cGMP Compliance

cGMP Compliance

cGMP (Current Good Manufacturing Practices)

cGMP compliance
cGMP compliance
cGMP compliance importance

What is cGMP compliance?

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. 

  • cGMP guidelines call for 
  • Rigorous documentation 
  • Quality control
  • Traceability, primarily preventing contamination, errors, and deviations that could pose risks to consumer health and product efficacy. 

Complying with cGMP is essential for regulatory compliance and delivering safe, effective, and reliable products.


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Why is cGMP Compliance Important?

cGMP compliance assures consumers that the drugs are manufactured following the stipulated quality practices. As cGMP emphasizes quality control, the facilities are built as per a regulated design and manufacturing process. The FDA emphasizes the need for cGMP compliance to ensure the drugs that reach the market are safe for consumption. Notably, the recent cGMP regulations were published in 2016. cGMP compliance implies that:
  • Facilities are in good condition.
  • Types of equipment are properly maintained and calibrated.
  • Employees are qualified and fully trained.
  • Processes are reliable and reproducible.
cGMP is flexible as it allows an individual manufacturer to decide how to best implement the necessary controls by using processing methods, sound design, and testing procedures.

There are various cGMP regulations:

  • 21 CFR Part 210 that is applicable in manufacturing processing and packing, or holding of drugs.
  • 21 CFR Part 211 for finished pharmaceutical.
  • 21 CFR Part 212 for positron emission tomography drugs.

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How to Implement cGMP Compliance?

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:

  • Establishing strong quality management systems that reduce or prevent product recalls and defective products from entering the market.
  • Obtaining appropriate quality raw materials.
  • Establishing robust operating procedures that result in shorter and fewer FDA inspections.
  • Detecting and investigating product quality deviations.
  • Maintaining reliable testing laboratories.
cGMP compliance implementation
FDA's role in cGMP compliance regulations

What is the FDA's Role in cGMP Compliance Regulations?

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.

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How to adhere to cGMP?

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:

  • Providing ample flexibility to design and implement effective policies and procedures that are easy to comply with and that can improve when necessary.
  • Assuring the identity, strength, quality, and purity of drug products.
  • Taking ownership and responsibility for the quality.


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What is the management’s role in creating a robust quality system?

To implement a functioning and compliant quality system that supports cGMP regulations, the company’s management must focus on the following parameters:

  • Leadership commitment that aligns with the plan to align quality system and quality strategy.
  • A robust organizational structure that ensures that all activities related to production and quality are assigned to authorities while the structure remains documented.
  • Scope, quality standards, and manufacturer’s policy during QMS implementation to comply with cGMP regulations.
  • Policies, plans, and objectives that align with the vision and quality commitment to all levels of the organization.
  • Periodic system review to continue sustainability, adequacy, and effectiveness.
management’s role in creating a robust quality system

ComplianceQuest and Salesforce
– a winning combination

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

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How does QMS help with cGMP compliance?

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

  • 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

Ensure your product meets FDA cGMP compliance regulations to assure the identity, strength, quality, and purity of drug products

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Frequently Asked Questions

  • 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.

  • CQ’s Training Management solution allows organizations to create and manage training programs and to quickly allocate content to the many job functions an employee may be assigned. By combining training content with developed assessments, the solution ensures that not only employees get trained but also verifies their comprehension. As part of the EQMS solution from ComplianceQuest, the training solution helps:

    • Identify training gaps, missed deadlines, and overdue training so employees can remain in compliance and properly skilled as requirements change.

    • Define training plans specific to particular job roles/titles to ensure position-specific functionality and compliance.

    • Gain a complete view of training compliance with your documents connected to training programs and data that is stored and easily retrieved from one place.

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