SOP Title: Preparation of Analytical Work Report
- Objective:
To lay down the procedure for Preparation of Analytical Work Report in Quality Control Department.
- Scope:
This SOP is applicable for Preparation of Analytical Work Report used to record results of analysis of Raw Material, Finished Product, In process Sample, Packing Material, Working Standard, Stability study in Quality Control Department.
- Responsibility:
- Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Preparation of Preparation of Analytical Work Report in Quality Control Department as per this SOP.
- Quality Assurance Department: To review and approve the SOP and Annexures.
- Accountability:
Head Quality Control Department, Head Quality Assurance Department.
- Procedure:
| Sr. No. | Procedure | ||
| 5.1 | Preparation of Raw Material AWR: | ||
| 5.1.1 | Analytical Work Report comprises of Header, Footer and Body. | ||
| 5.1.2 | Prepare Analytical Work Report as per following procedure. | ||
| 5.1.3 | Header should contain the following: | ||
| 5.1.4 | 1. Company logo
2. Company Name (Font: Times new roman, Font style: Bold, font size 22) 3. Address of the company (Font: Times new roman, Font style: Regular, font size 12) 4. Department name (Font: Times new roman, Font style: Bold, font size 18) /Page No.( Font: Times new roman, Font style: regular, font size 12) 5. Title as ‘Analytical Work Report’ (Font: Times new roman, Font style: Bold, font size 14) 6. Sub title as ‘Raw Material’ (Font: Times new roman, Font style: Bold, font size 14) 7. ‘AWR No.’ i.e. Analytical Work Report Number (Font: Times new roman, Font style: Bold, font size 12) |
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| 5.1.5 | Body contains all the detail information of Raw Material, Number of tests to be carried out with details, Results obtained and as per respective Raw Material Specification. | ||
| 5.1.6 | Body is divided into two parts. | ||
| 5.1.7 | 1. AWR No.
2. Name 3. A. R. No. 4. Manufacturer 5. Supplier 6. Batch No. 7. Quantity Received 8. Analysis completion Date 9. GRN No. and Date 10. Mfg. Date 11. Exp. Date 12. Quantity Sampled 13. Sampled by and Date 14. Effective date 15. Version Number 16. Refer STP No. |
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| 5.1.8 | Remaining pages of AWR includes Raw Material below the Header. | ||
| 5.1.9 | Second part contains all the Tests parameters as per respective Standard Test Procedure and Specification. | ||
| 5.1.10 | All the tests should be in the same order as per Standard Test Procedure. | ||
| 5.1.11 | Each test should include following details:
1. Name of the test 2. Instrument ID No. (if applicable) 3. Details of Solution Preparation/Calculations (if applicable) 4. Reference Materials Details (if applicable) 5. Observations 6. Analysed By/Date 7. Complies/Does not comply
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| 5.1.12 | Footer comes only on the last page of AWR. | ||
| 5.1.13 | Footer contains final conclusion of the analysis as follows:
Remark: The sample complies / does not comply with respect to the above tests as per IP/BP/USP/IHS and Raw Material Specification No.: _____________ |
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| 5.1.14 | After remark, footer contains Analysed by, Checked by and Approved by signatures with date and revision history. | ||
| 5.1.15 | Analyst (who performed analysis), Reviewer or supervisor (who checked the Analytical Work Report) and Quality Control Head (who approves the Analytical Work Report) should sign on the AWR. | ||
| 5.2 | |||
| 5.2.1 | Follow the same procedure as mentioned for preparation of Raw Material AWR except the following: | ||
| 5.2.2 | In the header, Title shall be ‘Finished Product’. | ||
| 5.2.3 | Body contains all the detail information of Finished Product, Number of tests to be carried out with details, Results obtained and as per respective Finished Product Specification. | ||
| 5.2.4 | First page of AWR includes all the detail information of Finished Product as follows:
1. AWR No. 2. Name 3. Batch No. 4. A. R. No. 5. Batch Size 6. Mfg. Date 7. Exp. Date 8. Quantity Sampled 9. Sampled by and Date 10. Analysis completion Date 11. Effective Date 12. Version Number 13. Refer STP No. |
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| 5.2.5 | Footer contains final conclusion of the analysis as follows:
Remark: The sample complies / does not comply with respect to the above tests as per IP/BP/USP/IHS and Finished Product Specification No.: _________________
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| 5.3 | |||
| 5.3.1 | Follow the same procedure as mentioned for preparation of Raw Material AWR except the following: | ||
| 5.3.2 | In the header, Title shall be ‘In process Sample’. | ||
| 5.3.3 | Body contains all the detail information of In process Sample, Number of tests to be carried out with details, Results obtained and as per respective In process Sample Specification. | ||
| 5.3.4 | First page of AWR includes all the detail information of In process Sample as follows:
1. AWR No. 2. Name 3. Batch No. 4. A. R. No. 5. Batch Size 6. Mfg. Date 7. Exp. Date 8. Quantity Sampled 9. Sampled by and Date 10. Analysis completion Date 11. Effective Date 12. Version Number 13. Refer STP No. |
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| 5.3.5 | Footer contains final conclusion of the analysis as follows:
Remark: The sample complies / does not comply with respect to the above tests as per IP/BP/USP/IHS and In process Sample Specification No.: _________ |
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| 5.4 | |||
| 5.4.1 | Follow the same procedure as mentioned for preparation of Raw Material AWR except the following: | ||
| 5.4.2 | In the header, Title shall be ‘Packing Material’. | ||
| 5.4.3 | Body contains all the detail information of Packing Material, Number of tests to be carried out with details, Results obtained and as per respective Packing Material Specification. | ||
| 5.4.4 | First page of AWR includes all the detail information of Packing Material as mentioned in the Raw material AWR preparation. | ||
| 5.4.5 | Footer contains final conclusion of the analysis as follows:
Remark: The sample complies / does not comply with respect to the above tests and Packing Material Specification No.: __________ |
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| 5.5 | Preparation of Working Standard AWR: | ||
| 5.5.1 | Follow the same procedure as mentioned for preparation of Raw Material AWR except the following: | ||
| 5.5.2 | Follow the same procedure as mentioned for preparation of Raw Material AWR except the following: | ||
| 5.5.3 | In the header, Title shall be ‘Working Standard’. | ||
| 5.5.4 | Body contains all the detail information of Working Standard, Number of tests to be carried out with details, Results obtained and as per respective Working Standard Specification. | ||
| 5.5.5 | First page of AWR includes all the detail information of Working Standard as follows: | ||
| 5.5.6 | 1. AWR No.
2. Name 3. WS No. 4. Source Batch No. 5. Source A. R. No. 6. Evaluated with Reference Standard No. 7. Reference Standard Lot No. / Batch No. 8. Analysis completion Date 9. Mfg. Date 10. Exp. Date 11. Manufacturer 12. Supplier 13. Effective date 14. Version Number 15. Refer STP No. |
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| 5.5.7 | Footer contains final conclusion of the analysis as follows:
Remark: The sample complies / does not comply with respect to the above tests as per Specification No.: _________ and certified to be used as Working Standard. |
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| 5.5.8 | Follow the same procedure as mentioned for preparation of Raw Material AWR except the following:
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| 5.6 | |||
| 5.6.1 | Follow the same procedure as mentioned for preparation of Raw Material AWR except the following: | ||
| 5.6.2 | In the header, Title shall be ‘Stability Study’. | ||
| 5.6.3 | Body contains all the detail information of Stability Sample, Number of tests to be carried out with details, Results obtained as per respective Stability Study Specification. | ||
| 5.6.4 | First page of AWR includes all the detail information of Stability Sample as follows: | ||
| 5.6.5 | 1. AWR No.
2. Name 3. Batch No. 4. Batch Size 5. Mfg. Date 6. Exp. Date 7. A. R. No. 8.Storage Conditions 9. Stability Period 10. Quantity Sampled 11. Sampled by and Date 12. Effective Date 13. Version Number 14. Analysis completion Date 15. Refer STP No. |
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| 5.6.6 | Footer contains final conclusion of the analysis as follows:
Remark: The sample complies / does not comply with respect to the above tests as per IP/BP/USP/IHS and Stability Study Specification No.: __________ |
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| 5.7 | |||
| 5.7.1 | Follow the same procedure as mentioned for preparation of Raw Material AWR except the following: | ||
| 5.7.2 | In the header, Title shall be ‘Purified Water/ Raw Water/Treated Water/Soft Water/Water Validation’. | ||
| 5.7.3 | Body contains all the detail information of Water Sample, Number of tests to be carried out with details, Results obtained and as per respective Water Specification. | ||
| 5.7.4 | First page of AWR includes all the detail information of Water Sample as follows: | ||
| 5.7.5 | 1. AWR No.
2. Name 3. Quantity Sampled 4. A. R. No. 5. Sampling Point 6. Sampled by and Date 7. Date of Analysis 8. Effective Date 9. Version Number 10. Refer STP No. |
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| 5.7.6 | Footer contains final conclusion of the analysis as follows:
Remark: The water sample complies / does not comply with respect to the above tests as per IP/BP/USP/IHS and water Sample Specification No.: _________ |
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| 5.7.7 | Numbering system for Analytical Work Report: AWR/XXX
Where AWR: Analytical Work Report XXX : Serial number of the Analytical Work Report |
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| 5.7.8 | AWR also shall include Version No. which begins with 00 and continue 01, 02……during revision. | ||
| 5.7.9 | All Analytical Work Report should contain AWR No. | ||
- Definition / Abbreviations :
- Definition:
- Abbreviations :
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| QC | Quality Control |
| QA | Quality Assurance |
| No. | Number |
| AWR | Analytical Work Report |
| A. R. No. | Analytical Reference Number |
| IP | Indian Pharmacopoeia |
| BP | British Pharmacopoeia |
| USP | United State Pharmacopoeia |
| Mfg. | Manufacturing |
| Exp. | Expiry |
| STP | Standard Testing Procedure |
*Note – Ready to use SOP available in “DOWNLOAD” Section.