Module 8 | Slide 1 0f 30 2012 Personnel Basic Principles of GMP 9.
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Transcript of Module 8 | Slide 1 0f 30 2012 Personnel Basic Principles of GMP 9.
Module 8 | Slide 1 0f 30 2012
Personnel
Basic Principles of GMP
9
Module 8 | Slide 2 0f 30 2012
PersonnelPersonnel
Objectives
To review general issues related to personnel
To review requirements for key personnel
To review the training of personnel
To consider some specific issues
Module 8 | Slide 3 0f 30 2012
9.1
PersonnelPersonnel
Principle
A satisfactory system of QA, manufacture and control of products
and APIs rely on people.
Must be sufficient qualified personnel to carry out tasks
Individual responsibilities must be clearly defined and understood by individuals concerned
Written job descriptions
All personnel should be aware of the principles of GMP that affect them
Module 8 | Slide 4 0f 30 2012
9.2
PersonnelPersonnel
General (1)
Personnel requirements:
Adequate number of persons
With necessary qualifications
With practical experience
An individual’s responsibilities should not be so extensive as to present a risk to quality
Module 8 | Slide 5 0f 30 2012
9.3
PersonnelPersonnel
General (2)
Specific duties in written job descriptions
Adequate authority to carry out responsibilities
May delegate to designated deputies with qualifications
No gaps or unexplained overlaps
Authorized organization chart
Module 8 | Slide 6 0f 30 2012
Basic Principles of GMPBasic Principles of GMP
Organization chart
This is NOT what it should look like
Module 8 | Slide 7 0f 30 2012
9.4
PersonnelPersonnel
General (3)
All personnel should be aware of GMP
Must receive training in GMP: initial training continuing training including hygiene standards
Motivated to support the establishment maintain high-quality standards
Module 8 | Slide 8 0f 30 2012
9.5
PersonnelPersonnel
General (4)
Prevent unauthorized access to: Production areas Storage areas Quality control
Stop personnel who do not work in these areas using them as passageways
Module 8 | Slide 9 0f 30 2012
Basic Principles of GMPBasic Principles of GMP
Module 8 | Slide 10 0f 30 2012
9.6
PersonnelPersonnel
Key Personnel (1)
Key personnel (which normally should be full-time) positions and include:
Authorized person Head of Production Head of Quality Unit
– Quality Assurance and Quality Control
May delegate functions – not responsibility Heads of Production and Quality Unit should be independent of
each other
Module 8 | Slide 11 0f 30 2012
9.7
PersonnelPersonnel
Key Personnel (2)
Should have appropriate qualificationsScientific education such as:
chemistry or biochemistry chemical engineering microbiology pharmaceutical sciences and technology pharmacology and toxicology physiology; or other related science subjects relevant to the responsibilities
to be undertaken
Module 8 | Slide 12 0f 30 2012
9.7
PersonnelPersonnel
Key Personnel (3)
Should have appropriate experience
Practical experience Manufacture and quality assurance Preparatory period under professional guidance sometimes
needed
Education and experience should enable personnel to take difficult decisions in an independent, professional and scientific way resolve the problems encountered in manufacturing and QC
Module 8 | Slide 13 0f 30 2012
PersonnelPersonnel
Shared Responsibilities (1)
Heads of Production and Quality Unit may share/jointly exercise some responsibilities relating to quality e.g.:
authorization of written procedures (SOPs) and other documentsmonitoring and control of manufacturing environmenthygieneprocess validation and calibration training, including application and principles of QAapproval and monitoring of suppliers and contract acceptors
9.8
Module 8 | Slide 14 0f 30 2012
PersonnelPersonnel
Shared Responsibilities (2)
Designation and monitoring of storage conditions for materials and products
Performing and evaluating in-process controls
Retention of records
Monitoring compliance with GMP
Inspection, investigation, and taking of samples to monitor factors which may affect quality 9.8
Module 8 | Slide 15 0f 30 2012
PersonnelPersonnel
Head of Production: Responsibilities (1)
Product production and storage according to appropriate documentation
Approval and implementation of production instructions, in-process QC and ensure strict implementation
Ensures that production records are evaluated and signed by designated person
9.9
Module 8 | Slide 16 0f 30 2012
PersonnelPersonnel
Head of Production: Responsibilities (2)
Checks maintenance of production department, premises and equipment
Ensures process validation and calibration performed, recorded, and reports are made available
Ensures initial and continuous training of production personnel
9.9
Module 8 | Slide 17 0f 30 2012
PersonnelPersonnel
Head of Quality Unit: Responsibilities (1)
Approve or reject starting materials, packaging materials, and intermediate, bulk and finished products in relation with their specifications
Evaluate batch records
Ensure that all necessary testing is carried out
Approve sampling instructions, specifications, test methods and other QC procedures 9.10
Module 8 | Slide 18 0f 30 2012
PersonnelPersonnel
Head of Quality Unit: Responsibilities (2)
Approve and monitor analyses carried out under contract
Maintenance of the department, premises and equipment
Validations (including analytical procedures) and calibrations of control equipment are carried out
Initial and continuing training of quality unit personnel
9.10
Module 8 | Slide 19 0f 30 2012
PersonnelPersonnel
Head of Quality Unit: Responsibilities (3)
Establishment, implementation and maintenance of the quality system
Supervision of the regular internal audits or self-inspections
Participation in external audit (vendor audit)
Participation in validation programmes
(See also other duties of QC later)9.10
Module 8 | Slide 20 0f 30 2012
PersonnelPersonnel
Authorized person: Responsibilities (1)
Compliance with technical and regulatory requirements
Approval of the release of finished product for sale
Function may be delegated to another person (e.g. QA)
In some countries, overall responsibility including
– The establishment and implementation of quality system
– Development of quality manual
– Supervision of self-inspections and quality audits9.11, 9.15
Module 8 | Slide 21 0f 30 2012
PersonnelPersonnel
Authorized person: Responsibilities (2)
No batch of product is to be released for sale or supply prior to certification by the authorized person(s).
Assessment of finished product include:– Review of production conditions – Results of in-process testing– Manufacturing (including packaging) documentation– Compliance with specifications– Examination of the finished pack
9.12, 9.13
Module 8 | Slide 22 0f 30 2012
PersonnelPersonnel
Person releasing the batch should ensure: (1)
Each batch meets manufacturing and marketing authorization requirements
Principles and requirements of GMP are met
All checks and tests have been performed
Production conditions and manufacturing records
Planned changes and deviations reported - including where necessary to drug regulatory authority 9.14 a - e
Module 8 | Slide 23 0f 30 2012
PersonnelPersonnel
Person releasing the batch should ensure: (2)
Additional sampling, inspection, checks and tests had been done when required
All production and control documents are completed and endorsed
Audits, inspections and spot-checks were done
QC approval has been given
All other relevant factors have been considered9.14 f - j
Module 8 | Slide 24 0f 30 2012
PersonnelPersonnel
Training (1)
Training, in accordance with a written, approved programme all personnel whose duties take them into production areas; into control laboratories; and for others whose activities could affect the quality of the
product including technical, maintenance and cleaning personnel
Induction and continuing training on theory and practice of GMP and their duties training records should be kept practical effectiveness checked training before undertaking any new task
10.1, 10.2
Module 8 | Slide 25 0f 30 2012
PersonnelPersonnel
Training (2)
Specific training for staff in special areas, e.g. Where contamination is a hazardClean areasAreas where highly active, toxic, infectious,
sensitizing materials are handled
The concept of QA - ensure understanding and its implementation
10.3, 10.4
Module 8 | Slide 26 0f 30 2012
10.5
PersonnelPersonnel
Visitors or Untrained Personnel
Should not to enter production and control areas. If this is unavoidable then:
They must be given information in advance: GMP personal hygiene protective clothing requirements Behaviour (no samples to be taken, touching etc.)
Must be accompanied and closely supervised at all times
Module 8 | Slide 27 0f 30 2012
10.6
PersonnelPersonnel
Consultants and contract staff
Should be qualified for the services provided
Training records maintained
Records should prove qualifications
Module 8 | Slide 28 0f 30 2012
PersonnelPersonnel
Group Session
What do you think will be the key personnel issues to arise during an inspection?
What sort of responses do you think you should give to these issues when they become apparent?
Module 8 | Slide 29 0f 30 2012
PersonnelPersonnel
Possible Issues – I
Limited number of staff
Inadequate qualifications
Inadequate experience
Owner interferes in quality decisions
Lack of means to develop training materials
Module 8 | Slide 30 0f 30 2012
PersonnelPersonnel
Possible Issues – II
Company procedures take precedence over local legislation
Unclear organization diagram
Staff movement
Inadequate training records
Illness