Galaxy Chemicals (Egypt) S.A.

Procedure for handling Document No. APEX/GCE/GMP/MOGP – 3.5

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

Title: Procedure for handling external audits

1. Purpose: To give guidelines for handling external audits

2. Scope: All the functional areas directly connected with quality management system.
3. Responsibility:
3.1. It is responsibility of MR or deputy MR to communicate and co-ordinate about external audit
schedule
3.2. It is responsibility of MR or deputy MR to communicate about observations and CAPA to external
4. Procedure:
Selection of auditees for external audits:

The selection of auditees for external audits is based on their experience, area of expertise and
knowledge:

 Government officers are attended by respective section incharges

 Legal inspector, Factory inspector, RS auditor – PE and legal department
 FDA inspector- Legal and QA ,conversion
 Customer audits: QA and conversion team
 QMS,SHE and GMP audit : Location MR

Apart from these auditees, other section in-charges face audits as per the need.

The auditees mentioned above held responsible to attend the auditor for entire audit period. The auditees
ensures arrangement of all relevant auditees, documents, evidences as per the requirement.

4.1. Skills of auditees : Technical:

1] Details of the process

2] Thorough knowledge rules and regulations applicable

3] Experience : Min 2 years experience in the field

4.2. Behaviour
 Carefully and attentively listens the question and answer in brief and to the
point
 Defends audit with proper evidences
 Never judges or criticizes and remains patient.
 Reports on time.
 Never argues with auditor

4.3. Audit closure:

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

Procedure for handling Document No. APEX/GCE/GMP/MOGP – 3.5

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

 The NC or suggestions needing attention of MRC members are discussed during

conversion or MRC meeting. Suggestion or areas of improvements observed during audit
are recorded in the auditor evaluation documents and this is taken into consideration.
 The responsibility is assigned to respective process owner
The auditee ensures closure of all NCRs of ISO 9001 and ISO 22716 within 90 days of
audit. In case of delay the auditee has to ensure closure of NC in 120 days.
4.4. The Audit reports :
Audit NCs are shared by auditor in their specified format.

The Audit reply / Closure of Non conformance:

4.5. Evidences of closure of non-conformance to be verified by Auditor.

4.6. Records: Are maintained by respective Quality Assurance.

5. Definitions/Abbreviations:
Nil
6. Annexures:
Nil
7. References:
In-House

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

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 released as per ISO 22716 :2007

requirements.

5 4 30.03.2023
Entire manual issued as per EFfCI GMP requirements

Owned by 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.: