APQR SOP in Pharma is GMP requirement that evaluates the consistency, quality, and performance of pharmaceutical products over a defined period. An effective APQR SOP provides a structured approach for reviewing manufacturing, quality control, stability, deviations, complaints, and process trends to support continuous improvement and ensure ongoing regulatory compliance.
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Purpose of APQR SOP in Pharma
The purpose of this SOP is to describe the detail procedure for preparation, review and approval of annual product quality review (APQR) with the objective of verifying the consistency of process, equipment and the system for meeting predetermined specification.
Scope of APQR SOP in Pharma:
This procedure is applicable to all the products manufactured to understand and review the process specification and is applicable for XYZ company.
Roles & Responsibilities:
| Designation | Responsibilities |
| Officer/Designee of Quality Control | To provide analytical data of raw materials, packing materials, in-process samples, finished products and stability samples for the review period.To provide details of analytical deviations, Out of Specification (OOS), Out of Trend (OOT), incidents, and laboratory investigations, if any.To Collect and organize all Quality Control Data associated with the APQR. |
| Officer/ Designee of Quality Assurance | To prepare the Annual Product Quality Review (APQR) report as per approved SOP and defined format.To collect required data and information from Production, QC, Warehouse, Engineering, and other concerned departments.To maintain approved APQR reports and supporting documents as per document retention procedure.To Collect and organize all Quality Assurance Data associated with the APQR provide summaries of results and generate Conclusions and recommendations reflecting the data. |
| Head QA/Designee | To review and approve the Annual Product Quality Review (APQR) plan, format as per SOP.Review and approve final APQR report.To review and approve the final APQR report for completeness, accuracy, and adequacy of data evaluation.The Head of Quality Assurance is the APQR owner i.e. the individual ultimately responsible for assuring that all provisions of this SOP are fulfilled. |
Reference:
- WHO TRS Annexure 2Good Manufacturing Practices for pharmaceutical products
- EU GMP Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Chapter 1
Abbrevation(s) Used:
SOP : Standard Operating Procedure
QA : Quality Assurance
APQR : Annual Product Quality Review
NA : Not Applicable
No. : Number
TRS : Technical Report Sheet
Training Requirements:
Personnel must:
- Read and understand the SOP.
- Complete training before performing related activities.
- Undergo periodic retraining as and when required.
Step By Step Procedure for APQR SOP in Pharma:
Definition:
Annual Product Quality Review (APQR): Review conducted annually to give an organized summary of all the production activities, analytical and physical, stability, deviations, change control, out of specifications recall and market complaint which assess the quality standards of each drug product.
It is the collection of data over a given 12 months period of time, presented in clear form, that makes possible to identify the quality problems, deviations and trends to substantiate constant quality.
Annual product review report shall be prepared annually for the period, it can be a calendar Jan. to Dec. or March to March year and called cut-off date for finalization of APQR.
Product Quality Review is regular periodic reviews of all manufactured products, the review is conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product, investigation to highlight any trends and to identify product and process improvements.
Selection of batches for APQR
The annual product quality review report shall be prepared by QA.
APQR plan shall be prepared for all batches of selected products manufactured in a year from January to December or March to March and all the APQR shall be completed within initial 90 working days of the calendar year.
APQR shall be prepared for product which have 10 batches and in case if less than 10 batches were manufactured during the review period than APQR for that product shall be prepared in next year considering the batches of both years.
In case of newly introduced Product the APQR will be prepared first time based on the data of minimum three batches. While “the APQR will be prepared from next year though no commercial batch is manufactured for the same product”. The data for the following parameters shall be reviewed in the no batch APQR i.e. Stability, Market Complaints, Observation of Control Sample etc.
No Batch APQR
In case no batch is manufactured during the review period then annual product quality review (APQR) shall be prepared with the review of all the available data like complaint review, stability data, deviations, change control, changes in process specifications or analytical methods, product recall observations of control/ retain sample etc of previous years and report shall be compiled for the next year.
If product is having different brand names but generic name, strength, manufacturing procedure, formulation, primary packing, physical and chemical specifications is same then considers this as a one product.
Product Quality Review Report: This Report is prepared to verify the consistency of the process regarding the various Quality parameters. Following parameters shall be included in the Product Quality Review Report:
Recording of Product details for APQR SOP in Pharma:
Details entered for the product while preparing the APQR are given below:
Batches manufactured: A review and number of all batches of the specific product manufactured including failed /rejected along with its Mfg. Date and Exp. Date during the review period for a specific product shall be listed in the APQR.
Raw material and Primary Packaging material: Raw materials [Active Pharmaceutical Ingredients (API) and Excipients] and Primary Packaging Materials should be listed with the approved vendors name and address and from new source if purchased for the manufacture of the product concerned.
Batch manufacturing Record: APQR shall include the material requisition list which is a part of Batch manufacturing record (BMR). It shall also include the review of whole BMR and evaluation of whole processes from manufacturing to packing.
A review of critical in-process controls and finished product results
A review of yield of final (packed product) of all batches.
Analytical results: Compile all the analytical data along with its limits / specifications of the critical quality parameters of all batches under review to assess the batch uniformity and integrity of API’s and drug products. It also includes Microbiological data. Any batch failing to establish the specification (rejected batch) shall also be included in APQR with reason of rejection and its corrective and preventative measures taken.
Numbering System:- Product quality review shall be numbered as,
ZZ/XYZ/APQR/AAA
Where,
APQR – Annual Product Quality Review
XYZ – Acronym for company Name
AAA – Product code
ZZ – Last Two digit of current calendar year
e.g. Annual Product Quality Review Report for ABC batch for year 2026 is 26/XYZ/APQR/AAA
Parameters to be checked at different Stage:
Bulk Stage
| Tablet | Capsule |
| Description | Description |
| Assay | Assay |
Semi Finished
| Uncoated Tablet | Coated Tablet | Capsule |
| Description | Description | Description |
| Avg. Wt. | Avg. Wt. | Avg. Wt. |
| Uniformity of weight | Uniformity of weight | Uniformity of weight |
| Hardness | NA | NA |
| Thickness | Thickness | Locking length |
| Disintegration Time/ Dissolution | Disintegration Time/ Dissolution | Disintegration Time |
| Friability | NA | NA |
Finished
| Uncoated Tablet | Coated Tablet | Capsule |
| Description | Description | Description |
| Avg. Wt. | Avg. Wt. | Avg. Wt. |
| Uniformity of weight | Uniformity of weight | Uniformity of weight |
| Hardness | NA | NA |
| Thickness | Thickness | Locking length |
| Disintegration Time/ Dissolution | Disintegration Time/ Dissolution | Disintegration Time |
Graphical representation shall be made for all quantitative test excluding quantitative test.
Change Control: A review of all the critical, major and minor Changes occurring during the quality system and its documentation such as manufacturing or testing and its equipment and/or instrument, Approved facility/utilities, Specifications (Raw, packing, in-process, finished product-release/ Finished product shelf life), Analytical testing method, Product shelf life/storage condition, Formulations, Vendor of Raw and packing materials, primary, secondary packing material shall be included in APQR protocol.
Deviation and Non Conformances: A review of all investigation related to deviations and non conformances should be performed which includes deviations in manufacturing, analytical systems or in analytical method development from the standard specifications with a review of adequacy of previous Corrective actions.
Stability Studies: A review on the stability data of all batches should be included in PQR along with its results. These data should be reviewed and compared with data from previous year to assure that no negative trend has developed and no stability failures occurred and that the data are within the limit before expiry date achieves.
Technical Complaints: Any Technical complaint with cause of complaint received from the respective markets during the duration of the review should be listed. Conclusion and preventive measures made as results of the investigation should be included.
Market withdrawals, Recalls and regulatory Alerts: Any withdrawal or recalled or regulatory alerts of any batch of the product made from the respective markets during the period of the APQR should be listed along with the reason and final interpretation for recall or withdrawal.
Annual Visual Examination of Control samples: Control sample should be visually examined once a year such that it would not affect the integrity of the control sample package for the evidence of deterioration of control sample should be investigated. Result of the investigation/examination with its brief description should be included in APQR. Statistical sampling may be used instead of 100% examination of all control samples.
Validation: Any equipment/instruments used in the specific product if undergoes validation during the time period of PQR of product then it should be detailed in APQR with its results.
Change History:
| Effective Date | Nature of revision | Change Control No. | Reason for Revision |