Certified Experts for Compliance and Quality Control
Companies that intend to manufacture, import, sell or distribute pharmaceutical products in the EU require an MIA license and a designated Qualified Person (QP) to oversee the product quality throughout the supply chain.
ProPharma Group has its own MIA license based in the Netherland that we can offer our clients to enable batch release within the EU/EEC. We also have a full team of experienced QPs that can be named on your own MIA license if you would like to take that route.
Acting as an extension of your organization, our QP consultants bring a deep understanding of Good Manufacturing Practice (GMP) processes. They work with your team to ensure compliant manufacturing and/or importation of products in the EU market. Learn about the responsibilities and criteria of a qualified person within the pharmaceutical industry. For expert guidance, contact us to learn about our QP services or read about them below.
Qualified Person Responsibilities
- Release batches to patients within the EU/EEC. This is called batch certification.
- QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP).
- Answering requests from health authorities.
- Providing health authorities with any other information relevant to product quality as well as being the single point of contact on a 24- hour basis.
- Having full quality oversight of the supply chain.
- Provide QP-declarations
- Being aware and having sufficient authority over the content of risk management plans.
- Perform or facilitate audits to ensure manufacturers are compliant with EU GMP regulations. This may include several types of audits, from broad-based quality system assessments to audits of individual suppliers.
Criteria for a Qualified Person
- Reside in the EU and be permanently and continuously at the disposal of the Medical Authorization Holder (MAH) and MIA License Holder.
- Appropriately qualified in accordance with DIRECTIVE 2001/83/EC. This stipulates a minimum of 4 years of university studies and 2 years of experience from a GMP regulated industry.
- Degree in pharmacology/medicine/chemistry or biology.
- In-depth knowledge of the product being certified.
- Dependent on EU country additional criteria can apply.
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.
Our Qualified Person 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 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