This document outlines regulatory perspectives on advanced GMPs for the 21st century. It discusses the FDA's 21st century initiatives to modernize pharmaceutical regulations using a risk-based approach focused on quality systems. The concepts of advanced GMPs emphasize building quality into products and processes rather than relying solely on end-product testing. A key aspect is implementing a robust quality system approach across the organization.

1. ADVANCED GMPs for 21st Century
Regulatory Perspective
Mr.J.Ramniwas
Founder and CEO
SAI PHARMA SOLUTIONS INC. VADODARA

2. Outline
 Changing Paradigm for GMPs
 21st Century Initiatives
 Concept of Modern Quality Systems
 Basis of Advanced GMPs
 Quality System Approach
 What’s new to meet challenges
 GMP Improvements
 Global Registration Requirements
 Expectations
 Summary J.Ramniwas 2

3. Changing Paradigm for GMPs
Product Process Systems
-1970 1980 - 1990 21st
[QC] [QA] Century
[QS]
J.Ramniwas 3

4. Background of FDA’s 21st
Century Initiatives
Limited resources and increased volume of work
 August 2002 – FDA announced the Pharmaceutical
cGMPs for the 21st Century – A Risk Based Approach
 Focus on the greatest potential risk to the public
 FDA’s intent to integrate quality systems and risk
management approaches - to modernize FDA’s
regulations
 Encourage industry to adopt modern and innovative
manufacturing technologies as well as modern quality
system approaches
 Necessary to harmonize the cGMPs with other non-
U.S. pharmaceutical regulatory systems
 Need to harmonize with FDA’s own medical device
quality systems regulations
J.Ramniwas 4

5. Background of FDA’s 21st
Century Initiatives contd...
Encourage Risk-Based approaches which focus on critical elements
Ensure FDA’s Review, Compliance and Inspection
Policies –based on state-of-art pharmaceutical
science
! Risk-Based Approach to Manufacturing and
Regulation
•#Pharmaceutical Inspectorate
– Experienced Field Investigators
•#Process Analytical Technology (PAT) Guidance
– Real-time measurements
•#Process Validation Guidance
– Life Cycle Approach - Built-in Quality, not tested into
product
•#21 CFR 11 Electronic Records Guidance
•#Quality Systems Guidance - September 2006 – FDA issued the final
version of the “,-./0123#456#71/-896:#51#;-0<.9:#=:893>8#?@@6502A#95
Pharmaceutical cGMP Regulations”
•#Systems-Based Inspection
•#6 systems J.Ramniwas 5

6. Philosophy of cGMP and
Modern Quality Systems
Quality should be built into
the product, and testing
alone cannot be relied
on to ensure product
quality.
J.Ramniwas 6

7. IA5-FA#,GH#.8#0#<3F0<#01/#63F-<0956:#
EA5-FA#,GH#.8#0#<3F0<#01/#63F-<0956:#
requirementK#.98#630<#.>@5690123#.8#.1#
requirementJ#.98#630<#.>@5690123#.8#.1#
protecting the health and ensuring the
confidence of those who use the
products we maL3
maM3
J.Ramniwas 7

14. A. Management Responsibilities Contd..
j Structure the organization to ensure the
assigned authorities and responsibilities
l
k Organizational structure is documented
n
m Support the total quality model
p
o Quality Systems departments have equal
standing with other departments within an
organization
r
q The Quality Manager has the authority to
detect problems, implement solutions, and
provide prompt feedback on quality issues to
the organization.
organization.
J.Ramniwas

15. A. Management Responsibilities Contd..
Play a key role in the design, implementation, and
management of a robust quality systems.
t
s Align quality plans with company’s visions and
mission
v
u Actively participate in Management Review meetings
– to ensure continuing suitability, adequacy and
effectiveness
x
w Articulate their vision of and commitment to quality to
all levels of the organization.
z
y Advocate continuous improvement of the operation
of Quality System
•#Strong
•#Strong and visible support for the quality system
•#Internal
•#Internal communication on quality issues at all levels
€
• Commit necessary resources
J.Ramniwas

16. A. Management Responsibilities Contd..
‚
• Management controls are always reviewed
by FDA
•#CAPA
•#CAPA
•#People
•#People qualifications
•#Change
•#Change control
•#Validation
•#Validation
J.Ramniwas

17. B. RESOURCES.
Œ
‹ General Arrangements
Personnel Development
– Communicative
Facilities and Equipment
Control Outsourced Operations
J.Ramniwas

18. B. RESOURCES Contd...
• Appropriate allocation of resources
intended purpose
– collection, storage,
examination of in-process, stability, and reserve samples
in-
Personnel
knowledge
-solving and communicative culture
– Education, training and experience
– GMP
J.Ramniwas

19. C. MANUFACTURING
! Design, develop and document Product and
Processes
•#$%&'()*
•#-./01'2)3)4.2
•#7(4)4/38#&(./'**'*
;
: Examine Inputs <#=3)'(438*
>#=3)'(438*
@
? Perform and Monitor A&'(3)4.2*
B&'(3)4.2*
•#$2)4('#D(.E0/)#F4G'#7H/8'
•#7(4)4/38#D(./'**'*#– N3(43M484)H
•#7(4)4/38#D(./'**'*# – L3(43M484)H
•#P)3)4*)4/38#D(./'**#7.2)(.8#QPD7R
•#DUV#–
•#DUV#– Monitor & reduce QC testing
Y
X Address Nonconformities J.Ramniwas

20. C. MANUFACTURING Contd...
•
Ž Address Nonconformities
•#Investigations,
•#Investigations, conclusion and follow -up must
follow-
be documented.
•#
•#CAPA
•#CAPA
J.Ramniwas 2

21. D. EVALUATION ACTVITIES
– Analyze Data for Trends
Conduct Internal Audits
sustainability of Quality Systems
– FDA is to refrain from
both reviewing and copying reports or records that result
from internal audits
J.Ramniwas 2

22. D. EVALUATION ACTVITIES Contd...
Quality Risk Management
•#Understanding
•#Understanding of quality issues
Effective decision- making
decision-
•#Risk
•#Risk assessment
and the severity of harm
•#Engage
•#Engage appropriate parties in risk assessment, e.g.
regulatory affairs, customers, appropriate manufacturing
personnel, development scientist, other stakeholders
•#Risk
•#Risk management – as a tool in the development of
product specifications and critical process parameters
•#Repeat
•#Repeat risk assessment – to improve processes
•#Proactive
•#Proactive approach to quality
Mitigate risk
J.Ramniwas 22

23. D. EVALUATION ACTVITIES Contd...
Corrective Action
significant problems do not recur
Preventive Actions
– Identify potential problems and root causes
– Assess possible consequences
– Consider appropriate actions
CAPA
level of detail of the evaluation process
J.Ramniwas 23

24. D. EVALUATION ACTVITIES Contd...
£ Sources of recurring problems
¤
– Non-conformance reports and re
Non-
– Product Returns
– Complaints
– Internal and External audits
– Trending data and risk assessment
– Management review decisions
•#Effectiveness
•#Effectiveness of CAPA
J.Ramniwas 24

25. D. EVALUATION ACTVITIES Contd...
 Promote Improvement
•#´44329.µ31388#01/#344.2.312:#54#0#¶-0<.9:#8:893>
•#=31.56#G010F3>319#–
•#=31.56#G010F3>319#– involve in the evaluation of
improvement process
•#½33@#0¾63089#54#2A01F38#.1#82.319.4.2#/3µ3<5@>3198#####
and regulatory requirements
J.Ramniwas 25

26. System Based cGMP Inspection
1. Quality System
2. Facility
6. Packaging
Full Inspection
the five systems
Abbreviated Inspection
system and one of the five systems
J.Ramniwas 26

27. State of Control
Á
À FD
are developed, manufactured and held in a state
of control, i.e. contribute to SISPQ
Identity, Strength, Purity, Quality
Ã
 Detailed inspection of a system so that the
findings reflect the state of control in that system
for every product
Å
Ä If one of the six systems is out of control, the
company is considered out-of-control
out-of-
J.Ramniwas 27

28. It is not the strongest species that
surviveÇ
surviveÆ nor the most intelligentÈ but
intelligentÉ
the ones most responsive to
change”
Charles Ì06Í.1
Î06Í.1
See today with the eyes of
tomorrow and change before the
change comes.
comes.
J.Ramniwas 28

29. A Unique Feature of Indians
………#………Ð……#……Ñ#71/.01#
Pharmaceutical Ó#71/.01#HA06>023-9.20<#
Ô#71/.01#HA06>023-9.20<#
Community has got fantastic flexibility
to accept any challenge Õ#0/0@9#95#
Ö#0/0@9#95#
accept any challenge ×#0/0@9#95#
Ø#0/0@9#95#
Change ………………#………………Ñ#
J.Ramniwas 29

30. The Plan
Ü1/368901/#9A3#63F-<09.518
Û1/368901/#9A3#63F-<09.518
•#´µ0<-093#ÍA363#:5-#063#µ368-8#ÍA363#:5-
need to be
•#Ì3µ3<5@#0#@65F60>#54#63¶-.63/#029.µ.9.38
•#Ì3936>.13#ÍA363#:5-#133/#3â93610<#8-@@569
•#H65/-23#0#82A3/-<3
•#Ì3936>.13#9A3#2589
J.Ramniwas 3

31. Advantages
Quality by design
Logical movement of personnel and material
Control at every stage of manufacture
Reduced risk of cross-contamination
Science based approach
Risk based approach
Confidence building
J.Ramniwas 3

32. Number ICH Guidelines
Q7 Good Manufacturing Practice Guide for
Active Pharmaceutical Ingredients
Q8 Pharmaceutical Development
Q9 Quality Risk Management
Q10 Quality Management System
Q11 Development and Manufacturing of Drug
Substances
FDA Process Validation Guidelines
J.Ramniwas 32

33. è.FA36#<3µ3<8#54#3â@32909.518#.1#9A3
following areas é
 Quality function Road Maps
 êA565-FA#63µ.3Í#01/#96018@06312:#.1#
exhibit batches
 Compliance and Audits
 ë60.1.1F##01/#344329.µ31388
J.Ramniwas 33

34.  ì31/56#?-/.98#01/#2369.4.209.51
 Environment controls and contamination
control
 í3Í#25123@98#.1#80>@<.1FJ#9389.1FJ#
contamination control and cleaning
validation
J.Ramniwas 34

35.  Quality of Operation reflected
through SOPs.
 IQ, OQ, PQ and higher levels of
scientific skills in validations
 Plant upgradations to the latest
in Pharma standards.
J.Ramniwas 35

36. Quality of Water and HVAC
systems
Stringent controls for sterile
products manufacture and
asceptic manufactured products
J.Ramniwas 36

37. Recent Changes to PIC
Product Quality Review (new clause 1.
î Commenced on 1 ï01-06:#ðññòÑ
ó01-06:#ðññòÑ
õ
ô Requires annual quality reviews of all products to verify the
consistency of the existing process to highlight trends ö#95
÷#95
identify the need for productø@652388#.>@65µ3>3198Ñ
productù@652388#.>@65µ3>3198Ñ
û
ú Requires reviews ofü ofý
•
þ Starting ‚ pacƒing materials„ especially from new sources…
• Critical in•process controls and finished product results…
in•
• All batches that failed to meet specifications…
• All significant deviations…
• All changes to processes and analytical methods…
• Marƒeting Authorisation variations…
• Stability monitoring and any trends…
• Recalls„ complaints and returns…
• Qualification status of equipment ‚ utilities…
• †echnical agreements… J.Ramniwas 37

38. Upcoming Changes to PIC
On-
On-going stability (new clauses 6.2 – 6.
Expected to commence on 1 June 2006 or soon after.
Requires monitoring of stability after marketing, against
a written protocol.
Stability program should be extended to the end of the
shelf life of the product.
One batch per year of each product strength
primary packaging type.
Maintain a written summary of the data generated.
J.Ramniwas 38

39. Upcoming Changes to PIC
Reference Samples "#$%&%'&()'#*+,-.%/#0'%1#2''%3#4 !
6
5 Expected to commence on 1 June 2006 or soon after.
8
7 Purpose and definitions.
:
9 Duration of storage.
<
; Size of samples.
>
= Storage conditions.
@ EB(&&%'#+CB%%,%'&/D
? AB(&&%'#+CB%%,%'&/D
G OI+&#&)#J)#('#&I%#%K%'&#)L#&I%#M.)/NB%#)L#+#
F HI+&#&)#J)#('#&I%#%K%'&#)L#&I%#M.)/NB%#)L#+#
manufacturer.
J.Ramniwas 39

40. Upcoming Changes to PIC*#]^_
Sterile Products (changes to Annex 1)
Q
P Expected to commence on 1 June 2006 or soon after.
S
R Changes to some particle size limits for clean -room
clean-
classification purposes.
U
T Media fill limits specified for the validation of aseptic
processing.
W Pre-
V Pre-sterilization bioburden assays required for aseptic
processing and terminal sterilization.
Y
X Grade A environment required forZ for[
- Partially stoppered freeze drying vials.
- Area where aluminium caps on aseptically filled vials are
crimped.
J.Ramniwas 4

41. Clean Room Environment Control
 Environment monitoring
 Scheduled programmes
 Establishment of limits and training.
 Sanitization, efficacy and monitoring
methods.
J.Ramniwas 4

42. Activities for Advanced GMP Compliance
Quality System Improvements
– Calibration
– Maintenance
– Change Control
– ZAP[#-'43)4.2#1323]'1'2)[#7UDU
^AP[#-'43)4.2#1323]'1'2)[#7UDU
– Training
– Complaints and recall procedures
– Critical utility and environmental monitoring and
sampling
– Gowning, personnel monitoring
– Material control
– Cleaning , sterili_3)4.2#32E#*324)4_3)4.2
sterili`3)4.2#32E#*324)4_3)4.2
42

43. Activities for Advanced GMP Compliance
Documentation
– Site Master File
– Quality Manual
– Master Batch Records
– SOPs and associated forms
– Trending Records
– Log books
– Approved critical drawings
– Documentation to support CTD
•#a%K%.)-,%'&+.#-B)&)M)./#+'J#B%-)B&/
•#*&+d(.(&e#&%/&('C#-B)&)M)./#+'J#B%-)B&/
J.Ramniwas 43

44. Activities for Advanced GMP Compliance
Upgrading Environments
– layout of facility
– Classification of environment
– gh_2#L(.&%B#('&%CB(&e#&%/&('C
ih_2#L(.&%B#('&%CB(&e#&%/&('C
– Room pressure differentials
– Air flows
– Air velocity and volume
– Monitoring and control
– Access of materials and personnel
J.Ramniwas 44

45. Activities for Advanced GMP Compliance
•#Upgrading l+&%B#*e/&%,/
m+&%B#*e/&%,/
– Overall design
– Instrumentation
– Dead legs, Slopes
– Valves
– Backflow prevention
– Materials, finishes
– Spray balls, vent filters, sanitary heat
exchangers
– Sanitisation and operation
– Recirculation, Flow rate
– Monitoring and control J.Ramniwas 45

46. Activities for Advanced GMP Compliance
•#o-CB+J('C#p),-B%//%J#]+/#*e/&%,/
– Moisture
– reJB)M+Bd)'s#t(.#uB%%
veJB)M+Bd)'s#t(.#uB%%
– Particles
– Filters
– Materials
– Monitoring
J.Ramniwas 46

47. Activities for Advanced GMP Compliance
Upgrading Equipment
•#
– Equipment Capability – 6 sigma
– Materials, Finishes
– Local environment
– Cleaning, sanitisation
– Monitoring and control
– “x+.(J+&+d(.(&e”#– 21 CFR Part 11
“x+.(J+&+d(.(&e”#–
J.Ramniwas 47

48. The Common Technical Document (CTD)
•#|I%#p|a#(/#+#L)B,+&#+CB%%J#de#hos#o*2#+'J###
Japan for submitting applications for new
products.
•#•&#(/#)BC+'(/%J#('#€#,)JN.%/D#^)JN.%#4#(/#
unique to each region. Modules 2 to ‚#+B%#
ƒ#+B%#
common across all regions
• Module 1 – Administrative Requirements
•#^)JN.%#…#– ‰(CI#.%K%.#/N,,+B(%/#)L#ˆN+.(&es#
•#^)JN.%#…#– ‡(CI#.%K%.#/N,,+B(%/#)L#ˆN+.(&es#
Clinical and Non clinical
J.Ramniwas 48

49. The Common Technical Document (CTD)
• Module Š#– Quality - Chemical, Pharmaceutical
‹#–
and Biological Documentation
•#^)JN.%#•#–
•#^)JN.%#•#– Toxicological and Pharmacological
(non clinical) study reports
•#^)JN.%#€#–
•#^)JN.%#€#– Clinical Study Reports
J.Ramniwas 49

50. The Common Technical Document (CTD)
• Generally dossier must be in English or the
language of the Reference Member State
• eCTD format was obligatory. But now
obligatory.
mandatory
• Mock up of packaging, specimen of packaging
and leaflet also required in language of
Reference Member State
J.Ramniwas 5

51. VALIDATION
•#Usually a ma—)B#L+(.('C#L)B#,+'e#,+'NL+M&NB%B/
ma˜)B#L+(.('C#L)B#,+'e#,+'NL+M&NB%B/
•#*&B+&%C(M#a)MN,%'&+&()'
– Production of an overall Validation Master Plan
and Validation Plans for specific areas.
– Production of a validation schedule
– Production of System Boundary drawings
– System Impact Assessment
J.Ramniwas 5

52. VALIDATION
• Design Qualification
– GMP review of Facility Design
– DQ (protocols execution and reports) of ma•)B
maž)B
Direct Impact Systems and Equipment
• Equipment Facilities and Utilities Qualification
– IQ, OQ, PQ Protocols execution and reports for
Direct Impact Systems including ¡x2ps Critical
¢x2ps
Utilities, Process Equipment and Laboratory
Equipment
J.Ramniwas 52

53. VALIDATION
• Validation
– Protocols execution and reports for
Process Simulation (Media Fills),
Cleaning Validation, Process
Validation and Method
Validation¤K%B(L(M+&()'
Validation£K%B(L(M+&()'
J.Ramniwas 53

54. Environment Monitoring Sterile Areas
Monitoring Methods :
 Surface Monitoring
 Active Air Monitoring
 Passive Air Monitoring
 Particulate Monitoring
J.Ramniwas 54

55. Some of the points cited in the
Regulatory Inspections
 Restricted access to computers and
data handling.
 Total traceability of Unit operation
in BMR with respect to machine
no., room no., time logs, operation
logs and verification
J.Ramniwas 55

56. Some of the points cited in the
Regulatory Inspections Contd…..
 Risk assessment for critical facilities and
equipments which can cause product
quality to be altered e.g. air handling
systems in sterile product manufacture
 Air handling system with single pass with
HEPA filters not re-circulation type.
J.Ramniwas 56

57. Some of the points cited in the
Regulatory Inspections Contd…..
 Validation Master Plan, detailed
execution through protocols and
executive summary on the study.
 100% identification of Raw Materials in
QC
 TSE/BSE certification and SOP for
incoming materials assessment through
vendor approval system
J.Ramniwas 57

58. Some of the points cited in the
Regulatory Inspections Contd…..
 Pest control, procedure with schematic
diagrams, effectiveness of chemicals and
disposal of dead rodents.
 Water systems with respect to plant
design, system validation, chemical and
microbial attributes and monitoring of
pesticides and radioactive traces.
J.Ramniwas 58

59. Laboratory
 Reference standards, working
standards, instrument logs, column
register, calibration, stability
monitoring and instrument audit
trials.
 Annual Reports on each product is
scrutinized.
J.Ramniwas 59

60. Laboratory Contd…
 Deviations and change control
mechanism thoroughly
investigated.
 Approved suppliers list and its tally
with vendor approval system.
 OOS handling.
J.Ramniwas 6

61. Laboratory Contd…
Technical agreements and its
executions.
Sterility assurance in bulk APIs
and dosage forms.
Media simulation trials and its
applicability to production run.
J.Ramniwas 6

62. Some of the USFDA Inspections
and Non-compliance
Deficiency in validation work.
Process validation as well as
analytical validation.
Process validation not done on
worst case simulation.
J.Ramniwas 62

63.  In a multiple product manufacturing site,
effectiveness of cleaning validation not
demonstrated through worst case in a
multiproduct matrix.
 Back-up system of stability chamber
inadequate.
 Inadequate temperature mapping in
warehouses.
J.Ramniwas 63

64.  Inadequate validation of vacuum
transfer system for cleaning operations.
 Changes in production, QC and
warehouse without change control.
 Complaint investigation lacking depth,
tracebility and time frame commitment.
J.Ramniwas 64

65. ADVANCED GMPs CONCERNS
 Lab Controls  SOPs
 Records and Reports  Reprocessing /
 Process Controls Reworks
 Equipment Cleaning  Ingredients controls
 Process Validation  Buildings and
 Water Systems Facilities
 Stability Programs  Training
 Investigations
J.Ramniwas 65

66. «¬Dp+&%C)B(%/#)L#$%CN.+&)Be#p)'M%B'
1. API -#a)/+C%#^LC Pending corrective actions
¥
2. Change of Site
6. Previous deviations
®D##u+M(.(&e#1(&IJB+1'# persist
and not informed
¯D##u(B,#')&#B%+Je#)'# ¦D##A+B'('C#§%&&%B
inspection call
°D##•'+J%±N+&%# ¨D##*%(©NB%
²/N-%BL(M(+.³#####
response ªD##•'—N'M&()' 66
J.Ramniwas

67. 10. Insufficient 1´D##p),-)'%'&#)B#
development data intermediate controls
11. Buildings ¹#L+M(.(&(%/ 1µD##a%K(+&()'#LB),#a^u#####
NDA ¶#2·a2
12. Inadequate change
control procedure 16. Deviation from
monograph
1ºD##p)'&+,('+&()'
1¸D##h'K(B)',%'&+.#
controls 67

68. 1ÂD##g).J('C##+'J## 2»D##tBC+'(©+&()'
distribution
2¼D##$%M)BJ/##B%-)B&/
1ÃD##§+d#M)'&B)./
20. Master record non- 26. Reprocessing
specific or deficient
2½D##*-%M(L(M+&()'/
21. Packaging and
labeling controls 2¾D##*&+d(.(&e#-B)CB+,
22. Production Ä##### 2¿D##*t_/#.+MÀ('C#)B####
process controls inadequate
2ÅD##ˆ2#LN'M&()'/ Á¬D##|B+('('C
J.Ramniwas 68

69. Ì4D##2_•#_B)M%//# ÆÇD##^%J(+#L(../
validation
ȦD##*e/&%,#•ˆ##tˆ
Í…D##p),-N&%B#K+.(J+&()'
ɨD##*M+.%-up validation
ΊD##h±N(-,%'&#M.%+'('C## failure
validation
Ê D##x+.(J+&()'#-B)&)M).#
Ï•D Equipment inadequate
qualification
ˬD#A+&%B#/e/&%,####
ЀD##gx2p#K+.(J+&()' validation
J.Ramniwas 69

70. GMP -Improvements
Renovation of facilities
Ò
Ñ Plant
Ô Ö+&%B
Ó Õ+&%B
Ø Úx2p
× Ùx2p
Ü
Û Storage
Þ
Ý Disposal
à
ß Training of personnel
â
á Upgrading equipment
ä
ã Identifying critical steps
æ In-
å In-process parameters
è
ç Validation
ê
é Self inspection J.Ramniwas 7

71. Global Registration Requirements
GMP •Basic prerequisite
ˆ Semi•regulated countries also need GMP compliant
Semi•
facilities
ˆ Many countries require pre•approved facilities
pre•
ˆ General GMP inspection of the facility
ˆ Some countries inspect the product manufacturing line
before granting marƒeting authorisation
ˆ Product specific GMP inspection
J.Ramniwas 7

72. †he Expectations
The evaluation of the risk should ultimately link back to
the potential risk to the patient.
patient.
The extent of the risk management process should be
commensurate with the level of risk associated with the
decision.
decision.
A more robust data set will lead to lower uncertainty.
uncertainty.
It is essential to have a clear delineation of the risk
question.
question.
Risk management should be an iterative process.
process.
J.Ramniwas 72

73. †he Expectations Contd……
People who apply risƒ management should have
the appropriate training„ sƒills and experience…
experience…
†he risƒ management process should be
appropriately documented and verifiable…
verifiable…
Šefining specifically the risƒ management problem
or question„ including the assumptions leading to
the question…
question…
Assembling bacƒground information and data on
the ha‹ard„ harm or human health impact relevant
to the assessment…
assessment…
J.Ramniwas 73

74. †he Expectations Contd……
Identifying the necessary resources„ members of
the team who have the appropriate expertise„ with
the leader clearly identified…
identified…
Asƒing the right risƒ assessment questions…
questions…
Stating clearly the assumptions in the risƒ
assessment…
assessment…
Assessing the quality and sufficiency of relevant
data…
data…
Specifying and deliverables for the risƒ
assessment…
assessment…
J.Ramniwas 74

75. Summary
Use regular internal audits to identify those areas
that require attention to comply with the GMP Guides.
Guides.
Utilise external consultant(s) if necessary.
necessary.
Prioritise implementation of corrective actions using a
risk based approach.
approach.
 Establish a budget to enable appropriate corrective
actions to be implemented.
implemented.
 ë%%- watch on Regulatory authority websites for
ì%%-
changes in GMPs coming up in the future.
future.
 Establish industry networking system to monitor and
report on inspection trends by GMP regulators.
regulators.
75

76. †hanƒ you for your attentionŒ
Any Questions•
Contact for consulting or technical advisory servicese
J.RAMNIWAS
Founder & CEO
SAI PfUg=U#PAFhViAjP#ij7k
Phone No
76
l0(#=.)).m#P)3()#).#G424*n[#''(H)n42]#42#M')o''2mk