Basic Principles of GMP

Personnel

| Module 8 January 2006

Slide 1 of 29

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

| Module 8 January 2006

Slide 2 of 29

Personnel
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 9.1 affect them
| Module 8 January 2006

Slide 3 of 29

Personnel
General (1)
Personnel requirements: Adequate number of persons With necessary qualifications With practical experience An individuals responsibilities should not be so extensive as to present a risk to quality
9.2

| Module 8 January 2006

Slide 4 of 29

Personnel
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
9.3

| Module 8 January 2006

Slide 5 of 29

Basic Principles of GMP

Organization chart This is NOT what it should look like

| Module 8 January 2006

Slide 6 of 29

Personnel
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

9.4

| Module 8 January 2006

Slide 7 of 29

Personnel
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
9.5

| Module 8 January 2006

Slide 8 of 29

Basic Principles of GMP

| Module 8 January 2006

Slide 9 of 29

Personnel
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
9.6

| Module 8 January 2006

Slide 10 of 29

Personnel
Key Personnel (2)
Should posses appropriate qualifications Scientific education such as: chemistry or biochemistry chemical engineering microbiology pharmaceutical sciences and technology pharmacology and toxicology 9.7 physiology; or other related science subjects relevant to the responsibilities to be undertaken
| Module 8 January 2006

Slide 11 of 29

Personnel
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 9.7 resolve the problems encountered in manufacturing and QC
| Module 8 January 2006

Slide 12 of 29

Personnel
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 environment plant hygiene process validation and calibration training, including application and principles of QA approval and monitoring of suppliers and contract acceptors
9.8

| Module 8 January 2006

Slide 13 of 29

Personnel
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 January 2006

Slide 14 of 29

Personnel
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 January 2006

Slide 15 of 29

Personnel
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 January 2006

Slide 16 of 29

Personnel
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 January 2006

Slide 17 of 29

Personnel
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 January 2006

Slide 18 of 29

Personnel
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 January 2006

Slide 19 of 29

Personnel
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 January 2006

Slide 20 of 29

Personnel
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 January 2006

Slide 21 of 29

Personnel
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 considered
9.14 f - j

| Module 8 January 2006

Slide 22 of 29

Personnel
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 10.1, 10.2 practical effectiveness checked training before undertaking any new task
| Module 8 January 2006

Slide 23 of 29

Personnel
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 January 2006

Slide 24 of 29

Personnel
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
10.5

| Module 8 January 2006

Slide 25 of 29

Personnel
Consultants and contract staff
Should be qualified for the services provided Training records maintained Records should prove qualifications

10.6

| Module 8 January 2006

Slide 26 of 29

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?

| Module 8 January 2006

Slide 27 of 29

Personnel
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 January 2006

Slide 28 of 29

Personnel
Possible Issues II
Company procedures take precedence over local legislation Unclear organization diagram Staff movement Inadequate training records Illness

| Module 8 January 2006

Slide 29 of 29