PQR FAQs for Contract Manufacturers: What CMOs Need to Know

Contract Manufacturing Organizations (CMOs) play a major role in the pharmaceutical supply chain. However, when it comes to Product Quality Review (PQR), there’s often confusion about responsibilities, documentation access, and compliance expectations. Here are the most frequently asked questions from CMOs regarding PQRs — with clear, expert answers. 

1. Who owns the PQR — the CMO or the sponsor company?

 Ownership typically resides with the Marketing Authorization Holder (MAH), i.e., the sponsor company. However, the CMO is responsible for compiling and providing the required manufacturing, testing, and deviation data for their part of the process. A collaborative approach ensures timely and complete reviews. 

2. What if we don’t have access to full stability or complaint data?

 This is common. CMOs often lack direct visibility into product complaints or long-term stability trends. In such cases, it’s essential to define a data-sharing agreement where the MAH provides that information in time to meet PQR deadlines. Regulatory expectations now assume such integration is pre-established. 

3. How do we handle PQRs when we produce for multiple MAHs?

 Each MAH requires a PQR for its respective product, even if it’s technically identical to another. Data segmentation, accurate batch traceability, and documentation alignment are key. CMOs must ensure that their QMS can support product-specific reporting across multiple clients. 

4. What are the PQR expectations during tech transfer?

 During tech transfer, the receiving site must incorporate historical PQRs from the transferring site to support process continuity and validation. CMOs should prepare to share this information during due diligence, especially when working across regions or regulatory frameworks. 

5. Can a CMO submit the PQR directly to a regulatory body?

 Not usually. Submission responsibilities fall to the MAH. However, regulators may inspect a CMO’s internal PQR records during audits. Therefore, your PQR processes must be complete, audit-ready, and aligned with the sponsor’s documentation. 

 As a CMO, your contribution to PQR isn’t just data provision — it’s proof of sustained GMP compliance. With regulatory agencies intensifying scrutiny on outsourced operations, CMOs who proactively align with PQR best practices stand out as trusted partners.