Galaxy Chemicals (Egypt) S.A.E.

Contents Document No. APEX/GCE/GMP/MOGP/CONTENT-1.1

Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. Page 1 of 3
Operating Process: Manual of General Procedures (MOGP)

Contents

Sec. Description No. of Pages

No.

- Title Sheet of Manual of General Procedures. 1

1.1 Contents 3
1.2 Distribution List 1
1.3 Glossary 3
2.1 Procedure for General Procedures 2
2.2 Procedure for Awareness on Quality Policy and Objectives including Quality 3
Management System
2.3 Procedure for Revising Quality Objective 1
2.4 Procedure for Document & Data Control 11
2.5 Good Documentation Practices 4
2.6 Document change request 2
2.7 SOP for Document Discrepancy 2
3.1 Procedure for Corrective and Preventive Action 8
3.2 Procedure for Control of Quality Records 3
3.3 Procedure for Internal Quality Audits 4
3.4 SOP for CAPA effectiveness 3
3.5 Procedure for External Audits 2
3.6 Organizational structure and roles and responsibilities of individual 3
3.7 SOP for Quality and management review Meeting 3
4.0 Procedure for Measurement, analysis and improvement 2
4.1 SOP for process and product development 2
5.0 Procedure for Control of nonconforming product 2
6.0 Procedure for Management of Change 3
6.1 Jewelry Policy 2

6.2 Glass Policy 2

GMP/MOGPMANUAL/30.03.2023 Rev04 Approver’s signature not required unless the document is printed
Copy No.:
 Galaxy Chemicals (Egypt) S.A.E.

Contents Document No. APEX/GCE/GMP/MOGP/CONTENT-1.1

Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. Page 2 of 3
Operating Process: Manual of General Procedures (MOGP)

Sec Description No. of Pages

. No.
6.3 Personal Hygiene & GMP Policy 6
6.4 Procedure for Correcting Entries & Filling blank column 1
6.5 Deviation and Incident control procedure 7
7.0 Formats 9
7.1 Format for CAPA effectiveness 3
7.2 Good documentation practice 1
7.3 Document change request 2
7.4 Format for document discrepancy 1
7.5 Process or Product Development Activity 2
7.6 Site master plan format 8
8.0 Review of Technical Transfer Document 3
8.1 Preparation of site master file 3
8.2 SOP for Vendor Audits and Vendor assessment for quality 8
8.3 SOP for Quality Risk Management 3
8.4 SOP Training 4
8.5 Complaints and recalls 1
8.5.a SOP for waste management 2
8.6 SOP for issuing of equivalency certificate 1
8.6.a SOP of action incase o policies not followed 1
9.0 Internal and external issues 1
10.0 Understanding the needs and expectations of interested parties 1
11.0 Leadership 1
12.0 Supplier evaluation 2
total 143

GMP/MOGPMANUAL/30.03.2023 Rev04 Approver’s signature not required unless the document is printed
Copy No.:
 Galaxy Chemicals (Egypt) S.A.E.

Contents Document No. APEX/GCE/GMP/MOGP/CONTENT-1.1

Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. Page 3 of 3
Operating Process: Manual of General Procedures (MOGP)

Change Record:

Sr. Effective date of

Revision No. Reason for change
No. issue

1 0 01.08.2012 Original issue of Document

2 1 01.04.2015 All the documents revised in line with global change of

documentation system.

3 2 01.04.2018 Entire manual revised as per ISO 9001 :2015

requirements.

4 3 01.04.2020 Entire manual issued as per ISO 22716 :2007

requirements only.

5 4 30.03.2023
Entire manual issued as per EFfCI GMP requirements

Prepared by Reviewed and Approved by Issued By

Sr. Manager -Quality Manager Director Management

Process Representative
Shantaram Kadam Dhaneshwar Patil Shantaram Kadam

GMP/MOGPMANUAL/30.03.2023 Rev04 Approver’s signature not required unless the document is printed
Copy No.: