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


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


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


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


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


Basic Principles of GMPBasic Principles of GMP

Organization chart

This is NOT what it should look like


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


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


Basic Principles of GMPBasic Principles of GMP


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


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


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


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


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


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


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


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


PersonnelPersonnel


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


PersonnelPersonnel


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


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


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


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


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


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


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


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


10.6

PersonnelPersonnel

Consultants and contract staff

Should be qualified for the services provided

Training records maintained

Records should prove qualifications


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?


PersonnelPersonnel

Possible Issues – I

Limited number of staff

Inadequate qualifications

Inadequate experience

Owner interferes in quality decisions

Lack of means to develop training materials


PersonnelPersonnel

Possible Issues – II

Company procedures take precedence over local legislation

Unclear organization diagram

Staff movement

Inadequate training records

Illness

module 8 | slide 1 0f 30 2012 personnel basic principles of gmp 9

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