04/09/23

1PHAM 500: QUALITY ASSURANCE

PRESENTATION

ON

PERSONNEL AND TRAINING

BY: KIROJ RAJBANSHI

KUSUM SHRESTHASURUCHI NEPAL

M Pharm 1st year, Batch 2011

3 DEC. 2011KUSOM, LALITPUR

Basic Principles of GMP

04/09/23

2

Personnel and Training

WHO Technical Report Series,908, Annex 4, WHO Technical Report Series 961

Personnel and Training

04/09/23

3

Objectives

To review general issues related to personnel

To review requirements for key personnel

To review the training of personnel

Personnel

04/09/23

4

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

Personnel

04/09/23

5

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

Personnel

04/09/23

6

General - II

•Individual written job description•Organization Chart :

it should not look like

Personnel

04/09/23

7

Director

QA manager Production Manager Admin manager

Qc Manager

Regulatory Officer

Officer microOfficer chemicalOfficer instrumentOfficer packaging

Store managerAssistant production manager

Engineering Manager

Tablet/Capsule Officer

Liquid/ointment officer

Packaging Officer

Engineering Officer

Purchase OfficerPersonnel Officer

Personnel

04/09/23

8

General - III Individuals must receive training in GMP:

initial training continuing training including hygiene standards

Motivated to support the establishment maintain high-quality standards

Personnel

04/09/23

9

General - IV

Prevent unauthorized access to production, storage, quality control

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

Key Personnel

This include Head of Production Head of Quality Units (WHO TRS 961) Authorized Person

04/09/23

10

Key Personnel

Usually must be a full timer Should possess appropriate

qualifications for handling the post Should have practical experience Should possess scientific education

04/09/23

11

Shared Responsibilities

Head of the Production and Quality Units may share some responsibilities relating to quality:

Authorization of written procedures and other documents

Monitoring and control of manufacturing environment

While carrying out Validation and Qualification Personnel Hygiene and Environmental Monitoring Training Monitoring compliance with GMP Internal Audits

04/09/23

12

Shared Responsibilities

Approval and monitoring of Suppliers and contract acceptors

Retention of Records Performing and evaluating In-process

Controls Designation and monitoring of storage

conditions for materials and products

04/09/23

13

Responsibilities of Head of Production Production of finished products and their

appropriate storage Production Planning Responsible for allocating Officer and Staffs to

different sections Approval and implementation of production

instructions, In process controls Ensure that procedures are followed as per the

written procedures and report deviations if any. Ensure production records are effectively

documented, evaluated and signed by the designated person

04/09/23

14

Responsibilities of Head of Production Ensure that Process Validation, Equipment

Qualification and Instrument Calibration are performed timely and all the records are maintained

Responsible for carrying out initial and continuous training of the production personnel and their motivation

Ensure that the production premise and equipments are maintained properly

04/09/23

15

Responsibilities of Head of Quality Unit Approval and rejection of starting materials,

bulk products, intermediate products, finished products and packing materials

Ensure that required testing are done in accordance with the established procedures

Ensure that Analytical Method validation and Instrument Calibration are performed timely and all the records are maintained

Responsible for carrying out initial and continuous training of the QC personnel and their motivation

Ensure that the QC premise and equipments are maintained properly

Approval of Quality control procedures like sampling and testing; specifications

04/09/23

16

Responsibilities of Head of Quality Unit Ensure that all the required equipments and

reagents for carrying out analysis are adequately available and are correctly utilized, cleaned and are in good condition

Organize duties of analysts effectively, efficiently and handle analytical technical problems

Implementation and control of documents as per GMP requirements

Establishment, implementation and maintenance of quality system

Supervision of regular internal audits or self inspection

Participation in the external audits (vendor audit) Participation in validation programmes

04/09/23

17

Responsibilities of Authorized Person Compliance with technical or regulatory

requirements related to quality of finished products

Approval of release of finished products for sale

In certain countries, by law, batch release is the task of authorized person from production together with the authorized person from QC

04/09/23

18

Authorized person who is responsible for batch release should ensure that following requirements have been met

Marketing authorization and manufacturing authorization requirement for the product have been met

The principles and guidelines of GMP have been followed

The principle manufacturing and testing procedures have been validated, if different

Any planned changes or deviation in manufacturing or quality control have been notified with well defined reporting system

All the necessary tests and checks have been performed

Approval have been given from head of QC All necessary production and QC documentation have

been completed Appropriate audits, self inspection have been carried

out by experienced and trained staff04/09/23

19

The function of approval of release of finished batch can be delegated to a designated person with appropriate qualification and experience.

This is normally done by QA by means of batch review

04/09/2320

GMP Requirements for Training

04/09/23

10.1. The manufacturer should provide training in accordance with a written programme for all personnel whose duties take them into manufacturing areas or into control laboratories (including the technical, maintenance and cleaning personnel) and for other personnel as required.

21

The Written Programme

04/09/23

POINTS THAT CAN BE INCLUDED IN SOP

Scope of the procedure

Types of training covered

Responsibilites of training Programme

WHO is to be trained, WHEN training to be conducted

Quality Unit Involvement

Learning Plans and Curricula

Qualification of Instructors

Documentation of participation in training

Maintainance of training materials

Retention of training materials

Reports to Mangement etc…..

22

GMP Requirements for Training

04/09/23

10.2. Besides basic training on the theory and practice of GMP, newly recruited personnel should receive training appropriate to the duties assigned to them.

Continuing training should also be given, and its practical effectiveness periodically assessed.

Approved training programmes should be available. Training records should be kept.

23

Types of Training

04/09/23

1. Orientation training for new employees2.Work Specific Area training GMP training On the Job Training Training on SOPs Safety Training3. Supervisor training4.Manager training 5. Trainers Training 6.Ongoing Training7.Remedial Training8.Job Change Training9.Temporary employee and contractor training

24

Table 1Amount of Training Required

04/09/23

MORE TRAINING IS REQUIRED WHEN…

LESS TRAINING IS REQUIRED WHEN…

The workforce is relatively new to the job

The workforce is experienced

There is a high, rapid employee turnover rate

There is a low employee turnover rate

New products are being added No new products are being added

There are many worker performance issues

There are few worker performance issues

The technology, equipment, or process is new or changing

The technology, equipment, or process is stable

New personnel are added; the firm is expanding

Few new personnel are added; the firm is staying thesame size

The facility operates 24 hours a day using multiple shifts

The firm operates on one shift

There are gaps between what a person can do when hired and what he is required to do.

There is a close match between knowledge and skills of and what he is required of them

25

GMP Requirements for Training

04/09/23

10.3 Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitizing materials are handled, should be given specific training.

26

04/09/23

HIGHLY ACTIVE(anticancer, steroids)

TOXIC (formaldehyde , ethylene oxide, hydrogen sulphide)

INFECTIOUS ( therapy involving live cells )

SENSITIZING MATERIALS

AREA WHERE CONTAMINATION IS HAZARD

SPECIFIC TRAINING SHOULD INCLUDE….

chemical hygiene plan

Location and availability of known reference material on the chemical hazards, and their safe handling, storage, and disposal including,but not limited to, Material Safety Data Sheets (MSDSs) received from chemical suppliers.

Measures that workers and their employers can take to protect employees from hazards

Know the toxic effects of the chemicals

Protective clothing etc…

27

GMP Requirements for Training

04/09/23

10.4 The concept of quality assurance and all the measures which aid its understanding and implementation should be fully discussed during the training sessions.

28

GMP Requirements for Training

04/09/23

10.5 Visitors or untrained personnel should preferably not be taken into the production and quality control areas. If this is unavoidable, they should be given relevant information in advance (particularly about personal hygiene) and the prescribed protective clothing. They should be closely supervised.

29

GMP Requirements for Training

04/09/23

10.6 Consultant and contract staff should be qualified for the services they provide. Evidence of this should be included in the training records.

30

Example of Impact of Training

04/09/23

One firm found that people were washing their hands much more frequently after a training course in which people put their hands – one washed and the other unwashed – on culture media plates (Petri dishes). The dramatic difference

that hand washing made became a motivating factor.

31

Example

04/09/23

A firm provided extensive training to key technical, production and quality personnel on how to investigate problems (i.e. deviations) and write reports. After a period of two years, because the investigation teams knew how to determine root causes to problems and recommend and implement corrective actions, they had a significant reduction in recurring deviations.

WHO/IVB/05.24 5

32

Training: In Nutshell as per GMP

04/09/23

10.1 Focuses on training to the personnel in manufaturing area , QC (including technical and maintainance)

10.2. Focus on the types of training to be given10.3. Focus of the safety 10.4 Focus on the discussion on QA, its

understanding and implementation10.5. Limits the reach of visitors /specifies the

need for supervision before their entrance10.6 Helps ensure that the consultant and

contract officers are qualified

33

CONCLUSION

04/09/23

In conclusion, training is an investment in people that pays its dividends in a more skilled workforce, improved productivity, and higher levels of product and service quality.

34

REFERENCES

04/09/23

WHO TRS 908 WHO TRS 961 A WHO guide to good manufacturing

practices .Part 3: Training Defining your GMP training programme

with a training procedure ; James L Vesper

www.osha.gov

35

04/09/23

THANK YOU

36