GXP Regulation

Kallik helps heavily regulated industries implement and maintain robust quality systems and processes for labeling to stay compliant with GxP regulations and Good Manufacturing Practice (GMP) principles and guidelines.

What is GXP?

GxP is a general abbreviation for the "good practice" quality guidelines to ensure products manufactured and distributed by regulated industries are safe and meet their intended use. GMP requires manufacturers of medical device, pharmaceutical, cosmetics and certain chemical related products to implement and demonstrate adherence to appropriate knowledge, practice and processes that underpin a quality driven, risk-based approach.

How does Kallik help with GXP?

Kallik helps regulated industries to build and demonstrate GxP compliant processes across the creation, review, print and publication of all product and package labeling, in particular software and processes that align to GAMP quality guidelines and 21CFR Part 11 regulations.

  • A robust Corrective and Preventative Action (CAPA) system implemented by Kallik, rapidly identifies and resolves any unplanned event to reduce risk of productivity loss and potential non-compliance
  • As an ISO 9001: 2015 certified organization, Kallik helps device and pharmaceutical manufacturers reduce validation timeframes and adhere to ongoing quality objectives throughout all aspects of product and package labelling including its suppliers, partners and distributors
  • Enables medical device and pharmaceutical organizations to demonstrate their chosen vendor’s product and processes are fully compliant with 21CFR Part 11 regulations

Timeline of Updates

Throughout 2000’s GxP Guidelines published by the FDA

GxP guidelines were established in the U.S. by the Food and Drug Administration (FDA). GxP is a set of regulations and quality guidelines formulated to ensure the safety of life sciences products while maintaining the quality of processes throughout every stage of manufacturing, control, storage, and distribution.

January 2009: GMP for Medicinal Products Published

The holder of a manufacturing authorization must manufacture medicinal products to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorization and do not place patients at risk due to inadequate safety, quality or efficacy.

January 2011: FDA publishes final guidance on process validation

The 2011 Guidance defined process validation as the collection and evaluation of data, from the process design stage through commercial production which establishes scientific evidence that a process is capable of consistently delivering quality product.

June 2013: FDA publishes draft guidance for Cosmetic GMP

Published guidance revised the “Cosmetic Good Manufacturing (GMP) Guidelines/Inspection. Checklist” by updating it to set forth current practice and clarify certain topic areas based on recent experience.

November 2016: FDA releases Guidance on Contract Manufacturer Quality Agreements

On November 22, 2016, the US Food and Drug Administration (FDA) finalized its Guidance on Contract Manufacturer Quality Agreements. The guidance describes FDA’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to CGMP requirements.

March 2018: MHRA publishes guidance on GxP Data Integrity

MHRA publishes guidance on the core elements of a compliant data governance system across all GxP sectors (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and good pharmacovigilance practice). It addresses fundamental failures identified by MHRA and international regulatory partners during GLP, GCP, GMP and GDP inspections.

January 2019: FDA approval of ISO Standard 14971: 2019

In December 2019, the International Organization for Standardization (ISO) published the revised standard ISO 14971:2019 on application of risk management to medical devices. This standard has now been added to the list of Recognized Consensus Standards by the US FDA.

How to be compliant

Prove GXP Compliance

Choose a vendor that follows the highest industry standards (GxP/GAMP), quality guidelines and regulations applying the best quality management systems and standard operating procedures (SOPs) to the design, development and delivery of its software.

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Deploy Validated Software

Select a labeling solution that can be validated (meaning that it can be demonstrated to be GMP compliant), including support for electronic records and electronic signatures.

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Standardize Processes

Grasp the opportunity to transform your labeling and reduce the risk of non-conformance with quality standards by standardizing processes across all internal and external stakeholders.

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Ensure Data Integrity

Data integrity plays a key role in all areas of GMP compliance including labeling and FDA expects data to be meaningful, taking into consideration the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.

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Develop Better Labeling SOPs

Well-developed SOPs built upon collaborative software platforms as well as continuous employee education and training all lead to an improved ability to meet GMP and data integrity compliance.

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Safeguard Your Reputation

Ensure that all relevant GxP processes including GMP, GCP, GDP are underpinned by a labeling solution that eliminates the risk of uncontrolled changes and errors entering print and package materials.