Product review pertaining to warehouse should include
List of all starting
raw materials and packing materials use for the product.
Review of all rejected
raw materials and packing materials if any.
Review of all Approved
vendor list (it includes list of all critical raw materials/packing material
vendors qualified for the review period).
pertaining to manufacturing should include the following:
List of All batches
manufactured, number of batches reprocessed/reworked, number of batches
rejected and number of batches cancelled.
An overview of
manufacturing process(specific to product) like product description and process
Review of critic
quality process parameters.
Trend analysis of
manufacturing yield/batch yield/packing yield.
A trend of variable
critical process parameters/quality attributes identified during validation or
Hold time reviews such
as bulk hold time , filling time and total processing time.
Laboratory phase review
should include the following:
Overview of process
control designs for identity , strength, quality and purity.
Review and trend
of critical API test results, in both
manufacturing and packing process
occurred for the review period.
Review / summary of
Evaluation of process
capability index for bulk and finished product stages.
Review of all
analytical method validations.
and maintenance review:
Review of manufacturimg
Review of preventive
maintenance and calibration of all relevant
equipments/ instruments and utilities
Review of all equipments involved in manufacturing and
Review of qualification
status of equipments and utilities eg., HVAC, water,compressed gases etc.
Management systems review.
Review of all
deviations and subsequent investigations
related to material, preventive maintenanace, calibration programme,
manufacturing process, testing process and packing process along with
corrective and preventive actions.
specifications/Out of trends investigations along with CAPA.
Summary of all market
complaints, product recalls, quality retuned returns etc.
Review of Quality
technical agreement/contractual agreements.
Review of all major
change controls and effectiveness of CAPA.
conclusion of previous PQR report and
subsequent CAPA if any