- Objective:
To lay down the procedure for Preparation of Certificate of Analysis in Quality Control Department.
- Scope:
This SOP is applicable for Preparation of Certificate of Analysis in Quality control Department.
- Responsibility:
- Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Preparation of Certificate of Analysis 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 Certificate of Analysis: | |
| 5.1.1 | On completion of Raw Material analysis, analyst or supervisor should prepare Certificate of Analysis as per respective Analytical Work Report of Raw Material. | |
| 5.1.2 | Certificate of Analysis comprises of Header, Footer and Body. | |
| 5.1.3 | Prepare Certificate of Analysis as per following procedure. | |
| 5.1.4 | Header should contain the following: | |
| 5.1.5 | 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 ‘Certificate of Analysis’ (Font: Times new roman, Font style: Bold, font size 16) 6. Subtitle as ‘Raw Material’ (Font: Times new roman, Font style: Bold, font size 16) |
|
| 5.1.6 | Body contains all the detail information of Raw Material, Tests parameters, Results obtained and Acceptance Criteria as per respective Raw Material Specification. | |
| 5.1.7 | Body is divided into two parts. | |
| 5.1.8 | First part contains detail information of Raw Material as follows:
1. Name 2. Manufacturer 3. Supplier 4. Batch No. 5. Quantity Received 6. A.R. No. 7. GRN No. and Date 8. Mfg. Date 9. Exp. Date 10. Quantity Sampled 11. Sampled by and Date 12. Release Date: 13. Retest Date: |
|
| 5.1.9 | Second part contains Serial Number, Tests, Results and Standard Limits. | |
| 5.1.10 | Footer contains final conclusion of the analysis as follows:
Remark: The sample complies / does not comply with respect to the above tests as perIP/BP/USP/IHSand Raw Material Specification No.:________ |
|
| 5.1.11 | After remark, footer contains Analysed by, Checked by and Approved by signatures with date. | |
| 5.1.12 | Analyst (who performed analysis), Reviewer or supervisor (who checked the Analytical Work Report and COA) and Quality Control Head (who approves the Analytical Work Report and COA) should sign on the COA. | |
| 5.2 | Preparation of Finished Product Certificate of Analysis: | |
| 5.2.1 | On completion of Finished Productanalysis, analyst or supervisor should prepare Certificate of Analysis as per respective Analytical Work Report of Finished Product. | |
| 5.2.2 | Follow the same procedure as mentioned for preparation of Raw Material Certificate of Analysis except the following: | |
| 5.2.3 | In the header, Title shall be ‘Finished Product’. | |
| 5.2.4 | Body contains all the detail information of Finished Product, Tests parameters, Results obtained and Acceptance Criteria as per respective Finished Product Specification. | |
| 5.2.5 | First part contains detail information of Finished Product as follows:
1. Generic Name 2. Brand Name 3. Batch No. 4. Batch Size 5. Mfg. Date 6. Exp. Date 7. A. R. No. 8. Quantity Sampled 9. Sampled by and Date 10. Release Date |
|
| 5.2.6 | Footer contains final conclusion of the analysis as follows:
Remark: The sample complies / does not comply with respect to the above tests as perIP/BP/USP/IHSand Finished Product Specification No.:__________ |
|
| 5.2.7 | Finished Product COA shall be approved by QA Head or Designee. | |
| 5.3 | Preparation of In process Sample Certificate of Analysis: | |
| 5.3.1 | On completion of In process Sampleanalysis, analyst or supervisor should prepare Certificate of Analysis (If required) as per respective Analytical Work Report of In process Sample. | |
| 5.3.2 | Follow the same procedure as mentioned for preparation of Raw Material Certificate of Analysis except the following: | |
| 5.3.3 | In the header, Title shall be ‘In process Sample’. | |
| 5.3.4 | Body contains all the detail information of In process Sample, Tests parameters, Results obtained and Acceptance Criteria as per respective In process Sample Specification. | |
| 5.3.5 | First part contains detail information of In process Sample as follows:
1. Generic Name 2. Brand Name 3. Batch No. 4. Batch Size 5. Mfg. Date 6. Exp. Date 7. A. R. No. 8. Quantity Sampled 9. Sampled by and Date 10. Release Date |
|
| Note: In process COA can be Prepare as per party requirement. | ||
| 5.3.6 | 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 and In process Sample Specification No.:_________ |
|
| 5.4 | Preparation of Packing Material Certificate of Analysis: | |
| 5.4.1 | On completion of Packing Materialanalysis, analyst or supervisor should prepare Certificate of Analysis as per respective Analytical Work Report of Packing Material. | |
| 5.4.2 | Follow the same procedure as mentioned for preparation of Packing MaterialCertificate of Analysis except the following: | |
| 5.4.3 | In the header, Title shall be ‘Packing Material’. | |
| 5.4.4 | Body contains all the detail information of Packing Material, Tests parameters, Results obtained and Acceptance Criteria as per respective Packing MaterialSpecification. | |
| 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 as per IP/BP/USP/IHS and Packing Material Specification No.:_______ |
|
| 5.5 | Preparation of Working Standard Certificate of Analysis | |
| 5.5.1 | On completion of Working Standard analysis, analyst or supervisor should prepare Certificate of Analysis as per respective Analytical Work Report of Working Standard. | |
| 5.5.2 | Follow the same procedure as mentioned for preparation of Working Standard Certificate of Analysis 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, Tests parameters, Results obtained and Acceptance Criteria as per respective Working Standard Specification. | |
| 5.5.5 | First part contains detail information of Working Standard as follows:
1. Name 2. WS No. 3. Source A. R. No. 4. Evaluated with Reference Standard No. 5. Reference Standard Lot No. / Batch No. 6. Date of Qualification 7. Validity 8. Storage Conditions |
|
| 5.5.6 | Footer contains final conclusion of the analysis as follows:
Remark: The sample complies / does not comply with respect to the above tests as per Specification No.:_________ and certified to be used as Working Standard. |
|
- Definition/Abbreviations:
- Definition:
- Abbreviations:
| Abbreviation | Expansion |
| No. | Number |
| COA | Certificate of Analysis |
| A. R. No. | Analytical Reference Number |
| IP | Indian Pharmacopoeia |
| BP | British Pharmacopoeia |
| USP | United State Pharmacopoeia |
| Mfg. | Manufacturing |
| Exp. | Expiry |
*Note – Ready to use SOP available in “DOWNLOAD” Section.