Follow
Objective: To set up a review procedure for exercising control over the manufacturing of finished products so as to ensure the highest quality and to support the continual improvement of quality system at (Company Name).
Scope: This SOP applies to finished products manufactured at all facilities of (Company Name).
Responsibility:
>> Manager QC or designee shall be responsible for collation of data with regard to testing related metrics being monitored.
>> Manager QA or designee shall be responsible for collation of data with regard to release related metrics being monitored.
Accountability: Head of Quality
Precautions: N/A
Procedure:
= Quality Metrics are derived data that shall be used to monitor systems in quality control and manufacturing processes as well as to drive continuous improvement efforts in drug manufacturing.
= Monitoring of quality metrics would help the BPL to:
>> Understand sources of variation, if existing in products manufactured
>> Detect the presence and degree of variation
>> Understand impact of the variation on process and ultimately on product attributes
>> Identify measures to control variations in a manner commensurate with risk, if it represents the processes and products
= Parameters to be reported
= The metrics suggested for data collation include:
>> The number of lots attempted of the product
>> The number of specification-related rejected lots of the product, rejected during or after manufacturing
>> The number of attempted lots pending disposition for more than 30 days
>> The number of out-of-specification (OOS) results for the product, including stability testing
>> The number of OOS results for lot release and stability tests for the product which are invalidated due to lab error
>> The number of analysis attempted in the laboratory
>> The number of product quality complaints received for the product
>> The number of APRs or PQRs required for the product.
= The data of the Quality metrics indicated above shall be collated on a monthly basis (except the PQR metrics) and discussed in the Quality Council Meeting.
= Calculations of the critical metrics that must be reported
= Lot Acceptance Rate: This is calculated with the formula, 1 – x, where x is the number of specification-related rejected lots in a specific timeframe divided by the number of number of lots attempted by the organization in the same timeframe.
= Product Quality Complaint Rate is the number of product quality complaints received for a specific product divided by the total number of lots of that product released in the same timeframe.
= Invalidated Out-of-Specification (OOS) Rate: This is the number of OOS test results for the finished product invalidated by the organization divided by the total number of OOS test results divided by the total number of tests performed by the organization in the same timeframe.
= Annual Product Review (APR) or Product Quality Review (PQR) on Time Rate: This is the number of APRs or PQRs completed within 30 days of annual due date in the organization divided by the number of products produced by the organization.
= The data will be collated by the QA and QC responsible personnel using FRM No. FQA/239, (Annexure I).
