HAND SANITIZER GMP (Good Manufacturing Practice)

Hand Sanitizer manufacturers should comply with GMP regulations. 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 products such as hand sanitizers.  Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for intended human use.

The FDA regulates antiseptic hand sanitizer as an over the counter (OTC) monograph drug (TFM Part 333 A) and Hand Sanitizer GMP (Good Manufacturing Practice) is applicable to any facilities engaged in dealing with Hand Sanitizers.  Hand Sanitizer manufacturers must comply with all the OTC drug regulations, which includes FDA GMP. These are the Quality Management System practices required in order to conform to the guidelines recommended by the FDA that control the authorization and licensing of the manufacture and sale of hand sanitzers.

HAND SANITIZERS AND 21 CFR 211

Manufacturers and distributors of Hand Sanitizers in the USA are required to comply with GMP requirements as per 21 CFR 211.  They must implement a Quality Management System. GMPs are overseen by regulatory agencies in various countries.  In the United States, GMP is enforced by the US FDA, but FDA does not issue a GMP certificate nor does the FDA recognize one issued by a third-party certification body.  They do site audits and inspections based on 21 CFR 211 and if any non-conformities observed FDA will issue an FDA 483 form with observations.

Another example of a GMP requirement is that facilities dealing with N95 Respirators and Surgical Face Mask  must implement a Quality Management System based on 21CFR 820

Other requirements includes US FDA Registration, NDC Labeler code, Hand Sanitizer listing with FDA, Label Compliance etc. Please refer to WWW.FDA.GOV for updated GMP requirements.

IMPORTANT SECTIONS IN HAND SANITIZER GMP (21 CFR 211)

•         21 CFR 211 Subpart A – General Provisions
•         21 CFR 211 Subpart B – Organization and Personnel
•         21 CFR 211 Subpart C – Buildings and Facilities
•         21 CFR 211 Subpart D – Equipment
•         21 CFR 211 Subpart E – Control of Components and Drug Product Containers and Closures
•         21 CFR 211 Subpart F – Production and Process Controls
•         21 CFR 211 Subpart G – Packaging and Labeling Control
•         21 CFR 211 Subpart H – Holding and Distribution
•         21 CFR 211 Subpart I – Laboratory Controls
•         21 CFR 211 Subpart J – Records and Reports
•         21 CFR 211 Subpart K – Returned and Salvaged Drug Products

LMG New York can assist you with full implementation of a GMP Quality Management System:

•         Quality Manual
•         Quality System Procedures
•         Internal Audit
•         External Audit support
•         GAP Analysis
•         FDA Audit Support
•         21 CFR 211 Maintenance

QUICK LINKS