Quality as Standard Procedure
WELDING is committed to a high quality and safety standard for all its active pharmaceutical and veterinary ingredients in the interests of the consumer.
Working in partnership with selected manufacturers across the globe, WELDING seeks out the best quality for its customers and supports them in all GMP and regulatory issues with a competent team of experts from its Quality Unit & Regulatory Affairs department.
An extensive and efficient supplier qualification system, which is firmly anchored in WELDING's EU GMP-certified quality management system, forms the basis for the supply of high-quality active ingredients.
Brief overview of the competencies of WELDING's Quality Unit & Regulatory Affairs team:
- An effective quality management system monitors all processes related to GMP and quality. The requirements of EU GMP, ISO 9001:2015, HACCP und FAMI-QS are incorporated into the quality management system.
- Service centred around the provision of goods, such as keeping the necessary import certificates, checking and, if applicable, releasing the batches (certificates of analysis, labels, packaging), transport and storage according to GDP for APIs and qualification of logistics service providers
- Ensuring traceability in the supply chain
- Ensuring the transfer of information in the event of changes at the manufacturer's premises
- Transparent and competent handling of complaints in cooperation with the customer and manufacturer
- Compilation of regulatory documents (e.g. CEPs, ASMF)
- Advice and support for extensive registration processes (e.g. in Europe for MRP and DCP as well as CEP procedures)
- Assistance of selected manufacturers in CEP submissions and revisions as an authorised representative; service for eCTD
- Provision of documentation for the supplier qualification of our customers (certificates, audit reports, questionnaires, confirmations)
- In the area of audits: organisation and supervision of our customers' audits at manufacturers' premises, provision of audit report summaries, coordination of third-party audits for our customers and audits by WELDING as part of supplier qualification or as a service for customers
- Requesting regulatory inspections for active pharmaceutical ingredients from third countries that are regulated by the provisions of Section 72a of the Medicinal Products Act
As a link between the manufacturer and the customer, WELDING provides long-lasting connections along with a high level of expertise in all matters related to quality.
As an importer of active pharmaceutical and veterinary ingredients, WELDING is monitored by the Hamburg Health and Consumer Protection Agency (BGV HH) and has been inspected and successfully re-certified by the authority every 3 years for more than 20 years.