Quality
Quality Assurance
PVpharm can help you to create a robust Quality System in Pharmacovigilance, Clinical Trials and GMP. We can adapt your SOPs to the latest GxP guidance or create a brand new Quality System to be compliant with GxP regulations.
- Risk análisis
- Elaboration of SOPs
- Implementation of quality systems
- GxP Training
- Liaison with Competent Authorities
Audits
Pharmacovigilance
EU Guidelines on Good Pharmacovigilance Practices (GVP Module IV), mandate that all Marketing Authorisation Holders (MAHs) perform audits of their Pharmacovigilance Systems.
PVpharm provides a risk-based Pharmacovigilance Audit Service, which focuses on the areas of highest risk to an organisation’s pharmacovigilance system, taking into account applicable local regulatory requirements.
With an average of +50 GVP audits per year in all geographical areas, PVpharm has a team of professionals that can conduct PV related audits in several areas, included but not limited to:
- Full PV systems audits
- Partner/Distributor PV audits
- Pre-qualification audits
- Patient Support Programs / Market Research Programs
- Local or country specific PV services
- Social Media
- Medical and Scientific literature monitoring
- XEVMPD
- Case management
- Signal detection
- PSURs
GCP
If you are a sponsor of clinical trials, we can support you with GCP audits. These services help to ensure that adoption of the principles of GCP meet international standards where trials are conducted to test both medical and non-medicinal products such as nutritional foods or cosmetics. We can Document review and audit your SOPs, Clinical GCP Protocols and Reports. We can also audit your submissions for ethical approval, Trial facilities, Critical Phases of the trial, Quality Systems and we can also perform sub-contractor audits.
GDP to wholesale distributors and transporters
All stakeholders in the supply chain of medicinal products need to comply with Good Distribution Practices as laid down in the European Guideline.
Manufacturers of medicinal products have to make sure that the products will be distributed under controlled conditions. Therefore, wholesalers, transport companies, warehouses and other partners in the supply chain will have to be selected carefully. An ongoing supervision of these organisations is necessary.
Mock inspections
Mock inspections will prepare your team for a real inspection. We perform all kinds of GxP inspections preparation with auditors that has real inspection experience.
GMP
If you are a European Medicinal Product Manufacturer (or European Manufacturer of “Active Substances used as Starting Materials”) PVpharm can cooperate with you by carrying out the following audits based in GMPs/GDPs:
- Audits to your CMOs (Contract Manufacturing Operators), according with Chapter 7 of GMPs “Outsourced Activities”
- Audits to your QMS (Quality Management System), according with Chapter 9 of GMPs “Self Inspection”
- Audits to your Manufacturers&Distributors of Starting Materials (Active Substances, Excipients), according with Chapter 5 of GMPs “Production”
- Audits to other Manufacturers&Distributors (Intermediate, Bulk Products, Packaging Materials…)
Type of company to be audited:
- Manufacturers
- Importers
- MAHs
Type of products
- Medicinal / Veterinary /Investigational products
- APIs / Excipients
- Cosmetics, Medical Devices and Food Supplements
Type of operations to be audited
- Manufacture
- Packaging
- Quality Control Testing
- Batch Certification
Years of experience, commitment and professionalism at your disposal. Always with the highest ethical values and transparency. Helping the pharmaceutical industry and patient safety are our core values.
