FHHFG Control

Galaxy Chemicals (Egypt) S.A.E.
Procedure for Document Document No. APEX/GCE/GMP/MOGP–2.4

Data Control Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. 1 of 13
Operating Process : Manual of General Procedures
Purpose: To ensure that all GMP documents are reviewed and approved by authorized
personnel before issue & latest documents are available at point of use.
Scope: All documents required for effective implementation of Quality Management System
at Galaxy as required by ISO 22716:2007 & EFfCI GMP standards.
Responsibility: Management Representative(s) is responsible for establishing, r e v i e w i n g and

documenting this procedure. Each member o f Galaxy is responsible f o r implementation
of this procedure.
Terminologies used:
Owned by – Person nominated by the process head by qualifying the responsible, senior from his
process to own the document
Reviewed by – Same or other process heads or his nominated qualified, responsible senior to review the
documents which are impacting the performance of all stakeholder process
Approved by– Process owners or their nominated, qualified personnel who approves t h e documents
Issued by – Who issues the documents as per document control protocol as per ISO 22716:2007
standard & EFfCI GMP i.e. Management Representative (MR)
Issue Date – Date on which the specific document is formally issued by MR
Effective Date – Date from which the specific document is implemented.
Date of Next Review – Date on or before 3 years from last effective d a t e
Procedure:
1.0 Structure of documentation system
The MS is established and demonstrated through five levels of documentation system as

mentioned below
2.0 Ownership, Review, Approval and Issue o f documents
GMP/MOGPMANUAL/30.03.2023 Rev04 Approver’s signature not required unless the document is printed
Copy No.:
Galaxy Chemicals (Egypt) S.A.E

Page No. 2 of 13
Type of Manual / Document Owned by Reviewed by Approved by Issued by
Apex (Quality Manual & Head Quality Process (India / Egypt) /

M.R. M.R.
MOGP) Managing Director (Egypt)
Functional Procedures/ Owner nominated by

Section Chief / Process Leader M.R.
Manual the process Leader
Leader –
Owner nominated by Leader -Quality
Mfg Work Instructions Conversion M.R.
the process Leader Process
Process
Owner nominated by
Individual Process WIs/SOPs Section Chief / Process Leader M.R.
the process Leader
Formats used for individual Owner nominated by

Section Chief / Process Leader M.R.
process the process Leader
Common QMS Formats M.R. MR-Corporate M.R.
Copy No.:

Page No. 3 of 13
3.0 Identification, Numbering of document
3.1 Every document is identified by a unique number.
3.2 The revision number, issue date, effective date & page number with X of Y format is mentioned in
header on each page of the document
3.3 Each page has the header and ONLY the last page would have footer for signing as per the
authorization mentioned in point 2.
3.4 Numbering of document is done as follows :
Apex manual e.g. APEX/GCE/QMS/QM-XXX –
Where Apex is the corporate manual
QMS- Quality Management System
QM- Quality Manual and
XXX is serial number of document as 01, 02, 03 ….
3.6 Each manual to have the following sections with the document identification as
Contents – Apex/QMS/QM-Contents
Distribution list – Apex/QMS/QM-Distn. List
Glossary – Apex/QMS/QM-Glossary
3.7 Functional documents e.g. QLT/QC/GP or LP-Tar/Tal/JH - XXX

Where QLT – Main Process - Quality
QC –Sub Process of Quality – Quality Control
GP – Global Procedure
LP – Local Procedure
GCE – Location i.e. Galaxy Chemicals Egypt
XXX – is the serial number of documents as 01, 02, 03…
3.8 SOPs or Work Instructions e.g. CP/Mfg/GP or LP- GCE/WI or SOP – XXX
XXX denotes document no as 01, 02, 03,
Copy No.:

Page No. 4 of 13
3.9 Technical Documents e.g. TD/FGSM/ IBC or STD - XXX

Where TD- Technical Document
FGSM – Finished Goods Specification Manual
DBC – Domestic Business Creation
IBC – Internal Business Creation
STD – Standard
XXX denotes document no as 01, 02, 03,
3.10 Formats e.g. F/QLT/QC/GP or LP- GCE- XXX
Where F-Formats
QLT – Main Process – Quality Process
QC-Sub Process – Quality Control
GP – Global Procedure
LP – Local Procedure
GCE – Galaxy Chemicals Egypt
XXX is the serial number of format as 01, 02, 03...
3.11 Index list of formats are reviewed and approved by respective process owner, same is formally
issued by respective site MR
3.12 Quality Records e.g. QR/QLT/QC/Tar (M3/N46/G59) or Tal or JH /GCE- XXX

Index list of quality records are maintained by respective process owner. QMS records are
controlled by respective sit e MRs
Copy No.:

Page No. 5 of 13
4.0 Process and Sub-Process of Galaxy
Following is the list of Abbreviation of Process (P) and Sub-Process (SP) of Galaxy. Sub-process
addressed as the operating process in header.
P Stands for Process SP Stands for Sub-Process

PE People Energy Process RCT Recruitment
TRG Training
ADMN Administration / Infrastructure
BC Business Creation IBC International Business Creation
Process DBC Domestic Business Creation
INV Innovation Process NPD New Product Development
VA Value acceleration
AD Application
SP Sourcing Process VD Vendor development
RMSP RM Sourcing
PMSP PM Sourcing
CP Conversion Process MFG Manufacturing
MAINT(MECH/ELEC Maintenance
/INST)
WH Warehouse
STR Incoming material stores
QLT Quality Process QA Quality Assurance
QC Quality Control
MICRO Microbiology
SHE Safety, Health & SFTY Safety
Environment HLTH Health
ENV Environment
GCD Global Customer Delight CS Customer Support
VS Vendor Support
ILE International Logistic Excellence
DLE Domestic Logistic Excellence
PPIC Production Planning & Inventory
Control
IT Information Technology & SW Software
communication HW Hardware
CG Corporate Governance LEGAL Legal & Regulatory
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Page No. 6 of 13
5.0 Revision of documents:
5.1 Documents are reviewed periodically at each process depending upon the emerging
requirements o f change with time.
5.2 Document change can emerge from internal audit, during monthly meeting of process or an internal
sub-process meeting or Business Group or MRC, during review of manuals/documents or from
customer’s complaint or their new requirements of final product quality and service, organizational /
process KRAs and statutory regulatory requirements or audit by customer or by Bureau Veritas or
internal observation rounds.
5.3 Document can also be revised whenever there is change or modification in process, customer
requirement, l e g a l requirement a n d change in equipment or infrastructure.
5.4 Other factors for revisions can be expansion/modifications of manufacturing facilities,

introduction/discontinuation of products including modifications in the process of the existing
product mix, restructuring of functions and technology/quality planning up-gradation including
corrective action and preventive m e a s u r e s .
5.5 Even if there is no necessity for periodical change observed, a formal review takes place across
all the documents at least once in 3 years for continuous suitability, effectiveness and to ensure
incorporation o f the current practices.
5.6 Responsibility of review lies with the owner of the document.
5.7 After the review, b o t h issue date and effective date is changed on the document.
5.8 Revision no. is indicated by 00, 01, 02...
5.9 Page no format X of Y is followed
5.10 Nature of changes are recorded as the change record at the end of each document. E.g.
Sr. No. Revision No. Date of issue Reason for change
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 s y s t e m .
5.11 Sub-process is addressed as the “Operating process”
Copy No.:

Page No. 7 of 13
5.12 He a de r to be used for all the Procedures, SOP/W Is
Record of Revisions Document No. APEX/GCE/QMS/MOGP/REVISION – 1.2

Revision No 02
Issue Date 01-04-2018
Effective Date 10-04-2018
Date of next review 01-04-2021
Page No. 7 of 13
5.13 Guide lines for footer to be use d for various documents
e .g. Foote r for Process (QA) Document
Owned by Approved by Issued By
Sr. Associate Sr. Manager – Quality Process Management Representative
Copy No
Copy No.:

Page No. 8 of 13
6.0 Issue of documents:
Manual is reviewed/updated by the

owner
Manual is reviewed for approval by

the section In-charge
Manual is reviewed for issuing by MR
If Manual is approved for Issuing by

MR, the previous revision No. of
manual will be collected to be
obsoleted
MR uploads the new soft copy of

manual as a PDF on server, and for
hard copies, red controlled stamp is
given
MR requests IT to authorize access

for the manual on server for read
only as per access through
electronic copy dist. list
IT confirms by mail that authorization

is given as requested
MR confirms access by checking

actual folder authorization and
acknowledge action done by mail to
IT
Copy No.:

Page No. 9 of 13
6.1 All the process owners send both hard and soft copies of revised document to respective MR
6.2 MR verifies the compliance of document control requirements and match both soft and hard copies.
If the requirements complied, MR arranges to issue the photocopy of revised d o c u m e n t s t o
members as per the distribution list defined in each manual by stamping a s “CONTROLLED
COPY” on each page of document.
For software manual only a soft copy is sent by owner for verification, and issued as a PDF by MR
on server.
6.3 MR takes the acknowledgment while issuing documents to members as defined in distribution list.
Acknowledgement can be either in soft form by mail or in hard form.
6.4 No uncontrolled copy is issued to any member of Galaxy.
6.5 However UNCONTROLLED COPY, can be issued by respective MR with prior permission of the
Directors or Process Heads or Process Leaders to external interested parties & such copies are
outside the scope of review & revision.
6.6 These copies are stamped in red ink as “UNCONTROLLED C O P Y ” on each page.
6.7 Apex Manual viz. Quality Manual (QM), Manual of General Procedures (MOGP) a r e
accessed through intranet by all members of Galaxy having e-mail access. (Read only access
given to all users).
6.8 Access to all GMP documents in both soft and hard form is given ONLY to the members as defined
in distributed list
6.9 Master record of “Document Distribution List” is maintained by M.R.
6.10 If a member of Galaxy is transferred from one process to other process or has resigned, the owner
of the process documents is responsible to inform this change to respective MR(s). Process
owners in consultation with MRs amends the distribution list.
6.11 Necessary training, communication to all the stakeholders is made before putting the revised
document as effective. An objective evidence is required to maintain by the respective process
owner for such communication, training to stakeholders.
6.12 MR – Corporate maintains a separate communication to all employees whenever changes made
in Apex documents
7.1 Control of Documents:

7.2 All GMP documents follows above mentioned document control system duly signed by those
authorized members in footer appearing ONLY at the end of document.
7.3 The signed off copies are considered as a “Master Copy”.
7.4 The master hard copy of all documents are retained by the respective MRs as defined in P o i n t 2.
7.5 Photocopy of the master document is taken by MR depending u p o n no. of copies mentioned in
distribution list and stamped in red stamp as “CONTROLLE D C O P Y ” on each page.
7.6 Whenever any manual is damaged, a duplicate copy is issued by photocopying master copy after
approval by respective location MR. The damaged copy surrendered by copy holder to MR for
disposition.
Copy No.:

Page No. 10 of 13
7.7 The soft copies of all approved g l o b a l and local documents are maintained by M R as defined in
Point 2.
7.8 MR ensures the availability of only the latest revised document at point of use by proper
acknowledgement of issuing new document and taking back the obsolete documents.
7.09 For all approved d o c u m e n t s back up master record are maintained at IT server.
8.0 Removal & Disposal of Obsolete Documents:
8.1 When a revised document is issued, obsolete copy of the same is collected immediately from
the copy holder by respective MR.
8.2 All obsolete copies excepting one copy are torn or shredded to avoid its misuse.
8.3 One copy is stamped as “OBSOLETE COPY” and retained for future reference by respective
MR.
9.0 Documents of external origin:
9.1 Document such as equipment manuals, calibration certificates, customer specifications, vendor
specifications, customer audit reports sent by customers, customer contracts, any o t h e r
external audit reports, statutory compliance documents, external test reports, BIS and other
international standards, etc... are considered as documents of external origin.
9.2 Documents of external origin are maintained by respective process owner.
9.3 List of such documents is maintained and updated by the process owner.
9.4 Process owner ensures that the latest applicable version o f documents of external origin are
available for use.
9.5 The distribution of documents of external origin is controlled by respective process owner based
on its requirement, use and confidentiality.
9.6 Retention of documents is decided by process owner
10.0 General Rules:
10.1 Manufacturing process work instructions are confidential documents and are not made
available on the intranet.
Copy No.:

Page No. 11 of 13
10.2 The customer specific data are treated as confidential and are not shared with other
customers. These are also not available on intranet. Such data is accessible ONLY to limited
members of Galaxy who are directly connected with that customer or process.
10.3 Whenever people are transferred, p r o m o t e d , rotated, terminated or they resign, documents
are not amended immediately and circulars issued by PEP or Process Head or Top
Management nominating either a new person for that post or any existing member to take
additional charge, such circulars are maintained by respective MR / Head as an evidence to
show why manuals/documents have not been amended immediately.
11. 0 R o l e of IT in control of documents
11.1 While issuing revised h a r d copies, soft copies of revised d o c u m e n t s are communicated
b y MR to IT Administrator.
11.2 IT Administrator converts document to PDF format and upload on intranet or Sharing
folder, access f o r authorized members.
11.3 While converting the Word document file in PDF format, protection of copying, printing, saving
is given and the converted file is loaded on Intranet.
11.4 Access is given to concerned users as per the distribution list given by owner of the
document.
11.5 Respective MR verifies t h e access rights given as per the distribution list.
11.6 The location IT personnel ensures that the documents on intranet are read only.
11.7 MR ensures that obsolete versions of documents are removed from the intranet.
12.0 Security of documents:
12.1 The various access rights for the Manuals are
1. Full Control – IT Administrator & MR

2. Read Only – ALL members as listed in the Distribution List
12.2 The file server for Intranet is as per the latest configuration with all security levels/window
updates in place
Copy No.:

Page No. 12 of 13
12.4 Copy of the Master Document is maintained by respective site MR.
12.5 The copy holder of the hard copies of documents is responsible to ensure that they are not
photo copied, misused, mishandled and kept in the safe custody.
13.0 Confidentiality of documents:
13.1 Documents related to customer pricing:
 All documents related to the pricing and the shipping terms will be kept confidential with the
customer support team, business creation team and the commercial team. The documents
include customer contracts, customer POs etc.
13.2 Documents related to quality specifications of customer products:

 The specifications shared by customers for their products will be kept confidential by the
quality team. This includes specifications shared by customers, COAs, Method of analysis
etc.
13.3 Documents related to RM specifications:

 All documents related to vendors w i l l be kept confidential with the sourcing team. This
includes RM specifications, RM prices etc.
13.4 Legal documents:

 All legal documents will be kept confidential with the corporate governance t e a m .
13.5 Logistics contracts:

 All documents in relation with logistics will be kept confidential w i t h the logistics department.
13. Records
Sr. Maintained Retention

Record No. Record Name Location
No. By Period
1 QR/QMS-001
Document Distribute d copies M.R.’s Office MR 3 years
2 QR/QMS-002 Document Obsolete copies M.R.’s Office MR 3 years
Copy No.:

Page No. 13 of 13
Change Record
Sr. No. Revision No. Date of issue Reason for change
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 s y s t e m .
3 2 01.04.2018 Entire manual revised as per ISO 9001:2015

requirements.
4 3 01.04.2020 Entire manual released as per ISO 22716:2007

requirements.
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
Copy No.:

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Galaxy Chemicals (Egypt) S.A.E.

Procedure for Document Document No. APEX/GCE/GMP/MOGP–2.4

Responsibility: Management Representative(s) is responsible for establishing, r e v i e w i n g and

Issue Date – Date on which the specific document is formally issued by MR

Effective Date – Date from which the specific document is implemented.

Date of Next Review – Date on or before 3 years from last effective d a t e

1.0 Structure of documentation system

The MS is established and demonstrated through five levels of documentation system as

2.0 Ownership, Review, Approval and Issue o f documents

Procedure for Document Document No. APEX/GCE/GMP/MOGP–2.4

Type of Manual / Document Owned by Reviewed by Approved by Issued by

Apex (Quality Manual & Head Quality Process (India / Egypt) /

Functional Procedures/ Owner nominated by

Formats used for individual Owner nominated by

Common QMS Formats M.R. MR-Corporate M.R.

Procedure for Document Document No. APEX/GCE/GMP/MOGP–2.4

3.1 Every document is identified by a unique number.

3.4 Numbering of document is done as follows :

Apex manual e.g. APEX/GCE/QMS/QM-XXX –

Where Apex is the corporate manual

QMS- Quality Management System

QM- Quality Manual and

XXX is serial number of document as 01, 02, 03 ….

Distribution list – Apex/QMS/QM-Distn. List

3.7 Functional documents e.g. QLT/QC/GP or LP-Tar/Tal/JH - XXX

Procedure for Document Document No. APEX/GCE/GMP/MOGP–2.4

3.9 Technical Documents e.g. TD/FGSM/ IBC or STD - XXX

3.10 Formats e.g. F/QLT/QC/GP or LP- GCE- XXX

QLT – Main Process – Quality Process

QC-Sub Process – Quality Control

GCE – Galaxy Chemicals Egypt

XXX is the serial number of format as 01, 02, 03...

3.12 Quality Records e.g. QR/QLT/QC/Tar (M3/N46/G59) or Tal or JH /GCE- XXX

Procedure for Document Document No. APEX/GCE/GMP/MOGP–2.4

P Stands for Process SP Stands for Sub-Process

Procedure for Document Document No. APEX/GCE/GMP/MOGP–2.4

5.4 Other factors for revisions can be expansion/modifications of manufacturing facilities,

5.6 Responsibility of review lies with the owner of the document.

Sr. No. Revision No. Date of issue Reason for change

1 0 01.08.2012 Original issue of Document

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

Procedure for Document Document No. APEX/GCE/GMP/MOGP–2.4

5.12 He a de r to be used for all the Procedures, SOP/W Is

Galaxy Chemicals (Egypt) S.A.E

Record of Revisions Document No. APEX/GCE/QMS/MOGP/REVISION – 1.2

5.13 Guide lines for footer to be use d for various documents

e .g. Foote r for Process (QA) Document

Owned by Approved by Issued By

Sr. Associate Sr. Manager – Quality Process Management Representative

Procedure for Document Document No. APEX/GCE/GMP/MOGP–2.4

Manual is reviewed/updated by the

Manual is reviewed for approval by

Manual is reviewed for issuing by MR

If Manual is approved for Issuing by

MR uploads the new soft copy of

MR requests IT to authorize access

IT confirms by mail that authorization

MR confirms access by checking

Procedure for Document Document No. APEX/GCE/GMP/MOGP–2.4

7.1 Control of Documents:

7.3 The signed off copies are considered as a “Master Copy”.

Procedure for Document Document No. APEX/GCE/GMP/MOGP–2.4

8.0 Removal & Disposal of Obsolete Documents: