Procedure For Annual Product Quality Review
| STANDARD OPERATING PROCEDURE | ||
| Title | : | Procedure For Annual Product Quality Review |
- OBJECTIVE
- To lay down a procedure for Annual Product Quality Review.
- SCOPE
- This procedure is applicable to Quality Assurance Department for annual product review of finished products .
- RESPONSIBILITY
- Executive-Quality Assurance
- ACCOUNTABILITY
- Manager-Quality Assurance
- VP – Plant & Operations
- PROCEDURE
- Annual Product Quality Review shall be carried out for each product manufactured in the previous year. Along with Annual product review, implementation of preceding year’s recommendations should be reviewed.
- For similar products with different brand names in formulation shall be grouped / clubbed for Annual product review.
- Annual Product Quality Review report should be completed by the month of February.
- Annual Product Quality Review shall essentially include the assessment of product history by involving the following attributes:-
- Trend analysis of essentially the following parameters shall be compiled product wise and batch wise.
- Assay, Disintegration test, Friability, Hardness, Water content, Uniformity of weight.
- Review of all batches that failed to meet established specifications and related investigation.
- A review of all deviations or non-conformances and related investigation.
- Review of any changes carried out to the processes, system or analytical methods.
- Product Recall, reason for Recalls and corrective actions taken / planned.
- Returned Goods and Salvaged Goods.
- Control sample review and observations.
- Out of specifications.
- Market Complaints, investigations and the corrective actions.
- Based on Annual Product Quality Review, recommendation should be made in the report for any desired changes.
- Annual Product Quality Review shall be prepared by Quality Assurance as per the format no. 1.
- Annual Product Quality Review shall be checked by Executive-QA.
- Manager – Quality Assurance shall approve Annual Product Review.
- Shall Authorized Annual Product Review?
- All record shall be archived in Quality Assurance.
- ABBREVIATIONS
- QA – Quality Assurance
- SOP – Standard Operating Procedure
- ATTACHMENT
| Sr. No. | Title | Format No. |
| 1. | Format for annual product quality review | 1 |
- DISTRIBUTION LIST
| Sr. No. | Copy No. | Department |
| Quality Assurance | ||
| Quality Control | ||
| Plant & Operations |
ATTACHMENT -I
annual product Quality review | ||
| Name of the Product : Generic Name : | Department | Quality Assurance |
Session | YYYY | |
- List of batches manufactured
- Trend analysis of quality parameter
- Deviations reported in the year
- Control sample observation
- Product recall
- Out of specification
- Batch failures
- Market complaints
- Change in process
- Abbreviations