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OOS Investigation Tools: A Comprehensive Guide

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Introduction In the pharmaceutical industry, Out-of-Specification (OOS) events can have significant consequences, impacting product quality, patient safety, and regulatory compliance. Effective OOS investigation is crucial to identify the root causes, implement corrective actions, and prevent future occurrences. This blog post will explore various tools and techniques employed in OOS investigations. Essential Tools for OOS Investigations Data Analysis Tools: Statistical Software: Leverage software like Minitab, Excel, or specialized statistical packages for data analysis, trend identification, outlier detection, and process variability assessment. Quality Management Systems (QMS): Utilize QMS software to centralize and manage quality data, facilitating efficient data retrieval, analysis, and reporting during investigations. Electronic Batch Records (EBR): Employ EBR systems to capture and store detailed manufacturing process information, aiding in tracing back steps, identifyi
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APQR In Pharma (Annual Product Quality Review)

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APQR In Pharma

(Annual Product Quality Review)

Posted By: Bhagyashree Prashant Devmore (M. Pharm)

Pharmaceutical Annual Product Quality Review (APQR) is evaluated annually for all the commercialized products. APQR is prepared for the evaluation of the process and quality attributes of the marketed products. This is mandatory as per regulatory guidelines. More, precisely, the APQR contains all the product information written from its dispensing to dispatch and after dispatch till complaints. these all data is compiled together and that is called an annual product quality review. 

Definition of APQR (Annual Product Quality Review):

APQR (annual product quality review) or PQR is a Good Manufacturing Process (GMP) requirement used to verify the consistency and appropriateness of an existing manufacturing process. It plays a critical role in identifying any trends in the process further leading to process or product improvements.

Reference:

Reasons to do APQR (Annual Product Quality Review):

It is a requirement as per the following guidelines.

1. EU-GMP part I, chapter 1
2. 21 CFR - part 210 and 211 subparts (J) and Records and reports 211.180 (e)
3. ICH Q7 and PIC/S

According to these guidelines, all finished product data should be reviewed annually for identification of appropriateness of an existing manufacturing process, quality standards to determine the need for change in specifications and manufacturing of drug products.


To check the consistency of existing processes, process parameters, specifications' correctness, and product quality.

Benefits of APQR (Annual Product Quality Review)

  • It gives an idea about the consistency of the process and minimizes the risk to develop a product consistently with the best quality
  • It helps to identify process and quality defects of product which gives links for improvement in analytical methods and manufacturing process
  • It is an effective product quality improvement tool. It will help in improvement in the final outcome from the company.
  • In APQR all trends data is compiled. Trends of analytical data including results of analysis of raw material, packaging material, finished product, API, and manufacturing parameters of the product. It is helpful to identify defects in results and processes.
  • All trend of raw material, API, and packaging material used in product manufacturing shows the quality of a final product.
  • The final consistency of the product can be determined with the help of these finished products and in-process results.
  • It gives an idea for improvement in specifications

Contents of APQR (Annual Product Quality Review):

1. Product details

Name, generic name, strength, market, label claim, pack style of primary and secondary, storage condition, shelf life, Product Batch details, Batch number, batch size, mfg date exp date, review of BMR, BPR including process parameters

2. Data of API, excipient, and packaging material

All details of API and raw material used in the batch. All details of packaging material. All data from analytical reports along with trends of API, finished product, raw materials, and packaging material

3. Details of Utility Supplies:

Compressed air, nitrogen gas, water, HVAC system, and any other utility used. Details of the qualification, validation, calibration status shall be included in APQR

4. Major manufacturing equipment and utilities

All details of major equipment used in batch and utilities like HVAC system, AHU, Compressed air. Qualification status of major equipment and utilities.

5. Quality of Water

The quality of water used in the process is checked. Analytical results of water like pH, conductivity, TOC, and microbial limits. Trends of all analytical results

6. Events

Details of all events that happened while processing batch like OOS, OOT, Deviation, CAPA, market complaints, QMS data, and CCR along with trend

7. Review of in-process checks parameters along with trends and graph

This included review and co-relation of all the data of in-process checks.

8. Status of CAPA

Status of CAPA related to process and drug product

9. Product complaints details

Review of complaints, number of complaints received. Open and closed status of complaints

10. Product recall and field alerts

Data of recalls and field alerts filled in a particular year is recorded.

11. Calculations

12. Stability data:

The stability data of the product is also reviewed to identify there are no anomalies in the stability of the product.

12. Conclusion of APQR:

Based on the review data of a product, it is evaluated that the existing manufacturing process is robust and data of manufactured batches is continually meeting process capability index as required. Hence no modification is suggested in the existing batch processing stages.

Terms used in calculations of APQR:

Cp- Process Capability-

Process capability is a tool to find out a measurable property of a process to a specification. Generally, the final solution of the process capability is specified in the form of calculations or histograms. A process is said to be capable if the spread of the natural variations fits in the spread of the specified limits

CpK- Process Capability Index-

APQR in pharma, APQR
  • It is the measure of process capability. It shows how close a process can produce the output to its overall specifications.
  • Cp and CpK both are used to measure the potential capability of the process. The higher the sigma level, the better the process is performing.
  • Cp is used to evaluate the variation of the process
  • CpK is used to evaluate the centering of the process
APQR in pharma, APQR
  • It is recommended that Cp/CpK values should be at 1.33 or above
  • Cp value less than 1 means that the process is wider than the specification with defects spilling out over the edges.
  • Cp value was greater than 1 means that the effective width of the process variation is less than the required specification with fewer defects occurring.
Formulas:
Cp    = (USL- LSL)/6σST
Cpu  = (USL- mean)/3σST
Cpl   = (Mean- LSL)/3σST
Cpk  = min (Cpu - Cpl)
        =min (USL- mean/3σST, mean- LSL/3σST)

References:

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