Galaxy Chemicals (Egypt) S.A.

Title: SOP for process Document No. APEX/GCE/GMP/MOGP – 4.1

and product Revision No 04
Issue Date 30.03.2023
development 05.04.2023
Effective Date
Date of next review 29.03.2026
Page No. 1 of 2
Operating Process : Manual of General Procedures (MOGP)

Title : SOP for process and product development

1. Purpose: As a part of continual improvement, improvements are done in manufacturing processes
or products. This SOP provides systematic way towards developments
2. Scope: This SOP is applicable for R&D, Quality, production departments at all locations at Galaxy
Surfactants Limited.
3. Responsibility:
3.1. QC and production departments are responsible for providing various improvement theams.
3.2. QA is responsible for evaluating changes in the process and ensuring consistency of the
process.
3.3. Other supportive departments may be required for execution of improvement processes.
4. Procedure:
4.1. QC, production, R&D or QA team can initiate a process improvement project.
4.2. Process improvement theme is presented to concerned departments and approval is taken by
initiator.
4.3. Initial experiments are planned along with QA.
4.4. Temporary MOC is raised for changes to be executed during manufacturing.
4.5. This MOC is approved by QA. Only after that actual process work can be initiated.
4.6. After experiments, these results are summarized and conclusion is drawn.
4.7. If the changes giving favorable results, permanent MOC is prepared, these changes are
implimented into process.
4.8. If Quality of the product is impacted, re-validation of process is requested.
4.9. Three consecutive batches are taken. Process validation is conducted as per SOP
“Performing process validation”.
4.10. QA reviews and approves protocol and report.
4.11. After successful completion of process validation, this procedure is included in routine
manufacturing.
4.12. SOPs, WIs are changed accordingly.
4.13. MOC is closed with all evidences.
Product development

4.14. Quality, R&D can initiate new product development.

4.15. Product development can be related to improvement in quality, cost saving or new customer
development.

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

Title: SOP for process Document No. APEX/GCE/GMP/MOGP – 4.1

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

4.16. Rationale is defined for product development and it is approved by management.

4.17. Various pathways are proposed to get desired results.
4.18. For new customer development, specification from customer can be used.
4.19. Initial experiments are carried out and results are recorded. If results are as per expectation,
these are confirmed by repeating the experiments.
4.20. Once confirmed, these products are designed as per customer specification.
4.21. Parameters once finalized are transferred to production after confirming with production and
R&D.
4.22. All activities shall be routed through MOC.
5. Definitions and Abbreviations:
5.1. MOC: Management of change
6. References:- In-house
7. Change Record

Sr. Revision Number Effective Date Of Reason for Change

No. Change

1 0 03.09.2016 Original issue of Document

Entire manual revised as per ISO 9001 :2015

2 2 01.04.2018
requirements.

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

requirements.
5 4 30.03.2023
Entire manual issued as per EFfCI GMP requirements

Owned by Reviewed & Approved by Issued By

Leader-Quality Process Head-Quality Process / Managing Director Management Representative

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