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Personnel

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Title: Personnel


1
Basic Principles of GMP
Personnel
2
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3
Personnel
  • Principle
  • Establishment and maintenance of satisfactory
    system of QA and manufacturing of products and
    actives rely on people
  • Must be sufficient qualified personnel to carry
    out tasks
  • Individual responsibilities must be clearly
    understood by individuals concerned
  • All personnel should be aware of the principles
    of GMP that affect them

4
Entering into a production area 1
  • Question who is the supervisor now?
  • Wrong answers
  • he just left us
  • he is supervising us from the office
  • we know what to do, do not need any
  • Right answer
  • according to the SOP No now I am!

5
Entering into a production area 2
  • Question what are you doing now?
  • Wrong answers
  • do not ask me!
  • we are making granules
  • the boss said that we should
  • Right answer
  • we are working according to the SOP No, the
    batch identification data are written on the door
    of this cabinet as well as on the equipment!

6
Personnel
  • General - I
  • Adequate number of qualified people with
    practical experience Is it easy?
  • An individuals responsibilities should not be so
    extensive as to present a risk to quality Is it
    easy?

7
Personnel
  • General - II
  • Individual written job description
  • Organization Chart
  • No gaps or unexplained overlaps
  • Adequate authority to carry out responsibilities

8
Personnel
  • General - III
  • Individuals must receive training in GMP
  • initial training
  • continuing training
  • including hygiene standards
  • Motivated to
  • support the establishment
  • maintain high-quality standards

9
Personnel
  • General - IV
  • Prevent unauthorized access to production,
    storage, quality control
  • Stop personnel who do not work in these areas
    using them as passageways

10
Personnel
  • Key Personnel - I
  • Key personnel (which normally should be
    full-time) positions include
  • Head of Production
  • Head of Quality Control
  • (Head of Sales and Distribution)
  • Heads of Production and Quality Control should be
    independent of each other

11
Question
  • Theoretically, how many people must work in the
    smallest possible manufacturing site?
  • 3!
  • The Head of Production and the Head of QC are
    independent of each other there should be a
    General Manager they are dependent of!

12
Personnel
  • Key Personnel - II
  • Key personnel should posses the qualifications
    of
  • Scientific education. For example
  • chemistry, biochemistry, chemical engineering,
    microbiology, pharmaceutical sciences and
    technology, pharmacology and toxicology,
    physiology or
  • other related science subjects relevant to the
    responsibilities to be undertaken

13
Personnel
  • Key Personnel - III
  • (Key personnel should posses the qualifications
    of, contd)
  • Practical experience.
  • under professional guidance
  • able to take difficult decisions in a
    professional and scientific way,
  • resolve the problems encountered in manufacturing
    and QC

14
Personnel
  • Shared Responsibilities I
  • Heads of Production and Quality Control may share
    some responsibilities depending on national
    regulations
  • authorization of written procedures (SOPs) and
    other documents, including amendments
  • environmental monitoring and control, and plant
    hygiene
  • process validation and calibration
  • training, incl. application and principles of QA
  • approval and monitoring suppliers

15
Personnel
  • Shared Responsibilities II
  • designation and monitoring of storage conditions
  • retention of records
  • monitoring compliance with GMP
  • inspection, investigation, and taking of samples
    to monitor factors which may affect quality

16
Personnel
  • Head of Production Responsibilities - I
  • Product production and storage according to
    appropriate documentation
  • Approval and implementation of production
    instructions, in-process QC and ensure strict
    implementation
  • Evaluate production records signed by
    designated person before passing to QC

17
Personnel
  • Head of Production Responsibilities - II
  • Maintenance of production department, premises
    and equipment
  • Process validation and calibration performed,
    recorded and reports made available
  • Training of production personnel initial and
    continuing

18
Personnel
  • Head of Quality Control Responsibilities - I
  • Approval or rejection of materials, packing
    materials, intermediates, bulk and finished
    products
  • Evaluation of batch records
  • Carrying out of necessary testing
  • Approval of quality control procedures sampling
    instructions, specifications, test methods, and
    other QC procedures

19
Personnel
  • Head of Quality Control Responsibilities - II
  • Approval and monitoring of all contract analysis
  • Maintenance of quality department, premises and
    equipment
  • Validation, including analytical procedure
    validation, and calibration of control equipment
  • Initial and continuous training of QC personnel

20
Personnel
  • Useful reference documents for inspectors
  • Organization Chart
  • Job descriptions

21
Personnel
  • Training - I
  • Training, in accordance with a written programme
    for
  • all personnel whose duties take them into
    production or
  • into control laboratories and
  • for others whose activities could affect the
    quality of the product
  • On induction and continuing
  • on theory and practice of GMP
  • approved by either the head of Production or QC
    as appropriate
  • training records should be kept
  • training before undertaking any new task

22
Personnel
  • Training - II
  • Staff in special areas
  • clean areas or
  • working with highly active, toxic, infectious,
    sensitizing materials
  • should be given specific training methanol
    and unexperienced workers
  • The concept of QA and its understanding and
    implementation should be fully discussed during
    training

23
Personnel
  • Visitors or Untrained Personnel
  • Preferable not to take them in. If this is
    unavoidable, for example GMP inspectors
  • Must be given information in advance
    particularly about
  • personal hygiene and
  • protective clothing requirements
  • Must be accompanied and closely supervised at all
    times

24
End of Personnel Section
25
Basic Principles of GMP
Premises
26
Premises
  • Principle
  • Premises must be located, designed, constructed,
    adapted and maintained for the operations
  • Minimize risks of errors and cross-contamination
  • Permit effective cleaning
  • Permit effective maintenance
  • Minimize build-up of dirt and dust
  • Eliminate any adverse effects on quality

27
Premises
  • Principle
  • Premises must be located to minimize risks of
    cross-contamination e.g. not located next to a
    malting factory with high airborne levels of yeast

28
Premises
  • Location
  • Geography, climate,
  • noise and economic
  • factors
  • Neighbours
  • What do they do?
  • What impact can they have on the business?
  • Pollution/effluent control

29
Premises
  • Premises should be
  • built to
  • Facilitate sanitation
  • Be maintained and cleaned
    easily
  • Services availability
  • Protection against entry of insects or other
    animals

Your opinion?
30
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31
Premises
  • Lighting important, particularly when
    organoleptic control
  • Moisture, heat, change of air they should not
    disturb the equipment

32
Premises
  • Allergenes, live microorganisms dedicated areas
  • Hormones, citostatics, non-medicines not on the
    same area/line as other medicines (segregated
    areas) or campaign working and thorough cleaning
    or dedicated manufacturing lines

33
Manufacture with pathogenic viruses
34
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35
Premises
  • Manufacturing area
  • Pipework no dead ends, far anogh from the wall
    to permit cleaning

36
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37
Premises
  • Pipes and pipings
  • Fixed pipework
  • clearly labelled
  • indicate contents
  • direction of flow
  • Service pipings
  • adequately marked
  • non-interchangeable connections or adaptors
  • Dangerous gases and liquids

water
38
Premises
  • Ancillary Areas
  • Rest and refreshment rooms
  • Changing, washing and toilet areas
  • Maintenance workshops
  • Animal houses

39
Premises
  • Other Areas
  • Personnel rest areas /cafeterias/changing rooms
  • away from operating areas
  • prevention of cross-contamination
  • prevention of operators going outside in work
    clothes
  • provision of access control
  • prevention of visitors access to operating areas
  • Maintenance service areas
  • separated from production areas whenever possible

40
Premises
  • Design Principles
  • Process flow
  • Material flow
  • People flow

41
Premises
  • Example of Materials and People Flow
  • Arrival of goods Entrance for visitors Entrance
    for Workers Shipment of goods




  • Material Flow


  • People Flow


  • Zone Clean


  • Zone Packaging


  • Zone Controlled




42
Premises
  • Weighing areas
  • Control systems
  • Environmental controls, dust control
  • Segregation
  • Smooth, impervious, durable, easy to clean
    finishes
  • Cleaning
  • Documentation

43
Premises
  • Production and Packaging
  • Logical flows of materials and people
  • Adequacy of working space and orderly and logical
    positioning of equipment
  • Interior surfaces smooth/crack-free/easy to clean

44
Premises
  • Windows should not open to the outside!

45
Premises
  • Finish of Floors, Walls and Ceilings
  • Difficult but not impossible to get right
  • Smooth, impervious, hard-wearing, easy to clean
  • Resistant to operations and materials in use
  • Windows not opening to the outside
  • Avoid sliding doors

46
Premises
Not these!
  • Finish of Floors, Walls and Ceilings
  • Difficult but not impossible to get right,
    smooth, impervious, hard-wearing, easy to clean
    but not bricks, tiles, wood or sliding doors!

47
Not this!
48
Not this!
49
Not this!
50
Premises
  • Finish of Floors, Walls and Ceilings
  • Much better

51
Muchbetterceiling!
52
Much better!(corridor)
53
Much better!(see thecorners,floor, walls)
54
Premises
  • Cross-contamination
  • 1. Segregated areas
  • 2. Airlocks and pressure differentials
  • 3. Treatment of recirculated air
  • 4. Protective clothing
  • 5. Effective cleaning procedures
  • 6. Closed production systems
  • 7. Residue testing
  • 8. Status labelling

55
Premises
  • Manufacturing and Packaging I
  • Pipework and other fittings sited to avoid
    recesses
  • Drain design
  • equipped to prevent backflow
  • open channels avoided

56
Premises
  • Manufacturing and Packaging II
  • Effective air handling to suit product
  • temperature
  • humidity
  • filtration
  • monitoring

57
Premises
  • Manufacturing and Packaging III
  • Specifically designed and laid out to avoid
    mix-ups and cross-contamination
  • Changing facilities to provide segregated access
  • Prevention of cross-contamination
  • Suitable lighting levels

58
Premises
  • In-Process and QC laboratories
  • Located separate from but near manufacturing
  • prevention of cross-contamination
  • separate biological , microbiological,
    radioisotopic areas
  • Designed for the operations being carried out
  • suitable storage space

59
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60
Premises
  • Warehouse I
  • Storage areas of sufficient capacity
    for
  • Clean, dry and maintained within acceptable
    temperature limits records of thermometer in
    log-books, maximum-minimum thermometer, automatic
    recording apparatus
  • Receiving-dispatching packs area under cover,
    protection from heat, dirt, and rain tablets in
    cellophane blisters and rain

61
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62
Premises
  • Warehouse II
  • Areas clearly marked and access limited for
    quarantine status good.
  • QC sampling area with GMP standards
  • Segregated areas for rejected, recalled and
    returned materials
  • Separate areas for highly active, hazardous,
    narcotic materials
  • Printed materials storage

Closed area! Enter with permission!
63
Premises
  • Warehouses
  • adequte space to store different products in
    separate spaces
  • Quaratine types segregated areas or computerised
    stores with built-in quarantine, but always
    labelling

Rejected
Quarantine
Released
64
End of Premises Section
65
Basic Principles of GMP
  • Equipment

66
Equipment
  • Principle, 1
  • Equipment must be
  • located
  • designed
  • constructed
  • adapted
  • maintained
  • to suit their intended use

67
Equipment
  • Principle, 2
  • Equipment layout and design must aim
  • to minimize risks of error
  • to permit effective cleaning
  • to permit effective maintenance
  • And to avoid
  • cross-contamination
  • dust and dirt build-up
  • any adverse effect on the quality of products

68
Equipment
  • Principle, 3
  • Equipment must be installed to
  • minimize risks of error
  • minimize risks of contamination

69
Equipment
  • Balances and Measuring Equipment
  • Appropriate range
  • Precision
  • Available to
  • production
  • quality control
  • Calibrated
  • scheduled basis
  • checks
  • records maintained

70
Equipment
  • Production equipment
  • Design
  • easily and thoroughly cleaned
  • scheduled basis
  • Location
  • Maintenance
  • No hazard to the products
  • suitable non-reactive materials
  • non additive
  • not absorptive
  • Defective equipment
  • removed
  • labelled

71
Equipment
  • Control laboratory equipment
  • Equipment and instruments
  • suitable for the tests to be performed CHN
    analysator for routine purposes?
  • Defective equipment
  • removed
  • labelled

72
Equipment
  • Washing and Cleaning
  • Design promotes easy cleaning
  • On scheduled basis
  • Washing and cleaning equipment
  • Manual
  • Automated (Clean in place (CIP), Steam in place
    (SIP))
  • Not the source of contamination

73
End of Equipment Section
74
Basic Principles of GMP
  • Materials

75
Materials
  • Objectives 1
  • To review specific requirements for each type of
    material
  • Starting materials
  • Packaging materials
  • Intermediate and bulk products
  • Finished products
  • Rejected and recovered materials
  • Recalled products
  • Returned goods
  • Reagents and culture media
  • Reference standards
  • Waste materials
  • Miscellaneous materials.

76
Materials
  • Objectives 2
  • To examine the problems associated with
    materials, and how to overcome them

77
Materials
  • Principle
  • Objective of the pharmaceutical manufacturer
  • produce finished products
  • combination of materials
  • Materials combined
  • active pharmaceutical ingredients
  • auxiliary materials(excipients)
  • packaging materials
  • Special attention

78
Materials
  • General requirements for materials
  • All incoming materials and finished products
  • quarantined after receipt,
  • until released for use
  • distribution
  • stored
  • under appropriate conditions
  • orderly fashion (batch segregation)
  • materials management
  • stock rotation (FIFO or FEFO)

79
FIFO and FEFO
  • FIFO First In, First Out if the material has no
    shelf-life (only re-analysis date, e.g. the
    majority of substances)
  • FEFO First Expire, First Out if the material
    (mostly dosage-forms and some degradable
    substances) has shelf-life

80
Materials
  • Starting Materials I
  • Purchasing
  • Suppliers
  • Consignment
  • integrity
  • seal
  • order
  • delivery note
  • suppliers labels
  • Cleaned and labelled

81
Materials
  • Starting Materials II
  • Damaged containers
  • Different batches in one consignment
  • Starting material label
  • name and internal code
  • batch number(s), (supplier and manufacturer on
    receipt)
  • status
  • expiry date or re-test date
  • Sampled containers identified

82
Materials
  • Examples of Labelling of Starting Materials

83
Materials
  • Starting Materials III
  • Use only released material
  • Dispensing
  • designated persons
  • written procedure
  • accurately weighed
  • clean, labelled containers
  • Independent checks
  • material and weight
  • Dispensed material
  • kept together and labelled

84
Materials
  • Packaging materials I
  • Primary and printed materials
  • as for starting materials
  • purchasing, handling and control
  • No unauthorized access
  • Storage and transport
  • avoid mix-ups
  • issue and return SOP

85
Materials
  • Packaging materials II
  • Specific reference number for batch or
    consignment
  • Packaging department checks
  • quantity, identity and conformity
  • Outdated or obsolete material

86
Materials
  • Intermediate and bulk products
  • Appropriate conditions
  • Purchased
  • as starting materials

87
Materials
  • Finished products
  • Quarantine until released
  • Storage conditions
  • Evaluation and documentation
  • product release

88
Materials
  • Rejected and recovered materials
  • Rejected materials
  • Clearly marked
  • Stored separately in restricted areas
  • Action
  • Reprocessing
  • exceptional
  • procedure and records
  • batch number
  • additional testing

89
Materials
  • Rejected and recovered materials
  • Recovery
  • prior authorization
  • additional testing

90
Materials
  • Recalled products and returned goods
  • Recalled products
  • identified
  • stored separately
  • access controlled
  • fate
  • Returned goods
  • SOP decision regarding the fate
  • nature of product, storage conditions
  • history, time lapse
  • records

91
Materials
  • Reagents and culture media
  • Recorded upon receipt or preparation
  • Reagents
  • preparation in accordance with SOP
  • label
  • concentration, standardisation factor,
    shelf-life, date that re-standardisation is due,
    storage conditions
  • signed and dated
  • Culture media
  • positive and negative controls

92
Materials
  • Reference standards
  • Official reference standards
  • use only as per monograph
  • storage
  • Reference standards prepared by the producer
  • tested, released
  • stored in same way as official reference
    standards
  • Secondary or working standards
  • appropriate checks and tests
  • regular intervals
  • based on official reference standards

93
Materials
  • Waste materials and miscellaneous materials
  • Waste materials
  • proper and safe storage
  • toxic and flammable materials
  • separate, enclosed, as per legislation
  • not allowed to accumulate
  • collected for safe disposal
  • regular intervals
  • Miscellaneous
  • rodenticides, insecticides, sanitizing material
  • contamination risks

94
Exam topics
95
Personnel in GMP
  • In general (which personnel dou you needfor drug
    manufacture?)
  • Organisational charts, job descriptions
  • How to regulate access to drug manufacturing
    areas
  • Who are Key personnel, their relationship and
    main responsibilities
  • Training and its topics

96
Premises in GMP
  • Principles (location, design, space, etc.)
  • Design principles of manufacturing premises
  • Design and operation principles of Warehouses
    (incl. storage of printed materials. Weighnig
    areas, windows)
  • How to prevent cross-contamination

97
Equipment in GMP
  • Principles (location, design, installation,
    maintenance)
  • Handling of pipework
  • Use of balances
  • Production equipment positioning
  • Labelling status

98
Materials in GMP
  • What is quarantine?
  • Proper labelling (colour, and content)
  • What to do with containers arrived damaged
  • What are the primary and secondary packaging
    materials
  • Special measures for printed materials
  • How to store rejected materials, when may
    recovery or reprocessing be done
  • Speak about reference standards
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