Modern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE Page I of 5 Title: Raw Materials Sampling SOP #QC-023C | Effective date: 01/06/2022 Prepared By: Quality | Reviewed By: Quality Reviewed By: Planning | Approved By: Quality Control Analyst Control Manager Manager Assurance Manager ‘Name: Eng. Tuga Khalil Signature: Signal Signature: Date: )- 62022 | Date: J-f-2e%% | Date:_ pe - Lot | Date: 01/06/2022 Name: Eng. Shafaa Dhyaa | Name: Mr. Emad Muslet_| Name: Dr. Mushtaq \ Hafiz : Signature: REVISION DATE: 3 years after effective date or when needed. TABLE OF CONTEN’ 1- HISTORY. 2- PURPOSE... 3- SCOPE. 4- REFERENCES. 5- ABBREVIATIONS AND DEFINITIONS... 6- PROCEDURE....... 7- RESPONSIBILITY... 8- DOCUMENT REVISION...Modern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE Page 2 of 5 Title: Raw Materials Sampling SOP # QC = 023C__ | Effective date: 01 / 06 72022 Prepared By: Quality | Reviewed By: Quality Reviewed By: Planning | Approved By: Quality Control Analyst Control Manager Manager Assurance Manager Name: Eng. Tuga Khalil ‘Name: Mr. Emad Muslet | Name: ir. Mushtaq Hafiz Signature: Si ae signe? Gore! Signature: <<”. “ Date: )— Date: (- 6 - Date:_| ~£-22t% | Date: 01/06/2022 1- HISTORY: This is the Fourth version SOP, review ,update the history and add attachment -1. 2- PURPOSE: To lay down the procedure for sampling of raw material. 3- SCOPE: This SOP applies in raw materials warehouse and QC department. 4- REFERENCES: MDI own generated SOP. 5- ABBREVIATIONS AND DEFINITIONS: ‘+ (SOP) Standard operating procedure. © (MDI) Modern Company for Drugs Industries. © (SO) International organization for Standardization, * (IRR) Initial Receiving Report. © (QA) Quality Assurance. = (QO) Quality Control. © (RM) Raw Material * (WH) Warehouse + (WO) Warehouse Officer © (vn) Root square for total number of containers.Modern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE Page 3. of 5 Title: Raw Materials Sampling SOP #QC-023C | Effective date: 01 / 06/2022 Prepared By: Quality | Reviewed By: Quality Reviewed By: Planning | Approved By: Quality Control Analyst Control Manager Manager Assurance Manager Name: Eng. Tuga Khalil | NameEng. Shafaa Dhyaa | Name: Mr. Emad Muslet | Name: Dr. Mushtaq 4 Hafiz Signature: Signature: <9 Date:_)- 6.2522. Date: 01/06/2022 6- PROCEDUR! Depend on the SOP # WH-004 (under 6.1: raw materials follow the points 6.1.1 to 6.1.5) ~ Check the details given on the material receiving report with the suppliers label on all raw material containers. ~ Check the physical condition and cleanliness of raw material containers before opening for sampling. ~ Damage container whose integrity is doubtful should be sampled and tested separately. ~ Make sure that cleaning label status on room label is available on the sampling booth before starting sampling. ~ Get the containers cleaned from out side, ~ Before sampling ensures that the surrounding environment is favorably dust free in case sampling of material shall be done outside the sampling room. ~ During sampling wear mask, glove, cap, and shoes cover. ~ Use clean and dry sampling utensil for sampling. - Used clean dry polyethylene bags for keep the solids samples. ~ Used clean dry amber bottles with screw caps for keep liquid samples. ~ Use sampling device after mopping with freshly prepared 70% alcohol for collecting sample for microbiological limit test. ~ Sample for microbial testing shall be taken first followed by other sampling, ~ Ensure that sterile bottle is used for sampling of materials to be tested for microbial test. ~ Bring only one batch of a particular raw material at a time inside a sampling room. ~ Use different sampling device for sampling different materials. ~ All solid (active and non active materials) as well as liquid materials except solvents are to be sampled in sampling booth. ~ For solid materials received in drums/container use specially designed sampling device by which material can be sampled from different level (top, middle, and bottom). ~ Sample all the moisture sensitive materials in airtight container. ~ Switch On the lamp specified for the light-sensitive material, and keep it black polyethylene bag. ~ Materials which are received in more than 100 liters barrel sampling done on the spot with proper care. ~ Check the labels on the container as per document received from warehouse if information correct carries out sampling as follow. ~ Record the number of containers (packets, bags, boxes, bundles, drum, ete.) received in the inspection / sampling report,Modern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE Page 4 of 5 Title: Raw Materials Sampling SOP # QC - 023C__ | Effective date: 01 / 06 /2022 Prepared By: Quality | Reviewed By: Quality Reviewed By: Planning | Approved By: Quality Control Analyst Control Manager Manager Assurance Manager ‘Name: Eng. Tuga Khalil | Name ‘Name: Mr. Emad Muslet_| Name: Dr. Mushtaq Hafiz signaore roo” Signature: Date:_/-¢-te%? _| Date: 01/06/2022 Signature: Signi Date:_/ wa Date: - The number of container to be opened for sampling is determined from the table given below: 1t05 310 100 3 ‘More than 100 (vn) + (1) Active & Non active = ensure proper closure of the sampled containers and affix “QC sampled” label on the container from which the sample has been taken with information : Sampling date, name and signature of the person how has taken the sample. ~ identify each sample with information The name of sampled material, Batch no., mfg date, exp. date, signature of the person who has taken the sample, and Sampling date. ~ The purpose of container wise sampling is to identify each container for its correct content. The simplest identification test may be carried out will also include physical appearance like color, odor texture, appearance of material. ~ Sampling analyst should report to Sr. QC officer immediately in case of any difference in each container while sampling,Modern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE Page 5 of 5 Title: Raw Materials Sampling _ SOP #QC-023C | Effe: cctive date: 01 06 / 2022 Prepared By: Quality Reviewed By: Quality Reviewed By: Planning ‘Approved By: Quality Control Analyst Control Manager Manager Assurance Manager Name: Eng. Tuga Khalil | Name: Eng. Shafaa Dhyaa | Name: Mi Muslet | Name: Dr. Mushtag Signature: Sign Signature: <6 foy Date: 7-2-2022 t6-Pe@U Date: [> é-12 te Date: 01/06/2022 7- RESPONSIBILIT" ~ It’s the responsibility of WH to arrange and mange the material for sampling. ~ It’s the responsibility of QC supervisor to check, sample and test as per Method of testing and specifications and according to the requirements of specific areas such as Normal, and penicillin, ~ It’s the responsibility of QC manager to rechecked and approved the reports of analysis = It's the responsibility of QA for follow up. 2 Scope 2 i Procedure 3 05-01-2019 Responsibility 3 : Ea 2 05/01/2022 History Z 2 Add attachment 1 01/6/2022 attachment logbook formModern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE, Page 1 of 1 Title: Raw Materials Sampling SOP # QC 023C [Effective date: 07 / 06 / 2022 Prepared By: Quality] Reviewed By: Quality Reviewed By: Planning| Approved By: Quality Control Analyst Control Manager Manager Assurance Manager ‘Name: Eng. Tuga Khalil | Name: Bog. Shafaa Dhyaa | Name: Mr. Emad Muslet | Name: Dr. Mushtaq, 7 a Hafiz Signature: Signatiire Signat Signature: Date: /~ 2 -Eozr _| Date: Date: 1-6 “*?*~| pate: 01/06/2022 “L) Attachment SOPHQC-023C Logbook Form