Registration of the samples received by the QC physical-and-chemical and microbiology laboratories for testing
OBJECTIVE
- To provide the registration of samples received by the QC physical-and-chemical and microbiology laboratories for testing.
SCOPE
- This SOP is applicable to the registration of samples received by the QC physical-and-chemical and microbiology laboratories for testing.
RESPONSIBILITY
- Quality Control Analyst shall be responsible to follow the procedure mentioned in this SOP.
ACCOUNTABILITY
- QC Head and QA Head shall be accountable for compliance of this SOP.
ATTACHMENTS
- Raw material inward Log Book – Attachment-I
- Finished products inward log book – Attachment-II
- Finished products registration log book – Attachment-III
- Packing material inward log book – Attachment-IV
PROCEDURE
- The sampling of raw materials is performed by the trained staff authorized by QC Head.
- The sample is to be accompanied by the following documents:
- Goods Receipt Note.
- Consignment Observation Sheet.
- Certificate of quality/analysis (from the manufacturer).
- The analyst appointed by the QC Head checks the received sample to be sure that the labeling corresponds with the information in the appointment card to test and fills the relevant logbook. (Attachment-I, Attachment-II, Attachment-III).
- The sample is dated, registered; and the information about the sample is entered into the registers.
- Each sample is given a relevant label.
- Samples for analysis are stored integrally under the conditions specified by the manufacturer.
REFERENCES
- If any
ABBREVIATIONS
- SOP: Standard Operating Procedure
- QC: Quality Control Department
- QA: Quality Assurance Department
DISTRIBUTION LIST
- QC: Quality Control Department
- QA: Quality Assurance Department
HISTORY OF REVISION
Attachment-I
Raw material inward Log Book
| S.No. | Name of Product | Date of Received | Manufacturer/Supplier | GRN/Challan No. | Batch No. | Qty. Received | Packing Size | Sampling Date | A.R. No. | Assay | Analyst | LOD/Moisture % | Date of Release | Remarks |
| Prepared By | Checked By | Approved By | |
| Designation | Quality Control Analyst | Quality Control Head | Quality Assurance Head |
| Sign / Date |
Attachment-II
Finished products inward logbook
Laboratory Logbook
| S.No | Name of Product | Date of Received | A.R.No. | Batch No. | Batch Size | Mfg. Date | Exp. Date | Assay | Dissolution | Analyst | Release Date | Remarks |
| Prepared By | Checked By | Approved By | |
| Designation | Quality Control Analyst | Quality Control Head | Quality Assurance Head |
| Sign / Date |
Attachment-III
Finished products registration logbook
Laboratory Logbook
| Date | Name (form, dosage) | Batch No. | Batch Size | Mfg. Date | Exp. Date | A.R. No | Date of analyses | Analyst | Release Date | Remarks |
| Prepared By | Checked By | Approved By | |
| Designation | Quality Control Analyst | Quality Control Head | Quality Assurance Head |
| Sign / Date |
Attachment-IV
Packing material inward logbook
Laboratory Logbook
| S.No. | Date | Name of Product | Manufacturer/Supplier | A.R. No. | Batch No. | Qty. | Packing Size | GRN/Challan No. | Sampled by | Analyst | Date of Release | Remarks |
| Prepared By | Checked By | Approved By | |
| Designation | Quality Control Analyst | Quality Control Head | Quality Assurance Head |
| Sign / Date |