GxP is an abbreviation for “good practice” guidelines and regulations. The “x” variable in GxP covers a wide range of processes utilized in the development, manufacturing, and distribution of regulated products such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Storage Practices (GSP), Good Documentation Practices (GDP), etc. Regulated industries, including food, pharma, medical devices, and cosmetics, are impacted by GxP.
cGMP Consulting can perform an audit and then provide a report with an attestation of compliance if you meet cGMP requirements. This third-party attestation of compliance is valuable for commercial claims of cGMP. The FDA or other regulatory body is the final arbiter of cGMP compliance.
The FDA does not recognize any certifications for cGMP. By registering with the FDA, you declare that you follow cGMP. The FDA reviews your compliance with cGMP during the approval process and then can audit you any time. To pass an FDA audit, you must have systems and procedures, followed with documented evidence, e.g., batch records and exception reports.
The experts at cGMP Consulting can identify your compliance gaps and help remediate them by establishing robust and enduring solutions, so you are always prepared for an audit.
cGMP Consulting Inc. utilizes risk management principles followed by the FDA’s ICHQ9 guidelines for assessing the design of facilities during the Research and Development phase. We help our clients define process materials for production control under good clinical manufacturing practices. Additionally, cGMP consultants help in developing the specifications for radiopharmaceutical products and identifying the criticality of the specifications.
We have assisted with facility design to transition from an R&D facility to one with cGMP production and quality systems. Previous projects included isotope production facilities that were produced for clinical supplies.
cGMP collaborated with companies and research facilities on projects which included:
- Isotope reactor use at the production facility for production control and assessing the design requirements.
- Defining the processes and material needed during production control.
- Radiopharmaceuticals basic quality system development in relation to specifications, process, and requirements for Phase I/II Clinical trials.
