Türkçe 
English 
PQR and APQR are periodic quality-review processes used in pharmaceutical and other regulated manufacturing sectors. PQR stands for Product Quality Review, while APQR stands for Annual Product Quality Review. These reviews assess whether a product has been manufactured in accordance with quality requirements over a defined period, whether the process remains under control, and how quality risks are managed.
In traditional PQR/APQR processes, data is collected manually from paper batch records, laboratory reports, deviation forms, CAPA records, and change control documents. Electronic Batch Record (EBR) systems, however, enable this data to be used in a more organized, traceable, and analyzable way. Centra's Electronic Batch Record (EBR) solution contributes to the more robust management of batch-based production and quality data needed in product quality assessment processes.
The Basic Structure of PQR and APQR
What is PQR?
A Product Quality Review (PQR) is a report that evaluates the quality performance of a product over a specific period. This report examines production batches, quality control results, deviations, complaints, recalls, changes, CAPA records, process trends, and critical quality indicators. The aim is to demonstrate that the product is manufactured consistently in terms of quality and to identify areas needing improvement.
What is the main purpose of PQR?
The primary goal of Product Quality Review (PQR) is to evaluate product quality holistically over a specific period, not just on a single batch basis. This allows for a clearer identification of recurring deviations, process slippages, quality control trends, and systemic risks.
What is APQR?
APQR refers to the annual assessment of product quality. Especially under GMP standards, commercially produced products are expected to undergo regular reviews. APQR collectively evaluates the quality performance of batches produced during the annual period and questions whether the current control strategy for the product is adequate.
Why is APQR conducted annually?
Annual evaluation allows us to see the long-term performance of the process. While individual batch review only shows the condition of that specific batch, APQR combines data accumulated over a year to reveal whether the process is sustainably under control.
What is the difference between PQR and APQR?
PQR is a more general product quality assessment concept. APQR, on the other hand, is the annual version of this assessment. In some companies, the two terms are used interchangeably. However, in practice, APQR specifically emphasizes the annual reporting format and GMP expectations. Both serve to evaluate the quality performance of the product, process stability, and needs for improvement.
Which one should be used?
The usage may vary depending on the company's quality system, regulatory market, and internal procedures. While the Product Quality Review concept is prominent in the European GMP approach, the term Annual Product Quality Review may be more commonly used in some global structures.
How can EBR data contribute to the PQR process?
EBR provides a powerful data source for PQR/APQR processes because it digitally collects batch data generated during production. Production dates, process parameters, critical quality controls, electronic signatures, deviations, out-of-limit values, and operator records can be retrieved from the system. This reduces the need for manual data collection.
How can EBR speed up PQR preparation?
Instead of reviewing paper records one by one, data can be extracted from the EBR based on product, batch, date, line, equipment, or parameter. This structure reduces report preparation time, increases data consistency, and allows the QA team to dedicate more time to the interpretation phase.
What data does PQR include?
The PQR report typically includes production batches, rejected batches, rework situations, QC analysis results, out-of-specification results, out-of-trend results, deviations, CAPA records, change controls, customer complaints, recalls, stability results, validation status, and critical process parameters.
Should all data be examined in the same level of detail?
No. PQR should be prepared using a risk-based assessment approach. Data that directly affects product quality are analyzed in more detail, while low-risk or non-recurring minor events can be addressed at a summary level.
Frequently Asked Questions about PQR and APQR
Why is PQR important from a GMP perspective?
PQR demonstrates that the GMP system monitors product quality not only during production but also periodically. Auditors want to see not only whether the company has closed individual deviations, but also whether these deviations are recurring, whether the process is under control, and the learning capacity of the quality system.
What does PQR prove in an audit?
PQR demonstrates that the product has been manufactured under controlled conditions over a specific period, quality incidents have been evaluated, necessary CAPAs have been opened, and process trends have been monitored. Therefore, it is an important quality system outcome in audits.
How often is a PQR report prepared?
In most GMP environments, PQR/APQR is prepared annually. However, more frequent interim assessments may be conducted depending on product risk, production volume, market requirements, or internal quality procedures. For critical products or processes with frequent deviations, periodic monitoring may be planned at shorter intervals.
Should an interim review be conducted in addition to the annual report?
Yes, it should be done in some cases. Especially if there are recurring deviations, decreases in CPK/PPK, an increase in complaints, or a deterioration in quality control trends, it may be more appropriate to conduct an interim quality assessment before the annual report.
How are deviation and CAPA assessments performed in PQR?
Deviations in PQR should not be listed simply as numbers. The type of deviation, frequency of occurrence, impact on product quality, root cause distribution, and the effectiveness of activated CAPAs should be evaluated. Concentration of the same type of failure in a particular line, shift, or piece of equipment may indicate a need for process improvement.
How is the CAPA event seen in the PQR?
After CAPA is disabled, it should be monitored whether the same deviation recurs. If the same problem persists, CAPA is not effective. EBR data can help show how the relevant parameter or event changes in batches after CAPA.
How to use trend analysis in PQR?
Trend analysis is one of the most valuable components of PQR. Critical quality characteristics, process parameters, QC results, deviation numbers, yield rates, and complaints are compared periodically. This analysis allows for the early detection of deviations that, while not yet out of specification, signal a risk.
What questions does trend analysis answer?
Trend analysis can answer questions such as: Is the process working close to the target? Is variability increasing? Is a particular parameter approaching its limit? Are deviations concentrated in a specific operation? Is there a deterioration in quality control results over time?
How does Centra support the EBR PQR/APQR process?
Centra EBR can strengthen the data base of the PQR/APQR process with its electronic batch records, process parameters, limit controls, electronic signatures, audit trails, deviation links, and reporting structures. This allows product quality assessment reports to be prepared faster, more consistently, and in a more auditable manner.
How to get started in digitizing the PQR/APQR process?
The first step is to identify the sources of the data used in existing PQR reports. Then, an analysis should be conducted to determine which data can be automatically retrieved from systems such as EBR, LIMS, QMS, and ERP. To digitize the PQR/APQR process and use EBR data in quality assessments, you can contact Centra via their information page.
