This video is about How to prepare APQR in Hindi and English
Time Stamps:
00:00 Introduction
00:46 Contents
01:08 Definition
02:10 APQR Flow Chart
06:25 APQR preparation step by step
16:22 Reference Guidelines
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APQR or PQR or APR or PAR or Annual Product Quality Review
APQR 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.
Introduction:
Annual Product Quality Review (APQR) is an evaluation which is prepared according to the cGMP requirements of different regulatory authorities.
A Good Manufacturing Practice ensures that the products are consistently produced and controlled according to quality standards.
Annual Product Quality Reviews not only are required by GMP but also required for robust quality improvement for manufacturing of the pharmaceutical product.
Annual product review is an evaluation conducted annually to assess the quality standard of each drug product with a view to verify the consistency of existing process and to check the appropriateness of current specifications and to highlight any trend in order to determine the need to change any drug product specifications or the manufacturing processes or control procedures.
It is a written report is required for every drug product, based on data collected at least annually.
It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
It is universally accepted by the industry and contents must specify a list of manufactured batches, release data and reviews of deviations, complaints, recall and returned goods.
Annual product quality review is an evaluation conducted at
regular periodic or rolling quality reviews of all registered
medicinal pharmaceutical products, including export (US
market & Europe market, UK, Canada, Australia and Row
market) to assess the quality standard of each drug product
with the view to verify the consistency of existing process and to check the appropriateness of current specifications and to highlight any tends in order to determine the need to change any drug product specifications or the manufacturing processes or control procedures.
It is an effective quality improvement tool to enhance the
consistency of manufacturing process and overall quality of
the product. It will capture broader review of product data and capturing trends will help determine the defects and possible improvements of the methods and Process. Where no significant changes have been made to the system or
manufacturing process, and a quality review confirms that the system or process is consistently producing material meeting its specifications, there is normally no need for revalidation.
Importance or Significance of APQR
Verify the consistency of the existing manufacturing
process and minimize the risks to pharmaceutical products which will be helpful for the pharmaceutical companies to
develop their products consistently of best quality on yearly basis.
It determines the quality and process defects of the
products.
It also determines possible improvements of the analytical methods and manufacturing process.
Trend of yield, analytical results, manufacturing parameters of the product are also highlighted. It is helpful
to identify the process and product defects.
It reviews the quality of the raw material and packaging
material which is used for the product.
Verifies the appropriateness of current specifications for
both starting materials and finished product to highlight any trends and to identify product and process improvements.
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