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QC 014e

In-Process Quality Check

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ahmedsalahmdi
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16 views

QC 014e

In-Process Quality Check

Uploaded by

ahmedsalahmdi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF or read online on Scribd
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Modern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE Page 1 of 11 Title: In-Process Quality Check [SOP #QC-014E | Effective date: 14 /09 /2023 Prepared By: Quality | Reviewed By: Reviewed By: Quality | Approved By: Quality | Control Department | Production Manager Assurance Department _| Assurance Manager ‘Name: Bio. Fargad | Name: Mr. Emad ‘Name: MSc. Ahmed Salah | Name: Dr. Mushtaq Hafiz Farhan 7 Muslet aC aa tote Signature: Signature: Dater 4/4/2024 | Date: 14 4/ 1623 | Daterky lo? T2ede Date: 14 / 09/2023 REVISION TABLE OF CONTENTS: 1. HISTORY....... 2- PURPOS! 3+ SCOPE... 4. REFERENCES... 5. ABBREVIATIONS AND DEFINITIONS... 6- PROCEDURE ..... 7- RESPONSIBILITY. 8- DOCUMENT REVISION. TE: 3 years afier effective date or when needed. Modern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE. Page 2 of 11 | Title: In-Process Quality Check SOP #QC-O14E __| Effective date: 14 / 09 / 2023 Prepared By: Quality | Reviewed By: Reviewed By: Quality ‘Approved By: Quality Control Department _| Production Manager ‘Assurance Department __| Assurance Manager ‘Name: Bio. Fargad ‘Name: Mr. Emad ‘Name: MSc. Ahmed Salah | Name: Dr. Mushtaq Hafiz Farhan | Muslet Ca ; Signature: signage Ft Signature! Signature: f | Date: I¥/4 /Zo2> _| Date: 1¥/ \/ 202 Date: \u/ % / 9/93 Date: 14 / 09/2023 1- HISTORY: This is the sixth version of SOP, review, change SOP number from SOP# QA-023D to QC-014E and responsibility section. 2- PURPOSE: ‘This procedure ensure that all necessary activities for the manufacturing and packaging comply with the requirements of in-process checks IPC of products are planned and controlled to ensure that all stages of production process ( manufacturing or packing ) confirm to the specified requirements. 3- SCOPE: ‘This SOP applies to all production and warehouse of MDI. 4- REFERENCES: MDI own generated SOP. 5- ABBREVIATIONS AND DEFINITIONS: © (SOP) Standard operating procedure. ‘* (MDI) Modern Company for Drugs Industries. «© GMP) Good Manufacturing Practice © QA) Quality Assurance. © (QC) Quality Control. © (RM) Raw Material, (WH) Warehouse. © (MPR) master packaging record. * (DT) Disintegration time. (Mfg) Manufacturing. © (Exp) Expire. © (CAL) Calibration. © (Temp) Temperature. * (IPC) In process check © (PRO) Production. + (PVC) Poly Phenyl Chloride. Modern Company For Drugs Industries MDI STANDARD OPERATING PROCEDURE Page 3 of 11 | Title: In-Process Quality Check SOP # QC-O14E | Effective date: 14/09 / 2023 Prepared By: Quality Control Department Reviewed By: Production Manager Reviewed By: Quality Assurance Department Approved By: Quality Assurance Manager Name: Bio. Fargad ‘Name: Mr. Emad Muslet ‘Name: MSc. Ahmed Salah | Name: 9. Mushtag Hafiz. Signature? i —_| Date: (4/7/2023 Date: 14/09 /2023 | Note: The staffs of (penicillin and normal department) are not allowed to enter other departments to prevent cross contamination. 7- RESPONSIBILITY: __ It’s the responsibility of production and WH to follow GMP rules. «e's the responsibility of production to performing the line clearance process and signs the documents = It’s the responsibility of IPC/QC to verified and sign the line clearance documents. It's the responsibility of IPC/QC to check every stage in manufacture and packaging act ies the responsibilty of QA manager to assuring that all steps at production and ware house are monitored by IPC as per requirements. ities. 8 DOCUMENTS REVISION: 0 i 1 History 2 “Abbreviations and definitions 2 Procedure 3 Responsibility 9 2 History 2 Purpose 2 3 9 2 2 (04-09-2019 Procedure Responsibility History Abbreviations and Definitions Procedure 38 Responsibilit u 4 History 2 ‘06/01/2022 Responsibility ul 02-05-2021 3 History 2 14/09/2023 Responsibility ul END OF DOCUMENT

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