through the Code of Federal Regulations (CFR) and carefully monitors the manufacturing practices of these products. GMP requirements for the methods, facilities and controls used in manufacturing, processing and packing of Hand Sanitizers are explained in 21 CFR Part 210 and 21 CFR Part 211.
Safety measures are paramount in the Food and Drug industry. The FDA periodically audits establishment’s manufacturing facilities to determine their ability to manufacture hand sanitizer by assessing their GMP Compliance. The audit includes the review of documents and an inspection of the facility and equipment. A warning letter (FDA 483) will be issued by FDA auditors if there are any concerns or non-compliance issues.
COVID 19 AND GMP FOR HAND SANITIZER
Due to the COVID-19 pandemic and the increased need to manufacture alcohol-based hand sanitizer products, the US Food and Drug Administration (FDA) has temporarily suspended enforcement of certain requirements to manufacture hand sanitizer products.
One relaxation in the requirement is the need to comply with the implementation of GMP Quality Management System, for the duration of the public health emergency, provided certain stipulations are met. This does not mean that the FDA has relaxed any GMP manufacturing requirements for these or any other products, but only postponed the enforcement of them.
Once the COVID-19 health emergency is under control, companies interested in continuing to manufacture, package, or label hand sanitizer product will fall under the oversight of the FDA as a drug manufacturing facility, and will be subject to Current Good Manufacturing Practices (GMP) site audits and inspections based on 21 CFR 211.
GMP CERTIFICATION FOR HAND SANITIZER
The FDA requires that manufacturers and distributors of Hand Sanitizers in the United States have a Quality Management System implemented as per GMP requirements 21 CFR 211. GMPs are overseen by regulatory agencies in various countries. In the United States, GMP is enforced by the US FDA, but the FDA does not issue a GMP certificate nor does the FDA recognize one issued by a third-party certification body.
Getting professional assistance from a qualified consultant will help figure out the GAP in your quality management system in relation to GMP standards. In addition, to be a regulatory or statutory requirement, GMP certification is a statement to customers, competitors, and the general public about your manufacturing practices.
It shows your commitment to the highest level of health, safety, and sanitation standards. It clearly distinguishes the quality of your products from your competitors in the Hand Sanitizer industry.
COST OF GMP FOR HAND SANITIZER
The cost of GMP for hand sanitizer manufacturers is based on the scope, complexity, and size of your business, the number of locations, the number of employees, and where your organization is in terms of your current quality management system in relation to GMP standards.
GMP FEES FOR HAND SANITIZER
GMP fees for Hand Sanitizer manufacturers can vary based on the scope of the business, location, and the amount of consultation you will require to successfully implement an effective quality management system tailored to your unique situation.
It is convenient and cost-effective for hand sanitizer manufacturers to integrate multiple quality management systems such as GMP and ISO 9001. It can enhance the credibility of the company and help them avoid developing and maintaining multiple lists of quality management system documents.
SECTIONS IN GMP FOR HAND SANITIZER (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
GMP CONSULTANTS FOR HAND SANITIZER
Liberty Management Group (LMG) is a leading GMP Consultant for Hand Sanitizer Manufacturers. We have a unique and step-by-step process that can be tailored to your unique needs and can be implemented without disrupting the day-to-day operations of our customer’s business. Our highly specialized and flexible consultants can fast-track the implementation of the GMP for Hand Sanitizer process cost-effectively and within your required time frame. Liberty Management Group’s Hand Sanitizer GMP implementation process includes:
- Quality Manual
- Quality System Procedures
- Review of your Standard Operating Procedures (SOP)
- Internal Audit
- External Audit support
- GAP Analysis
- FDA Audit Support
- Corrective and preventive actions (CAPA) addressing non-conformities
- 21 CFR 211 Maintenance
