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Interested to know more about FDA QSR 21 CFR Part 820 Implementation or FDA 483 response support, please contact us.

21 CFR 820 - Quality System Regulation

FDA 21 CFR Part 820

The 21 CFR 820 Quality System Regulation, is often known as the Current Good Manufacturing Practice (cGMP). Manufacturing, contract manufacturing, re-labeling, re-processing, and distributing medical devices are all covered under 21 CFR 820.

 

To ensure that their goods consistently fulfill applicable criteria and specifications, the company must establish and follow quality systems. We are consultants, subject experts, and lead auditors who support worldwide customers.

  • GMP Implementation support
  • GMP Training
  • Gap analysis audit
  • Full or partial internal QSR audit
  • Supplier audit
  • FDA pre-inspection audit
  • FDA QSR mock audit
  • FDA Post Inspection Support for Closing 483’S

Applicability of 21 CFR Part 820 Regulation

The 21 CFR 820 regulation and strict GMP norms applicable for those detailed below.

  • Note 1: Any device that is suitable for human use. No matter the condition of packaging, labelling and nature of sterility.
  • Note 2: Any accessory suitable for human use such as blood tubing and diagnostic x-ray components.

21 CFR Fees

  • Remote documentation of Quality Manual & Mandatory Procedure and relevant templates: 1500 USD in 14 working days
  • Onsite Implementation by Interacting process owners by travelling to client location: 600 USD /person-day + travel & Accommodation

  • Understanding of FDA observation and preparing an action plan: 400 USD per each observation  (Remote or Onsite)
  • FDA Response preparation: 600 USD
  • Support in Closing Observation / 483’s : 1500 USD /man-day + travel & Accommodation

For clients in Asia Pacific, the Middle East, and Europe, I3CGLOBAL is the finest option. We have the expertise and experience to assist Medical Device companies in responding to FDA warning letters 483. The following are some additional advantages:

 

  1. Will be laid solid foundation for those who are implementing.
  2. Important document drafting
  3. Interaction with process owners and explanations of all processes
  4. IQA training and awareness
  5. Internal Audit Assistance
  6. FDA Pre-inspection GAP analysis.

Subpart A – General Provisions
§ 820.1 – Scope.
§ 820.3 – Definitions.
§ 820.5 – Quality system.

 

Subpart B – Quality System Requirements
§ 820.20 – Management responsibility.
§ 820.22 – Quality audit.
§ 820.25 – Personnel.

 

Subpart C – Design Controls
§ 820.30 – Design controls.

 

Subpart D – Document Controls
§ 820.40 – Document controls.

 

Subpart E – Purchasing Controls
§ 820.50 – Purchasing controls.

 

Subpart F – Identification and Traceability
§ 820.60 – Identification.
§ 820.65 – Traceability.

 

Subpart G – Production and Process Controls
§ 820.70 – Production and process controls.
§ 820.72 – Inspection, measuring, and test equipment.
§ 820.75 – Process validation.

 

Subpart H – Acceptance Activities
§ 820.80 – Receiving, in-process, and finished device acceptance.
§ 820.86 – Acceptance status.

 

Subpart I – Nonconforming Product
§ 820.90 – Nonconforming product.

 

Subpart J – Corrective and Preventive Action
§ 820.100 – Corrective and preventive action.

 

Subpart K – Labeling and Packaging Control
§ 820.120 – Device labeling.
§ 820.130 – Device packaging.

 

Subpart L – Handling, Storage, Distribution, and Installation
§ 820.140 – Handling.
§ 820.150 – Storage.
§ 820.160 – Distribution.
§ 820.170 – Installation.

 

Subpart M – Records
§ 820.180 – General requirements.
§ 820.181 – Device master record.
§ 820.184 – Device history record.
§ 820.186 – Quality system record.
§ 820.198 – Complaint files.

 

Subpart N – Servicing
§ 820.200 – Servicing.

 

Subpart O – Statistical Techniques
§ 820.250 – Statistical techniques.