Certified Experts for Compliance and Quality Control
Companies that intend to manufacture, import, sell or distribute pharmaceutical products in the EU require a MIA license and a designated Qualified Person (QP) and Responsible Person (RP), to oversee the product quality throughout the quality assurance (QA) process.
Acting as an extension of your organization, our QA consultants bring a deep understanding of Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) processes. They work with your team to ensure compliant manufacturing and distribution of products in the EU market.
Responsible Person Services for Wholesaling of Medicinal Products and Active Pharmaceutical Ingredients Under GDP
Our highly experienced QPs and RPs can act as contractors named 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.
Quality Defects and Product Recalls
We can help to investigate your product complaints to establish their root cause and ensure that appropriate corrective and preventative actions (CAPAs) are implemented to ensure they do not occur again.
Should you be in the unfortunate position of having a product recall we can advise and support you with your interaction with the respective national regulatory agencies.
Specialized QP/RP/ RPi Services
ProPharma Group’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, market access, Brexit preparations, 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
- Providing full oversight of the QMS to maintain product quality in the distribution to pharmacies, hospitals, or other wholesalers
- 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
- Supply chain mapping and risk assessment thereof to comply with the Falsified Medicines Directive 2011/62/EU