When are the current Good Manufacturing Practices cGMP applicable?

This article explains when is the Current Good Manufacturing Practices cGMP applicable to the industry.  Moreover, you can discover how to get a Document Management Procedure Template and Document Management Software Application to handle your GMP records activities fast and easily.

cGMP Applicability

The cGMP’s are applicable to the companies involved in the manufacturing process, from raw materials to storage and transport, of food items, drugs, and medical devices in the interstate commerce of the United States.

In addition to processes, current Good Manufacturing Practices cGMP’s also applies to the involved buildings and facilities, staff, and pieces of equipment supporting the manufacturing of products that are intended to be used by the persons.

The cGMP’s are applicable to the quality management systems, to handle appropriate quality raw materials, to establish operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.

It is intended to prevent instances of contamination, mix-ups, deviations, failures, and errors.

Moreover, it assures that drug products meet their quality standards.

It is important to note that cGMPs are minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.

The current Good Manufacturing Practices cGMP’s are not applicable to products on research and development or any other low-risk activity to the public health.  Either is applicable to the manufacturing and testing of medical devices used in clinical trials, with the exception of design controls (21 CFR 820.30). Marketed medical products must, with some exceptions, be manufactured using GMP controls, which includes quality control testing. For additional facts about current good manufacturing practices cGMPs, click here.

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For more details on specific FDA expectations and how to create quality management system documents, follow us.

Three (3) Options to Create Quality Management Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the quality procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on the current Good Manufacturing Practices cGMP.

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality System Procedures as per current Good Manufacturing Practices cGMP.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

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REFERENCES:

httpss://www.fda.gov/files/drugs/published/Overview-of-Quality-System-Regulation.pdf

httpss://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

httpss://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/medical-devices-current-good-manufacturing-practice-cgmp-final-rule-quality-system-regulation

httpss://ispe.org/initiatives/regulatory-resources/gmp

httpss://www.fda.gov/media/73141/download

Food and Drug Administration References

1. Glossary of Computerized System and Software Development Terminology (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, FDA 1995)
2. General Principles of Software Validation; Final Guidance for Industry and FDA Staff (FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, 2002)
3. Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices (FDA, Center for Devices and Radiological Health, 1999)
4. Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems ApproachExternal Link Disclaimer (FDA 2002)
5. httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
6. httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1

Industry References: 

1. The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) (https://www.ispe.org/gamp/)
2. ISO/IEC 17799:2000 (BS 7799:2000) Information technology – Code of practice for information security management (ISO/IEC, 2000)
3. ISO 14971:2002 Medical Devices- Application of risk management to medical devices (ISO, 2001)