PKP 200 308 Conduct Inspection

Document No.
QUALITY PROCEDURE PKP/200/308

Version
bpfk PROCEDURE FOR CONDUCTING AN
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9
INSPECTION 1 / 20
REVISION HISTORY
Version Prepared by Approved by Effective date
Ahmad Syamsury Dr. Tajuddin

1 01 April 2003
Sulaiman Akasah
Mohd Nasrul Dr. Tajuddin

2 01 July 2004
Mohamad Noor Akasah
Mohd Nasrul Kadariah Mohd

3 01 July 2006
Mohamad Noor Ali
Mohd Nasrul Kadariah Mohd

4 01 March 2007
Mohamad Noor Ali
Sufian Hardi Mohamed Sulaiman Hj.

5 02 May 2008
Zuhair Ahmad
Dr. Tajuddin
6 Belinna Abu Bakar 01 July 2009
Akasah
Ahmad Kamal Ahmad Sulaiman Hj.

7 16 April 2010
Suhaimi Ahmad
Ahmad Kamal Ahmad Sulaiman Hj.

8 01 July 2012
Suhaimi Ahmad
Mohd Husnizaen Sulaiman Hj.

9 01 July 2014
Mohamed Ahmad
REFERENCES
Document No Title
BPFK /100 BPFK Quality Manual
PKP/200/309 Procedure for Preparing a GMP Audit Report
PKP/200/307 Perlantikan Pemeriksa dan Penentuan Premis Yang Perlu
Diperiksa
_______________________________________________________________________________________________________
REFER TO MASTER LIST

ENSURE CORRECT VERSION OF DOCUMENT IS USED
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INSPECTION 2 / 20
Change History:
First Revision
Item 3.1, 4.1.1,4.1.2.3,4.7.3,4.7.4,4.8.1

Change of ‘Head of GMP and Licensing Division’ to Head of Centre For GMP’
Item 2,4.6.2,4.9,4.10
Change of ‘GMP and Licensing Division’ to ‘Centre For GMP’
Item 2
Update Definition Type of Inspection
Item 4.1.1
Update Scheduled and Unscheduled and Unscheduled Inspection
Second Revision
Item 2
To update the definition of Verification Inspection
To add the definition of Re-Pre-licensing Inspection
Remove out the definition of Initial Visit
Item 4.1.1
To add sentences ‘Unannounced routine inspection will be conducted on premises
with poor GMP compliance in the previous inspection or depending on special
conditions.’ under para Scheduled Inspections
To add the wording of Re-Pre-licensing
Remove out Initial Visit under para Unannounced
Item 4.8.2
To add sentences ‘Company must reply to the inspection report within 30 days unless
there is acceptable reason. The responsible Auditor will monitor the time frame for
the reply letter.’
Item 5.2
To add ‘Record numbers of audit reports’
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Third Revision
Item 4.1.1,4.1.2.3,4.7.3,4.7.4,4.8.1
Change of ‘Head of Centre For GMP’ to ‘Head of Centre For Compliance &
Licensing’
Item 2,4.6.2,4.9,4.10
Change of ‘Centre For GMP’ to ‘Centre For Compliance & Licensing’
Item 4.6.2
Change ‘…within fourteen days…’ to ‘…as described under Appendix 3,
APB/200/309…’
Item 4.7.3
Change ‘…within fourteen days’ to ‘…as described under Appendix 3, procedure
APB/200/309’
Fourth Revision
Item 4.1.1, 4.1.2.3, 4.7.3, 4.7.4, 4.8.1

Change of ‘Head of Centre for Compliance & Licensing’ to ‘Deputy Director of the
Centre for Compliance & Licensing’
Item 2
Removed out sentences ‘Examples: Manufacturer of Veterinary products and Active
Pharmaceutical Ingredient’ under para Pre-Certification Inspection
To add sentences ‘Initial Inspection is an inspection conducted only on new cosmetic

premises which is not in the Routine Inspection Schedule’ under para Initial
Inspection
Item 3.1, 4.1.1

Change of ‘Head of Centre’ to ‘Deputy Director’
Item 4.1.1
Removed out sentences ‘Unannounced routine inspection will be conducted on
premises with poor GMP compliance in the previous inspection or depending on
special conditions’ under para Routine Inspections
To add sentences ‘These inspections will be conducted according to the Annual GMP
Inspection List’ under para Routine Inspections
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To add ‘These inspections will be conducted following the notification approval for
cosmetic products produced in Malaysia’ under para Initial Inspections
Fifth Revision
Item 4.1.3
Change of ‘Centre for GMP’ to ‘Center for Compliance & Licensing’.
Item 4.1.4.1
Removed ‘Aide-Memoire’ and rephrased ‘Prepare an inspection plan Aide-Memoire,
may be useful as a guide’
Item 4.5.2
Removed ‘There are two possible ratings, conforming or non-conforming with GMP
principles’
Item 4.7.2
Rephrased ‘In situations where there is an Inspection Team, the GMP Lead Auditor
signs the report’
Item 4.7.3
Removed ‘within fourteen days’
Sixth Revision
Item 2
To rephrase ‘an audit of manufacturing premises’ to ‘an audit of a manufacturing
premise’
Item 2
Change of ‘with’ to ‘have’ under para Verification Inspection
Item 2
To add the word ‘have’ under para Pre-Licensing Inspection
Item 2
To add the sentence ‘Initial Visit is a visit conducted on manufacturing premises that
manufacture products that are going to be regulated’
Item 4.1.1
To add ‘Initial Visit’ under para Unscheduled Inspections
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INSPECTION 5 / 20
Item 4.1.2.1, 4.5, 4.5.1.1, 4.6.2, 4.7.1

Change of ‘APB’ to ‘PKP’
Item 4.1.2.3
Change of ‘identifies its’ to ‘identify his/her’
Item 4.1.3
Change of ‘held’ to ‘hold’
Item 4.5.1.1
Change of ‘subject’ to ‘prone’
Item 4.6.2
Change of ‘Appendix 3’ to ‘Appendix 1’
Item 4.7.4
Change of ‘Director of NPCB’ to ‘Director of Regulatory Pharmacy’
Item 5.1
To remove the word ‘Audit Reports’
Seventh Revision
Change of document format based on the decision made by the management of NPCB
in a few aspects including Revision History, enforcing the details of changes such as
inclusion of para 3 for ‘DEFINITION’, para 4 for ‘FLOWCHART’, para 8 for
‘FORM/ANNEXES’ and removal of para (9)-‘End’.
Reparagraph
Definitions under para 2 reparagraphed to para 3
Renumbering Items
- 3.1, 3.2 renumbered to 5.1, 5.2
- 4.1, 4.1.1, 4.1.2, 4.1.2.1, 4.1.2.2, 4.1.2.3, 4.1.2.4, 4.1.2.5, 4.1.3, 4.1.4, 4.1.4.1,
4.1.4.2, 4.1.5, 4.1.6, 4.2, 4.3, 4.3.1, 4.3.2, 4.3.3, 4.3.4, 4.3.5, 4.3.6, 4.3.7, 4.3.8, 4.4,
4.4.1, 4.4.2, 4.4.3, 4.5, 4.5.1, 4.5.1.1, 4.5.1.2, 4.5.2, 4.6, 4.6.1, 4.6.2, 4.6.3, 4.6.4,
4.6.5, 4.7, 4.7.1, 4.7.2, 4.7.3, 4.7.4, 4.8, 4.8.1, 4.8.2, 4.8.3, 4.8.4, 4.9, 4.10 renumbered
to 6.1, 6.1.1, 6.1.2, 6.1.2.1, 6.1.2.2, 6.1.2.3, 6.1.2.4, 6.1.2.5, 6.1.3, 6.1.4, 6.1.4.1,
6.1.4.2, 6.1.5, 6.1.6, 6.2, 6.3, 6.3.1, 6.3.2, 6.3.3, 6.3.4, 6.3.5, 6.3.6, 6.3.7, 6.3.8, 6.4,
6.4.1, 6.4.2, 6.4.3, 6.5, 6.5.1, 6.5.1.1, 6.5.1.2, 6.5.2, 6.6, 6.6.1, 6.6.2, 6.6.3, 6.6.4,
6.6.5, 6.7, 6.7.1, 6.7.2, 6.7.3, 6.7.4, 6.8, 6.8.1, 6.8.2, 6.8.3, 6.8.4, 6.9, 6.10
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INSPECTION 6 / 20
- Para 5 renumbered to para 7
Document title, Item 1.1, 2.1, 3.2

Change of ‘Audit’ to ‘Inspection’
Item 2.1, 4.1.2.1, 4.1.2.2, 4.1.2.3, 4.1.2.4

Change of ‘Auditors’ to ‘Inspectors’
Item 4.1.2.4, 4.1.2.5, 4.1.3.1, 4.7.2

Change of ‘GMP Lead Auditor’ to ‘GMP Lead Inspector’
Item 2.3
Removal of ‘or non-punitive action taken on premises that have poor GMP
compliance’
Eighth Revision
Renumbering Items
Renumbering Items throughout the procedure
Item 1.1
Change of ‘objective of this SOP’ to ‘Objectives of this procedure are’
Change of ‘every inspection must be objective’ to ‘every inspection must be planned’
Item 3.3
To add the word ‘action’.
Item 3.5
Removed Item 3.5 regarding ‘Re-Pre-licensing Inspection:
Re-Pre-Licensing Inspection is an inspection conducted on the premises that have
been previously inspected but did not have any manufacturing license after a certain
period or following a punitive action taken on premises with unacceptable GMP
compliance.
Item 3.8
To add ‘Inspection’ after the word ‘Pre-Certification’
Item 3.11
To add ‘by Drug Control Authority’
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Item 6.1.1.2
To add sentence ‘Centre for Compliance & Licensing, NPCB has the right to inspect
at any time. Inspection may be announced in advance or unannounced.’ under para
Scheduled Inspections
To remove ‘Re-Pre-licensing’ from para Announced under Unscheduled Inspection
Item 6.5
Change the first sentence ‘final meeting’ to ‘exit meeting’
Rephrase second sentence to ‘The deficiencies will be presented to the company in

the exit meeting.’
Item 6.5.2
To remove ‘or where several deficiencies are rated as major’ from the second
sentence of para 6.5.2.1
Item 6.6.2
Rephrase first sentence to ‘Deficiencies should be presented to the company by
highlighting important issues that require immediate attention.’
Item 6.7.3
Omit the sentences ‘of Centre for Compliance & Licencing’
Item 6.7.4
Rephrase fourth bullet point to ‘be signed by the Deputy Director, on behalf of
Director of Regulatory Pharmacy, before issued out to the manufacturer.’
Item 6.1.2.1Addition of statement:

‘Where warranted, Deputy Director will invite external expert(s) as co-inspector for
specific area that is currently being built. The qualification of the expert(s) will be
subjected to their respective department/centre/organization recognition.’
Item 6.1.5.1
Rephrase the statement to ‘Contact the company before inspection with the proposed
inspection date.’
.
Item 6.2.1
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• Omission of bullet point statement ‘with a copy of inspection plan’ to only

‘provide the company with inspection plan’
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INSPECTION 9 / 20
1. OBJECTIVE
1.1 The objectives of this procedure are to:

• describe the procedure for conducting an inspection
• ensure that every inspection must be planned and appropriately
conducted
2. SCOPE
2.1 This procedure is to be used by GMP Inspectors, Centre for Compliance &
Licensing, NPCB for conducting an inspection of a manufacturing premise.
3. DEFINITION
3.1 Deputy Director:

Deputy Director of Centre for Compliance and Licensing
3.2 Routine Inspection:

Routine Inspection is a surveillance inspection conducted according to
planned schedule
3.3 Verification Inspection:

Verification Inspection is an inspection conducted following a punitive
action. Depending on the condition, verification inspection can be
combined together with routine inspection
3.4 Pre-Licensing Inspection:

Pre-Licensing Inspection is an inspection conducted on new premises that
have never been licensed
3.5 Investigation Inspection:

Investigation Inspection is an inspection conducted on premises based on
complaint received by NPCB
3.6 Foreign Inspection:

Foreign Inspection is an inspection conducted on abroad manufacturing
facility
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3.7 Pre-Certification Inspection:

Pre-Certification Inspection is an inspection conducted on premises that are
not regulated by Drug Control Authority
3.8 Pre-Approval Inspection:

Pre-approval Inspection is an inspection conducted on new production line
of licensed manufacturers
3.9 Initial Inspection:

Initial Inspection is an inspection conducted only on new cosmetic premises
which is not in the Routine Inspection Schedule
3.10 Initial Visit:

Initial Visit is a visit conducted on manufacturing premises that
manufacture products that are going to be regulated by Drug Control
Authority
4. FLOW CHART
Not applicable
5. RESPONSIBILITY
5.1. Deputy Director

5.2. Inspector(s)
6. PROCEDURE
6.1. Preparation
6.1.1 Planning of inspections
6.1.1.1 The Deputy Director under the NPCB, Ministry of

Health Malaysia, coordinates the scheduling of
inspections.
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6.1.1.2 GMP Inspections Schedule:
Scheduled Inspections:
• Routine Inspections:
The schedule (Annual GMP Inspection List) will be
issued out early of the year. These inspections will
be conducted according to the Annual GMP
Inspection List.
• Centre for Compliance & Licensing, NPCB has the

right to inspect at any time. Inspection may be
announced in advance or unannounced.
Unscheduled Inspections:
i. Announced
• Verification Inspections, Pre-licensing
Inspections, Foreign Inspection, Pre-
Certification Inspections, Pre-approval
Inspections, Initial Visit:
These inspections will be conducted only
upon invitation by the company.
• Initial Inspections:
These inspections will be conducted
following the notification approval for
cosmetic products produced in Malaysia.
ii. Unannounced
• Investigational Inspections:
These inspections will be conducted only
upon instruction by Deputy Director.
6.1.2 Inspection Team
Composition of the team
6.1.2.1 Inspectors are appointed according to procedure

PKP/200/307
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6.1.2.2 It is anticipated that for the most part, one GMP Inspector
will be involved per inspection. If required, a team may
be established. The composition and size of the team will
be determined based on skills, workloads, experience in
the type of inspections required, overall economics of
travel, etc.
6.1.2.3 The Deputy Director will nominate the Lead Inspector;

the Lead Inspector will identify his/her team member(s),
who shall be in charge of the inspection.
6.1.2.4 Where warranted, Deputy Director will invite external

expert(s) as co-inspector for specific area that is currently
being built. The qualification of the expert(s) will be
subjected to their respective
department/centre/organization recognition.
Mandate of the Inspection Team
6.1.2.5 The mandate of the Inspection Team is as follows:
• to conduct a GMP inspection
• to cooperate, by discussing and resolving, where

possible, any major problems that may occur during
the inspection
• to ensure all GMP Inspectors play an active role in the

inspection
• to make decisions on inspection findings by way of

consensus; however, where this is not possible, the
GMP Lead Inspector makes the final decision
• to prepare an inspection report
• to conduct any follow-up measures
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6.1.2.6 In addition, the GMP Lead Inspector is responsible to

organize, coordinate, and lead during all stages of the
inspection and act as spokesperson.
6.1.3 Review of company files
6.1.3.1 GMP Lead Inspector, prior to conducting the inspection,

will hold a Pre-Inspection Meeting (if necessary), to
review any relevant documentation obtained by the
Centre for Compliance & Licensing, such as the Site
Master File.
6.1.4 Inspection plan
6.1.4.1 Prepare an inspection plan as it may be useful as a guide.

Ensure that the inspection plan is risk-based and covers
all critical activities. Key elements in the plan may
include:
• the type of inspection to be conducted
• the scope and objectives of the inspection
• information from previous GMP inspections,

including any follow-up measures
• any available post market surveillance information
• names of the person(s) who are directly responsible

for production and quality control / quality assurance
• names of the Inspection Team members and their

respective roles
• the time, date and place for the opening meeting
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• the organizational units to be inspected, taking into

consideration if the company has multiple sites
• the expected time and duration for each major

inspection activity
• a schedule of meetings, including a daily briefing to

be held with company management
• a tentative list of documents for review
• samples (if any) to be taken
• a tentative time, date and place for the exit meeting
6.1.4.2 Be flexible with the inspection plan so as to accommodate

any changes needed to meet the site-specific demands or
situations encountered or discovered. Notify the company
of any changes to the plan. Document the reasons for not
meeting any of the inspection objectives.
6.1.5 Announcement of the inspection
6.1.5.1 Contact the company before inspection with the proposed

inspection date.
6.1.6 Note taking
6.1.6.1 Throughout the inspection, make clear, accurate and

legible notes. The notes should contain relevant yet
detailed facts that serve as a record of what is directly
observed or heard.
6.2 Opening meeting
6.2.1 Upon arrival at the company, arrange an opening meeting with the
company’s management and key personnel. The purpose of this
meeting is to:
• introduce the member(s) of the Inspection Team
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• provide the company with inspection plan
• outline the purpose, type and scope of the inspection
• discuss the proposed schedule and make the necessary

arrangements
• review the company’s organizational structure
• discuss any previous inspections, and what corrective and

preventative measures were implemented. Discuss any
significant changes in facilities, equipment, products and
personnel since the last inspection, if applicable
• identify any suppliers of starting materials, packaging

materials, bulk process intermediates
• identify any companies used for contract manufacture or

analysis
• allow the company the opportunity to present an overview of

the quality management system and to discuss their current and
proposed activities.
6.3 Inspection of plant facilities
6.3.1 Conduct a plant tour. Assess whether the facilities and equipment
are of suitable layout and design, if they are maintained properly
and if they are suited for the intended operations.
6.3.2 Examine the manufacturing process of each dosage form.

Determine the most critical steps in terms of the success of the
overall process. Assess how these steps are controlled, monitored
and recorded, taking into account the detailed guidelines of GMP.
6.3.3 Focus on higher-risk activities, known problems and deviations

from standard practices.
6.3.4 Confirm that the company is effectively implementing their current

procedures.
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6.3.5 Interview all levels of personnel, as deemed necessary. Likewise,

request any pertinent documents, e.g., procedures, records, raw
data and personnel training records.
6.3.6 Confirm the accuracy of the observed deficiencies with the

immediate supervisory personnel. Keep management informed of
the deficiencies.
6.3.7 Investigate all deficiencies to establish their extent, particularly if

there are concerns about product safety.
6.3.8 If a critical deficiency is found during the course of the inspection,

notify the company’s management and request immediate
corrective and preventative measures.
6.4 Review of documentation
6.4.1 Assess the company’s overall documentation management system,

including their change control practices. Evaluate the batch release
procedure and the role of the person who is responsible for this
duty.
6.4.2 Criteria for selection of products to be reviewed include:
• the inherent risk associated with use of the product
• if the manufacturer makes multiple dosage forms
• special storage conditions
• complex manufacturing processes
• complaints or any known problems with the product
• products that have recently received a marketing authorization
• products with recent, significant changes to the marketing

authorization.
6.4.3 The following documents may be reviewed:

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• master formula and processing instructions
• specifications for starting materials, primary packaging

materials, intermediate, bulk products and finished products
• batch manufacturing records
• complaints
• incident reports
• relevant standard operating procedures and records, e.g., recall

procedure
• relevant contracts
• job descriptions and training records
• validation information
• laboratory books
• stability data
• self inspection program and reports. This should be done

towards the end of the review.
6.5 List of deficiencies
The team should meet regularly throughout the inspection and prior to the
exit meeting to discuss the findings and any inspection issues. The
deficiencies will be presented to the company in the exit meeting.
Categorize each deficiency according to the PKP/200/309 and state the
inspection rating.
6.5.1 Deficiencies
6.5.1.1 Each deficiency should be:
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• clear, concise, accurate, factual, objective, complete,

not subjected to misinterpretation, facilitates
corrective action(s)
• written in the past tense
• classified according to the procedure PKP/200/309
• referenced to a specific section of the GMP guide
• cover only one issue per observation. Multiple

deficiencies dealing with the same issue may be
combined.
6.5.1.2 Deficiencies that are corrected during the inspection

should be included in the inspection report with a
statement that it has been corrected.
6.5.2 Inspection rating
6.5.2.1 Assign the overall inspection rating. The rating is related

to the risk classification of each deficiency. A non
conformance rating may be assigned where a deficiency
is rated as critical.
6.6 Exit meeting
6.6.1 At the end of the inspection, hold a meeting with the company’s
management to discuss the outcome of the inspection.
6.6.2 Deficiencies should be presented to the company by highlighting

important issues that require immediate attention. Inform them that
the Centre for Compliance & Licensing will send the final
inspection report as described under Appendix 1, PKP/200/309 and
that a written response will be requested within the following thirty
days.
6.6.3 Present a summary of both the positive findings and the GMP
deficiencies. The company may wish to further discuss or clarify
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some of the deficiencies. It is important to ensure that all of the

deficiencies are accurate and are not subject to misinterpretation.
6.6.4 All points of contention should be discussed during this meeting.
6.6.5 A record should be made of the people attending the meeting.
6.7 Report writing
6.7.1 Refer to the procedure PKP/200/309.
6.7.2 In situations where there is an Inspection Team, the GMP Lead

Inspector may sign the report on behalf of his/her Inspection Team.
6.7.3 Send the final report to the Deputy Director. The report will be
reviewed and approved by the Deputy Director.
6.7.4 Prepare a cover letter to be sent with the report. This letter should:
• include the dates of the inspection and the address of the site
that was inspected
• state the inspection rating that was assigned
• request a written response. The time frame for corrective and

preventative measures is dependent on the risk category of the
deficiencies and the inspection rating. Generally, the company
is given 30 days to respond to the inspection report.
• be signed by the Deputy Director, on behalf of Director of

Regulatory Pharmacy, before issued out to the manufacturer.
6.8 Follow up
6.8.1 The Deputy Director will receive the company’s response letter
and send it to the Inspector for review.
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6.8.2 Company must reply to the inspection report within 30 days unless
there is acceptable reason. The responsible Inspector will monitor
the time frame for the reply letter.
6.8.3 Deficiencies may be considered as resolved if the company’s

response letter:
• states that corrective and preventive measures have been

implemented, and includes supporting documentation, if
necessary,
• provides a written commitment, providing a clear and

reasonable schedule for implementation of corrective and
preventive measures.
6.8.4 If the corrective and preventive measures taken by the company are
not considered to be acceptable, further correspondence may be
necessary.
6.9 Distribution of the inspection report
6.9.1 The inspection report is the property of the Centre for Compliance
& Licensing.
6.10 Archiving of inspection information
6.10.1 The Centre for Compliance & Licensing will retain all inspection
information, including inspection reports, any further
correspondence.
7. QUALITY RECORD
7.1. Record numbers of inspection reports
8. FORMS/ANNEXES
Not applicable
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Document No.

QUALITY PROCEDURE PKP/200/308

Version Prepared by Approved by Effective date

Ahmad Syamsury Dr. Tajuddin

Mohd Nasrul Dr. Tajuddin

Mohd Nasrul Kadariah Mohd

Mohd Nasrul Kadariah Mohd

Sufian Hardi Mohamed Sulaiman Hj.

Ahmad Kamal Ahmad Sulaiman Hj.

Ahmad Kamal Ahmad Sulaiman Hj.

Mohd Husnizaen Sulaiman Hj.

REFER TO MASTER LIST

Item 3.1, 4.1.1,4.1.2.3,4.7.3,4.7.4,4.8.1

REFER TO MASTER LIST

Item 4.1.1, 4.1.2.3, 4.7.3, 4.7.4, 4.8.1

To add sentences ‘Initial Inspection is an inspection conducted only on new cosmetic

Item 3.1, 4.1.1

REFER TO MASTER LIST

REFER TO MASTER LIST

Item 4.1.2.1, 4.5, 4.5.1.1, 4.6.2, 4.7.1

REFER TO MASTER LIST

- Para 5 renumbered to para 7

Document title, Item 1.1, 2.1, 3.2

Item 2.1, 4.1.2.1, 4.1.2.2, 4.1.2.3, 4.1.2.4

Item 4.1.2.4, 4.1.2.5, 4.1.3.1, 4.7.2

REFER TO MASTER LIST

To remove ‘Re-Pre-licensing’ from para Announced under Unscheduled Inspection

Rephrase second sentence to ‘The deficiencies will be presented to the company in

Item 6.1.2.1Addition of statement:

REFER TO MASTER LIST

• Omission of bullet point statement ‘with a copy of inspection plan’ to only

REFER TO MASTER LIST

1.1 The objectives of this procedure are to:

3.1 Deputy Director:

3.2 Routine Inspection:

3.3 Verification Inspection:

3.4 Pre-Licensing Inspection:

3.5 Investigation Inspection:

3.6 Foreign Inspection:

REFER TO MASTER LIST

3.7 Pre-Certification Inspection:

3.8 Pre-Approval Inspection:

3.9 Initial Inspection:

3.10 Initial Visit:

5.1. Deputy Director

6.1.1 Planning of inspections

6.1.1.1 The Deputy Director under the NPCB, Ministry of

REFER TO MASTER LIST

6.1.1.2 GMP Inspections Schedule:

• Centre for Compliance & Licensing, NPCB has the

6.1.2 Inspection Team

Composition of the team

6.1.2.1 Inspectors are appointed according to procedure

REFER TO MASTER LIST

6.1.2.3 The Deputy Director will nominate the Lead Inspector;

6.1.2.4 Where warranted, Deputy Director will invite external

Mandate of the Inspection Team

6.1.2.5 The mandate of the Inspection Team is as follows:

• to conduct a GMP inspection

• to cooperate, by discussing and resolving, where

• to ensure all GMP Inspectors play an active role in the

• to make decisions on inspection findings by way of

• to prepare an inspection report