WHO - PSM
PersonnelWorkshop on
GMP and Quality Assurance of TB products
Kuala LumpurMalaysia, 21 – 25 February 2005
Maija Hietava M.Sci.Pharm
Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster
Tel: +41.22.791.3598 Fax: +41.22.791.4730
World Health OrganizationE-mail: [email protected]
Basic Principles of GMP
Part One, 9 - 11
WHO - PSM
Personnel
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
WHO - PSM
Part One 9.1
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
WHO - PSM
Part One 9.2
Personnel
General - I
Adequate number of qualified people with practical experience
An individual’s responsibilities should not be so extensive as to present a risk to quality
WHO - PSM
Part One 9.3
Personnel
General - II
Individual written job description
Organization Chart
No gaps or unexplained overlaps
Adequate authority to carry out responsibilities
WHO - PSM
Part One 9.3
Personnel
Question no 1
What is the main resource of the pharmaceutical industry ???
WHO - PSM
Part One 9.4
Personnel
General - III Individuals must receive training in GMP:
initial training dedicated training for the job in question continuing training including hygiene standards
Motivated to support the establishment of high quality standards maintain high-quality standards
WHO - PSM
Part One 9.5
Personnel
General - IV
Prevent unauthorized access to production, storage, quality control
Stop personnel who do not work in these areas using them as passageways
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Part One 9.6 – 9.7
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
WHO - PSM
Part One 9.7
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
Practical experience. under professional guidance able to take difficult decisions in a professional and scientific
way, resolve the problems encountered in manufacturing and QC.
WHO - PSM
PersonnelShared 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, including application and principles of QA
approval and monitoring suppliers
Part One 9.8
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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
Part One 9.8
WHO - PSM
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
Part One 9.9
WHO - PSM
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
Part One 9.9
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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
Part One 9.10
WHO - PSM
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 personnelPart One 9.10
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PersonnelTraining - 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
Part One 10.11 - 10.12
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Personnel
Training - II
Staff in special areas clean areas; or working with highly active, toxic, infectious,
sensitizing materials
should be given specific training
The concept of QA and its understanding and implementation should be fully discussed during training
Part One 10.3 - 10.4
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Personnel
Training - III
What can be a training session to be documented Seminar or congress – in or outside the company Training in the comapany Regular department meeting dealing with quality
matters Training of SOPs Etc. Etc.
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Personnel
Training – IV- Assessment of training Training is successful when
employee sees his/her work as part of the totality of quality work, which has a direct input in the safety and quality of medicines
employee understands that she/he can cause a lot of trouble and damage for the users of medicines and also problems to her/his employer , if if she/he is careless and don't follow the guidelines and SOPs
as a result of the training there is a knowledgeable, motivated and satisfied employee
WHO - PSM
Part One 10.5
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
WHO - PSM
Part One 10.5
Personnel
Question no 2
What has to be planned and continuous in pharmaceutical industry, which normally also motivates personnel???
WHO - PSM
Personnel
Possible Problems Limited number of staff
Inadequate qualifications
Inadequate experience
Owner interferes in quality decisions
Lack of means to develop training materials
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