Product Quality Review

Blue Reg has an experienced team for Product Quality Review (PQR) writing including CMC, Quality and Regulatory Affairs consultants dedicated to supporting your company through PQR reviews for your medicinal products.

From data gathering, through data analysis and PQR writing, we provide flexible solutions to meet your company’s requirements.

Our services

PQR is a regulatory requirement (EU-GMP chap 8, US 21 CFR part211, and ICHQ7A) and an effective quality improvement tool to verify the consistency of the existing process and overall quality of the product, to be conducted annually. These PQRs are assessed thoroughly by inspectors during Health authority inspections and should be carefully managed by trained and knowledgeable staff.

 

BlueReg can fully support you to set up the PQR process in your company and/or manage your annual reviews. Our experienced team utilize the following approach which can be tailored to your specific needs:

Data Gathering

  • Manufacturer PQR
  • Local data (variations, deviations, contracts, complaints and recalls)

Data Analysis

  • Compliance to GMP requirements
  • Critical review of batch data evaluation performed by the manufacturer
  • Evaluation of the overall quality of the product
  • Assessment of the consistency of the existing manufacturing process
  • Highlight of any trends
  • Review of the proposed CAPAs, highlighting action plans to be monitored or added
  • Verification of the consistency between local data and information provided by the manufacturer

Writing the PQR for the « Exploitant »

  • Writing in accordance with the client or BlueReg template
  • Assessing manufacturing results and setting conclusions on process control
  • Providing a global assessment on the local data and the evaluation undertaken by the manufacturer

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