Category: Uncategorized

ISO 9001

ISO 9001 is the international standard for a Quality Management System (QMS) laid out by the International Organization for Standardization. The standard is implemented by organizations to demonstrate that their products and services meet regulatory requirements.

An organization may choose to implement 9001 for its entire operations or for a particular operation or department.

ISO 9001 can be implemented in all types of industries, small or large, service or manufacturing industry.  ISO 9001 is process based standard. It does not define quality of products. It helps streamline the processes that must be followed to obtain desired outcome.

Some benefits of becoming ISO 9001 certified are:

  1. Improved quality of products or services
  2. Defined roles, responsibilities and guidelines that are easy to follow for everyone in the organization thus clarity to the employees
  3. Better financial performance
  4. Minimum scope for errors as everything is documented
  5. Constant improvement in processes
  6. Improved credibility of business

Some companies obtain an ISO certification as it improves their chances to bag business opportunities. Others may obtain a certification just to improve their business processes.

Liberty Management Group Ltd can help organizations with ISO 9001 right from documentation to implementation to certificate issuance. A certificate could be from an accredited or a non-accredited certification body depending upon the choice of companies.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: September 11, 2019

Who regulates cosmetics for animals?

The Federal law defines cosmetics as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles.

The Act specifically addresses cosmetics used on human body.

So, what about the cosmetics used on animals?

Cosmetics used on animals are commonly referred to as grooming aids. Animal soaps, shampoos and other products that are intended for cleansing or promoting attractiveness of animals are not regulated by FDA. So, the FDA requirements that apply to human cosmetics do not apply to animal grooming aids.

However, if such products are intended for any therapeutic purpose or if they are intended to affect the structure or function of the animal, they are subject to FDA regulations as new animal drugs. Such products can be introduced into US markets after FDA’s approval and compliance to all the FDA regulations regarding animal drug products.

Liberty Management Group Ltd. can help you classify your animal products into FDA regulated vs not FDA regulated category and help you with FDA regulations if required.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: July 17, 2019

Color Additives in Cosmetics

FDA regulates cosmetic products and its ingredients. Color additives are added to cosmetic products to improve their appearance. Color additives are subject to strict system of approval under the FD&C Act. Failure to meet US color additive requirements may cause a cosmetic to be adulterated and make it subject to detention at the port of entry.

The FDA requirements for color additives that are added to cosmetics are as follows:

  1. All Color additives must be approved by FDA. There must be a regulation specifically addressing a substance use as a color additive, specifications and restrictions.
  2. Along with approval, many color additives are also required to be batch certified by FDA if they are to be used in cosmetics marketed in the US. This means that FDA chemists have analyzed a sample from the batch and have found that it meets the requirements for composition and purity stated in the regulation—called a “listing regulation”—for that color additive. FDA determines the need for batch certification based on whether the color additive needs this level of control to protect the public health. Some color additives, in their uncertified forms, might contain impurities at levels that pose a health concern.
  3. Color additives may only be used as stated in the regulations pertaining them including maximum permissible concentration in the finished product.

FD&C Act categorizes color additives into two main types:

  1. Those subject to certification – Petroleum based color additives aka coal tar dyes or synthetic organic colors. Such colors usually have 3-part names e.g.; FD&C Yellow No. 5
  2. Those exempt from certification – Obtained primarily from mineral, plant or animal sources.

A list of color additives approved for use in cosmetics can be found here https://www.fda.gov/industry/color-additives-cosmetics/color-additives-listed-use-cosmetics-code-federal-regulations

Some color additives are approved for use for one use and excluded for use in another.

To ensure that the cosmetic products do not contain any unapproved color additive or other unapproved ingredients, a manufacturer can avail LMG’s label and ingredient review service.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: July 03, 2019