module 8slide 1 of 22 who - edm personnel basic principles of gmp part one, 10

Module 8 Slide 1 of 22 WHO - EDM

Personnel

Basic Principles of GMP

Part One, 10


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


Part One 10.1

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


Part One 10.2

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


Part One 10.3

Personnel

General - II

Individual written job description

Organization Chart

No gaps or unexplained overlaps

Adequate authority to carry out responsibilities


Part One 10.4

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


Part One 10.5

Personnel

General - IV

Prevent unauthorized access to production, storage, quality control

Stop personnel who do not work in these areas using them as passageways


Part One 10.6 – 10.7

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


Part One 10.7

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.


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 10.8


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 10.8


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 10.9


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 10.9


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 10.10


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 10.10


Personnel

Useful reference documents for inspectors:

Organization Chart

Job descriptions


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 - 10.15


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 10.11 - 10.14


Part One 10.15

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


Personnel

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?


Personnel

Possible Issues – I Limited number of staff

Inadequate qualifications

Inadequate experience

Owner interferes in quality decisions

Lack of means to develop training materials


Personnel

Possible Issues – II Company procedures take precedence over

local legislation

Unclear organisation diagram

Staff movement

Inadequate training records

Illness

module 8slide 1 of 22 who - edm personnel basic principles of gmp part one, 10

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