Module 2 | Slide 1 of 19 January 2006 Quality Management Basic Principles of GMP Section 1 and 2.
Module 8 | Slide 1 of 29 January 2006 Personnel Basic Principles of GMP 9.
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Transcript of Module 8 | Slide 1 of 29 January 2006 Personnel Basic Principles of GMP 9.
Module 8 | Slide 1 of 29 January 2006
Personnel
Basic Principles of GMP
9
Module 8 | Slide 2 of 29 January 2006
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 of 29 January 2006
9.1
PersonnelPersonnel
Principle
Establishment and maintenance of satisfactory system of QA, manufacture and control of products and actives 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 of 29 January 2006
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 of 29 January 2006
9.3
PersonnelPersonnel
General (2)
All responsible staff should have specific duties recorded in individual written job descriptions
Have adequate authority to carry out responsibilities
May delegate to designated deputies with qualifications
No gaps or unexplained overlaps
Organization chart
Module 8 | Slide 6 of 29 January 2006
Basic Principles of GMPBasic Principles of GMP
Organization chart
This is NOT what it should look like
Module 8 | Slide 7 of 29 January 2006
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 of 29 January 2006
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 of 29 January 2006
Basic Principles of GMPBasic Principles of GMP
Module 8 | Slide 10 of 29 January 2006
9.6
PersonnelPersonnel
Key Personnel (1)
Key personnel (which normally should be full-time) positions include: Authorized person Head of Production Head of Quality Control May delegate functions – not responsibility Heads of Production and Quality Control should be
independent of each other
Module 8 | Slide 11 of 29 January 2006
9.7
PersonnelPersonnel
Key Personnel (2)
Should posses 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 of 29 January 2006
9.7
PersonnelPersonnel
Key Personnel (3)
Should posses 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 of 29 January 2006
PersonnelPersonnel
Shared Responsibilities (1)
Heads of Production and Quality Control may share/jointly exercise some responsibilities relating to quality:
authorization of written procedures (SOPs) and other documents, including amendments
monitoring and control of manufacturing environmentplant hygieneprocess validation and calibration training, including application and principles of QAapproval and monitoring of suppliers and contract acceptors
9.8
Module 8 | Slide 14 of 29 January 2006
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 of 29 January 2006
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 of 29 January 2006
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 of 29 January 2006
PersonnelPersonnel
Head of Quality Control: Responsibilities (1)
Approval or rejection of materials, e.g. packing materials, intermediates, bulk and finished products, in accordance with specifications
Evaluation of batch records
Ensures carrying out of necessary testing
Approval of quality control procedures, e.g. sampling and testing; specifications
9.10
Module 8 | Slide 18 of 29 January 2006
PersonnelPersonnel
Head of Quality Control: Responsibilities (2)
Approval and monitoring of all contract analysis
Checks maintenance of quality department, premises and equipment
Ensures validation (including analytical procedure validation) and calibration of control equipment
Ensures initial and continuous training of QC personnel
9.10
Module 8 | Slide 19 of 29 January 2006
PersonnelPersonnel
Authorized person: Responsibilities (1)
Compliance with technical and regulatory requirements
Approval of the release of finished product for sale
Establishment and implementation of quality system
Development of quality manual
Supervision of self-inspections and quality audits
9.11
Module 8 | Slide 20 of 29 January 2006
PersonnelPersonnel
Authorized person: Responsibilities (2)
Oversight of the QC department
Participation in external audits and vendor audits
Participation in validation programmes
May delegate approval of release of product through approved procedure
Normally by QA by means of batch review
9.12, 9.13
Module 8 | Slide 21 of 29 January 2006
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 22 of 29 January 2006
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 23 of 29 January 2006
PersonnelPersonnel
Training (1)
Training, in accordance with a written, approved programme all personnel whose duties take them into production areas; or 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 24 of 29 January 2006
PersonnelPersonnel
Training (2)
Specific training for staff in special areas, e.g. Where contamination is a hazard Including clean areas; or 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
10.3, 10.4
Module 8 | Slide 25 of 29 January 2006
10.5
PersonnelPersonnel
Visitors or Untrained Personnel
Preferable not to enter production and control areas. If this is unavoidable then:
They must be given information in advance, particularly about personal hygiene protective clothing requirements
Must be accompanied and closely supervised at all times
Module 8 | Slide 26 of 29 January 2006
10.6
PersonnelPersonnel
Consultants and contract staff
Should be qualified for the services provided
Training records maintained
Records should prove qualifications
Module 8 | Slide 27 of 29 January 2006
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 28 of 29 January 2006
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 29 of 29 January 2006
PersonnelPersonnel
Possible Issues – II
Company procedures take precedence over local legislation
Unclear organization diagram
Staff movement
Inadequate training records
Illness