ISO 9000 standards provide guidelines for quality management systems. The standards have evolved over time from an initial focus on quality control to greater emphasis on quality assurance and preventative actions. Key changes in the 2000 version included a focus on customer satisfaction, value-adding processes, and continual improvement. The standards are based on quality management principles like customer focus, leadership, involvement of people, and continual improvement. The structure of the standards includes requirements for management responsibility, resource management, product realization, measurement and improvement.

1. ISO
ISO series, guide ofpharmaceutical
manufacturing facilities, productivity
By :
BALASUNDARESAN M
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2. Contents
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 Introduction.
 History.
 ISO: 9000series.
 ISO:14000series.
 Guide toPharmaceutical Manufacturing
Facilities, Productivity.
 References.
2

3. Introduction
What are ISO 9000 Standards?
 ISO9000Standards
 Definethe required elements of an effective quality
management system
 Canbe applied to any company
 Adopted by the United States astheANSI/ASQCQ90
series.
STANDARD BODIES
154 COUNTRIES
Bureau of Standards Jamaica
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4. • ISO WAS FORMED FEBRUARY 23, 1947 IN
GENEVA
• FIRST FAMILY OF QUALITY STANDARD
RELEASED 1987
– To eliminate country to country
differences
– To eliminate terminology confusion
– To increase quality awareness
• FIRST ENVIRONMENTAL STANDARD
RELEASED IN 1996
Background Who Created Standards
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5. HOW DID ISO GET STARTED
1906 - International Electro-technical Commission
1926 - International Federation of the National Standardizing
Associations (ISA)
1946 London - delegates from 25 countries decided to create a new
international organization "the object of which would be to facilitate the
international coordination and unification of industrial standards
1947 - ISO began to officially function
1951 - The first ISO standard was published
"Standard reference temperature for industrial length
measurement".
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6. ISO 9000 CONSISTS OF 5 DOCUMENTS
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ISO9000Quality Management andQualityAssuranceStandards
ISO 9001 Quality Systems - QA Model for Design/Development,
Production, Installation, and Service
ISO 9002 Quality Systems - QA Model for Production and Installation(no
design)
ISO 9003 Quality Systems - QA Model for Final Inspection andTest
ISO 9004 Quality Management and Quality System Elements -
Guidelines
6

7. ISO 9000 Family of Standards
7
MBS
•ISO 9000-2 - Generic guidelines for applying ISO 9001, ISO 9002, and
• ISO 9003
ISO 9000-3 - Guidelines for applying ISO 9001 to the
development, supply, and maintenance of software
ISO 9000-4 Application for dependability management
ISO 9004-2 Guidelines for services
ISO 9004-3 Guidelines for processed material
ISO 9004-4 Guidelines for quality improvement
ISO 9004-5 Guidelines for quality plans
•ISO 9004-6,7- Guidelines for project & configuration management
7

8. What has ISO Accomplished?
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• ISO film speed code
• TL9000 Standard format for telephone and banking cards
• ISO 9000 which provides a framework for quality
management and quality assurance
• ISO 14000 series provides a similar framework for
environmental management
• Internationally standardized freight containers
• Standardized paper sizes.
• Automobile control symbols
• ISO international codes for country names, currencies
and languages
• AS 9100 the Aerospace Basic Quality System Standard
8

9. ISO 9000:1987 series
International Organisation
for Standards (ISO) adopted
a series of quality
standards, ISO 9000:1987
based on BS5750
strongly influenced by the
US Department of Defence
Military Standards
(MILspecs).
initial version was focused
on quality control using
retroactive checking
and corrective actions.
ISO 9000:1994 series
ISO 9000 was revised in
1994
greater emphasis on quality
assurance via preventive
actions.
required evidence of
compliance with
documented procedures
tended to create a
significant volume of
associated procedure
("do it as you document it")
manuals and bureaucracy.
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10. QS-9000
Ford, Chrysler, General
Motors and other
automotive/truck
manufacturers identified
deficiencies in
ISO9000:1994
undertook a re-
interpretation and
extension to develop QS-
9000
additionally addressed
continuous
improvement, manufacturin
g capability and production
part approval processes.
ISO9000:2000 series
2nd revision of Quality
Management System
Requirement Standard from
International Organization for
Standards
moved towards
process performance metrics
reduced the need for
documented procedures
where clear evidence exists
that the process is working
well.
Replacement for previous ISO
9001 / 9002 and 9003
standards of 1994
MBS 10

11. ISO9000:2000
series
 standards provide criteriafor
companiesto
 "certify" theirquality
management
 recertification isrequired
every threeyears
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 achieve "registration"by third-
party auditor.
 the system
 verifies practiceand
processes
 provides objective3rd
party validation
 enables benchmarking.
T C 1 7 6 , t h e I S O 9 0 0 1
t e c h n i c a l c o m m i t t e e
h a s s t a r t e d i t s r e v i e w
o n t h e n e x t v e r s i o n o f
I S O 9 0 0 1 , w h i c h wi l l i n
a l l l i k e l i h o o d b e
t e r m e d t h e I S O
9 0 0 1 : 2 0 0 8 s t a n d a r d ,
a s s u m i n g i t s p l a n n e d
r e l e a s e d a t e o f 2 0 0 8 i s
m e t . E a r l y r e p o r t s a r e
t h a t t h e s t a n d a r d wi l l
n o t b e s u b s t a n t i a l l y
c h a n g e d f r o m i t s
2 0 0 0 v e r s i o n .
Future
Version : 2008
11

12. New ISO 9001
QMS
Resource
management
Measurement,
analysis &
improvements
Product
Realization
Management
Responsibility
Continual Improvement cycle
MBS
General
requirements
General
requirements
12

13. I SO 9001: M
odel
CUSTOMERS
System
5.Management
Responsibility
Quality Management
7. Product
Realization
6. Resource
Management
8. Measurement
Analysis and
Improvement
Requirements
CUSTOMERS
Satisfaction
Continual Improvement of
the Quality Management System
Consumption
Product
MBS 13

14. Principle Of New Standards
Based on eight
quality
management
principles
System
approach to
Management
Continual
improvement
Mutual
beneficial
supplier
relationship
Factual
approach
to
decision
making
Customer
focus
MBS 14

15. Principles of new standard
Customer focus
•Organization depends customers
•Understand current & future customer needs.
•Meet / exceed customer expectations
Leadership
•Leaders establish purpose & direction of the organization
•Should create & maintain environment to achieve
organization’s objectives
Involvement of People
•People of all levels are essence of an organization
•Their full involvement for organization’s benefit
Process approach
Desired results are achieved more efficiently when activities and
resources are managed as process
MBS 15

16. Principles of new standard
System approach to Management
Identifying, understanding and managing interrelated process as a
system contributes to the organization’s effectiveness & efficiency
Continual improvements
Continual improvement of the organization’s overall performance
should be a permanent objective of the organization
Factual approach to decision making
Effective decisions are based on the analysis of data and information
Mutually beneficial supplier relationships
•An organization & its suppliers are interdependent
•Mutually beneficial relationship enhances the ability of both to
create value
MBS 16

17. Expectations of the new
Standard
Avoid the application of systems that are separate from the
organization’s business process
Enable the development of a Quality system that is fully
integrated into the normal operations of organization’s business
Enable Continual improvements of the system for enhanced
customer satisfaction
Enable compliance to statutory & regulatory requirements
MBS 17

18. Important changes
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Criteria Previous version New Version
Main focus Products Customer satisfaction
Approach 20 quality elements Value adding processes
Product requirements Requirements specified by
customer / organization
+ Statutory & regulatory
requirements
Involvement of
people
What to do, When, Whom & How
to do
+ Why it is to be done
Improvements Maintain the system
requirements
Continual improvements
should be achieved
18

19. Process approach
Process definition
Set of interrelated or interacting activities which transforms
inputs into outputs
Ensure
continual
improvemen
ts
Identify
the
processes
Do it for all value adding processes
Establish
measurin
g criteria
Identify the
Interaction
s to other
processes
Identify
the Inputs
& outputs
MBS 19

20. Process approach –
Continual improvements of Process
PDCACycle
Processes in terms
Of Added Value
DO
Continual improvements
of Processes based on
objective measurements
ACTION
Measure results of process
Performance and effectiveness
- Objective Measurements
CHECK
Understandings &
meeting requirements
PLAN
MBS 20

21. System Requirements / Structure of the
Standard
Provision of
resources
Human
resources
Infrastructures
Work
environment
6 ISO9000
structure I
I
Resource
Management
General
requirements
Documentation
Requirements
Planning
Customer
related
processes
Design &
development
Purchasing
Production &
service
provision
Management
Commitment
Customer focus
Quality policy
Planning
Responsibility,
authority &
communication
Management
Reviews
5 ISO9000
structure I
Management
Responsibility
8 ISO9000
structure
I
V
Measureme
nt Analysis
&improveme
nt
4 Quality
Manageme
nt System
7 ISO9000
structure
I
I
IProduct
Realization
General
Monitoring &
measurement
Control of NCP
Analysis of data
Improvements
MBS 21

22. 4 - Quality management system
4.1 General
requirements
Identification
of processes
required
Criteria and
methods to ensure
Operation & control
Availability of
information &
resources for
operation & control
Monitoring and
Measuring of
processes
Continual
improvements
MBS 22

23. 4 - Quality management system
4.2 Document requirements
Quality Policy
Quality Objectives
Quality Manual
Procedures required by the Standard
Procedures required for planning, operation
& control of Organization activities
Records
MBS 23

24. 5 - Management Responsibility
5.6
Responsibility
authority &
communicate
5.4
Planning
5.1
Management
commitment
5.2
Customer
focus
5.7
Management
Review
5.3
Quality
policy
Quality
objectives
QMS
planning
General
Review
inputs
Review
outputs
Internal
communication
Management
representative
Responsibility
& authority
MBS 24

25. 5 - Management Responsibility
Development, implementation and
continually improvement of QMS
Communication of importance of
•Regulatory & statutory requirements
•Meeting customer requirements
•Quality Policy & Quality objectives
•Responsibilities & authorities
•Appointment of Management
Representative
•Conducting Management
Reviews
•Providing required resources
Establishment of
•Quality Policy
•Quality Objectives
Identification of Customer requirements
Top
Management’s
commitment
MBS 25

26. 6 - Resource Management
6.4
Work
Environment
6.3
Infrastructures
6.2
Human
Resources
General
Competence,
awareness &
training
6.1
Provision of
resources
MBS 26

27. 6 - Resource Management
Resources required to
Implementing, monitoring & continual
improvements
Enhance Customer satisfaction by
meeting customer requirements
Human Resources
Infrastructures
Infrastructures needed to achieve product
conformity
Work environment
Work environment needed to achieve product
conformity
Resource
Managemen
t
MBS 27

28. 6 - Human Resources
Competent on the basis of appropriate
education, skill and experience
Define competencies for people
performing work affecting product quality
Provide training or actions
Evaluate effectiveness of the training /
actions
Employees should aware importance of the
activity being performed
6.2
Human
Resource
s
MBS 28

29. 7 - Product Realization
7.6
Control of
monitoring
measuring
devices
Control
Preservationof
product
Validationof
processes
Identification &
traceability
Customer
property
7.5
Production
& service
provision
Verification of
purchased
products
Purchasing
process
Purchasing
information
7.4
Purchasing
Design planning
Design inputs
Design outputs
Design review
Design Changes
Design validation
Design
verification
7.3
Design and
development
7.1
Planning
of product
realization
Identification of
customer
requirement
Review of
customer
requirement
Customer
communication
7.2
Customer
related
processes
MBS 29

30. 7 - Product Realization
Quality objectives of Products
Processes, procedures to realize
product
Verification, validation, monitoring, ins
pection and testing of product
Record to demonstrate conformance
7.1
Planning of
Product
realization
MBS 30

31. 7 - Product Realization
Review of requirements related
product prior to acceptance /
commitment to customers - ability
to meet customer requirements
Effective communication with customer in relation to
•Product information
•Sales order handling
•Customer feedback
•Customer complaints
Identification of Customer / Market
requirements
•Specified by customer
•Requirements taken for granted
•Statutory / Regulatory requirements
7.2
Customer related
processes –
(Sales)
MBS 31

32. 7 - Product Realization
Design inputs and outputs
Review and verification, validation and control of changes
•Accuracy
•Potential hazards & faults
•Corrections
•Evaluations against lessons learned
Planning
•Effective & efficient
•Expectations of interested parties
7.3
Design and
Development –
(Product)
MBS 32

33. 7 - Product Realization
Supplier evaluation
Verification of purchased product –
Inspection and testing
Degree of control depends on effects of
subsequent processes and effect on final
product
7.4
Purchasing
Purchasing is done
in controlled
manner to ensure
that purchased
products conforms
to specific
requirements
MBS 33

34. 7 - Product Realization
Product
characteristics Procedures and work instructions
Suitable equipments to manufacture.
Monitoring and inspection & testing
Product release, delivery and post
delivery
Process validation
Identification and
traceability
Customers property
Material supplied by customers – e.g.. 3rd party blending
7.5
Production and
service provision
Manufacturing /
service provision
under controlled
condition to ensure
conformity of product
MBS 34

35. 8 - Measurement, analysis
and improvement
8.2
Monitoring &
measurements
8.4
Analysis
of data
8.5
Improvement
8.3
Control of
non
conforming
product
Measurement
of product
Internal audits
Customer
satisfaction
Measurement
of processes
Corrective
action
Preventive
action
Continual
improvements
8.1
General
MBS 35

36. 8 - Measurement, analysis and improvement
8.1 - To demonstrate
• Conformity of the product
• Conformity to QMS requirements
• Continually improvements and the effectiveness of the system
8.2 - Monitoring and Measurements
•Customer satisfaction / perception
• Internal audits - conformity planned arrangements of QMS and
ISO9001
•Monitoring and measurements of processes – to determine /
demonstrate ability of processes to achieve required results
•Monitoring and measurements of product – Conformity to
product requirements
8.3 - Control of NCP
•To assure that NCP products are identified and controlled to
prevent unintended use / delivery
MBS 36

37. 8 - Measurement, analysis
and improvement
4. - Analysis of data
Collection and analysis of data generated through QMS
activities to verify suitability, effectiveness and continual
improvement of the system
Analysis shall provide information related to
•Customer satisfaction / perception
•Conformity to specs, requirements
•Trends of processes and products
• Opportunities for preventive actions
•Suppliers
MBS 37

38. 8 - Measurement, analysis
and improvement
8.5 - Improvements
Continual Improvements
•QMS needed to be continually improved
Corrective action
•Actions to prevent recurrence of NCP, NCR etc
•Includes reviews, determination of causes, need of action,
implementation of action, review of action and maintenance
of relevant records
Preventive action
•Actions against potential non conformities to avoid their
occurrence
•Includes identification of potential non conformities, cause,
need for action, implementation of action, review of action
and maintenance of records
MBS 38

39. Criteria for measurements
–Internal audits
•Effectiveness & efficiency of processes
•Opportunities for improvements
•Use of data / information
•Effective & efficient use of resources
•Adequacy, accuracy and performance of measurements
• Relationships with customers/ suppliers/ other interested
parties
–Financial measurements
•Prevention cost
•Non conforming / failure cost
•Lifecycle cost
Self assessment
–Satisfaction surveys for customers and other interested
parties
•Feedback on products
•Customer & market requirements
System
performanc
MBS
e
39

40. Criteria for measurements
–Process capability / process validation
–Reaction time
–Cycle time / throughput (Capacity)
–Utilization of technology
–Waste reduction
–Cost reduction
Products
–Inspection and testing of incoming, in process and final
product
–Product verification
–Product validation
Processe
s
MBS 40

41. W
hat i s I SO 14000?
Primarily concerned with Environmental Management
Minimize harmful effects on the environment
Continual Improvement of environmental performance
The formation of ISO Technical Committee 207 (TC 207) in 1993 marks
the beginning of the development of the ISO 14000 series. The US
Technical Advisory Group (TAG) for ISO/TC 207 (US/TAG forISO/TC
207) represents the United States in international negotiation on ISO
14000
ISO 14000
EMS- General Guidelines on
Principles, Systems and
Supporting Techniques
ISO 14001
EMS- Specification with
Guidance for Use requires a
substantial commitment of time
and resources
MBS 41

42. ISO 14004
EMS - General Guidelines
on Systems, Principles and
Supporting Techniques
ISO 14010
EA- General Principles of
EnvironmentalAuditing
ISO 14011
EA- Auditing of
Environmental Management
Systems
ISO 14012
EA- Qualification Criteria for
EnvironmentalAuditors
ISO 14013
Management of
EnvironmentalAudit
Programs
ISO 14014
Initial Reviews
ISO 14015
Environmental SiteAssessments
ISO 14020
EL- Basic Principles of
Environmental Labeling
ISO 14021
EL- Self Declaration-
Environmental Claims- Terms
and Definitions
42
MBS 42

43. ISO 14022 EL- Symbols
ISO 14023
EL- Testing and Verification
Methodologies
ISO 14024
EL- Practitioner Programs-
Guiding principles, practices
and certification procedures
of multiple criteria (type1)
ISO 14031
Environmental Performance
Evaluation
ISO 14040
LCA- General Principles and
Practices
ISO 14041
LCA- Goal and
Definition/Scope and
InventoryAssessment
ISO 14042
LCA- ImpactAssessment
ISO 14043
LCA- Improvement
Assessment
ISO 14050
Terms and Definitions
ISO 14060
Guide for the Inclusion of
Environmental Aspectsin
Product Standards
MBS 43

44. Guides To Pharmaceutical Manufacturing Facilities &
Productivity
MBS
 Quality
 Facilities andEquipment
 Materials
 Production
 Packaging/Labeling
 Laboratory Controls
44

45. N
eed of gui del i nes i n phar m
aceut i cal s
f a c i l i t i e s & productivity
 Detailed guidelines of asystem sothat the
findings reflect the state of control in that
system for every product (profile) class
 If one of the six systems is out of control, the
firm is considered out of control
 Asystem is considered out of control basedon
GMPdeficiencies which suggest lack of
assurance of quality
MBS 45

46. Quality System
Quality must be built into the
process
Quality is not tested into the product
Assurance of Quality comes from
- Design of robust process based on
thorough knowledge of that process and the
sources of variability
Effective Quality System in place
Quality
System
MBS 46

47. Role of Management in QS
MBS
 Management is responsiblefor:
 Organizational structure
 All Processes
 All Procedures
 Facilities & Resources
 In short, everything to insure product quality, customer
satisfaction and continuousimprovement
47

48. Quality System Responsibilties
MBS
 Assures overallcompliance
with cGMPs
 Review and approvalduties
for:
1) Product QualityReviews (at
least annually)
2) Complaint reviews
3) Discrepancy/failure
investigations
4) ChangeControl
5) CAPA(CorrectiveAnd
Preventive Action)
6) Reprocess/ Rework
7)Validation/ Revalidation
8) Rejects
9) Stability Failures/ Outof
trend data
10)Quarantine products
11)Documented GMP&Job
RelatedTraining
48

49. Laboratory Control System (I)
Adequately staffed laboratories (supervisory
and bench personnel)
Written specifications for raw
materials, intermediates, APIs,label
s & packaging
Written procedures for sampling,
testing, approval or rejection of
materials and for the recording and
storage of data
Method validation/ revalidation
Validation and Security for computerized handling of test results
and related data; system for assuring integrity of all lab data
Laboratory Control
System:
Adequate lab facilities
under the Quality Unit
which is independent
MBS
from Production
49

50. Laboratory Control System (II)
Reference Standards (primary; secondary)
Laboratory controls followed and
documented
Calibration: written
procedures, schedule, documentation
Equipment Qualification
Written procedure (SOP) covering out of specification “oos” results
Laboratory Control
System
MBS 50

51. Laboratory Control System (III)
Investigation of “oos” results conducted in a timely
manner as per SOP and documented (complete
records maintained).
Conclusions from “oos” investigations
documented and corrective actions/ need
for addition investigation identified and
implemented.
“oos” review included in Product
Quality Reviews
Description of samples
Identification of method used
Raw data for sample/ standard preparation, reagents
Laboratory
Control
System
MBS 51

52. Laboratory Control System (IV)
Date/ signature of second qualified person who reviewed original test
records for accuracy, completeness and compliance with established
standards
Complete record of all data from testing
Record of all calculations
Statement of the test results; how
compare with established acceptance
criteria
Laboratory Control
System
Signature of the person who performed
each test; dates tests performed
MBS 52

53. Production
System (I)
Contemporaneous, accura
te and complete batch
production documentation
Implementation
and
documentation
of in-process
controls, tests,
and
examinations
Training
(documente
d; job-
related)
MBS 53

54. Production system ( I I )
Adequate written procedures & practice
for charge-in of materials
Identification of equipment with contents,
stage of manufacturing, status
Equipment cleaning records
Established time limits for completion of
production steps/ stages
Deviations investigated and documented
contemporaneously with investigation
MBS 54

55. Production system ( I I I )
Justification and consistency of in-process
specifications and final product specifications
Data/ information documented and available
to Quality Unit for review (trending, investigations etc.)
Process validation based on knowledge of process
(scientific basis for identifying critical steps/
critical process parameters/control points)
MBS 55

56. Facilities & Equipment System
Location, design, construction appropriate to facilitate
cleaning, maintenance, operations
Layout and air handling designed and
constructed to prevent cross-
contamination
Flow of materials & personnel designed
to prevent mix-ups or contamination
Defined areas or other control systems to prevent mix-ups or
contamination includes as:
Facilities &
Equipment
System
MBS 56

57. Facilities & Equipment System
Incoming materials
(id, quarantine) Sampling area (prevent
contamination)
Quarantine (intermediates,APIs)
Released materials
Rejection
b) EQUIPMENTS
Appropriate design, size, location, non-reactive product
contact surfaces
Facilities &
Equipment
System
MBS 57

58. Facilities & Equipment System
Identification clearly
marked Calibration
Preventive Maintenance schedule
and procedures
Cleaning procedures and validation
Records of
use, cleaning, maintenance
Closed or contained equipment. -
Inspection prior to use
Separate facilities or containment where needed (penicillin's, highly
potent compounds etc.)
Facilities &
Equipment
MBS
System: b)
EQUIPMENTS
58

59. Utilities
Qualified and appropriately monitored;
drawings should be available
Designed and constructed to prevent
contamination or cross-contamination
Recirculated air to production
(same concern)
Permanently installed pipe work should be
appropriately identified
Drains of adequate size with air break
Utilities
MBS 59

60. Water
API to be used for incorporation into sterile dosage form – water used in
later stages should be monitored and controlled for total microbial counts,
objectionable organisms and endotoxins
Process water at minimum meeting WHO
guidelines for potable water
Justify quality of water used to
achieve stated API quality and
establish specifications
Water
Water treatment facilities validation
MBS 60

61. Materials System
Written procedures for receipt, identification,
quarantine, storage, handling, sampling, testing and
approval or rejection of materials
System to evaluate suppliers (critical materials)
Purchased against agreed specification
Change control process for
changing suppliers
Upon receipt check for correct labeling,
seals
Before co-mingling bulk material, id/test
Assurances obtained from non-dedicated
tankers
Materials
System
MBS 61

62. Materials System
Identification on large storage containers and
associated manifolds, filling and discharge lines
Code given to received batches; status identity
At minimum, a specific identity test
on incoming batches.
Supplier evaluation should include three
fully tested batches; one fully tested
batch/year
Written sampling plan with justification
Prevent contamination of sampled containers
Materials
System
MBS 62

63. Materials System
Stored in manner to prevent degradation,
contamination, no adverse effect on quality
Drums, bags, boxes off the floor
First in, first out
Rejected materials identified and
controlled under a quarantine system
Established re-test/ re-evaluation periods
Materials
System
MBS 63

64. Packaging & Labeling System
Written procedures for receipt, identification,
quarantine, sampling, examination and/or testing P&L
P&L should conform to specifications
Records maintained for each shipment
(showing receipt, examination & result)
Containers protective, clean, not alter product
quality; if re-used, cleaned & labeling defaced
Access to label storage area limited
Written procedures for reconciliation;
- investigation if discrepancy
MBS 64

65. Packaging & Labeling System
All excess labels with batch #, destroyed
Obsolete labels destroyed
Printing devices controlled to insure accuracy
of label (against batch record)
Print labels checked against master
and a copy placed into the batch record
Documented procedures to assure correct
packaging materials/ labels used
Operations designed to prevent mix-ups
MBS 65

66. Packaging & Labeling System
Labels: API name, batch #, storageconditions
Shipped API: Name/ address manufacturer;special
transport conditions; expiry/ retest date
Documented clearance before operations
Packaged/ labeled intermediates or APIs
examined as part of packaging (documented)
Seal employed to assure package integrity
MBS 66

67. Benefits
 Certificationdemonstratestherecognition of quality
throughout organization
 Decreasein wasted time, materials, and efforts.
 Inculcating values of excellenceand best practices.
 Establishleadership role within organization.
 Increasedrecognition by international partners
 Ability to maintain standards of quality and
excellence.
MBS 67

68. References
 Lachman L. Lieberman A. Kanig JL. The
Theory Of Industrial Pharmacy, 2nd edi,
Varghese Publication House; Bombay-14
 Gilbert s. Banker, Christoher T. Rhodes,
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69. MBS 69