Training of Employees

Training of Employees

OBJECTIVE:

To provide a procedure for adequate training to all employees, & workmen as appropriate to their job responsibilities, specific to the area of working & related to GMP.

PROCEDURE:

The training shall normally include the following, but not be limited to.

• Safety, personal hygiene & health aspects.
• GMP & GLP
• Functional training related to processes, operations of the respective departments & SOPs.
• Gowning & de-gowning procedure.
• Response to emergency situations.

Functional & cGMP training shall be provided by internal faculty i.e. Department Head or Head of QA as per schedule.

The training to be provided should be one of the following types –

• Induction Training
• On-job Training
• cGMP/GLP Training
• External Training

The means of training may be Slides, PowerPoint Presentations, SOPs, literature, practical training, verbal training, etc.

The company may also arrange to send the people for training to seminars, and training institutes or may also arrange to impart training by external agencies based on training needs.

Respective department personnel will prepare the training schedule in consultation with the Head of this department.

The schedule shall be prepared to take all aspects of the defined area & may also include training from the client company (machine/equipment/instrument manufacturer or supplier).

Taking into account a comprehensive training calendar shall be prepared by each department & will be submitted to QA Department. The training calendar should be prepared in the month of December for the next year or in the first quarter of the calendar year.

The training matrix should be approved by the Head of QA prior to implementation.

A controlled copy of the training Calendar shall be issued to the HR department along with all HODs for planning & compliance with the training program.

Training attendance for all types of training will be recorded on Training Attendance Record and also will be maintained in the Individual Training Record of every employee.

INDUCTION TRAINING (FOR  TECHNICAL STAFF)

Each new entrant trainee chemist, supervisor, and above shall be given training on the following аspects:

• Introduction about company, rules & regulations.
• Safety
• Personal hygiene, do & don’ts, good housekeeping practices.
• Importance of cGMP & GLP & their key elements as appropriate.

Each new workman shall be given training on the following aspects:

• Introduction about company, rules & regulations.
• Safety
• Personal hygiene, do & don’ts, good housekeeping practices.
• Briefing about GMP & its key elements as appropriate.
• Cleanliness at the workplace & good working habits.

For administrative & other non-technical staff

Each new Administrative & Non-Technical Staff shall be given training on the following aspects:

• Introduction about company, rules & regulations.
• Safety
• Personal hygiene, do & don’ts, good housekeeping practices.
• Briefing about GMP & its key elements as appropriate.
• Cleanliness at the workplace & good working habits.

The Induction Training Records will be performed and maintained by HR Department and also will be maintained in the Individual Training Record of every employee.

Assessment of induction training is not essential since it is for familiarization with the organization.

ON-THE-JOB TRAINING

Each employee will be given job-related training to his / her job by the Department Head.

This training will be related to the job he/she is supposed to do & will be by means of either classroom training, on-site training, practical demonstration either verbally or by giving notes, or by means of presentation either on a computer or by presentation slides.

For critical jobs where it will impact product quality, the employee will be closely supervised till he/she gets hands-on experience to do the job independently.

The training given will be assessed by means of oral or written tests or by means of practical demonstration to judge the skills involved on the job. If the individual is found to be deficient (less than 70 %) in understanding the training given; he/she shall be RETRAINED. (If the Trainee has been assessed by written test, maintain the record.

Training attendance for all types of training will be recorded on Training Attendance Record and also will be maintained in the Individual Training Record of every employee.

cGMP and GLP TRAINING

This training will be on regular basis at regular intervals to all the technical staff & workmen in Warehouse, Production, QC, QA, Engineering department & Housekeeping Administrative department as this is the most important aspect to be followed.

This training will be given by the Head of QA, the Head of QC Head of Production. This will be conducted mostly in groups.

The Training given will be assessed by means of oral or written tests or by means of questionnaire to judge the understanding of cGMP. If the individual is found to be deficient (less than 70 %) in understanding the training given; he/she shall be RETRAINED. (If the Trainee has been assessed by written test, maintain the record.

Training attendance for all types of training will be recorded on Training Attendance Record and also will be maintained in the Individual Training Record of every employee.

EXTERNAL TRAINING

External training shall be imparted to supervisors, executives, and managers & may include other personnel as & when required & records of the same are maintained. The following topics are to be considered for external training –

• Current good manufacturing practices
• Good laboratory practices
• Equipment cleaning & validation
• Air handling system
• Other topics as per training needs of the personnel
• Training Records of External Training will be recorded in Individual Training Records.