Training in cGMP Environment for Begninners

This presentation is compiled by “ Drug Regulations” a
non profit organization which provides free online
resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
11/3/2014 1

 This presentation is compiled from freely
available resources like the websites of FDA,
EMA, WHO.
 “Drug Regulations” is a non profit
organization which provides free online
 Visit http://www.drugregulations.org for
latest information from the world of
Pharmaceuticals.
11/3/2014 2
Drug Regulations : Online
Resource for Latest Information

 Regulations Governing Training
 Food and Drug Administration
 European Medicines Agency
 World Health Organization
11/3/2014 3

 Training in current good manufacturing
practice shall be conducted by qualified
individuals on a continuing basis and with
sufficient frequency to assure that employees
remain familiar with CGMP requirements
applicable to them.
11/3/2014 4

◦ Each person responsible for supervising the
manufacture, processing, packing, or holding of a
drug product shall have the education, training,
and experience, or any combination thereof, to
perform assigned functions in such a manner as
to provide assurance that the drug product has
the safety, identity, strength, quality, and purity
that it purports or is represented to possess.
11/3/2014 5

◦ There shall be an adequate number of qualified
personnel to perform and supervise the
manufacture, processing, packing, or holding of
each drug product.
11/3/2014 6

◦ The personnel shall receive initial and ongoing
training, the effectiveness of which shall be verified,
covering in particular the theory and application of the
concept of quality assurance and good manufacturing
practice, and, where appropriate, the particular
requirements for the manufacture of investigational
medicinal products.
11/3/2014 7

◦ 2.8 The manufacturer should provide training for
all the personnel whose duties take them into
production areas or into control laboratories
(including the technical, maintenance and
cleaning personnel), and for other personnel
whose activities could affect the quality of the
product.
11/3/2014 8

◦ 2.9 Besides the basic training on the theory and practice of
Good Manufacturing Practice, newly recruited personnel
should receive training appropriate to the duties assigned to
them. Continuing training should also be given, and its
practical effectiveness should be periodically assessed.
Training programmes should be available, approved by either
the head of Production or the head of Quality Control, as
appropriate. Training records should be kept.
11/3/2014 9

 2.10 Personnel working in areas where contamination is a
hazard, e.g. clean areas or areas where highly active, toxic,
infectious or sensitising materials are handled, should be
given specific training.
11/3/2014 10

 2.12 The concept of Quality Assurance and all the
measures capable of improving its understanding and
implementation should be fully discussed during the
training sessions.
11/3/2014 11

 10.1 The manufacturer should provide training in
accordance with a written programme for all
personnel whose duties take them into
manufacturing areas or into control laboratories
(including the technical, maintenance and cleaning
personnel) and for other personnel as required.
11/3/2014 12

 10.2 Besides basic training on the theory and practice
of GMP, newly recruited personnel should receive
training appropriate to the duties assigned to them.
Continuing training should also be given, and its
practical effectiveness periodically assessed.
Approved training programmes should be available.
Training records should be kept.
11/3/2014 13

 10.3 Personnel working in areas where contamination
is a hazard, e.g. clean areas or areas where highly
active, toxic, infectious or sensitizing materials are
handled, should be given specific training.
11/3/2014 14

 10.4 The concept of QA and all the measures which
aid its understanding and implementation should be
fully discussed during the training sessions.
11/3/2014 15

 10.5 Visitors or untrained personnel should
preferably not be taken into the production and QC
areas. If this is unavoidable, they should be given
relevant information in advance (particularly about
personal hygiene) and the prescribed protective
clothing. They should be closely supervised.
11/3/2014 16

 10.6 Consultant and contract staff should be
qualified for the services they provide. Evidence of
this should be included in the training records.
11/3/2014 17

 All personnel should be aware of GMP
 Production
 Control Laboratories
 Others whose activities could affect Quality of the
products
 Including Technical , Maintenance & cleaning
personnel
11/3/2014 18

 All personnel Must receive training in GMP:
 Initial
 Continuing
 Specialized
 Including Hygiene Standards
11/3/2014 19

 Written & approved program
 On theory and practice of GMP and their duties
 Training records should be kept
 Practical effectiveness checked
 Training before undertaking any new task
11/3/2014 20

◦ Specific training for staff in special areas, e.g.
 Where contamination is a hazard
 Clean areas, Aseptic Processes
 Areas where highly active, toxic, infectious,
sensitizing materials are handled
◦ The concept of QA should be fully discussed during
training to facilitate proper understanding to ensure
its implementation
11/3/2014 21

 Each person
 Quality , Manufacturing, Engineering , Warehouse, House
keeping, Contractors
 Area of work + cGMP
 Experts in area of operation + cGMP by qualified
individuals
 Continuing basis , Sufficient frequency
 Approved training program
 By Quality , By Production
11/3/2014 22

 Practical effectiveness checked
 Observing on the job , Written Questioners , Oral
Interviews
 Periodically assessed
 Specialized Training
 Sterile , OOS , Potent substances
 Quality Assurance to be discussed in training
 Records maintained
11/3/2014 23

24
Assessment Stage
Organizational
Needs
Task Needs
Development of
Training
Objectives
Development of
Criteria for
Evaluation
Training Stage
Design & Select
Procedures
Train
Evaluation Stage
Measure Training
Results
Compare Results
to Criteria

25
 Assessing training needs
 Preparing training plan
 Specifying training objectives
 Designing training program(s)
 Selecting instructional methods
 Completing the training plan
 Implementing the training program
 Evaluating the training
 Planning future training

26
 Participation: Involve trainees, learn by doing
 Repetition: Repeat ideas & concepts to help people learn
 Relevance: Learn better when material is meaningful
 Transference: To real world using simulations
 Feedback: Adjust training methods to audience.

27
 Is Training Crucial ?

Import Alerts –
2 plants
2 Warning Letters
29
Performance/Results
No Import Alert
No Warning Letter
No 483”s
Time
Expected Results
Actual Results
Gap
5 % Productivity Increase
7 % Decrease in Productivity
483’s – 20
observation
10 % Cost Reduction
10 % Cost Increase
High Stock Price
Stock Price Crashes
Exports : $ 150 million
Loss of Export Revenue

30
 Training is simply one of the means to fill the gaps of
performance between the actual results and the expected
results.
 This GAP can be separated into 3 main themes
1. Attitude
2. Skills
3. Knowledge

31
1. Attitude
2. Skills
3. Knowledge
• Easy
• Moderately difficult
• Most difficult

32
1. Attitude
 Jung's definition of attitude is a "readiness of the
psyche to act or react in a certain way"

33
2. Skills
 Skill refers to
 The ability of using information and applying it in a
context.
 Practical application of knowledge
 Practical exposure and can also be in-born
 Skill is required to master a field of study

34
3. Knowledge
 Knowledge refers to theoretical information acquired
about any subject
 Knowledge can be learned
 Knowledge is also required to master a field of study

35
 Deviation reports
 OOT/OOS reports
 Non conformance reports
 Audit reports
 FDA form 483
 Warning letters
 Accidents report
 Sick leave report
 Wastage report
 Efficiency report
 Machinery out-of-order
report

11/3/2014 36
Rank.
12
13
Ref No Freq
2012
2013
Description
1
1
21 CFR
211.22 (d)
169
155
The responsibilities and procedures
applicable to the quality control unit are not
[in writing] [fully followed].
2
2
21 CFR
211.192
119
131
There is a failure to thoroughly review [any
unexplained discrepancy] [the failure of a
batch or any of its components to meet any
of its specifications] whether or not the
batch has been already distributed.

11/3/2014 37
Rank
12
13
Ref No Freq
2012
2013
Description
6 5 21 CFR
211.67(b)
73
77
Written procedures not
established/followed for cleaning &
main of equip.
7
12
21 CFR
211.68(a)
69
56
Calibration/Inspection/Checking not
done
8
7
21 CFR
211.67(a)
65
71
Cleaning / Sanitizing / Maintenance not
done
9
11
21 CFR
211.100(b)
64
59
Written production and process control
procedures are not followed .

1. Warning Letter to a Contract Manufacturer.
 “An operator performing critical aseptic operations with
exposed skin at the forehead, posing an unreasonable
risk of the product becoming contaminated.
 Operators moving very quickly in the aseptic area, which
may create unacceptable turbulence in the area, and
disrupt the unidirectional airflow.
 Operators leaning halfway in and out of the class 100
area while performing interventions over opened bottles.”
11/3/2014 38

2. Warning letter issued to a Contract Manufacturer.
◦ “ Your firm failed to document in the batch record that
the sterilization cycle for (b)(4) Solution, lot (b)(4) was
aborted due to a failure to reach the (b)(4) set point
temperature during production.
◦ …….. The sterilization cycle deviation was not
documented in batch records or your firm’s incident
logs. Your firm also lacked any documentation, such
as a printout, of the (b)(4) time and temperatures for
the aborted load. ”
11/3/2014 39

3. Medium Size MNC in India
◦ Surfaces are not always sanitized prior to use….the investigator
observed an operator bringing the out-feed vial transfer belt from
outside the primary HEPA area and re-attaching it to the line without
sanitizing the belt.
◦ Aseptic manufacturing interventions are not performed in a manner to
protect sterile drug products from contamination…the investigator
observed at least two instances in which operators performed
interventions requiring them to reach over unstoppered vials. In both
cases, the exposed vials were not removed and line clearance was not
performed.
11/3/2014 40

5. Warning Letter to a Large Indian Company
◦ “The FDA investigator observed a microbiological
plate that contained one (1) large colony forming
unit (CFU) of mold. However, your firm’s
laboratory documentation reported 0 CFU for the
same microbiological plate”.
11/3/2014 41

◦ “Your microbiologists reported microbiological
plates as “nil” while each plate contained one (1)
colony forming unit (CFU)”.
11/3/2014 42

◦ “Your firm repeatedly delayed, denied, limited an
inspection or refused to permit the FDA
inspection.
◦ “The FDA investigators found unofficial batch
records for approximately 75 batches of
injectable finished drug products torn in half in a
waste area”.
11/3/2014 43

◦ “It appears that QC analysts attempted to mask
the practice of performing sample “trial”
injections by labeling them as standards rather
than by the actual batch numbers or other
identifying information”.
11/3/2014 44

9. Warning Letter to a Medium Sized Indian
Company
◦ “Your firm repeated these assays, and selectively
reported only the passing retest values in the
final assay results, then disregarded the initial
OOS data without conducting investigations”
11/3/2014 45

10.“Warning Letter to a Medium size MNC in India
◦ “We observed and documented practices during the
inspection that kept some samples, data and results
outside of the local systems for assessing quality.
◦ This raises serious concerns regarding the integrity
and reliability of the data generated at your plant.
◦ During the inspection your firm also repeatedly
delayed, denied, limited or refused to provide
information to the FDA investigators”.
11/3/2014 46

◦ FDA form 483 issued to a medium sized Indian
company
◦ “Established laboratory controls are not followed and
data is not recorded at the time of performance:
 Sample and standard analytical weight print outs are not
printed at the time of weighing.
 Analytical balance clocks are set back in order to create
falsified weight printouts that appear to be printed at the
time of sample weighing.
 Drug product test method validation data is falsified”
11/3/2014 47

◦ EMA GMP-Non-Compliance Statements
 Companies from India and China are by far the most
represented.
 What is really freighting is the number of NCR’s which
cite data falsification in their report.
 Out of the 34 Non Compliance reports for the Indian
Companies 50 % cite Data Falsification as a Critical issue.
11/3/2014 48

49
 Regulatory Requirements
 Maintains qualified products / services
 Achieves high performance /service / quality standards
 Provides information to new comers
 Refreshes memory of old employees
 Achieves learning about new requirements , standards , technology,
products , service delivery
 Reduces mistakes - minimizing costs
 Opportunity for staff to give feedback / suggest improvements
 Improves communication & relationships - better teamwork

 This presentation is compiled from freely
available resources like the websites of FDA,
EMA, WHO.
 “Drug Regulations” is a non profit
organization which provides free online
 Visit http://www.drugregulations.org for
latest information from the world of
Pharmaceuticals.
11/3/2014 50

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