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Raw materials presentation

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Raw materials presentation

  1. 1. SAMPLING, TESTING AND RELEASE / REJECTION OF RAW MATERIALS Presented by Malangsha shkrahul42@gmail.com 1 SAMPLING, TESTING AND RELEASE / REJECTION OF RAW MATERIALS Presented by Malangsha shkrahul42@gmail.com
  2. 2. Quality control shall receive "Material Received Report (MRR) from Warehouse as an intimation for raw material sampling. Upon receipt, sampling Executive shall verify the details on the MRR and supplier COA. Sampling Executive shall enter the details in the Raw Material Inward Record as per the MRR and assigns an Analytical Reference Number as per SOP. Sampling I analysis priority shall be decided upon the requirement of material and production plan, in case of multi MRR receipt. Executive-QC shall prepare the required number of labels (i.e., "Sample for analysis" and"Sampled") as defined in the below sampling plan. 2 Quality control shall receive "Material Received Report (MRR) from Warehouse as an intimation for raw material sampling. Upon receipt, sampling Executive shall verify the details on the MRR and supplier COA. Sampling Executive shall enter the details in the Raw Material Inward Record as per the MRR and assigns an Analytical Reference Number as per SOP. Sampling I analysis priority shall be decided upon the requirement of material and production plan, in case of multi MRR receipt. Executive-QC shall prepare the required number of labels (i.e., "Sample for analysis" and"Sampled") as defined in the below sampling plan.
  3. 3. Sampling plan 1 to 5 All 6 to 10 6 11 to 20 7 21 to 56 8 More than 56 --./n+ 1* If the decimal in --./n value is less than 5, it shall be rounded to the lowest value, if it is more than or equal to 5, it shall be rounded to the highest value. 3 Sampling plan 1 to 5 All 6 to 10 6 11 to 20 7 21 to 56 8 More than 56 --./n+ 1* If the decimal in --./n value is less than 5, it shall be rounded to the lowest value, if it is more than or equal to 5, it shall be rounded to the highest value.
  4. 4. Note: For the new vendor first three consignments of starting raw materials, composite sample shall be prepared from all the containers (100% sampling), irrespective of the sampling plan. Executive-QC shall carry self-sealed polyethylene bags, glass bottles, cleaned sampling devices (such as SS Scoop, thief sampler/glass sampler), prepared labels and sampling record to proceed for sampling.  Sampling Executive shall verify the physical condition, consignment details and "Under Test" label of the containers against MRR. In case of discrepancy the same shall be recorded and immediately informed to warehouse in charge for rectification. 4 Note: For the new vendor first three consignments of starting raw materials, composite sample shall be prepared from all the containers (100% sampling), irrespective of the sampling plan. Executive-QC shall carry self-sealed polyethylene bags, glass bottles, cleaned sampling devices (such as SS Scoop, thief sampler/glass sampler), prepared labels and sampling record to proceed for sampling.  Sampling Executive shall verify the physical condition, consignment details and "Under Test" label of the containers against MRR. In case of discrepancy the same shall be recorded and immediately informed to warehouse in charge for rectification.
  5. 5. Executive-QC shall randomly select the containers for sampling and instruct the warehouse personnel to shift the same containers to sampling booth. Executive-QC shall wear the safety devices and proceeds for sampling of selected containers one by one in the sampling booth. Sampling Executive shall check the physical appearance of the material and mix the contents thoroughly within the container by sampling devices (SS scoops/Thief sampler for solids or glass sampler for liquids) and collects the sample in self sealed bags (for solids) and glass bottles (for liquids). 5 Executive-QC shall randomly select the containers for sampling and instruct the warehouse personnel to shift the same containers to sampling booth. Executive-QC shall wear the safety devices and proceeds for sampling of selected containers one by one in the sampling booth. Sampling Executive shall check the physical appearance of the material and mix the contents thoroughly within the container by sampling devices (SS scoops/Thief sampler for solids or glass sampler for liquids) and collects the sample in self sealed bags (for solids) and glass bottles (for liquids).
  6. 6. Post sampling, container shall be sealed or closed immediately and "Sampled" labels shall be affix on the containers adjacent to under test Labels.  Sampling Executive shall take equal quantity from each container and collect composite sample .  If the physical appearance of the material is varying from container to container and specification as well, sampling activity shall be discontinued and informed to Head-QC.  In such case Head-QC along with QA representative shall approach ware house and verifies the physical appearance of the material. 6 Post sampling, container shall be sealed or closed immediately and "Sampled" labels shall be affix on the containers adjacent to under test Labels.  Sampling Executive shall take equal quantity from each container and collect composite sample .  If the physical appearance of the material is varying from container to container and specification as well, sampling activity shall be discontinued and informed to Head-QC.  In such case Head-QC along with QA representative shall approach ware house and verifies the physical appearance of the material.
  7. 7. If the material is confirmed failing in physical appearance, consignment shall be rejected without OOS investigation. If the physical appearance of the material in all the containers is similar and complying, all the samples shall be collected compositely.  All observations of sampling shall be recorded in "Raw material sampling record" Sampled containers shall be shifted to their original place immediately. Details of sampling shall be entered into the sampling booth usage and cleaning record of warehouse. 7 If the material is confirmed failing in physical appearance, consignment shall be rejected without OOS investigation. If the physical appearance of the material in all the containers is similar and complying, all the samples shall be collected compositely.  All observations of sampling shall be recorded in "Raw material sampling record" Sampled containers shall be shifted to their original place immediately. Details of sampling shall be entered into the sampling booth usage and cleaning record of warehouse.
  8. 8. Collected composite sample shall be brought to QC and divided into 3 parts in sample distribution area. One part shall be preserved as retention sample (for starting raw material only) and other two parts shall be used for complete analysis (at wet and Instrumentation labs) The QC Analyst shall test the samples as per respective standard test procedures.  If the sample meets the individual specification, material shall be approved and retention sample shall be logged. Incase sample does not meet the specification OOS shall be raised and investigation shall be carried out. 25.0 Based on the investigation status of the material shall be 8 Collected composite sample shall be brought to QC and divided into 3 parts in sample distribution area. One part shall be preserved as retention sample (for starting raw material only) and other two parts shall be used for complete analysis (at wet and Instrumentation labs) The QC Analyst shall test the samples as per respective standard test procedures.  If the sample meets the individual specification, material shall be approved and retention sample shall be logged. Incase sample does not meet the specification OOS shall be raised and investigation shall be carried out. 25.0 Based on the investigation status of the material shall be
  9. 9. Liquid raw materials (in tankers) sampling sequence: Sampling Executive shall take prepared sample labels, Glass bottles, sampling checklist, Glass sampler and proceeds for sampling. Sampling Executive shall verify the compartment wise Seal Naive intact and "Under test labels" before sampling.  Sampling Executive shall break the compartment seals and open the lids one by one. Sampling Executive shall rinse the sampler thrice with the material and collect the samples from the top of each compartment compositely into a glass bottle, if the physical appearance is similar in all compartments. 9 Liquid raw materials (in tankers) sampling sequence: Sampling Executive shall take prepared sample labels, Glass bottles, sampling checklist, Glass sampler and proceeds for sampling. Sampling Executive shall verify the compartment wise Seal Naive intact and "Under test labels" before sampling.  Sampling Executive shall break the compartment seals and open the lids one by one. Sampling Executive shall rinse the sampler thrice with the material and collect the samples from the top of each compartment compositely into a glass bottle, if the physical appearance is similar in all compartments.
  10. 10. Sampling Executive shall open the bottom valves and drain about 5 to 10 liters of the liquid into buckets. Then samples shall be collected from bottom of each compartment compositely into a glass bottle, if the physical appearance is similar in all compartments. Post sampling, compartments shall be sealed or closed immediately and "Sampled" labels shall be affix on the tanker adjacent to under test Label. If the physical appearance of the material is varying from container to container and specification as well, sampling activity shall be discontinued and informed to Head-QC. 10 Sampling Executive shall open the bottom valves and drain about 5 to 10 liters of the liquid into buckets. Then samples shall be collected from bottom of each compartment compositely into a glass bottle, if the physical appearance is similar in all compartments. Post sampling, compartments shall be sealed or closed immediately and "Sampled" labels shall be affix on the tanker adjacent to under test Label. If the physical appearance of the material is varying from container to container and specification as well, sampling activity shall be discontinued and informed to Head-QC.
  11. 11. ln such case Head-QC along with QA representative shall personally verify the physical appearance of the material. If the material is confirmed failing in physical appearance, consignment shall be rejected without OOS investigation.  If the physical appearance of the material in top / bottom portion is similar and complying, a composite sample shall be prepared and brought to QC for analysis. The QC Analyst shall test the samples as per respective standard test procedures. If the sample meets the individual specification, material shall be approved and tanker material shall be unloaded into bulk storage tank. 11 ln such case Head-QC along with QA representative shall personally verify the physical appearance of the material. If the material is confirmed failing in physical appearance, consignment shall be rejected without OOS investigation.  If the physical appearance of the material in top / bottom portion is similar and complying, a composite sample shall be prepared and brought to QC for analysis. The QC Analyst shall test the samples as per respective standard test procedures. If the sample meets the individual specification, material shall be approved and tanker material shall be unloaded into bulk storage tank.
  12. 12. Quantity unloaded shall be intimated by warehouse and the same shall be recorded in the raw material inward! sampling check list and protocol. Warehouse shall request a fresh A.R.No. for the composite material of storage tank once unloading is completed. Incase sample does not meet the specification OOS shall be raised and investigation shall be carried out. Based on the investigation, status of the material shall be decided accordingly. Analyst shall perform the analysis as per the product STP and records the raw data in the. "Raw material test protocol". 12 Quantity unloaded shall be intimated by warehouse and the same shall be recorded in the raw material inward! sampling check list and protocol. Warehouse shall request a fresh A.R.No. for the composite material of storage tank once unloading is completed. Incase sample does not meet the specification OOS shall be raised and investigation shall be carried out. Based on the investigation, status of the material shall be decided accordingly. Analyst shall perform the analysis as per the product STP and records the raw data in the. "Raw material test protocol".
  13. 13.  Analyst shall record instrument usage details in respective equipment logbooks. Analyst shall attach the calculations / observations / chromatograms with the test protocols. Test wise results shall be compiled in the certificate of analysis and forwarded to reviewer (section head) for cross verification. Section head shall review the raw data thoroughly and upon execution further forwards the report to Head-QC/Deputy for approval. In-charge - QC I deputy shall verify the data randomly and approves the document for release. 13  Analyst shall record instrument usage details in respective equipment logbooks. Analyst shall attach the calculations / observations / chromatograms with the test protocols. Test wise results shall be compiled in the certificate of analysis and forwarded to reviewer (section head) for cross verification. Section head shall review the raw data thoroughly and upon execution further forwards the report to Head-QC/Deputy for approval. In-charge - QC I deputy shall verify the data randomly and approves the document for release.
  14. 14.  Status label (Approved/Rejected labels) labels shall be prepared and pasted on the under test labels of the containers. MRR shall be sent to warehouse with status details along with certificate of analysis.  In the case of failure in quality parameters, OOS (Out of specification) shall be initiated for raw materials.  Further thorough investigation shall be carried out with document evidence for OOS materials.  Based on the investigation recommendation, status of the material shall be concluded. The final status of the material shall be recorded in the raw material inward registers along with date of release. 14  Status label (Approved/Rejected labels) labels shall be prepared and pasted on the under test labels of the containers. MRR shall be sent to warehouse with status details along with certificate of analysis.  In the case of failure in quality parameters, OOS (Out of specification) shall be initiated for raw materials.  Further thorough investigation shall be carried out with document evidence for OOS materials.  Based on the investigation recommendation, status of the material shall be concluded. The final status of the material shall be recorded in the raw material inward registers along with date of release.
  15. 15. Gases, Hazardous and Toxic raw materials:  Upon receipt of Gas cylinders/Tankers, Hazardous, Toxic raw materials sampling Executive shall verify the details on the MRR and supplier/manufacturer COA.  Sampling Executive shall enter the details in the Raw Material Inward register as per the MRR and assigns an Analytical Reference Number. Sampling Executive shall approach the consignments and visual verification shall be done. 15 Gases, Hazardous and Toxic raw materials:  Upon receipt of Gas cylinders/Tankers, Hazardous, Toxic raw materials sampling Executive shall verify the details on the MRR and supplier/manufacturer COA.  Sampling Executive shall enter the details in the Raw Material Inward register as per the MRR and assigns an Analytical Reference Number. Sampling Executive shall approach the consignments and visual verification shall be done.
  16. 16. Sampling shall not be performed for such raw materials and released as per the vendor certificate of analysis. In the case of captive consumption material transfers, earlier tested certificate of analysis shall be considered for release. 16

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