In this article, you will learn the main 3 types of quality audits according to FDA requirements and cGMP Good Manufacturing Practices.
WHAT TYPES OF QUALITY AUDITS MUST YOUR ORGANIZATION ACCOMPLISH?
Even though audits are common activities for many industries in general, this article aims more specifically to the GMP Quality Audits necessary and required by the cGMPs and the QMS Quality Management System.
Sometimes initial audits are followed by a risk-based requirement of additional recurrent re-auditing activities based on a lapse of time or triggered by some quality key indicators as complaints, field actions, CAPA investigations, non-conformances, out of specifications, etc.
TOP 3 TYPES OF QUALITY AUDITS:
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Three (3) Options to Create Document Control Management DCM Procedures:
Bronze Option. You Can Create Your Own Quality Procedures, using a Template.
You can download samples of the Document Control Management DCM 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 Formal Training about the types of Quality Audits.
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 Procedures.
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: Types of Quality Audits
STATUTORY AND REGULATORY REQUIREMENTS
TITLE 21–FOOD AND DRUGS
PART 820 Medical Devices
820.22 Quality audit. Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance
2 CFR § 200.501 – Audit requirements
For more information about the types of Quality Audits, refer to: