Annual Product Reviews SOP

Annual Product Reviews are created by all departments of the Pharmaceuticals Industry. Because Annual Product Reviews SOP reviews of products in all departments.

 

1. Table of Contents

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   PURPOSE

To outline a procedure that

• Provides instructions for Annual Product Reviews (APRs) of all marketed products of Pharmaceuticals.

• Includes a collection of data, evaluation of data & review of data by Technical Team.

2. SCOPE

This SOP applies to all departments through which products are manufactured, packed, inspected and tested during a year i.e. from January – December time period. All batches finally closed in this duration are included in Annual Product Reviews. 

3. RESPONSIBILITY

• Quality Assurance Department.
  • Enter the relevant data timely at respective step of a batch.
  • Review the data required by QA to ensure that no entry missing
  • Enlist pending issues of previous APR follow-up,
  • Follow up of corrective actions identified by Technical Team during APRs.
• Quality Control Department.
  • Enter the relevant data timely at respective step of a batch.
  • Review the quality control data required to ensure that no entry missing.
  • Provide status of Analytical Method Validation, Shelf Life study, Reference standards and Pharmacopoeial review.
• Production Department(s)
  • Enter the relevant data timely at respective step of a batch.
  • Review the all product manufacturing / packaging data required to ensure that no entry missing.
  • Provide status of Equipment Qualification and other information as required in summary report.

4. MATERIAL & EQUIPMENT

Not Applicable.

 

5. PROCEDURE

 

• DEFINITION
  • ANNUAL PRODUCT REVIEW (APR)

An organized and comprehensive summary of all production, analytical and customer data associated with a pharmaceutical product.

• APR CUT-OFF DATE

The date through which all released or rejected batches is included in an APR. It is from 1^st January to 31^st December.

• PREPARATION FOR APR
  • A list “Selection of Batches for APRs” is finalized by the QA Deptt. which will establish the specific products to be reviewed, APR is conducted in the first month of every year (i.e. January) to review the last year’s working.
  • At the start of a calendar year, “Annual Product Review Summary” reports format is collected from QA department by Production & QC.
  • Production, QC and QA departments enter the relevant data in “Annual Product Review Summary” reports.
  • DATA BY QC DEPARTMRNT

Data and information required by Quality Control Department is:

1. Product Testing Record including release, retest or reject such as Out Of Specifications (OOS).
2. Record of Instrumentation Stoppage / Out of Order related to product testing.
3. Repeat Testing of Raw Material / Product.
4. Status of Analytical Method Validation of testing procedures for all products in the APR list.
5. Status of Pharmacopoeia Review of all products in the APR list along with their Raw materials.
6. Status of Reference Standards including Primary, Secondary, working standards, their proper testing and documentations for traceability.
7. Status of Shelf Life Study.
8. Status of Equipment Qualification related to product testing instruments.
   • DATA BY PRODUCTION / MAINTENANCE DEPARTMENT

Data and information required by Production / Maintenance Departments is:

1. Reprocess / Rework.
2. Product Stoppage related to Major machine breakdown.
3. Report of Raw Material / Packing Material not received in time.
4. Status of Equipment Qualification for all products in the APR list.
5. Status of Equipment Qualification related to product testing.
   • DATA BY Q.A. DEPARTMENT

Data and information required by Quality Assurance Department is:

1. Product Changes of all products.
2. Deviations of all products.
3. External Complaints
4. Status of Process validation of all products in APR list.
5. Report of recalled products.
   • Others (as required by Management).

• Each department review their respective data required by them to ensure that no entry is missing in Summary Report.
• After reviewing APR Summary Reports, Process capability Analysis will be done by determining C_pk C_pk represents the distance of the centre of the process to the nearest specification limit in units process width. Therefore, it shows the amount of variation and the centering of the process.
  • C_pk is calculated according to following equation for capability Index:

C_{pL =  X – LSL}                         C_{pU =  USL  –  X}                   C_{pk = min (}C_pL, C_pU)

3ϭ                                   3ϭ

Where  x is mean  and ϭ is Standard Deviation

5.4.2   To determine C_pk values quantitative results are taken from the FG test reports. A C_pk value of less than 1.0 means that the result is out of specification and unacceptable accordingly. V Values in 1-1.33 range indicate the need for improvement. Cpk = 1.33 or higher is the desired state.

• After list of batches for APR, all above data in APR Summary reports is checked for reasoning evaluated by APR Team on “Evaluation of Annual Product Review Data”.
• APR Team includes :
  • Quality Assurance Manager,
  • Quality Control Manager,
  • Production Manager,
  • Section Incharge.
  • Executive Director
• The review by above APR Team comprise of following:
  • PROCESS IN CONTROL

This conclusion indicates no abnormalities within sets of data and confirms that the process continues to function within specified parameters of validation.

• ACTIONS RECOMMENDED

This conclusion indicates that some recommended actions should be considered but the process is essentially functioning as designed and validated, the process continues to operate in a state-of-control.

• CORRECTIVE ACTIONS REQUIRED

This conclusion indicates the need for immediate actions or corrections for the process which is not operating in a state-of-control and investigation is required that includes evaluating the root causes of issues observed & then taking appropriate corrective actions for these products. Such products require special attention throughout the coming year for all technical departments (PRD / QA / QC) till it is ensured that the product’s process is in a state-of-control. Recommended & corrective actions of technical team are forwarded to all concerned departments for corrective & preventive actions along with the target dates.

• Recommended & Corrective actions are classified into Critical, Major, Minor for the follow up on the basis of their significance.

1. Critical

That directly affect the Product/ material/ test quality, purity or safety e.g. formulation, Process change.

1. Major

That can cause product/ material/ test quality, purity or safety in question e.g. Process parameters.

1. Minor

That do not directly affect product/ material/ test quality, purity or safety e.g. specifications.

• All recommended & corrective actions with responsible persons and their significance are collected on “Annual Product Review (APR) follow up Report” by Q.A. Department for proper & in time follow up.
  • Critical actions are given high priority by all team members for early closure. They are listed in review form in the same order i.e.

1. Critical,
2. Major,
   • APR follow up report is conducted by QA department. All APRs data is properly filed and kept secured by the Q.A. Department, for a minimum period of 5 years.

6. REPORTING

• Product Summary Report for Annual Product Review
• Selection of Batches for Annual Product Review
• Annual Product Review (APR) follow up report
• Evaluation of Annual Product Review Data

7. REFERENCE DOCUMENTS

 

• SOP for Corrective & Preventive Action
• SOP for Customer Complaint

A simplified statistical model to assess product capability. (Pharmaceutical Engineering online exclusive, ISPE )