Every organization in the life sciences industry is required to have a current and compliant quality system to ensure the safety and quality of all products and services. Quality assurance involves upholding the desired level of quality in your products throughout every stage of the process, from production to delivery to the patient.
At ProPharma, our quality assurance professionals enhance your internal capabilities to ensure the consistency and safety of products. 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 manufacture or import medicinal products in the EU and UK 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 processes. They work with your team to ensure compliant manufacturing and/or importation of products in the EU and UK markets. Our global team of certified QPs have broad experience covering multiple types of formulations, complex supply chains, technical transfer projects, aseptic/sterile manufacturing, radiopharmaceuticals, biologics, ATMPs, and supply for clinical trials.
To procure, sell and distribute medicinal products in the EU and the UK markets you need a Wholesaler Dealer Authorization (WDA) and a Responsible Person (RP) named on the license. In the UK a WDA can also be utilized to import QP-certified medicinal products from the EU. In that case, you would need a Responsible Person (import). 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.
Our highly experienced RPs can act as contractors named on your, or a third-party's, WDA for both human and veterinary medicines under EU and UK Guidelines. If you are new to the EU/UK market we can help you in navigating the road from QMS build, through the WDA application process, a successful inspection, and obtaining your very own WDA license.
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Specialized QP/RP/RPi Services
ProPharma's global team of certified experts have broad experience covering multiple types of formulations, complex supply chains, technical transfer projects, aseptic/sterile manufacturing, radiopharmaceuticals, biologics, ATMP’s, market access and supply for clinical trials.
Our QP/RP/RPi services include:
- Partnering with your organization to lead or assist in obtaining the manufacturer’s import license and wholesale distributor license
- Building Quality Management Systems (QMS)
- Providing strategic recommendations in addition to standard QP oversight. We will support your organization to reduce issues, delays, and costs in the manufacturing process
- Helping organizations develop a flexible staffing model that caters to specific needs ranging from long-term lead assignments (named on the client’s license) to interim support
- Providing around the clock support, enabled by at least two QPs per assignment, delivering full continuity, and reduced risk
- QP Declaration
- QP Confirmation
- QP Batch certification
- Providing full oversight of the QMS to maintain product quality in the distribution to pharmacies, hospitals, or other wholesalers
- Supply chain mapping and risk assessment thereof to comply with the Falsified Medicines Directive 2011/62/EU
Support for Pharmaceutical Products & Services
- Capsules, both hard and soft shell
- Liquids, creams, and ointments, both sterile and non-sterile
- Sterilization by filtration, irradiation, and ethylene oxide
- API supplier auditing, both small and large molecule to EU GMP Part II/ ICH Q7
- Excipient supplier auditing to IPEC-PQG guidelines
- Packaging supplies auditing, covering leaflets, labels, cartons, foils & films, primary containers to GMP, and PS9000:2016
- Contract analytical laboratory auditing to GMP and ISO 17025:2017
- Storage and distribution warehouse auditing to GDP
- Commercial products
Interim Qualified Person (QP)
Companies that intend to manufacture, import, sell or distribute pharmaceutical products in the EU/UK 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 the EU/UK authorities.
In certain instances, volumes or circumstances may not justify hiring a QP. 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 the EU/UK market.
Interim Responsible Person (RP/RPi) Services
Wholesaling of Medicinal Products and Active Pharmaceutical Ingredients Under GDP
Our team of extensively skilled QPs and RPs is ready to function as contractors listed on your or a third parties Wholesale Dealers Authorization for both human and veterinary medicines under European Guidelines 2013/C 343/01 human medicines and 2015/C 95/01 APIs for medicinal products for human use.
Complex Needs Require Custom Solutions
Unlock your organization's potential in the life sciences industry with ProPharma's specialized QP/RP/RPi services. Partner with our global team of certified experts to ensure compliance, enhance product quality, and streamline your manufacturing and distribution processes.