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GxP Compliance and FDA Compliance

GxP Compliance and FDA Regulations


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GxP And FDA Regulations

Complying with GxP And FDA Regulations to keep Pace with New Commercial Opportunities and Legislative Changes

A proactive approach to implementing all the controls identified as necessary for the delivery of a reliable, safe and usable end product or service

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Overview of GxP Compliance

GxP is a set of regulations and quality guidelines formulated to ensure the safety of life sciences products and the integrity of the data used to make product-related safety decisions along with maintaining the process quality throughout every stage of manufacturing, control, storage, and distribution. The term GxP embraces a wide range of compliance-related activities like Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and others, with product-specific requirements that life sciences organizations must execute based on

  • their type of products
  • the country where their products are sold

The major intent of GxP requirements is to ensure that food and medical products are safe for consumers. The GxP standards were determined by the Food and Drug Administration for a range of compliance-related activities and are identified as:

G: Stands for good

x: Variable

P: Stands for practices

FDA Compliance

Best Practices Of GxP Compliance

GxP compliance ensures that the product under development meets requirements and is fit for the intended purpose. Applying relevant GxP process regulations is necessary for highly regulated industries. There are different sectors that may need to use different practices, but these are the most popular ones:

  • OSHA -1
    Good Manufacturing Practices (GMP)
    GMP addresses issues around cleanliness, valid process usage, handling complaints, sanitation, hygiene, record keeping, and personnel qualifications and takes the necessary proactive measures to ensure the safety, purity, and effectiveness of their products. GMP guidelines allow manufacturers to understand how to implement them in their specific environments.
  • OSHA -2
    Good Automated Manufacturing Practices (GAMP)
    GAMP is basically the automated version of GMP, which guides companies in taking a risk-based approach to creating scalable, verifiable computerized systems while achieving or maintaining compliance with regulations.
  • OSHA -3
    Good Clinical Practices (GCP)
    GCP is a global standard by the International Conference on Harmonization (ICH), which focuses on the moral aspects of clinical trials, stipulating that the interests of corporations are not to be prioritized above human life in clinical trials where human subjects are involved.
    GCP enables companies to follow particular protocols to ensure that subjects’ wellbeing, rights, and safety don’t get infringed. All potential risks have to be resolved and measured against the possible benefits.
  • OSHA -4
    Good Laboratory Practices (GLP)
    GLP requirements target to ensure the repeatability, uniformity, reliability, quality, and integrity of human or animal health products via non-clinical safety tests in research labs.
    The key principles of GLP are the following:

     

    • Risk management and safety testing are applied to medicines, cosmetics, veterinary drugs, food additives and other industrial chemicals
    • Organization and personnel’s responsibilities for management, sponsor, study director, principal investigator, study personnel are clearly determined
    • Everything is developed, implemented, traced, and tested under a certified QMS System (ISO 9001)
    • No manipulation or change in the reporting of results
  • OSHA -4
    Good Documentation Practices (GDP)
    GDP is the minimum standard that a wholesale distributor must meet to ensure that the quality and integrity of medicines are maintained throughout the supply chain.
    Conforming to GDP ensures the following:

     

    • The European Union (EU) legislation-authorized medicines in the supply chain
    • Medicines are kept and transported in proper condition
    • Contamination is prevented in all situations
    • The right products reach the right recipient within an appropriate time period
    • The distributor implements activities to find defective products

    The best solution for achieving compliance by applying the above principles is using a holistic QMS that enables the use of workflows in a modern and shared work environment and can also automate the process documentation. This results in minimizing human error which is the primary cause of failure at audits.

5 Ps of GxP Compliance

GxP compliance is divided into five main elements. The ‘5 Ps’ are:

  • Opening Conference
    People

     

    • Highly skilled and valued for the work they do
    • Having definite roles and responsibilities
    • Following all procedures
  • Walkaround

    Procedures

    • Properly documented and recorded covering all critical processes
    • Ensure deviations are thoroughly investigated and reported
  • Closing Conference

    Products

    • Include specifications for raw materials, components, intermediate and finished products
    • Follow methods for packing, testing, sampling, status control, stability testing and records
  • Closing Conference

    Premises & equipment

    • Enable proper cleaning and avoid cross-contamination
    • Validated and calibrated having procedures, schedules and records
  • Closing Conference

    Processes

    • Completely established, consistent and documented
    • Identifying critical steps
    • Having robust change control procedures

Guide to FDA Compliance

FDA compliance has been designed to ensure that companies enforce QMS processes that will create higher quality products. In today’s competitive world, it is difficult for businesses to meet stringent FDA regulations as they are seeking to balance both quality control and ROI. ComplianceQuest is the leading provider of FDA GxP QMS solutions that improve your organization’s quality processes and compliance with FDA regulations. FDA compliance programs provide instructions and guidelines to FDA personnel for getting information to help achieve agency plans in the particular program area and are made available online. The guidelines predominately focus on the following areas:

  • ISO 9001
    Traceability – Ensuring that the product development history can be reverse-engineered.
  • ISO 9001
    Accountability – Identifying every individual’s contribution involved in the development process.
  • ISO 9001
    Integrity of Data – Ensuring data reliability.

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Why is FDA Compliance Important?

FDA Compliance complies with a rule, such as policy, standard or law stated by the US government. FDA compliance guidelines are essential for researchers working on clinical trials and marketing professionals and are continually evolving to reflect new technologies. Achieving regulatory compliance requirements is crucial for every business by complying with regulations set out by regulatory bodies. Businesses in the pharmaceutical, medical device and healthcare industries gain the following benefits:

 

  • ISO 9001
    Mitigates Risk:
    This major benefit of compliance with the regulatory requirements is when organizations can mitigate, identify, and eliminate risk at all stages. Risk mitigation is one of the key purposes of regulatory compliance while regulatory agencies provide a complete guideline that acts as a ready reference for organizations to identify and mitigate risks.
  • ISO 9001
    Improves Customer and Investor Confidence:
    Gaining trust from across the board, right from the customers, stakeholders, employees and investors, can be challenging but made possible by complying with regulatory requirements, the greatest guarantee and safeguard for the efficiency and efficacy of a product.
  • ISO 9001
    Reduces Costs:
    Another benefit of FDA compliance with regulatory requirements is saving costs throughout the product lifecycle. If any product fails to pass regulatory requirements and the test of regulatory approval, they have to meet the penalty requirements of the FDA or other regulatory agencies. So, meeting regulatory compliance requirements at every stage is very important and more economical.

Frequently Asked Questions

What is GXP Compliance?
GxP refers to the ‘good practice’ guidelines and regulations and GxP compliance is an essential component within the life science industries created to ensure that food, medical devices, drugs and other life science products are safe and effective. GxP compliance is ensured by agencies and government bodies through regular inspections, certification requirements, and unplanned auditing. As a result, many companies are now trying to adopt GxP compliance software to protect their markets, supplier status and future business as they will get numerous advantages including:

  • Creating good performing products with consistent quality
  • Reducing risk of product failure
  • Providing evidence that regulated products comply with regulatory requirements
  • Ensuring knowledge is maintained in your organization
  • Obtaining accountability for regulated activity across an organization

Businesses working in regulated industries ensure that products are meeting strict quality standards throughout the entire process of production. GxP guidelines are usually similar across countries, and each country has its own regulator.

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