N95 and Surgical Face Mask GMP (Good Manufacturing Practice) is a set of regulations covering the manufacturing, processing, packaging facilities and controls for manufacturing enforced by the United States Food and Drug Administration (FDA) to ensure the quality of the product. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high quality, for their intended use.
FDA regulates N95 Respirators (Commonly known as N95 Masks) and Surgical Face Masks as Medical Devices. GMP (Good Manufacturing Practice) is applicable to any facilities engaged in dealing with medical devices such as Surgical or N95 respirator masks (Face Mask GMP). These manufacturers must comply with all the FDA regulations, which include FDA GMP.
N95 RESPIRATORS/SURGICAL FACE MASKS AND 21 CFR 820
Facilities dealing with N95 Respirators and Surgical face masks are required to be compliant with GMP requirements as per 21 CFR 820. This is also known as medical devices GMP (Good manufacturing practices). These are the practices required in order to conform to the
guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of devices such as surgical face masks and N95 Face masks.
In the United States, manufacturers are required to implement a quality management system. FDA will do site audits and inspections based on 21 CFR 820 and if any non-conformities are observed, the FDA will issue a FDA 483 form with observations. The GMP Requirements described in 21 CFR Part 820 are similar to the international standard ISO 13485. Unlike ISO 13485 or CE Marking, there is no certification for GMP.
Another example of GMP requirement is facilities dealing with Hand Sanitizers, who must implement a Quality Management system based on 21 CFR 211.
Please refer to WWW.FDA.GOV for updated GMP requirements.
IMPORTANT SECTIONS IN N95/SURGICAL FACE MASK GMP (21 CFR 820)
- 21 CFR 820 Subpart A – General Provisions
- 21 CFR 820 Subpart B – Quality System Requirements
- 21 CFR 820 Subpart C – Design Controls
- 21 CFR 820 Subpart D – Document Controls
- 21 CFR 820 Subpart E – Purchasing Controls
- 21 CFR 820 Subpart F – Identification and Traceability
- 21 CFR 820 Subpart G – Production and Process Controls
- 21 CFR 820 Subpart H – Acceptance Activities
- 21 CFR 820 Subpart I – Nonconforming Product
- 21 CFR 820 Subpart J – Corrective and Preventive Action
- 21 CFR 820 Subpart K – Labeling and Packaging Control
- 21 CFR 820 Subpart L – Handling, Storage, Distribution, and Installation
- 21 CFR 820 Subpart M – Records
- 21 CFR 820 Subpart N – Servicing
- 21 CFR 820 Subpart O – Statistical Techniques
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