Qvents Apps and Tools For QMS and GMP Processes

FDA 483 to Chinese API Manufacturer Sichuan Deebio cites Data Integrity issues (Qvents News).

• For APIs, Excipients, Process Water, Drug Products
• Provides structured user-friendly solutions. Guides you through the Risk Assessment Questionnaires
• Fill in the Questionnaire responses, Get the Nitrosamine risk results and carryover potential for Nitrites, Amine residues
• The tools assess the Nitrosamine formation risk, generate Recommended actions
• The tools are aligned with current US FDA and EU guidelines, IPEC Questionnaire for Nitrosamine Risk Evaluation

Click Here for the Nitrosamine Risk Assessment Tools

• Designed in line with USFDA’s 2011 guidance on Process Validation
• Generate Control Charts with Signal identification, Shifts, Drifts, Outliers, CpK, Control Limits (LCL, UCL), Coefficients of Variation
• Fill in your CPV Criteria – Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), Critical Material Attributes (CMAs) and defined limits. Enter Batch details. Define the number of batches to be considered for setting Control limits
• Submit and generate the Control charts.
• The Qvents Post Continuous Process Verification (CPV) and Evaluation Templates guides you through the
  • Selection of CPV Criteria
  • Interpretation of the CPV Criteria – CpK, %RSD, Detection of process variability through Signals, Shifts, Drifts in the Control charts and the CPV Parameters

Click Here for the Qvents CPV Tool

Supply Chain Traceability Mapping Tool

• EUGMP, EudraLex, Annex 16 require complete Manufacturing and Distribution supply chain of medicinal products to be documented and available
  • APIs, Excipients, Packaging Materials, Key Components, Manufacturers,
  • Intermediaries involved – EU Importer, Warehouses, EU Testing Labs, QP Certifying the batches
• Qvents Supply Chain Traceability Mapping Tool provides a useful tool for generating the Supply Chain Traceability Tree and Visual Map.
• Fill in the details, generate the supply chain tree and traceability map. Move and adjust the nodes in the map to get the best visual representation of the supply chain map.

Click Here for the Qvents Supply Chain Traceability Mapping Tool

EUGMP require MAH holders to ensure excipients are suitable to use in pharmaceutical products

• Perform formalised risk assessment of Excipients with respect to safety, quality and function of each excipient in a drug product
• Risk Assessment of Excipient based on
  • Source – Source Risk Assessment
  • Function of the excipient in the drug product, covering all drug products in which the excipient is used – Functional Risk Assessment
• Ascertain Appropriate GMPs applicable for the Excipient based on risk level
  • Fundamental GMP Elements
  • Additional GMP elements
• Perform GMP Gap Analysis
• Generate Excipient Control Strategy

Follows Guidance for Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal Products for Human Use (EU 2015/C 95/02)

Click here for Qvents Excipient Risk Assessment Tool