emphasize product quality and documentation of processes, implementing a QMS helps with cGMP compliance in several ways. Some of them listed below:
Analyze data for trends to help identify and resolve problems, and prevent mishaps
Evaluate the effectiveness of implementation and maintenance of quality systems through periodic internal audits
Understand the various elements of risk for effective decision-making process through quality risk management
Prepare corrective action by addressing the root cause to prevent the recurrence of significant problems
Create succession planning, training, institutional knowledge, plans for changes as part of preventive actions
Effective and efficient use of a robust QMS promotes improvement
CGMP for Finished Pharmaceuticals – Control of Components and Drug Product
Checklist | November 29th, 2021
Pharmaceutical CGMP Regulations with Quality System Part 2
Checklist | July 29th, 2021
Pharmaceutical CGMP Regulations with Quality System Part 3
Checklist | August 5th, 2021
Pharmaceutical CGMP Regulations with Quality System Part 1
Checklist | July 27th, 2021
Quality system and CGMP compliance regulations training should focus on both the employees’ specific job functions and the related CGMP regulatory requirements. While cGMP training is important, managers must determine the training program’s relevance to the employee’s role in the organization. Simply put, managers must focus on training programs that include the following:
Evaluation of training needs
Provision of training to satisfy these needs
Evaluation of the effectiveness of training
Documentation of training and/or re-training
While FDA does not mandate the frequency of cGMP training, it is essential to conduct the training at regular intervals of time instead of one massive session. The training must be conducted periodically based on employee availability, the time needed to conduct the training, type of training, whether class or online, and the establishment or removal of processes. Continuous cGMP compliance training is essential to:
Ensure that employees remain proficient both in their operational functions and in their understanding of CGMP regulations.
Address the policies, processes, procedures, and written instructions related to operational activities, the product/service, the quality system, and the desired work culture (e.g., team building, communication, change, behavior).
Gain skills that can be implemented in the day-to-day performance.
4,000 Employees Supported, Training Timelines Reduced from One Month to Weeks, and CAPA Approvals Cut Nearly in Half
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