What is 21 CFR 820?

As per Code of Federal Regulations, title 21 refferes to food and drugs and part 820 refferes to Quality System Regulation. 21 CFR 820 covers the general provisions, quality system requirements, Design Controls, Document Controls, Purchasing Controls, identification and traceability, production and process controls, acceptance activities, nonconforming product, corrective and preventive action, labeling and packaging contro, handling, storage, distribution, records, servicing and statistical techniques.

 

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Do you know if your organization is compliant to 21 CFR 820? Do you have an established quality system that will cover all of the above requirements? if you need any help setting up new quality system, assessing an existing quality system and remidiatign and existing one, we are a call away. Please contact us today.

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