SOP Title: Analytical Data Review and Result Transcription
- Objective:
To lay down the procedure for Analytical Data Review and Result Transcription in the Quality Control Department.
- Scope:
This procedure is applicable for Analytical Data Review and Result Transcription in the Quality Control Department.
- Responsibility:
- Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Analytical Data Review and Result Transcription in Quality Control Department as per this SOP.
- Quality Assurance Department: To review and approve the SOP and Annexure.
- Accountability:
Head Quality Control Department, Head Quality Assurance Department.
- Procedure:
| 5.1 | Compilation of Analytical Data: | ||
| 5.1.1 | Analysis shall be carried out as per standard testing procedure and reporting of results shall be carried out with respect to specification. | ||
| 5.1.2 | All raw data like printouts of weight prints, chromatograms, spectrum, and contract testing laboratories reports shall be affixed. | ||
| 5.1.3 | Raw data sheet and all weight prints, chromatograms, spectrum shall be signed by the analyst and reviewed by reviewer. | ||
| 5.1.4 | Ensure that all entries shall be in respective log Books during analysis. | ||
| 5.1.5 | All relevant information shall be filled in respective raw data sheet. | ||
| 5.1.6 | Ensure that always use the current lot of working standard and reference standard, wherever applicable. | ||
| 5.1.7 | Ensure that correct factor used during the water content testing with Karl Fischer Titrator and correct molarity with Automatic Potentiometer Titrator. | ||
| 5.1.8 | Analytical results shall be carry forward to next stage in case of dose form of product is same like; results of coated tablets, uncoated tablet, Filled capsules, cream and ointment shall be transcribed during analysis finished product, wherever applicable. | ||
| 5.1.9 | Ensure that reference A.R. No. shall be mentioned in finished product report during the transcription of results from respective stage.
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| 5.1.10 | In case data transcribed from previous stage, ensure that at least description and identification test to be carried out. | ||
| 5.1.11 | In case, identification test to be done for finished product by HPLC then, one Blank, one standard and one sample shall be injected in the HPLC. | ||
| 5.1.12 | In case, only identification test to be done for raw material by HPLC/GC then, one Blank, one standard and one sample shall be injected in the HPLC/GC. | ||
| 5.1.13 | Micro analysis shall be carried out in finished pack, if applicable. | ||
| 5.1.14 | If any customer, ask for the complete test after packing then all test shall be carried out after packing. | ||
| 5.2 | Review of Analytical Data : | ||
| 5.2.1 | Person having sufficient experience or subject expert shall be responsible for review of analytical data. | ||
| 5.2.2 | Ensure that all relevant details of tested materials / product entered in raw data sheet. | ||
| 5.2.3 | Ensure that all the relevant entries made in the respective log books. | ||
| 5.2.4 | Ensure that analysis is completed as per respective current specification. | ||
| 5.2.5 | Ensure that use of working standard and its potency is as per current/effective working standard. | ||
| 5.2.6 | Ensure that analysis has been completed by using the corrected HPLC/GC columns. | ||
| 5.2.7 | Ensure that all print outs / chromatograms / spectrum duly signed and dated by analyst and attached with raw data sheet. | ||
| 5.2.8 | Ensure that correct Normality/Molarity of volumetric solution is used. | ||
| 5.2.9 | Ensure that correct factor is used for water content testing by using Karl Fischer. | ||
| 5.2.10 | Ensure that all units mentioned correctly in raw data sheet. | ||
| 5.2.11 | Rounding of digits shall be done as per SOP ‘Rounding and Reporting of Test Results’. | ||
| 5.2.12 | Ensure the correctness of calculations. | ||
| 5.2.13 | Reviewer shall check all raw data attached with report for its correctness and accuracy. | ||
| 5.2.14 | Reviewer shall put the signature along with date on raw data sheet. | ||
| 5.2.15 | Reviewer shall sign and date raw data, wherever applicable. | ||
| 5.2.16 | Always follow approved specification and standard testing procedure for the review of document. | ||
| 5.3 | Reviewer Certification: | ||
| 5.3.1 | Before reviewing any data, reviewer shall be assessed by his/her supervisor to check sufficient knowledge and understanding of relevant records possessed by that particular person. | ||
| 5.3.2 | Supervisor shall allocate one complete current analytical report for checking to the reviewer to do the assessment of his/her reviewing skills. | ||
| 5.3.3 | After completion of review of analytical report, supervisor shall re-check same analytical report for its correctness and accuracy. | ||
| 5.3.4 | If all data reviewed by new reviewer and supervisor are matching then supervisor shall recommend to the new reviewer for certification as per Annexure. | ||
| 5.3.5 | Finally certification of reviewer shall be done by Head Quality Control/Designee. | ||
- Definitions / Abbreviations :
- Definitions :
- Abbreviations :
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| QC | Quality Control |
| QA | Quality Assurance |
*Note – Ready to use SOP available in “DOWNLOAD” Section.