(APQR) Annual Product Quality Review

Annual Product Quality Review (APQR)  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.
Process Capability (CpK) :
Process Capability (CpK) shall be carried out for critical analytical parameters e.g. Assay.
CpK = USL-MEAN /3*SD   or    MEAN -LSL/3*SD
Batch No.	Result	Assay limit
ABCDF22001	99.9	NLT 97% to NMT 103%
ABCDF22002	99.1
ABCDF22003	99.6
ABCDF22004	99.6
ABCDF22005	99.6
ABCDF22006	98.7
ABCDF22007	98.9
ABCDF22008	99.9
ABCDF22009	99.5
ABCDF22010	99.9
USL	103	EXCEL FORMULLA	LSL	97	EXCEL FORMULLA
MEAN	99.47	AVERAGE	MEAN	99.47	AVERAGE
SD	0.41	STDEV.P	SD	0.41	STDEV.P
USL-MEAN	3.53	USL-MEAN	LSL-MEAN	2.47	LSL-MEAN
3*SD	1.22	3xSD	3*SD	1.22	3xSD
CP	2.89	USL-MEAN/3*SD	CP	2.02	USL-MEAN/3*SD
This calculation helps to understand how close the process is producing outcomes compared to what the specification is.
Interpretation:
CpK < 1.0 i.e. Process is not Capable
CpK 1.00 to 1.33 i.e. Product is Barely Manufactured
CpK 1.34 to 3.00 i.e. Process is Good
CpK > 3.0 i.e. Process is Excellent
Note: Minimum 10 batches are required to calculate the Process Capability (CpK).
Importance of APQR in Pharmaceuticals -----
1. APQR is a regulatory requirement CFR 211.180 (e) basically specifies that the quality standard of every product must be evaluated at least once a year based on the current specifications and records to determine whether modifications to product specifications, manufacturing instructions or control procedures are required.
Chapter 1 (Pharmaceutical Quality System) of EU guidelines also recommends to evaluate the consistency of existing process annually through APQR.
PQR is an effective quality improvement tool to enhance the consistency of the existing process & overall quality of the product (PQR helps to highlight any trends and to identify product & process improvements)