Galaxy Chemicals (Egypt) S.A.

Procedure for Internal Document No. APEX/GCE/GMP/MOGP – 3.3

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 4
Operating Process : Manual of General Procedures

Title: Procedure for Internal GMP Audit

Purpose: To determine whether quality management system related activities and results comply
with planned arrangements and whether these arrangements are implemented effectively
and are suitable to achieve quality management system objectives.

Scope: All the functional areas directly connected with quality management system.

Responsibility: MR

Procedure:

1. Selection of internal auditors :

Purpose of any audit is to collect facts therefore following parameters are kept in mind while selecting
internal auditors:
 Auditors are selected from the Associate and above level however, to spread the awareness on quality
activities experienced plant operators are also selected as trainee auditors who are given brief specific
audit assignments by M.R., after training. Depending upon learning level of the auditing skills and
knowledge of the quality system such plant operators can be inducted as an auditor over a period of
time.
 Personal attributes like open mindedness, attention to details, scanning ability, maturity, sound
judgment, analytical skills, tenacity, communication & listening qualities.
 Experience: any length of experience after confirmation of employment including ability to get along
with people.
 Managerial: capabilities like planning the audit, documenting observations, communicating and
clarifying audit findings/requirements, reporting audit results.

2. Training of internal auditors :

 Training to internal auditors is given by was given Management representatives or members

attended Lead Auditor course from outside by an external agency.
 Refresher training is also conducted for senior auditors as and when required by MR. and members
attended outside Lead Auditor course.
 Important areas of training are as follows :

a) Understanding levels of documents/manuals and thorough knowledge of interpretation of the

ISO:22716:2007 good manufacturing practices standard & EFfCI GMP standard including
audit planning, recording and reporting of non-conformities based on objective evidence.
b) Auditor - Auditee relation: To avoid any mistrust and doubt, the auditor states the purpose of
verifying effectiveness of quality management system. If the system is ineffective, the negative
criticism or sarcasm is avoided.
c) Formulating Questions: Open-ended questions which allow greater flexibility are used. For
example, how do you control temperature?; why do you have this particular control?; tell me more
about your calibration procedure; could you please explain your incoming material inspection
procedure?; could you give me an example?; etc.

GMP/MOGPMANUAL/30.03.2023 Rev04 Approver’s signature not required unless the document is printed
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 Galaxy Chemicals (Egypt) S.A.E

Procedure for Internal Document No. APEX/GCE/GMP/MOGP – 3.3

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 4
Operating Process : Manual of General Procedures

d) Don’ts: Avoid asking question too rapidly; avoid referring to opinions, feelings or vague concepts.

e) Auditor’s Behavior :
Effective listening is the key element of any good audit which helps the auditee to express himself
therefore following behavioral aspects are explained to auditors during training so that he/she :

i. Carefully and attentively listens and does not prepare the next question while listening to an
answer
ii. Demonstrates a genuine interest in the explanations provided by the auditee.
iii. Never judges or criticizes and remains patient.
iv. Neither approves or disapproves.
v. Maintains eye contact.
vi. Reports on time.

3. Evaluation of internal auditors and quality of audits:

 The NC or suggestions needing attention of MRC members are discussed during quarterly MRC
meeting. Suggestion or areas of improvements observed during audit are recorded in the auditor
evaluation documents and this is taken into account in the performance of auditors.
 Members of the MRC sometimes attend the internal audit with or without pre-intimation to the auditee
or auditor.
 Ongoing evaluation of the auditors is carried out by MRs or by members attended outside Lead
Auditor course to know their awareness, participation, punctuality, auditing skills, auditor-auditee
relations and knowledge of the quality management system including quality manual, through question-
answer session or test papers given during refresher training workshops.
 MRC reviews the performance of the internal auditors and names of the non- performing auditors are
deleted from the list however, definite trends shall emerge in due course of time.
 Internal auditors are evaluated based on written exam or by conducting actual audit
 In written exam auditor has to score min 80% marks

4. The Audits:

 The main objective of internal audit is to assess complete implementation and maintenance of the
Quality management system.
 Management takes internal auditing as a serious activity and stands committed towards corrective
action and preventive actions.
 Any type of nonconformity pointed out by an internal auditor is personally taken care, by the auditee
and followed up by respective MR. Verification of corrective action and preventive action is done in the
subsequent audit.
Following stages of audits are applicable:

a) First stage certification audit (Pre-assessment audit) conducted by certification agency when
informal 6 month adequacy audits are conducted by internal auditors at unit located to be
certified.
b) Final stage audit by certification agency (BVC) is conducted when they certified the units.

GMP/MOGPMANUAL/30.03.2023 Rev04 Approver’s signature not required unless the document is printed
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 Galaxy Chemicals (Egypt) S.A.E

Procedure for Internal Document No. APEX/GCE/GMP/MOGP – 3.3

Audits Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. 3 of 4
Operating Process : Manual of General Procedures

c) Internal compliance audits are conducted after every 6 months

d) Surveillance Audits - conducted at an interval of one year by Certification agency.
e) Recertification audit is conducted at an interval of 3 years by Certification agency.

5. Audit Plans:
 M.R. or MR Dy. prepares the annual audit plans and circulated to all related team members well
in advance(minimum of 10 days’ time).
 Whenever, any change in audit date is required for specific reasons by auditee or auditor, request is
made immediately on receipt of the plan. M.R. or MR Dy tries to replace the date or substitute the
auditor if possible, otherwise M.R. or MR Dy give new date to both team.
 Internal auditors are chosen from different process / sub-process areas. For auditing, auditors from
same process / sub-process are not deputed.
 All processes / sub-processes at respective locations are covered regularly in audit schedule at an
interval of 6 months to 12 months (however, if status of the activity requires audit at short intervals,
same is followed for specific area with frequency decided by M.R. or MR Dy).

Note: Since entire business creation process is controlled from Head office, so no audit done here

International Standard for ISO:22716 & EFfCI GMP, Apex quality manual, Manual of General
Procedures, Process / Sub-process manual of procedures and Work instructions including technical
specification are the base of reference for auditors.

6. The Audit reports:

 Audit report is submitted as per format appearing in section no. 7.0 of this manual indicating names of
the auditee / auditor, date of audit, audit schedule no., audit report no., etc. including degree of non-
conformity.
 Before preparing the audit report, auditor explains the observations / findings to auditee and then
report is jointly signed by both.
 For GMP Audit the audit checklist format No. (FMT – GCE-QA/132), available as support to auditor.

 Audit report are distributed as follows -

 First Copy : Auditee
 Photo Copy : M.R. or MR Dy

7. The Audit reply / Closure of *Observation/ Non conformance:

 Audit report is submitted to auditee within a week of performing audit.

 Root Cause, Correction, Corrective actions are given by auditee within a week from receiving
audit report.
 Corrective Action Plan (CAP) given by auditee is evaluated by auditor and accepts or rejects.
 If accepted, CAPs is taken up for implementation. If rejected, auditee would review further and
update CAPs. Where the intervention of M.R. or MR Dy is required, same is being followed.
 If the nature of NCR warrants immediate correction, corrective action, same is done on priority
by auditee.

GMP/MOGPMANUAL/30.03.2023 Rev04 Approver’s signature not required unless the document is printed
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 Galaxy Chemicals (Egypt) S.A.E

Procedure for Internal Document No. APEX/GCE/GMP/MOGP – 3.3

Audits Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. 4 of 4
Operating Process : Manual of General Procedures

 If the closure of non-conformance requires more than 30 days, same to be mentioned in the
non-conformance report and follow up comment to be put by respective auditor / MR after
verification.
 Individual process heads ensure that all NCRs are tracked periodically and report to MR the
status on monthly basis.
 If corrective actions are not implemented within 90 calendar days from the date of performing
audit, respective process owners are required to communicate to M.R. or MR Dy with
complete justification. Same thing is reported and reviewed during MRC meeting.
 Evidences of closure of *Observation/Non-conformance to be verified by Auditor, M.R. or MR Dy.
Records: Are maintained by respective M.R.

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 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
Change Record

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
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