Hand Sanitizer – GMP Consultant
Hand sanitizer (Alcohol based) is considered as one of the best options to reduce the risk of covid-19 after hand washing. The requirement for hand sanitizer in the USA and all over the world increased drastically due to covid-19 pandemic. As a result of this great demand several new companies start hand sanitizer production, most of these companies does not have previous experience in hand sanitizer or any other OTC Drug manufacturing. Some of these companies may have experience with cosmetic manufacturing but the GMP requirements for cosmetic and drug are different.
Do I need a GMP Consultant for Hand Sanitizer?
If you are in the drug industry and only adding hand sanitizer as a new product to the existing product line, you can use your current quality system and does not require a GMP consultant. If you are a small company and new to hand sanitizer industry, it is sensible to get help from an experienced GMP or quality system consultant.
Role of GMP Consultant
Hand sanitizer is regulated by the US FDA as an OTC Drug product, GMP compliance is a mandatory requirement for all drug products marketed in the USA. FDA audits are based on GMP regulations. FDA may issue warning letter (FDA 483) after audit, if your quality system is not in compliance with FDA GMP requirements. An experienced GMP consultant can help you to
- Develop a quality manual.
- Develop quality system procedure.
- GMP Implementation
- Internal audit assistance
- FDA pre-audit support
- FDA audit support
- Closing Non-conformities found in FDA audit.
LMG is one of the best hand sanitizer GMP consultant having offices in Chicago and New York. LMG offers hand sanitizer GMP documentation and implementation assistance to Chicago and suburbs from Aurora, Illinois and New York & surrounding states from Manhasset, New York.
Our Consulting Services includes
For more information, Please contact us with detailed information.