Modern Company For Drugs Industries MDI _ STANDARD OPERATING PROCEDURE Page | of 4 Title: Procedure OF Keeping Retain Samples For ‘Normal Products SOP # QC- 005D | Effective Date : 01/01/2021 Prepared By: Quality Control Analyst Reviewed By: Quality Control Manager Approved By: Quality Assurance Manager Name: Chem. Faten Mahmood Signatures Fo A—__ Date: 1.1. 25a) Name: Dr. Abdulhakeem Daham Signer psf Date: ‘Name: Dr. Mushtaq Hafi Signature: ¢ °- Date: 1-1~ ee REVISION DATE: 3 years after effective date or when needed. TABLE OF CONTENTS: 1. HISTORY.. 2+ PURPOSE. 3- SCOPE. 4- REFERENCES. 5- ABBREVIATIONS AND DEFINITIONS..... 6- PROCEDURI 7- RESPONSIBILITY. 8- DOCUMENTS REVISION... BRERRRLEModern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE Page 2 of 4 Title: Procedure OF Keeping Retain Samples For Normal Products SOP # QC- 005D Effective Date : 01/01/2021 Prepared By: Quality Control Reviewed By: Quality Control Approved By: Quality Assurance Analyst Manager Manager ‘Name: Chem. Faten Mahmood | Name: Dr. Abdulhakeem Daham Name: Dr. Mushtaq Hafi: Signatures FA Signature: e =e Date: Date: ewe \-2oa 2er) 1- HISTORY : ‘This is the fifth version SOP. Review and update the procedure. 2- PURPOSE: ‘The purpose of this SOP is to ensure that all retain samples are being handled according to the proper standard procedures and under proper specified conditions. 3- SCOPE: ‘This SOP applies in QC department/ retains samples room in normal production building. 4- REFERENCES: MDI own generated SOP. 5- ABBREVIATIONS AND DEFINTIONS: ‘+ (SOP) Standard Operating Procedure, * (MDI) Modern Company for Drugs Industries, © (QA) Quality Assurance. © QC) Quality Control * (°C) Degree Centigrade. + (%) Percentage. * (Temp.) Temperature. + (Humid) Humidity.Modern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE Page 3 of 4 Tile: Procedure OF Keeping Retain Samples For SOP # QC-005D | Effective Date : 01/01/2021 Normal Produets Prepared By: Quality Control | Reviewed By: Quality Control ‘Approved By: Quality Assurance Analyst Manager Manager Name: Chem. Faten Mahmood | Name: Dr. Abduthakeem Daham —_| Name: Dr. Mushtaq Hafiz. Signatures. %— Signatur TP Date: 1-2 aa Date: |). 221 = 6-PROCEDURE : 6.1 The retain samples of all kinds of raw material, and finished products will be kept in specified room. 6.2 The number of samples will be kept in retain sample as follows: For raw materials =double the quantity as compare to the normal routine testing sample quantity according to the complete testing. For finished products = quantity taken for 3 complete testing (minimum) as per procedure of each product 6.3 Temperature of the retain sample room will be monitored and recorded on daily basis twice a day at 8:00am and 1:00 pm using (Appendix-1), for two location as per two devices. 6.4 The temperature of the retain samples room should comply with (18-25) °C the humidity of the retain sample should not be more than 60%. 6.5 in case of any deviation in temperature and humidity the engineering department should immediately be informed for corrective action, 6.6 During the temperature deviation a review of the duration and temperature excursion will be reviewed by QA and appropriate action will be taken including raising deviation. 6.7 all the retain samples will be kept till the shelf life plus one year then discard according to the proper procedure. 6.8 Retain samples should be checked as per table below and record the result in a log book, in case of any result out of specification QA department should be informed to take the suitable action . « _ Frequency of check | Suspension Each 3 Month Physical check ( pH, Sedimentation in suspension and change in appearance) ‘Syrup Each 6 Month Physical check (Appearance, pH and color) Tablet Each 6 Month Physical check (Appearance, Color, Disintegration Time And Friability) 6.9 Retain sample room should be cleaned weekly and recorded in a logbook.Modern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE Page 4 of 4 Title: Procedure Of Keeping Retain Samples For SOP # QC- 005D | Effective Date : 01/01/2021 Normal Products. Prepared By: Quality Control Reviewed By: Quality Control ‘Approved By: Quality Assurance Analyst Manager Manager ‘Name: Chem. Faten Mahmood | Name: Dr. Abdulhakeem Daham Name: Dr. Mushtaq Hafiz Signature: (k— Signature: —J_ casas} | Signatu Date: -(-@ 09 Date: ean Date: 1 7- RESPONSIBILITY: = Itis the responsibility of QC department to record the temperature and hut = Itis the responsibility of QC manager to ensure that the retain sample room is monitored as per requirements. = Itis the responsibility of QA for follow up the compliance of SOP. 8- DOCUMENTS REVISIO! Ea AMesection Woe eaaay i 1 History Scope Procedure Responsibility 2 History Procedure 3 History Procedure 12-09-2017 22-02-2018 01-01-2021 te tule re]e ee 0] ATTACHMENTS: = Record of Temperature and Relative Humidity (Appendix-1)Modern Company For Drugs Industries SOP REF # QC-005D Appendix-1 page 1 of 1 Recording of Temperature & Relative Humidity Month / year: ~ Limits: Temperature (18-25 °C) Humidity (NMT 60 %) Time Date 8:00 Am 1:00 PM. QC signature Note ‘Temp. Humid. | Temp. Humid.