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PIC/S Assessment & Joint Reassessment Programme - REVISED PIC/S AUDIT CHECKLIST
# PS / W 1/2005 (Rev. 2) Annex dated 20 October 2014

JFDA Responsible Person for JFDA Document Name / Doc. #

Indicator Sub-component 1A Legislative and regulatory requirements and scope - Empowering legislation (Critical) this item Additional Comments
#

The legislation identifies key delegations/functions in the organisation/regulatory authority assigned for overall responsibility of the GMP regulatory law state that :(its not allowed to
1 compliance programme.2 legal Drug and pharmacy law no.12 of start production before a GMP
( 2 For PIC/S, the main issue is whether there is someone responsible for the compliance of the assessed authority with the Scheme’s requirements.) 2013- article 42/B compliance inspection is performed
by JFDA designated inspectors)

Accreditation of manufacturing
legal + inspectorate site criteria 2016- appendix 9
2 The authority to designate inspectors is vested in legislation. -article 2 inspectors delegated by D.G

legal + inspectorate delegation letter

1) legislation published on the news
3 The identity of designated inspectors and scope of jurisdiction of legislation are available to companies being inspected. legal + inspectorate no documents were found paper and available on jfda website
2) inspectors delegation letter 3)
inspector badges

There is legal authority for an inspector to enter at any reasonable time in any place where active pharmaceutical ingredients and medicinal products are Drug and pharmacy law no.12 of
4 manufactured, imported and exported. legal + inspectorate 2013 article 66/A2
Drug and pharmacy law no.12 of
5 There is legal authority for taking samples and submitting them to designated laboratories. legal + inspectorate 2013 article 66/c
Drug and pharmacy law no.12 of inspectors have law enforcement
6 There is legal authority for obtaining evidence such as documents, photographs/videos of premises and equipment. legal + inspectorate 2013 article 66/c authority
Drug and pharmacy law no.12 of
7 There is legal authority to open and examine any article subjected to legislation. legal + inspectorate 2013 article 66/c

Drug and pharmacy law no.12 of

8 There is the legal authority to seize or detain articles believed to be in violation. legal + inspectorate 2013 article 94/B //Drug and
pharmacy law no.12 of 2013 article
66/c

9 The legislation allows entry to a private dwelling.3 legal + inspectorate Drug and pharmacy law no.12 of
( 3 Property.)
2013- article 66/A2

10 Legislation requires that the person who has the responsibility of the site where active pharmaceutical ingredients and medicinal products are legal + inspectorate Drug and pharmacy law no.12 of
manufactured, imported and exported, to cooperate and not obstruct an inspector. 2013- article 66/B

11 Legislation requires a marketing authorisation holder and a manufacturer of medicinal product to report to the regulatory authority any serious adverse pharmacovigilance pharmacovigilance instructions of
medicinal product reactions. 2016 -Article 4

12 Legislation requires a marketing authorisation holder and a manufacturer of active pharmaceutical ingredients or of medicinal product to document any pharmacovigilance pharmacovigilance instructions of incase it affect its safety
product defect impacting its quality. 2016 -Article 7,12

13 Legislation requires the marketing authorisation holder and the manufacturer to notify a competent regulatory authority upon commencement of a recall of pharmacovigilance pharmacovigilance instructions of
medicinal product and to submit pertinent information. 2016 -Article 12
All companies that manufacture, import, export medicinal products are required to hold a manufacturing authorisation or be identified as holder of a Drug and pharmacy law no.12 of
14 manufacturing authorisation or as a registered company for active pharmaceutical ingredients. registration 2013- articles: 24/40-46

The holder of the manufacturing authorisation is required to notify the regulatory authority of significant changes or of conditions, which may affect the criteria of drugs registration of
15 quality, safety or efficacy of a medicinal product. registration 2015 and its amendments/ article
16
Legislation requires that the manufacturing authorisation include: the address of each site, the manufacturing activities, the category of medicinal products accreditation of manufacturing site
16 and the dosage form. legal + inspectorate criteria 2016 Master File

Legislation prohibits the sale and processing of active pharmaceutical ingredients and medicinal products under unsanitary conditions or leading to Drug and pharmacy law no.12 of law state that "the pharmaceutical articles
17 adulteration. legal + inspectorate 2013- article 28 products should be preserved in 28
accordance with valid legislation"

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guideline for GDP 2010 - article
5/F+H

18 GMPs are legal requirements. legal + inspectorate Drug and pharmacy law no.12 of law doesn't specify certain GMP
2013 article42/B

law doesn't state specific penalties

for liable person/manufacture for
19 The legislation specifies that a manufacturer and/or a person is liable for a defective medicinal product and provides for prosecution and/or penalties upon legal + inspectorate Drug and pharmacy law no.12 of ""defective"" products ///a set of
conviction 2013 articles 86-93 sanctions aimed at deterring
Manipulation, fraudulence and
trading of counterfeit medications

20 There is legislative authority to suspend, revoke or amend a manufacturing authorisation. legal + inspectorate Drug and pharmacy law no.12 of
2013 article 18

pharmaceutical products intended

21 Active pharmaceutical ingredients and medicinal products intended for exportation only are covered in the legislation the same way as products intended Import & Export exportation procedures 5/D/EX/1 for exportation only are not covered
for the domestic market. to 5/D/EX/9 in same way as products intended
for domestic use

JFDA Responsible Person JFDA Document Name / Doc. #

Indicator Sub-component 1B Legislative and regulatory requirements and scope - Conflict of interest (Very important) for this item Additional Comments
#
signing Code of conduct during
22 A policy/guideline exists that details the situations regarded as conflict of interest. legal + inspectorate+Hr. recruitment process
23 Employees are required to declare their compliance with the conflict of interest policy. legal + inspectorate+Hr.
JFDA Responsible Person JFDA Document Name / Doc. #
Indicator
Sub-component 2A Regulatory directives and policies - Procedures for designating inspectors (Very important) for this item
Additional Comments
#

Accreditation of manufacturing
24 A process for designation of inspectors exists. legal + inspectorate site criteria 2016 /appendix 9 & criteria don’t cover the details of
designation process
appendix 11

Sub-component 2B Regulatory directives and policies - Enforcement Policies

Included under sub-component 7B. Enforcement powers and procedures - Non-compliance management.
JFDA Responsible Person
Indicator Sub-component 2C Regulatory directives and policies - Code of conduct/ Code of ethics (Very important) for this item JFDA Document Name / Doc. # Additional Comments
#

25 A policy/guideline exist that details situations regarded as Code Of Conduct/Code Of Ethics. legal + inspectorate signing Code of conduct during general guideline
recruitment process
Sub-component 2D Regulatory directives and policies - Training certification policies/guidelines
Included under sub-component 4C. Inspection resources - Training programme.

Sub-component 2E Regulatory directives and policies - Alert/crisis management policies/procedures/guidelines

Included under sub-component 8A. Alert and crisis systems - Alert mechanisms.

Sub-component 2F Regulatory directives and policies - Organisational structure

Included under sub-component 11A. Quality management system
JFDA Responsible Person JFDA Document Name / Doc. #
Indicator Sub-component 3A GMP Standards - Details/ scope of GMP (Critical) for this item Additional Comments
#
26 GMPs are covered within a regulatory framework. legal + inspectorate no document were found

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The GMP regulatory framework covers all GMP requirements including but not limited to:
Quality management,
Premises,
Equipment,
Personnel,
Sanitation,
Raw material testing, Accreditation of manufacturing
site criteria 2016 require GMP as a "WHO GMP" & "Arab guidelines on
27 Manufacturing control, legal + inspectorate requirements for licensing without GMP" both used as references
Quality control department, during inspection
Packaging material testing, specifying certain gmp
Finished product testing,
Records,
Samples,
Stability, and
Sterile products.

1
Sub-component 3B GMP Standards - Process validation
Included under sub-component 3A GMP Standards - Details/ scope of GMP.
JFDA Responsible Person
Indicator Sub-component 4A Inspection resources - Staffing: Initial qualification (Very important) for this item JFDA Document Name / Doc. # Additional Comments
#

Accreditation of manufacturing
28 The minimum qualifications for GMP inspectors are defined HR+inspectorate +legal site criteria 2016 -appendix 11
qualifications of inspectors /////job
description

no document details how to cover

29 Duties of staff involved in the GMP regulatory compliance programme are defined. HR+inspectorate job description the scope & objectives of each
inspection

30 Evidence exists that the GMP inspectors meet the minimum qualifications. HR+inspectorate job description couldn’t be considered as an
evidence
JFDA Responsible Person JFDA Document Name / Doc. #
Indicator Sub-component 4B Inspection resources - Number of inspectors (Very important) for this item
Additional Comments
#

31 The number of inspectors dedicated to the GMP inspection programme is sufficient to meet the prescribed inspection frequency/inspection programme. HR+inspectorate not sufficient based on the interview with
inspectorate Dept. Head
JFDA Responsible Person JFDA Document Name / Doc. #
Indicator Sub-component 4C Inspection resources - Training programme (Very important) for this item
Additional Comments
#
32 A training programme for inspectors is established and records are maintained. Hr. not available

33 A mechanism to evaluate the effectiveness of training exists. Hr. not available only for lab personnel SOP#DQCL-
SOP020
Sub-component 4D Inspection resources - QA mechanism to assure effectiveness of training programme
Included under sub-component 4C Inspection resources - Training programme.
JFDA Responsible Person
Indicator Sub-component 5A Inspection procedures - Inspection strategy (Very important) for this item JFDA Document Name / Doc. # Additional Comments
#

34 Documents that describe the work expected, anticipated results and resources applied to fulfil the functions of GMP inspections are available. inspectorate SOP# 5/D/INS/11 should be revised

inspection schedule based on

35 A scheduling system identifies companies due for inspections within a set time frame. inspectorate inspection schedule companies' GMP certification
validity due date
JFDA Responsible Person
Indicator Sub-component 5B Inspection procedures - Pre-inspection preparation (Very important) for this item JFDA Document Name / Doc. # Additional Comments
#
36 A procedure details the requirements for pre-inspection activities, and is followed. inspectorate not available

37 The inspection plan is based on the company’s GMP compliance history, critical activities and type(s) of dosage forms or products manufactured. inspectorate not available

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JFDA Responsible Person JFDA Document Name / Doc. #
Indicator Sub-component 5C Inspection procedures - Format and content of inspection reports (Very important) for this item
Additional Comments
#
38 A procedure for the format and content of inspection reports is available. inspectorate no procedure only form inspection report form available

39 Observations are factual and are based on proper interpretation of applicable legislation. inspectorate yes based on the interview with
inspectorate Dept. Head
40 Observations are classified/categorised according to risk. inspectorate classification not available
41 Assessment of the company’s overall compliance rating is in line with the inspection findings. inspectorate rating system not available
yes, based on "accreditation of
42 Inspection reports are completed in the required reporting format and timeframe. inspectorate manufacturing site criteria 2016 /
appendix 9

Sub-component 5D Inspection procedures - Inspection methodology

Included under sub-components 5E. Inspection procedures - SOP for conducting inspections
JFDA Responsible Person
Indicator Sub-component 5E Inspection procedures - SOP for conducting inspections (Critical) for this item JFDA Document Name / Doc. # Additional Comments
#

43 A procedure details the requirements for conducting inspections and is followed. inspectorate 5/D/INS/11 should be revised / without details

accreditation of manufacturing site

44 Critical stages and parameters of manufacturing processes are assessed. inspectorate criteria 2016 /appendix 12: areas general
and sys to be inspected

45 Qualification and validation are assessed. inspectorate yes /no documented evidence based on the interview with
inspectorate Dept. Head

46 The inspection plan is adjusted, where warranted, based on the findings of the inspection. inspectorate yes/no documented evidence based on the interview with
inspectorate Dept. Head

47 The depth of the inspection is in line with the inspection findings. inspectorate yes/no documented evidence based on the interview with
inspectorate Dept. Head
JFDA Responsible Person JFDA Document Name / Doc. #
Indicator Sub-component 5F Inspection procedures - Post-inspection activities (Very important) for this item Additional Comments
#
48 A procedure details the requirements for post-inspection activities, and is followed. inspectorate 5/D/INS/11

49 Inspection findings and conclusions are subject to an internal review. inspectorate 5/D/INS/11 reviewed by inspectorate Dept. Head

JFDA Responsible Person JFDA Document Name / Doc. #

Indicator Sub-component 5G Inspection procedures - Storage of inspection data (Important) for this item Additional Comments
#
50 A policy/procedure is available for the storage of inspection data. inspectorate not available
51 An inspection report database (or archive) is maintained in a secure and controlled manner. inspectorate not available
Sub-component 6A Inspection performance standard - Performance standards (Very important)
Included under sub-component 11A Quality Management System - Quality management system
Sub-component 7A Enforcement powers and procedures - Provision for written notice of violations
Included under sub-component 7B Enforcement powers and procedures - Non-compliance management
JFDA Responsible Person JFDA Document Name / Doc. #
Indicator Sub-component 7B Enforcement powers and procedures - Non-compliance management (Critical) for this item Additional Comments
#
52 There is provision for written notice of violations to be sent to the company. inspectorate yes based on SOP# 5/D/INS/11
53 Recall procedures/mechanisms and records are available. pharmacovigilance yes based on SOP # 4/d/rdu/5
54 GMP certificates, manufacturing authorisation suspension/withdrawal procedures/mechanisms are available and a list of suspended/withdrawn authorisation inspectorate not available

55 Seizure procedures/mechanisms and records are available. inspectorate yes based on SOP# 5/D/INS/4 and
records are available

56 Prosecution procedures/mechanisms and records are available. legal no procedure where found/records mechanism without procedure
are available
JFDA Responsible Person JFDA Document Name / Doc. #
Indicator Sub-component 7C Enforcement powers and procedures - Appeal mechanism (Important) for this item Additional Comments
#

yes, Drug and pharmacy law no.12

57 Appeal procedures/mechanisms and records are available. legal + inspectorate of 2013- article 13, records are mechanism without procedure
available

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Sub-component 7D Enforcement powers and procedures - Other measures
Included under sub-components 7B Enforcement powers and procedures - Non-compliance management
JFDA Responsible Person JFDA Document Name / Doc. #
Indicator Sub-component 8A Alert and crisis systems - Alert mechanisms (Critical) for this item Additional Comments
#

a set of SOPs cover two way alert

58 Two-Way alert procedures/mechanisms and records are available. pharmacovigilance system; SOP# 4\D\RDU\ 4 , SOP# records are available
4\D\RDU\ 1, SOP# 4\D\RDU\ 2

Sub-component 8B Alert and crisis systems - Crisis management mechanisms

Included under sub-component 8A Alert and Crisis systems - Alert mechanisms
JFDA Responsible Person JFDA Document Name / Doc. #
Indicator Sub-component 8C Alert and crisis systems - Alert performance standards (Important) for this item
Additional Comments
#

performance standard: performance standard for reporting

pharmacovigilance instructions
59 Performance standards for the transmission of two-way alert and management of crisis system are established and are followed. pharmacovigilance 2016 - article 8 2) no crisis adverse drug reaction from
manufacturer and importer
management sys available

JFDA Responsible Person JFDA Document Name / Doc. #

Indicator Sub-component 9A Analytical capability - Access to laboratories (Critical) for this item Additional Comments
#

instruction of accreditation of
60 The regulatory authority has access to laboratories capable of conducting necessary analyses for the purpose of official testing. lab reference laboratories for
pharmaceutical product analysis of
2011

JFDA lab has ISO 17025

61 Regulatory Authority’s or contract laboratories are qualified according to a recognized standard. lab accreditation /R&D section JFDA
dons' have an contract lab

62 All reported products defects are documented and investigated. lab yes in case of "OOS" only SOP#:
DQCL-SOP014
JFDA Responsible Person
Indicator Sub-component 9B Analytical capability - SOPs for analytical support (Very important) for this item JFDA Document Name / Doc. # Additional Comments
#
63 Documents are available that detail the work expected, anticipated results and resources applied to fulfil the functions of the laboratories. lab yes, lab SOPs
64 Procedures covering all elements of laboratory operations are available and are followed. lab yes, lab SOPs
Indicator
#
Sub-component 9C Analytical capability - Validation of analytical methods (Very important)
65 The test method validation guideline is equivalent to the ICH standard and records are available. lab yes, SOP#: DQCL-SOP024
Indicator
#
Sub-component 10A Surveillance programme - Sampling and audit procedure (Very important)
instructions of testing drugs, instruction doesn't address risk as a
66 The market surveillance programme for active pharmaceutical ingredients and medicinal products is developed involving at least the inspection and lab medical device and sterilizers of main criteria for market surveillance
laboratory departments using risk management principles and covers dosage forms of different medicinal product types. 2017 program
67 The market surveillance programme performance is reviewed annually and records of review are available. pharmacovigilance reviewed, but not annually records of revision not available
Sub-component 10B Surveillance programme - Recall monitoring
Included under sub-component 7B Enforcement powers and procedures - Non-compliance management
JFDA Responsible Person JFDA Document Name / Doc. #
Indicator Sub-component 10C Surveillance programme - Consumer complaint system (Critical) for this item Additional Comments
#

inspection procedure
68 A consumer complaint system/procedure and records are available. Q&P+ lab+ inspectorate 5/D/INS/5 ///// quality quality and inspection SOPs should
procedure1/Q/3//// lab procedure be revised
DQCL -SOP086

yes, no documented evidence

69 Issues of high risk are investigated immediately. lab+inspectorate were found
70 Compliance staff and or inspection staff can access complaint information. inspectorate yes

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71 All reported products defects are documented and investigated. lab in case of "OOS" only SOP#: DQCL-
SOP014

Sub-component 10D Surveillance programme - Adverse reaction reporting system/procedures

Not evaluated - not considered within the scope of a GMP regulatory compliance programme.4
( 4 Pharmacovigilance is outside the scope of the GMP compliance programme with the exception of indicator 11.)

Sub-component 10E Surveillance programme - Drug Medicinal product defect reporting system/procedures
Included under sub-component 10C Surveillance programme - Consumer complaint system
JFDA Responsible Person JFDA Document Name / Doc. #
Indicator Sub-component 11A Quality management system - Quality management system (Critical) for this item Additional Comments
#

72 The quality management system is defined based on a recognized international standard. Q&P+ lab only for lab ISO17025 accreditation

73 The quality manual covers all elements of GMP regulatory compliance programme. inspectorate no
74 Key performance indicators (KPI) for the overall GMP regulatory compliance programme are established and available. inspectorate no
75 The quality management system has been implemented and is followed. Q&P+ lab no/ only in lab ( R&D section )
76 A documentation control system is in place. Q&P+ lab no/ only in lab ( R&D section )
77 Quality audit plans and records are available. Q&P+ lab no/ only in lab ( R&D section )
78 Management reviews ensure the performance of the quality management system on an annual basis. Q&P+ lab no/ only in lab ( R&D section )

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QUESTIONNAIRE FOR COMPETENT AUTHORITIES TO BE USED FOR ASSESSMENT, REASSESSMENT AND SELF-EVALUATION

# PS/W 1/2011 dated 22 July 2011

JFDA Responsible Person for

# Annex 2 to PS/W 1/2011 - List of Supporting Documents (to be submitted in English) this item JFDA Document Name / Doc. # Additional Comments
I. National legislation enabling inspections, licensing, sampling and testing and recalls
II. Information requested from companies prior to undertaking GMP Inspections e.g. Site Master File
III. GMP standard if different from PIC/S, EU or WHO GMP Guides (the document should be submitted)

The number of manufacturers/wholesalers currently inspected and licensed/ registered showing type of medicinal
products (incl. APIs) manufactured
IV. NB: A list (or access to the relevant database) should be given during the on-site assessment
V. Copy of Quality Manual
VI. List of SOPs
VII. Programme for introduction and ongoing training for inspectors
VIII. Names of inspectors carrying out GMP inspections on full-time or part-time bases including any specialist inspectors
Main professional requirements for inspectors, senior/principal inspectors, chief inspector
IX. (The CVs of inspectors should be made available during the on-site assessment)
X. SOP for how to carry out inspections
XI. Report format if different from PIC/S format
XII. Statistical information on numbers of inspections carried out

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