Hand Sanitizer GMP - Good Manufacturing Practice.
FDA regulate hand sanitizers as an OTC Monograph drug. All domestic and foreign hand sanitizer manufacturers whose products are marketed in the USA must comply with Current Good Manufacturing Practice (GMP or CGMP) regulations. Implementing proper GMP will help the manufacturer to make sure the safety and efficacy of the hand sanitizer.
The GMP requirements for hand sanitizer are same as other OTC Drug products, which is explained in 21 CFR Part 210 and 21 CFR Part 211. These two parts of 21 CFR describe the minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of hand sanitizer and other drug products.
Hand Sanitizer GMP Certificate
GMP Compliance certificate is not a requirement; also, FDA will not recognize a third party GMP certificate. Getting assistance from a third-party certification body for the GMP audit will help to find the GAP’s in the quality system. Most certification bodies issue a GMP compliance certificate after the audit, you can present the GMP certificate as a proof of GMP compliance to the hand sanitizer industry.
FDA GMP Inspection – Hand Sanitizer
In case of FDA inspection, FDA investigators determine establishment’s ability to manufacture hand sanitizer by assessing the GMP Compliance, which includes the review of documents and inspecting the facility and equipment. If any significant findings or concerns FDA auditors will discuss with top management and may issue a warning letter also known as FDA 483.
Contents of Hand Sanitizer GMP Includes
- Subpart A—General Provisions
- Subpart B—Organization and Personnel
- Subpart C—Buildings and Facilities
- Subpart D—Equipment
- Subpart E—Control of Components, Containers and Closures
- Subpart F—Production and Process Controls
- Subpart G—Packaging and Labeling Control
- Subpart H—Holding and Distribution
- Subpart I—Laboratory Controls
- Subpart J—Records and Reports
- Subpart K—Returned and Salvaged Drug Products
LMG offers hand sanitizer GMP documentation and implementation assistance to Chicago and suburbs from Aurora, Illinois and New York & surrounding states from New York.
Our Consulting Services includes
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