| Sampling of Raw Material in Cepha Block |
1.0 OBJECTIVE 1.1 To lay down the procedure for sampling of raw material in Cepha Block in quality control lab. 2.0 SCOPE 2.1 This procedure is applicable for sampling of raw materials in Cepha Block., so as to get the representative sample of whole the lot in Quality Control Department. 3.0 RESPONSIBILITY 3.1 QC – Chemist / Officer / Executive 4.0 ACCOUNTABILITY 4.1 Head-QC 5.0 PROCEDURE 5.1 QC will receive the GRN along with certificate of analysis from the warehouse person of Cepha Block. 5.2 Executive-QC will arrange the sampling of raw material on receipt of the GRN. 5.3 The planned raw material to be sampled is bought near the sampling booth from warehouse location. 5.4 Cleaning of raw material sampling area: 5.4.1 Floor cleaning: Clean the floor with teepol 1% v/v and disinfectant with Dettol 2.5% v/v or Savlon 2.5% v/v weakly rotation at the beginning and end of each shift. After every batch sampling, cleaning of the area shall be done with 2.5% v/v disinfectant solution (Dettol or Savlon) in quality control lab. 5.4.2 Wall cleaning: Clean the walls every weekend with a clean wet mop with 2.5% v/v disinfectant (dettol) followed by a clean dry cloth. 5.4.3 RLAF booth cleaning: The two criteria shall be followed: • When same active with different batch numbers: then only dry mopping shall be done. • When two different raw material to be sampled, first wet mop with 2.5% v/v disinfectant solution (Dettol or Savlon), then dry mopping shall be done. 5.4.4 Note: At the end of the cleaning, QC chemist shall inspect the area and make a record of it in the “RLAF Sequential log for usage and cleaning” as per format number XXX. 5.5 Physical check before sampling: 5.5.1 Check the vendor list to ensure that the material is from approved vendor. If the material received is not from approved vendor, then sampling shall not be done. 5.5.2 If the COA of the raw material is not received, then inform to head QC, after approval from head QC, sampling shall be done in warehouse. 5.5.3 Check the physical status of the container/bags and make entries in “Inspection Report of Raw Material” (as mentioned in format number XXX. 5.5.4 Check the packing conditions of container/bags/packs for any damage. 5.5.5 Information shall be given to the Head QC for any container/bag found physically damaged or found without seal. QC head will inspect the container/bag for intactness of innermost packing in sampling area. If the innermost packing is found intact, then sampling should be done specifically from the same container/bag, otherwise, physically damaged container/bag should not be considered for sampling and the same should be rejected. 5.5.6 The rejected label shall be affixed on the rejected container/bag as per format number XXX. 5.6 Preparation for Sampling 5.6.1 Before starting sampling, ensure that sampling booth is cleaned including RLAF unit and cleared from all the previous raw materials. 5.6.2 Check the differential pressure of the sampling booth cubical (Between 5 and 15 mm of WC). Enter the sampling booth through man entry. 5.6.3 Switch on the RLAF unit and keep idle for 25 – 30 minutes before sampling of raw material. 5.6.4 Monitor the sampling room for environmental conditions for temperature not exceeding 25°C and RLAF differential pressures (between 5 and 15mm of WC). If the sampling room temperature exceeds 25°C or manometer reading is not within specified limits, then inform to head engineering and head QC. Sampling shall be done after rectification. 5.6.5 Ensure all the sampling tools are having cleaned status before sampling. 5.6.6 Clean the raw material container/bag and bring the raw material container/bag with pallet inside sampling booth cubicle first through material entry. Bring only the raw material container/bag inside cubicle second and then in RLAF for sampling. 5.6.7 Based on sampling plan, prepare sample for analysis (QCS038/F/01), control sample(QCS046/F/03), under test label (QCS046/F/02). 5.6.8 Sampled and approved labels as per format numberQCS046/F/01 and QCS046/F/04 respectively shall be printed. 5.6.9 Prepare labels for microbiology test (whenever required). For microbiology samples, write microbiology within bracket after “SAMPLE FOR ANALYSIS” on the label. 5.7 Sampling plan: 5.7.1 For active material, sampling should be done from all received container/bags/drums (100%) from warehouse. 5.7.2 For excipients sampling : If container/bags are 4 or less, carry out sampling from all the container/bags (100%). If container/bags are more then 4, follow √n + 1 rule for sampling from warehouse. 5.8 Sampling procedure: 5.8.1 QC chemist shall enter the sampling booth through man entry. 5.8.2 The raw material container/bags shall be open by removing the seals/stitches. Open the seal of the inner packing. 5.8.3 After removing the seal of container/bag, check any physical damage, if damage is there, then inform to QC head for further action. 5.8.4 Before sampling, ensure that RLAF is on for at least 30 minutes. 5.8.5 Start the sampling from the raw material container/bags, based on the above sampling plan. 5.8.6 After sampling, the inner packing of the container/bag is sealed with yellow tie band. 5.8.7 After completion of sampling, the material container/bag is also sealed with yellow tie band and returned through the material entry to ware house. 5.8.8 For microbial tests, collect the sample in a sterile container/bag. 5.8.9 For empty hard gelatin capsule, collect the sample in polythene bag for chemical analysis and for microbial testing collect in sterile container/bag. 5.8.10 Stick the under test label (format number XXX) on all the container/bags and sampled label (format number XXX.) on the container/bags from which the sampling has been done. 5.8.11 Start the RLAF and ensure that the manometer reading should be in between 5 to 15 mm across HEPA filter. 5.8.12 Observe visually for appearance of the material for any abnormalities like discoloration, lumps, non-characteristic odor, foreign matter and physical heterogeneity. 5.8.13 In case of any abnormalities observed, inform to head QC and reject the entire consignment. 5.8.14 Record all observations in “Inspection Report of Raw Material” 5.8.15 Record the entries of raw material samples separate register (Cepha Block) from General block, in raw material sampling record as per format number XXX. 5.8.16 Only one batch material should be sampled at a time. 5.8.17 Withdraw approximately equal quantities from all marked container/bags/packs and also prepare a pooled sample. 5.8.18 Sampling tools to sample different type of raw materials, should be as mentioned below: SS sampling rod – For sampling of liquids from drums. Glass- pipette /rod – For sampling of liquids from bottles using rubber teat. Spatula – For sampling of material from small solid bulk container/bags. SS sampling rod – For sampling of solid raw materials from bags/drums. 5.8.19 Label the bottles/poly bags in which samples are taken with appropriate labels. 5.8.20 Affix ‘Sampled’ labels duly signed on the container/bags that should be completely visible. 5.8.21 Mix pooled sample thoroughly and divide it into two sets in the ratio of 1 : 2 5.8.22 On one sample, label should be “sample for analysis” (ratio 1) and on another sample for “control sample” (ratio 2) affixed. 5.8.23 Affix the control sample label as per format number XXX and maintain the raw material control sample record as per format number XXX. 5.8.24 Use cleaned and dried set of sampling equipment’s for each item while sampling. 5.8.25 Use always clean dry bottles with screw caps for collecting liquid samples and fresh poly bags/dry bottles for solids. 5.8.26 In case of light sensitive materials use black poly bags or amber bottles for sampling. 5.8.27 Send samples along with bulk inspection checklist and supplier’s certificate of analysis to QC laboratory for analysis. Note: For active materials, samples to be collect in the separate sample container/bags from the each pack/container/bag. Identification test should be performed for individual samples. If the individual sample is passing with respect to identification then pooled sample of the individual samples should be used for rest of the analysis 5.8.28 After sampling each sampled stored at room temperature, protected from light and moisture. 5.8.29 After every six month add the new raw material in this SOP, but between six month from the effective date of SOP, receive the raw material and add by pen (written) in the list and approved by QA this page. 6.0 ABBREVIATIONS 6.1 SOP : Standard operating procedure 6.2 GRN : Goods receipt note 6.3 QC : Quality control 6.4 RLAF : Reverse Laminar Air Flow 6.5 °C : Degree centigrade 6.6 COA : Certificate of analysis 6.7 HEPA : High Efficiency Particulate Air |
