QA Consultancy (APR & PQR)
Streamline your APR and PQR processes with expert support
QbD Group offers full support for Annual Product Review and Product Quality Review — from data analysis and PQR writing to compliance review. These mandatory reviews ensure product quality, safety, and market readiness.
What is APR/PQR Support?
An APR or PQR evaluates product quality and performance to ensure safety, compliance, and market readiness. QbD Group provides end-to-end support for the entire process, from crunching the data to compiling comprehensive reports.
Key aspects include: comprehensive data management — gathering, processing, and analyzing data from multiple systems, regulatory compliance — ensuring all reviews meet GMP standards, detailed reporting with proposed action plans, and yearly insights providing trend analysis across PQRs.
Why are APR/PQRs important?
Patient safety
APR and PQR processes detect potential risks, ensuring products meet safety standards and safeguarding patient health.
Supply chain stability
Timely reviews prevent production setbacks and stockouts, ensuring consistent product flow.
Regulatory compliance
APR/PQRs are a GMP requirement and are reviewed during inspections. Complete, timely reviews demonstrate that your products remain in a state of control.
How can we help?
QbD Group offers tailored APR/PQR services to meet your organization's unique needs:
Deadline management
Ensuring timely completion of all reviews.
PQR writing
Compiling comprehensive reports ready for approval.
Data analysis and statistics
Crunching numbers and identifying trends.
Review for compliance
Ensuring consistency and regulatory alignment.
Our process
From data collection to follow-up actions, we support the full APR/PQR cycle, whether you need to establish, improve or execute your process.
Data collection
We gather production, deviation, quality and trend data from your processes and systems, including data from your CDMOs where manufacturing is outsourced.
Trend analysis
We analyze the data and identify trends that require attention.
Report drafting
We draft a complete APR/PQR report, ready for your review.
Quality review & follow-up
We review the report for compliance and consistency, and identify follow-up actions.
稳健体系持续合规
您值得信赖的合作伙伴
Partnering with QbD Group for APR/PQR support provides:
Expert knowledge
extensive experience ensures precise and thorough data evaluation.
Ready-to-approve reports
receive reports with actionable insights, ready for your approval.
Workload management
reduce the burden on your QA team during peak periods.
Scalable solutions
handle multiple products or reviews efficiently and consistently.
质量体系审计实践
常见问题
