Areas covered by the cGMPs Document Management?

The cGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in the manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

The Good Manufacturing Practices GMP’s regulation is divided into the following areas covered by the cGMPs:

• Materials,
• Buildings,
• Equipment,
• Records,
• Procedures

The regulation covers the following topics:

• Quality Systems Management
• Organization and Personnel Equipment
• Control of Materials
• Production Controls
• Packaging and Labeling
• Laboratory Controls
• Documentation
• Compliance Program Guidance

SUBSCRIBE AND FOLLOW US TO LEARN MORE ABOUT THE AREAS COVERED BY THE CURRENT GOOD MANUFACTURING PRACTICES cGMP.

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 following the current Good Manufacturing Practices GMP:

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 Good Manufacturing Practices GMP.

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 Good Manufacturing Practices GMP.

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: Areas covered by the Good Manufacturing Practices GMP

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)