The quality review process is an integral part of quality management in the pharmaceutical sector. It encourages pharmaceutical manufacturers to proactively assess product quality attributes across manufacturing and production processes and pushes firms in the pharmaceutical industry supply chain to carry out end-to-end product oversight, more effectively mitigate risks associated with the manufacturing of pharmaceutical products, and drive continual improvement throughout the product lifecycle. Through quality review, firms can detect and resolve quality issues early and maintain their reputation as a trusted source of high-quality medicines among regulators, trading partners, healthcare providers, and patients.
The benefits of quality review
Product quality review is an accepted part of Good Manufacturing Practice (GMP) regulations in many parts of the world, and regular quality reviews are required by the US, the EU, and Canada. They are an important quality assurance and process improvement tool. While the content and objectives of the product quality review differ somewhat by jurisdiction, they are generally used to verify the consistency and appropriateness of existing manufacturing processes and identify opportunities to improve product quality.
Product quality review is a mechanism used to carry out the four key activities of the pharmaceutical quality system as described in the ICH Q10 guidelines. These include process performance and product quality monitoring, corrective action and preventive action (CAPA), change management, and management review.
By formally and regularly reviewing product quality and compliance related information, firms are able to better:
- Monitor manufacturing process performance and product quality.
- Implement corrective actions resulting from the investigation of recalls and deviations and regulatory inspections as well as preventive actions resulting from the discovery of adverse trends in process performance or product quality.
- Ensure that continual process and product quality improvement is carried out promptly and effectively.
Learn what it takes to build a more agile and resilient supply chain. Download the eBook: What You Must Know to Survive a Supply Chain Crisis—5 Priorities from 4 Industry Experts.
Quality review in the US and the EU
Title 21 Part 211 of the Code of Federal Regulations (CFR) of the U.S. Food and Drug Administration (FDA) requires that product quality reviews be carried out annually in order to evaluate the quality standards of commercial drug products, which includes active pharmaceutical ingredients (APIs) and finished products. The purpose of these evaluations is to verify the consistency of manufacturing processes and identify the need for changes in a drug product's specifications or associated manufacturing and control procedures.
In the EU, product quality reviews are required by EU GMP guidelines for APIs and finished products with a marketing authorization. Product quality reviews are carried out on a periodic basis, generally annually, to verify the consistency of current manufacturing processes, assess the appropriateness of existing specifications for starting materials and finished products, highlight significant trends in product quality, and identify opportunities for product quality or process improvement. In both the US and the EU, quality review is a tool used to foster continuous improvement in product quality and manufacturing process performance.
Expediting quality review with software tools
Completing product quality reviews in a timely manner can be a challenge, however, particularly for pharmaceutical companies working with third-party manufacturing organizations. When carried out manually, the processes of collecting and compiling data and preparing and reviewing documents for quality review is labor-intensive and oftentimes disjointed. The lack of visibility and continued reliance on inefficient or unreliable communication methods across the pharma value chain can result in lengthy document review times and missed commitment dates. What pharmaceutical manufacturers and their contract partners need is a secure, collaborative workspace and software tools that they can use to facilitate knowledge transfer and expedite issue and change management tracking.
A powerful suite of tools for pharmaceutical quality management
On its digital supply network for the healthcare sector, TraceLink provides its customers with an integrated suite of supplier management applications—for quality management, issue resolution, and change management—software tools that pharmaceutical firms and their trading partners can use to obtain greater transparency and facilitate collaboration across the pharma supply chain.
Organizations using TraceLink's software for supply chain quality management can exchange quality review documents and provide commentary in a secure, collaborative workspace on the cloud. Pharmaceutical firms get the real-time visibility and collaboration tools they need to drive continuous improvement in product quality and manufacturing and packaging processes across their sites, suppliers, and contract partners.
Find out how pharma and healthcare organizations are building resilience and agility in the aftermath of COVID-19. Download the IDC Whitepaper: Solving the Pharma Supply Chain Struggle.
Quality Review FAQs
What is quality review?
The product quality review is a quality assurance and quality improvement tool used by drug manufacturers to verify the consistency of their current manufacturing processes as well as the appropriateness of their existing specifications for ingredients and finished products. It is a periodic evaluation that is used to pinpoint opportunities for improving product quality and process performance.
What are the benefits of carrying out periodic product quality reviews?
Quality reviews help pharmaceutical companies better understand their manufacturing processes and create an organizational culture that supports continuous improvement in product quality and manufacturing process performance. The product quality review is a tool that can help them find inconsistencies in their current manufacturing processes, identify inappropriate product specifications, and pinpoint other areas in need of improvement to ensure that quality is built into every step of production. The information gathered in the quality review process can also be used to inform new product development.
What information should be reviewed in a product quality review?
Your quality management team should first review the corrective actions or recommendations provided in previous reports and then examine finished product testing results and critical in-process controls. They should also review basic statistics such as the number of batches manufactured, the percentage of batches rejected, and the percentage of batches reworked or reprocessed. And they should look at significant deviations, stability studies, returns, complaints, recalls, and other related issues for the product line under examination.