Current Good Manufacturing Practice (CGMP) Certificate Apostille
- USnotary
- 3 hours ago
- 3 min read
What is a Current Good Manufacturing Practice (CGMP) Certificate?
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.
The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards.
It is important to note that CGMP regulations for drugs contain the minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.
More details can be found at the FDA's website.
🔎 What does a CGMP look like? 👇
How to Apostille or Authenticate a Current Good Manufacturing Practice (CGMP) Certificate?
Document issued by the Department of Health and Human Services FDA division in the United States needs to be apostilled or authenticated before its use in other countries outside the United States.
Requirements for your FDA Current Good Manufacturing Practice (CGMP) Certificate
Must be original
Must be on agency letterhead
Must include a legible signature of the official's name, printed name and title, and seal of the agency
The apostille or authentication process for you is quite simple. Simply place an order below according to your situation and email us the original document which needs apostille or authentication.
1. Order the Apostille service online.
▶️ If the destination country is a member of the Hague Convention of 1961, it needs to get an Apostille certificate. Once the apostille is completed, It is ready for use.
▶️ However, if the destination country is NOT a member of the Hague Convention of 1961, more steps are needed. Specifically, the document needs to be authenticated by the U.S. Department of State, and the embassy of that destination country which is located in Washington D.C.
2. After you place the order, please email us the original digital copy of the CGMP to info@usnotarycenter.com.
That's it. Once the apostille or authentication process is completed, we will mail it to your mailing address, either domestically or internationally. Shipping costs apply.
We provide apostille, authentication, and embassy legalization services for other personal documents and corporate documents issued in 50 states and DC.
If you have any questions and do not know which service to order, please contact us by describing ① the type of the document, ② which state the doc is from, and ③ in which country the doc will be used, and we will get back to you as soon as possible.
American Notary Service Center Inc. provides fair, fast, confidential, and professional document notarization and certification services for our clients. We also provide various assistance services to small businesses led by socially and economically disadvantaged groups. Our service helps small businesses obtain federal government contracts, gain a foothold in the market, and boost their sales. For more information, please visit our website at www.usnotarycenter.com, and contact us by calling 202-599-0777 or by email at info@usnotarycenter.com.