In this article, you will learn how to establish the frequency of the quality audits according to the cGMP Good Manufacturing Practices in three (3) single steps.
Many federal regulations and company policies require to comply with specific audit schedules, control of audit tools and features, view completion dates, audit observations or results, and detailed information such as issues that require further investigation, CAPA generation, etc.
Three (3) Steps to Determine the Frequency of the Quality Audits.
The frequency of the quality audits can be established based on one or more of the following considerations:
Even though most companies perform audits using a pre-established frequency between every three (3) months to every year to different quality systems, other companies establish their own frequency of auditing based on a risk assessment to determine which type of audit shall be done to each area.
Based on this information, a recurrent audit date or frequency can be generated, and certificates of audit completion must be sent and stored in the document control file.
CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at firstname.lastname@example.org.
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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 frequency of the 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: How to establish the frequency of the 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
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