Quality Management
OBTAINING PHARMACEUTICAL ESTABLISHMENT LICENSE (PEL/WDL)
Pharmaceutical companies that distribute medicinal products in Switzerland require a Pharmaceutical Establishment License (PEL). Swissmedic issues PEL based on a successful inspection of the Quality System. We prepare the Quality System, either as a “stand alone” or integrated in your already existing international structures and assist you during the inspection to meet Swissmedic standards and pass the inspection.
- Authors SOPs and quality agreements or adapts your already existing ones
- Laisses with Swiss logistic provider, pre-wholesaler and conducts audits
- Prepares application for Pharmaceutical Establishment License
- Communicates with health authorities and inspectors
SERVICES OF RESPONSIBLE PERSON
Swissmedic and four regional cantonal inspectorates carry out regular inspections to maintain your pharmaceutical establishment license. They examine different aspects of the quality performance. We prepare the documentation demonstrating your performance and assist you during the inspection to meet Swissmedic standards and pass the inspection.
- Represents your company during Swissmedic inspection
- Reviews and revises Quality System as required by Swissmedic to maintain PEL
- Provides and maintains access to Swissmedic e-platform
- Conducts Batch Release and all other QA task as required
Target BioScience AG has a year’s long experience in different types of company’s settings and can provide services for small size and complex company’s structures. Detailed information is provided upon request.
RP Provision
QUALIFIED PERSON SERVICES
Our team acts as an extension of your Quality Unit, utilizing a hands-on and risk-based approach to quickly improve quality and compliance while implementing practical solutions for your organization. Companies that intend to distribute medicinal products in Switzerland require a Manufacturing and Import Authorization (MIA) license and a designated named Qualified Person (QP) to oversee the product quality throughout the supply chain. Acting as an extension of your organization, our QP consultants bring a deep understanding of GMP and GDP processes. They work with your team to ensure compliant manufacturing and/or importation of products in Switzerland. To procure, sell and distribute medicinal products in Switzerland you need a Wholesaler Dealer Authorization (WDA) and a Responsible Person (RP) named on the license. The RP is tasked with supervising the quality of the company's wholesale operation and takes on the primary responsibility for ensuring compliance with GDP regulations and maintaining the quality of the distributed products.
INTERIM QUALIFIED PERSON (QP)
Companies that intend to manufacture, import, sell or distribute pharmaceutical products in Switzerland require a MIA license and a designated Qualified Person (QP) to oversee the product quality, and ultimately certify each batch of medicinal product for being manufactured, tested and released in accordance with EU GMP and the documents submitted to Swissmedic. In such situations our QPs act as an extension of your organization, bringing a deep understanding of Good Manufacturing Practice (GMP) processes. They work with your team to ensure compliant manufacturing and distribution of products in Switzerland.
CONTRACT QUALIFIED PERSON
Designated experts will support you with full responsibility for product quality and batch release in accordance with applicable national regulations. Designated qualified personnel will also support your company in the implementation and optimization of your project and in all aspects related to compliance, such as:
- Managing the pharmaceutical quality management system and ensuring continuous improvement
- Serves as the primary point of contact during inspections by competent authorities.
- Collaboration with contract manufacturers or third-party logistics providers.
- Handle quality complaints, returns, recalls, change control, deviations and CAPA.
- Ensure readiness for inspections
Your benefits
- Avoiding problems related to change of personnel (ensuring long-term relationships with authorities and inspectors)
- Cost advantages (part-time work)
- broad experience
- secured deputy arrangements