|This article describes what areas covered by the cGMPs.
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:
The regulation covers the following topics:
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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 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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Food and Drug Administration References
Industry References: Areas covered by the Good Manufacturing Practices GMP