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: hietavam@who.int

Basic Principles of GMP

Part One, 9 - 11

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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

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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

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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

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Part One 9.3

Personnel

General - II

Individual written job description

Organization Chart

No gaps or unexplained overlaps

Adequate authority to carry out responsibilities

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Part One 9.3

Personnel

Question no 1

What is the main resource of the pharmaceutical industry ???

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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

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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

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Part One 9.7

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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.

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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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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

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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

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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

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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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Personnel

Useful reference documents for inspectors:

Organization Chart

Job descriptions

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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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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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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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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

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Part One 10.5

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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

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Part One 10.5

Personnel

Question no 2

What has to be planned and continuous in pharmaceutical industry, which normally also motivates personnel???

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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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Personnel

Possible Problems Company procedures take precedence over

local legislation

Unclear organisation chart

Staff movement

Inadequate training records

Illness