Modern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE Page I of 4 Title: Lists of Instruments and Equipment in QC Labs | SOP# QC -004G Effective Date:15 /07/2021 Prepared by: Quality Control Manager Reviewed by: Quality Assurance department Reviewed By: | Maintenance Manager Approved by: Quality Assurance Manager ‘Name: Eng. Shafaa Dhyaa 7 Signatufe;s-——> Date: 57 21 Name: MSc. Ahmed Salah Signature: Date: 77/2021 Name : Eng. Khalid Mahdi Signatu Date: 1SGS 2. 2 Name: Dr. Mushtaq Hafiz eP. Date: 15-9_ 2054 I 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- PROCEDURE... 7- RESPONSIBILITY. 8- DOCUMENTS REVISION......Modern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE Page 2 of 4 Title: Lists of Instruments and Equipment in QC Labs | SOP# QC -004G | Effective Datel 07203 Prepared by: Quality Reviewed by: Quality | Reviewed By: Approved by: Quality | Control Manager | Assurance department __| Maintenance Manager _| Assurance Manager Name: Eng, Shafaa | Name: MSc, Ahmed Name : Eng. Khalid ‘Name: Dr. Mushtag Hafiz Dhyaa Signaturé; ras Date: | 'Z_ 2.21 Salah Mahdi ee Signature: Ye | Signatu Signore) Date: pon Ay Date : ay | Date: 5-7. way 1. HISTORY: This is the eighth version SOP. Review and update the history. 2. PURPOSE: To make sure that the list of instrument and equipment in QC laboratory is maintain and update according to the availability of instrument / equipment in lab 3. SCOPE: This SOP applies in QC laboratories. 4. REFERENCE: Technical catalogs of the equipments and instruments which are supplied by the manufacturers and suppliers. 5. ABBREVIATIONS AND DEFINITION: * (SOP) Standard Operating Procedure. * (GMP) Good Manufacturing Practice, * (MDI) Modern Company for Drugs Industries. © (QA) Quality Assurance. * (QC) Quality Control. © (UV- Spectro) Ultra Violet Spectrophotometer. * (HPLC) High Pressure Liquid Chromatography. * (FTIR) Fourier Transform Infrared Spectroscopy. * (Lab) Laboratory. + (FP) Finished product, + (Mfg) Manufacturing, * (Micro) Microbiology. © (PW) Purified Water. * (TDS) Total Dissolved Solid. * GC) Gas Chromatography. * (TOC) Total Organic Carbon,Modern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE Page 3 of 4 Title: Lists of Instruments and Equipment in QC Labs | SOP# QC -004G | Effective Datel (07200 Prepared by: Quality Reviewed by: Quality] Reviewed By: ‘Approved by: Quality Control Manager Assurance department _| Maintenance Manager _| Assurance Manager ‘Name: Eng, Shafaa ‘Name: MSc. Ahm Name : Eng. Khalid Name: Dr. Mushtaq Hafiz Dhyaa _- | Salah Mahdi ee Signauig7 S| Signature i Seal Signature: ae Date: /'5-F- tet [Date ie yqyeo) [Dale Is \ | Date: 15-9. 24 6. PROCEDURE: A. The list (Attachments 1 & 2) use as a reference for information related to Equipments / instruments, Model, Mfg., and serial number. B. Attachment -1 is containing list of instruments for three laboratories chemical lab. , instruments lab. And microbiological lab. In normal product department. C. Attachment -2 for two laboratories chemical lab. And microbiological lab. In penicillin product department. D. The information of any new equipment or instrument should be added to the list attached as (Attachment -1 & 2) and update the date. E, Any instrument/equipment not in use or not work will be removed from the lists. 7. RESPONSIBILITY: ~ _ Itis the responsibility of an analyst to maintain and keep the equipments / instruments lists updated. ~ _Itis the responsibility of QC manager to check, follow up, and keep equipments / instruments lists updated. ~ _ Itis the responsibility of engineering department to add equipments / instruments to preventative maintenance schedule, ~ _ Itis the responsibility of QA for follow up the compliance of sop.Modern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE Page 4 of 4 Title: Lists of Instruments and Equipment in QC Labs | SOP# QC -004G | Biieative Dawte 10772021 Prepared by: Quality Reviewed by: Quality] Reviewed By: Approved by: Quality Control Manager Assurance department Maintenance Manager Assurance Manager ‘Name: Eng. Shafaa Name: MSc. Ahmed Salah Signature: " < Date: Jeray al Name : Eng. Khalid Mahdi Siete, ee Date : FT ea Name: Dr. Mushtag Hafiz te L Signature: Date: 15-7 221 NGS PRE EN Section EES _nitials/ Date History 2 27.07.2014 Attachment-1 2 Attachment -2 1 2 History 2 23.10.2014 Abbreviations & Definitions 2 Attachment-1 2 3 History 2 15.01.2015 Attachment-1 2 4 History 2 09.03.2015 Attachment-1 2 3 History 2 01.04.2016 procedure 3 responsibility 3 Attachment-1 & 2 All pages 6 History 2 15-07-2018 Procedure 3 Attachment-1 All pages 7 History 2 15-07-2021 Abbreviations And Definitions 2 ATTACHMENT: Lists of instruments and equipments in normal product building. (Attachment-1). Lists of instruments and equipments in penicillin product building. (Attachment -2).