Product Quality Review

Blue Reg has an experienced team for PQR writing including CMC, Quality & 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, ICHQ7A) and an effective quality improvement tool to verify the consistency of the existing process & overall quality of the product, to be conducted annually. These PQRs are assessed deeply by inspectors during Health authorities inspections and should be carefully managed by trained and knowledgeable people.

BlueReg can help you to set up the PQR process in your company and/or manage your annual reviews.

We propose the following process, to be adapted and designed according to your request.

Data Gathering

  • Manufacturer PQR
  • Local data (ie. variations, deviations, contracts, complaints, recall)

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 »

  • In accordance with the review template provided by the client or using BlueReg template
  • Assessing manufacturer results and setting conclusions on process control
  • Providing a global assessment on the local data and the evaluation done by the manufacturer

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