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21 CFR 820 (Medical Device GMP)
21 CFR 820 applies to any finished medical devices manufactured in the US or imported into and intended for use in the United States. QSR 21 CFR 820 is often known as the current good manufacturing practice.
Manufacturing, contract manufacturing, re-labeling, re-processing, and distributing medical devices are all covered under 21 CFR 820. To ensure that their goods consistently fulfil applicable criteria and specifications, the company must establish and follow quality systems.
21 CFR 820 Consultants
We are a team of 21 CFR 820 consultants, subject experts, and lead auditors. We guide on implementing and maintaining processes and procedures required for the design, manufacture, and distribution of medical devices and in-vitro diagnostic devices in the United States. Here are some reasons why companies may seek the services of 21 CFR 820 consultants:
- 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
The custom-oriented 21 CFR 820 guidance and technical support play a crucial role in supporting medical device companies in their efforts to meet regulatory requirements, maintain product quality, and ensure patient safety.
21 CFR 820 Implementation can be extremely tedious and time-consuming if you do not have in-house experts. We take care of your QMS and maintain it throughout the year!!
Benefits of Pre and Post Audit Consultation
We have the expertise and experience to assist Medical Device companies in responding to FDA warning letter 483. The following are some additional advantages:
- Will be laid solid foundation for those who are implementing.
- Important document drafting
- Interaction with process owners and explanations of all processes
- IQA training and awareness
- Internal Audit Assistance
- FDA Pre-inspection GAP analysis.
21 CFR 820 Regulation
Strict GMP / FDA QSR 21 CFR 820 focuses on class II or III devices and a few class I medical device manufacturing – to ensure that finished devices will be safe and effective. The CFR 820 regulation and strict GMP norms are 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 820 Sections
§ 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 labelling.
§ 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.
21 CFR 820 Implementation can be extremely tedious and time-consuming if you do not have in-house experts. We take care of your QMS and maintain it throughout the year!!