Consultancy Services for EU GMP

Đối Tác Tin Cậy Cho Dịch Vụ Tư Vấn EU-GMP

The pharmaceutical production in Vietnam is extensive, with about 250 manufacturing plants, many of which are newly constructed.

Fierce competition for quality between domestic pharmaceutical companies leads to an indispensable trend of upgrading quality systems to meet EU-GMP standards – the great advantages of bidding for groups 1 and 2 in the group of generic drugs for distribution to hospitals and public clinics. However, implementing this improvement necessitates significant investments in finance, human resources, facilities, and other areas for all companies, which can pose even greater challenges for small companies.

The EU-GMP certificate is granted after the complied audit result by the Pharmaceutical Authority of one of the EU member states, which demands careful and long-term preparation. With mission support for the Vietnam pharmaceutical industry, SEN Pharma collaborates with renowned European consulting firms to provide EU-GMP consulting services.

1. Why SEN Pharma is a good choice for you?

SEN Pharma – a trustworthy partner for EU-GMP consulting services for Vietnam pharmaceutical factories.

  • SEN Pharma cooperates with experienced and dedicated experts in pharmaceutical research and production who have worked at leading international pharmaceutical firms as well as small to medium-sized enterprises in Vietnam.
  • SEN Pharma is the exclusive representative for KI Pharma Alliance GmbH (KIPA), the unit has successfully consulted on numerous EU-GMP compliance projects in several ASEAN countries, the Far East, and South Asia. KIPA has a representative office in Austria as well as other subsidiaries in Hong Kong, Thailand, and Southeast Asia.
  • The combination of native specialists who have expertise working in EU-GMP factories and international EU-GMP auditors will bring complete, optimal solutions at reasonable pricing to pharmaceutical factories in Vietnam.

2. EU-GMP Services from SEN Pharma

a) Hardware:Design and construct the plant, consult on machinery and equipment purchase.

b) Software: Create a quality system, procedures, training courses, product research, and product registration.

  • Plant design review, comprising concept design (CD), basic design (BD), and detailed design (DD).
  • Equipment evaluation includes a review of the URS (User Requirement Specification), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Building a quality management system (QMS): Building a list of records – documentation, standard operating procedures.
  • Personnel training includes EU-GMP theoretical training, training for validation and qualification (factory, machinery, cleaning, manufacturing process, analytical methods), coaching in operating and maintaining the quality management system, and so on.
  • Mock audit: Analyzing and evaluating the current GMP status; reporting and recommending improvement strategies; performing supplier evaluation, and performing a trial for EU-GMP audit.
  • Permitting EU-GMP audit and supporting CAPA (Corrective Action Preventive Action) implementation.
  • Develop new products:
    • Researching the formula and manufacturing process for medicines circulating throughout Europe.
    • Conducting bioequivalence tests in a European standard laboratory.
    • Provide Product technical documents (Product tech pack) that have been distributed in Europe.
    • Transferring of technology.
    • Preparing and submitting drug registration dossiers in Europe.
  • SEN Pharma takes on the role of MAH and promotes product circulation. Collaborate with European partners to distribute high-output items. committed to selling products in Europe at a rate that exceeds 70% of the expected volume.

So far, SEN Pharma and KIPA teams have signed a contract to provide EU-GMP consulting services to one of the largest manufacturers in Vietnam. Don’t hesitate to contact SEN Pharma if your company is looking for a trustworthy and professional EU-GMP consulting service.

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