Drugdu.com expert's response:

WC, fully known as Written Confirmation, is a requirement for non-EU countries exporting Active Pharmaceutical Ingredients (APIs) to the EU market. The certification requirements for WC can be elaborated from the following aspects:

I. Certification Authority and Document Issuance

The WC certification document is an official document issued by the pharmaceutical regulatory authority of the API-producing country. This document certifies that the exported APIs comply with the Good Manufacturing Practice (GMP) standards of the EU.

II. Application Conditions and Prerequisites

Prerequisites: Pharmaceutical GMP certification involves rigorous audits of a manufacturer's quality management system, production processes, equipment, and personnel to ensure that the drugs produced meet the relevant quality and safety requirements of the EU. Only enterprises that have passed GMP certification can obtain WC documents to export APIs to the EU market.

Application Conditions: These typically include production licenses, descriptions of the quality management system, product details, production processes, and control measures.

III. Application Process

Prepare Necessary Documents: This includes detailed introductions to the company, production locations, facilities, and capabilities; GMP compliance certificates, descriptions of quality control systems, and other quality standards and compliance proofs; as well as product safety and quality assurance measures that outline production processes, quality testing, and safety safeguards.

Submit the Application: Submit the WC certification application to the pharmaceutical regulatory authority of the country where the enterprise is located. This usually includes a complete package of documents detailing production conditions and quality control measures.

Await Review and Approval: The regulatory authority will review the application, which may include site inspections and reviews of submitted documents.

IV. Content and Validity of Certification Documents

Content: The WC certification document should include information such as the API name and CAS number, the name, address, and GMP certification number of the producing enterprise, the production batch number and production date of the API, the quality standards and analytical methods for the API, and whether the API complies with the quality and safety requirements of the EU.

Validity: The validity period of the WC document is usually 6 months, and it needs to be reapplied after expiration.

V. Precautions

The specific application process and requirements for WC certification documents for APIs may vary depending on the product type and exporting country. Therefore, before applying, it is recommended to carefully understand the local requirements and processes to ensure smooth processing of the certification documents and successful export.

In summary, the certification requirements for WC involve multiple aspects, including the certification authority and document issuance, application conditions and prerequisites, application process, content and validity of certification documents, and precautions. Enterprises need to operate strictly according to these requirements to ensure that APIs can be successfully exported to the EU market.