1.0 PURPOSE:
1.1 To lay down the procedure for Sampling of Raw materials.
2.0 SCOPE:
2.1 This procedure is applicable for all the Raw materials (Non-sterile).
3.0 RESPONSIBILITY:
3.1 Chemist – Quality Control.
3.2 Section Head - Quality Control.
3.3 Chemist - IPQA
4.0 ACCOUNTABILITY:
4.1 Head - Quality Control.
5.0 PROCEDURE:
5.1 Upon receipt of “Material Receipt Report (MRR)” from warehouse, IPQA chemist shall check the details on the MRR and supplier COA.
5.2 IPQA chemist shall enter the details in the Raw Material Inward register as per the MRR (Refer Format No.: xxxxx
Sequential activities of Sampling Chemist.
5.3 Solid & Liquid (in carboys & drums) Raw materials.
5.3.1 Shall prepare the sampled labels the number of labels shall be as per the table below.
Sampling plan
S.No. No. of containers received/Batch No. of containers to be sampled
1 Up to 3 All
2 Above 3
?N + 1 or minimum 3
5.3.2 Shall take prepared sampled labels, MRR, Analytical data sheet, cleaned sampling devices from Quality control (such as Thief – sampler, Glass sampler, etc.), Personnel safety devices (such as Hand gloves, Goggles, Nose mask etc.) and sample collection polythene bags (for solids) or glass bottles (for liquids).
5.3.3 Shall check the consignment details and quarantine label on the containers with respect to MRR. Any discrepancy shall be immediately informed to warehouse in-charge to resolve it.
5.3.4 Critical solid samples shall be sampled under Laminar Air Flow (LAF) and the liquid sampling shall be done in the quarantine area only.
5.3.5 Shall wear the safety devices and shift the randomly selected containers as per above sampling plan to sampling booth (In case of solids) one by one and open them.
5.3.6 Sampling shall be done from the selected containers in such a way that the total quantity shall be sufficient for three analysis (approximately 60 g for solids and 200 mL for liquids).
5.3.7 Shall collect the sample separately from each container in self sealed polythene bag (for solids) or in glass bottle (for liquids) and seal or close the sample containers immediately.
5.3.8 Shall close the opened containers and paste the sampled labels adjacent to quarantine labels, then shift back to quarantine area.
5.3.9 Shall enter the observations during sampling in the “Sampling Observation sheet of Analytical data sheet.
5.3.10 Shall bring all the individual samples to IPQA and shall check the physical appearance and nature of the individual samples.
5.3.11 Shall blend (in case of individual samples are identical) all the samples and make a composite sample and handover the samples to Quality control chemist with MRR.
5.3.12 Upon receipt of sample QC-Chemist divide this into three equal parts. One part for analysis and two parts for retention sample (Retention sample in case of critical raw materials only)
5.3.13 Shall keep the sample for analysis in the tray labeled as “Raw Materials under analysis”.
5.4 Liquid (in tankers) Raw materials.
5.4.1 Shall take MRR, Analytical data sheet, Sampling devices (such as Glass sampler), Personnel safety devices (such as Hand gloves, Goggles, Nose mask etc.) and sample collection glass bottles.
5.4.2 Shall wear the safety devices and shall inform the tanker driver to move the tanker forward and backward few yards to mix the contents in the tanker.
5.4.3 Shall break the compartment seals and open the lids.
5.4.4 Shall rinse the sampler thrice with the material and collect samples of all compartment top portions in a glass bottle, label and close it immediately with the lid.
5.4.5 Shall open the bottom valve and recycle about 30 liters of the liquid. Then collect the samples of all compartment bottom portions in a glass bottle, label and close it immediately with the lid.
5.4.6 Shall sample from all the compartments top and bottom portions in such a way that the total quantity shall be sufficient for two analysis (approximately 200 mL).
5.4.7 Shall enter the observations during sampling in the “Sampling Observation sheet “
5.4.8 Shall bring both the individual samples to IPQA and shall check the physical appearance and nature of the individual samples.
5.4.9 Shall blend (in case of individual samples are identical) composite top portion and bottom portion in to a glass bottle and this composite sample hand over to Quality Control for complete analysis. along with MRR
5.4.10 Upon receipt of sample from IPQA, QC chemist distribute the sample to respective sections for analysis
5.4.11 Shall keep the sample for analysis in the tray “Raw Materials under analysis”.
Note: Bottom portion samples shall not be required for Acid and Alkali tankers.
5.5 Used sample devices shall be cleaned.
Raw materials, quality control, sampling, bottle
