THE NEED FOR CONTINUAL TRAINING PROGRAM AS A PART OF cGMP IN PHARMACEUTICAL INDUSTRIESReg no. 160617009

Presented by Ms. SHIKHA Y. SINGH

Under the guidance of Dr. GIRISH PAI K.

DEPARTMENT OF PHARMACEUTICS

MCOPS MANIPAL UNIVERSITY

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INDEX INTRODUCTION

CONTINUAL cGMP TRAINING

TRAINING POLICIES & PROCEDURE

CONTINUAL TRAINING PROGRAM

NEED OF CONTINUAL TRAINING PROGRAM

cGMP REQUIREMENTS

CONCLUSION

REFERENCES

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INTRODUCTION Every organization in regulated industry must train its employees

This training is scheduled in several ways

Refresher training may be schedule more frequently than on an annual basis

According to the USFDA

Rather than referring to “ANNUAL” cGMP refreshing training

CONTINUING cGMP

training

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Basic scheduling distinction between

training that is delivered

In response to a

perceived deficiency

Training deliver

according to calendar

New employee orientation NEO

Training for business process redesign & SOP revision

Technical training

Much of regulatory training---periodic refresher training that is mandated in cGMP

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CONTINUAL cGMP TRAINING FDA regulations call for continuing cGMP training The training in cGMP

Shall be conducted by QUALIFIED INDIVIDUALS

Shall be conducted on a CONTINUING BASIS

Shall address cGMP REQUIREMENTS

With SUFFICIENT FREQUENCY

Employees should remain FAMILIAR with cGMP requirements

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TRAINING POLICIES & PROCEDURE

Scope

Trainees

Curricula

Training plansCourse development &

acquisitionTraining materials

Training administrationChange control to training

materialAssessment & evaluations

Instructor & trainers

Training records

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CONTINUAL TRAINING PROGRAM

Orientation training for new

employees

Work-specific

area training

Ongoing training

Remedial training

Job-change training

Trainers training

Supervisor &

manager training

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ORIENTATION TRAINING FOR NEW EMPLOYEES Should be as simple as possible New employees- will not understand GMP rules during their 1st day

in the company Training new employees in cGMP is an extremely critical activity Employees never exposed to cGMPs

NEW EMPLOYEE-

ORIENTATION TRAINING

PHASE-I PHASE-II

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PHASE IHistory of the company

Organizational chart

FacilitiesCompany policies & company standard practices Basic GMP concepts

General safety trainingCarried out during the employee’s 1st day in the company

PHASE II Location of the working area Characteristics of the working area

Product knowledge

Job description

Work-specific training programme

Basic documentationCarried out during the employee’s 1st week in the company

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WORK-SPECIFIC AREA TRAINING Employee whose activities could impact on the quality of the

product should receive work-specific training at the time of joining the company and on a continuing basis

Work-specific area training should cover

three aspects

Safety trainin

g

On-the job

training

CGMP trainin

g

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1. cGMP TRAINING Training should be completed in 1st two months following entrance

in the company To ensure that employees understand & follow cGMP requirements

applicable to their jobs • Manufacturing of products

• Aseptic processing

• QC• QA• Animal

facilities • Product

development• Visual

inspection & packaging

• Warehousing & distribution

• Maintenance• Purchasing

Specific CGMP training-

developed according to CGMP requirements for

each area

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2. ON-THE JOB TRAINING Frequently underestimated Not performed in a very professional way New employee is simply assigned to the most experienced one to

watch New person learns same practices–some bad, some good of the

experienced person Supervisor is responsible for this training Based on the SOPs & acquisition of technical skills needed for the

job Particularly important at this stage to teach the trainee not only

what he/she should do & how but why it must be done in such a way Also known as STRUCTURED on-the-job training Should include having a checklist of topics & preferred sequence in

which they are to be covered

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TRAINING ON SOPS• Supervisor will provide the current copy of the SOP related to the task & allocate time for reading

• Trainee will read the pertinent document

• Supervisor will review the SOP with the trainee & will answer any questions regarding the documents

• Supervisor will show the trainee how to do the task

• Trainee will perform the procedure under supervision

• Supervisor will review the work in such a way that positive performance will be reinforced

• A checklist to evaluate the performance of the trainee

• Then trainee will perform the procedure without supervision

• When the supervisor is satisfied with the trainee’s performance, the supervisor and the trainee will sign the training record

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3. SAFETY TRAINING

Safety training will be developed from the specific safety requirements for the area

It will be given to all those employees in at-risk occupations Safety department identifies those who need to have safety

training, which may be given individually or to a group of employees in related occupations

According to the existing risks & complexities. These should cover:

Knowledge of mechanisms of exposure to the specific risk agent including toxic chemicals & biohazards

Appropriate use of personal protection itemsHow to proceed in an emergency

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ON-GOING TRAINING Also known as reinforcement training, refresher training,

continuous or periodic training Conducted to update, reinforce & refresh the knowledge and skills

of employees

cGMP

On-the job training

Safety training

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REMEDIAL TRAINING Remedial training is given when there is evidence that the original

training was not adequate, resulting in a person who cannot correctly, safely, effectively or efficiently perform the task

Remedial training is frequently used incorrectly, as corrective actions to failures

“Retrain the operator” or “retrain the lab analyst” It should be planned when specific deficiencies related to training

are identified during the performance of a job or task It may only need to emphasize why the correct, required way must

be done & potential outcome of shortcuts

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Useful when employees have forgotten their knowledge & skills after a long absence from the job or by infrequent assignment to a job or task

Supervisor provides the current copy of the SOPs

Trainee rereads the SOPs

Trainee performs, under supervision, the procedures he/she was originally trained in

Trainee performs the procedures without supervision

Supervisor is satisfied with trainee’s performance, supervisor and the trainee sign the training record

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JOB-CHANGE TRAINING Defined training program consider the training needs of someone

who moved from one position in the company to a new position Adequate training must therefore be given to every employee

when she/he is assigned to a new job function Work-specific training should be conducted for the employee’s

new needs Job change training may be organized in following way

Review employees training record

Review training requirements for new job position

Prepare a training plan for employee based on analysis

Perform trainee’s assessment

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SUPERVISOR & MANAGER TRAINING Supervisor training It is the responsibility of the supervisor

To provide clear direction to lead by To set high standards of performance To provide feedback To ensure adequate resources

Supervisor training should be conducted to guarantee that supervisors be adequately trained in:

Areas they are going to supervise SOPs used in their department Their responsibilities under cGMP Change control

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Manager training Quality, motivation & education are very closely related- Managers

plays an important role in motivating their staff Training should be carried out from the top to the bottom of the

staff & with managers involved as much as possible Managers should learn to communicate effectively with

supervisors & subordinates and also to learn diverse ways to motivate & encourage their staff

Managers and supervisors need to be trained in their responsibilities under cGMPs & Good laboratory practice (GLPs) for non-clinical studies

Managers and supervisors should also be trained in aspects such as:

Communication Motivation Decision-making Problem solving

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TRAINER’S TRAINING Trainers should have an understanding of how trainees learn & in

providing effective feedback to trainees Desire to train, help others & continually learn are traits trainers

have in common Trainers need to continually develop their skills as communicators

& coaches“Andragogical model”- (adult learning theory) It states that adults are self-paced learners who need

involvement, visualization & a clear connection between new & existing information that they already have

Adults are motivated to learn if they can see the value & benefit that the knowledge can contribute to their lives or situation

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NEED OF CONTINUAL TRAINING PROGRAM Dynamic process that cannot be satisfied by a single training

course to be given to an employee at the time of hire

Investment in people that pays its dividends in a more skilled workforce, improved productivity & higher levels of product and service quality

DYNAMIC PROCESS

Training an employee receives in

his/her career

Keep pace with job requirements & performance expectations

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More training is required when… Less training is required when… The workforce is relatively new to

the jobThe 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 addedThere are some/many worker

performance issuesThere are few worker performance

issuesThe technology, equipment, or

process is new or changingThe technology, equipment, or

process is stableNew personnel are added; the firm is

expandingFew new personnel are added; the

firm is staying the same size The facility operates 24hours a day

using multiple shiftsThe firm operates on one shift

There are gaps between what a person can do when hired & what

he is required to do

There is a close match between knowledge & skills of personnel &

what is required of them

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SOME EXAMPLES OF HOW TRAINING HAS HAD AN IMPACT ON PEOPLE AND ORGANIZATIONSDuring cGMP training

course:Materials-handling personnel at a firm making biological products, contamination & product purity People were washing their hands One washed & other unwashed – on culture media plates (Petri dishes)Record-keeping techniquesNo. of “first-time-right” batch records greatly increased-QA review time

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cGMP REQUIREMENTSAs per WHO-cGMP: The manufacturer should have an adequate number of personnel

with the necessary qualifications & practical experience All personnel should be aware of the principles of cGMP that affect

them & receive initial and continuing training relevant to their needs

The manufacturer should provide training in accordance with a written programme

Newly recruited personnel should receive training appropriate to the duties assigned to them

Continuing training should also be given & its practical effectiveness periodically assessed

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CONCLUSION FDA recommends that cGMP training not be conducted in one

massive training session Rather, it should be presented in smaller more manageable

sessions held throughout the year, or at a minimum be held once a year

cGMP training should be revisited at frequent intervals & needs to be conducted by qualified individuals

cGMP Regulations indicates that “Training should address the policies, processes, procedures & written instructions related to operational activities, the product/service, the quality system, and the desired work culture”

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REFERENCES A WHO guide to good manufacturing practice (GMP) requirements

– Part 3: Training printed by the WHO Document Production Services, Geneva, Switzerland

Guidance for Industry Quality Systems Approach to Pharmaceutical cGMP Regulations

"Developing a Continuing cGMP Training Program," Journal of GXP Compliance, Vol. 13, No. 4, Fall 2009, pp. 86-96.

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ANY QUERIES???

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