This article explains the difference between GMP and 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.
current Good Manufacturing Practices cGMP versus GMP
Since the GMP’s are revised and updated annually in the United States, the most recent version is called the current Good Manufacturing Practices, (cGMP’s).
The “c” in GMP’s just means “current” revision. The regulations require that manufacturers follow the current Good Manufacturing Practices cGMP. The “current” in front of that just acknowledges that what is considered ‘actual, effective, improved’ over time. Typically, each year the FDA expects companies to continually improve and implement the most recent regulatory changes in their facilities bringing training to their employees annually in the updates procedures and standards.
Following these practices ensures that the end product is completely safe for human use and consumption. It also means that the products are efficacious and pure, without any errors or contaminations.
For the medical devices industry, the current good manufacturing practices cGMP’s requirements are described in Volume 21 of the Code of Federal Regulations Part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act). Refer to https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820
For the Pharmaceutical industry, the cGMP requirements are described in Volume 21 of the Code of Federal Regulations Part 210 and 211 (21 CFR part 210 and 211).
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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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Food and Drug Administration References
Industry References: current Good Manufacturing Practices cGMP