What is a WC in Pharma?
Alexander Doroshenko | Posted on October 16, 2023
Navigating the world of pharmaceuticals can be akin to a maze. Have you ever found yourself wondering what all those acronyms mean? One of the most crucial, yet misunderstood, terms is “Written Confirmation.” This essential document serves as the backbone of API sourcing and regulatory compliance. Interested? Keep reading!
The Importance of Written Confirmation
Understanding Written Confirmation isn’t just regulatory jargon; it’s a key to ensuring quality and safety in the pharmaceutical industry. Let’s dig into why it’s so vital.
A Written Confirmation is a document issued by a competent authority, verifying that the quality of an API produced in a third country is compliant with the standards of the importing country. Think of it as a passport for APIs.
Scope and Relevance
The Written Confirmation is not a one-size-fits-all piece of paper. It varies depending on factors like the type of API, the country of origin, and the regulations of the importing country. It’s the cornerstone of effective, transparent API sourcing.
Do I need a Written Confirmation?
For many countries, you’ll need a Written Confirmation. An exception is made for APIs imported from countries that are on the so-called “White List.” No written confirmation is required for imports from these countries. These include, for example, Brazil, the USA, Switzerland and Japan. On the website of the EC (European Commission) you can find a complete list of these countries and the admission procedure:
|Country / territory||Date of request||Status|
|Taiwan||8 December 2021||Equivalence assessment ongoing|
|Canada||1 October 2018||Adopted|
|South Korea||22 January 2015||Adopted|
|New Zealand||26 June 2013||Assessment on hold pending clarification of the scope of the existing MRA|
|United States||17 January 2013||Adopted|
|Japan||6 December 2012||Adopted|
|Brazil||4 October 2012||Adopted|
|Singapore||17 September 2012||No listing for the moment (the relevant Singapore legislation provides for a non-mandatory GMP certification scheme). Contacts ongoing. In the meantime, Singapore issues written confirmation.|
|Australia||18 September 2012||Adopted|
|Israel||9 May 2012 / 3 September 2014||Adopted|
|Switzerland||4 April 2012||Adopted|
The Components of Written Confirmation
Understanding what goes into a Written Confirmation can streamline your workflow. Here’s a breakdown of its essential components.
A competent regulatory body from the exporting country is responsible for issuing Written Confirmations. For the U.S., the FDA would fulfill this role. Knowing the issuing authority can boost your confidence in the document’s credibility.
A Written Confirmation typically includes details like the name of the API, manufacturing site, and quality standards met. It serves as a comprehensive snapshot of what you’re importing.
Compliance and Verification
Compliance isn’t just about obtaining the document; it’s about what you do afterward.
Steps for Compliance
- Obtain the Written Confirmation from a competent authority.
- Verify its contents against the API being imported.
- Keep it on record for inspections.
These steps help ensure that you’re not just compliant, but also operating with due diligence.
Along with Written Confirmations, there are other certifications like GMP, FDA, DMF, and CEP that companies must adhere to. To better understand the differences and importance of each, you can explore this article.
Consequences of Non-Compliance
Failure to comply can result in legal repercussions and reputational damage. It can lead to the rejection of API shipments or even a ban on future imports from that particular supplier.
Real-world examples can provide valuable insights into the application and importance of Written Confirmations.
In 2019, a European pharmaceutical company successfully imported a novel API using Written Confirmation, paving the way for groundbreaking treatments.
Failures and Lessons Learned
A U.S.-based pharma company faced regulatory hurdles due to lack of proper Written Confirmation. This incident highlighted the imperative nature of this document.
Future of Written Confirmation in Pharma
As the pharmaceutical landscape evolves, so do its regulations.
Updates to the Written Confirmation requirements are often in line with global healthcare advancements. Staying informed can set you ahead of the curve.
The increasing adoption of digital formats for Written Confirmations is making it easier for companies to remain compliant while accelerating their API sourcing process.
Written Confirmation in the pharmaceutical industry is more than just a document; it’s a seal of quality and safety. As the industry moves toward more stringent regulations and technological advancements, understanding and adapting to the nuances of Written Confirmation will be indispensable.
What is Written Confirmation?
It's a document that verifies the quality and safety of an API sourced from another country.
Who issues Written Confirmations?
A competent regulatory authority from the exporting country.
Why is Written Confirmation important?
It ensures that APIs meet the quality and safety standards of the importing country.
What happens if you don't comply Written Confirmation?
Non-compliance can result in legal repercussions and loss of reputation.
How is Written Confirmation evolving?
Digital formats and updated regulations are making Written Confirmations more efficient and reliable.