SOP for Induction Program and Training of Personnel

OBJECTIVE

To lay down a procedure for the training plant personnel.

SCOPE

This procedure is applicable to all operations of PharmaInfo Limited.

RESPONSIBILITY

Trainer: Responsibilities of individual(s) / concerned departments are as follows:

• Induction Training: HRD and Department In-charge.
• On-the-job training and safety training: Department Incharge / HOD.
• cGMP Training/refresher cGMP training: QA Manager / His designate.
• Retraining: Training In charge / HOD.
• External Training and specific training: HOD.

Trainee: Responsible for attending the training, report writing filling up the Training Log Book, and keeping up-to-date the Employee Training Card for self.

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PROCEDURE

Induction Training

• The induction training program shall be organized so that new employee is introduced to the interacting departments, and staff members and gets familiarized with the overview of the organization, unit, and department.
• HRD along with the concerned department in charge shall prepare the induction schedule in consultation with the concerned HOD and record the details in the Induction Training Schedule (Refer to Attachment-I).
• New recruit shall be introduced by HRD to his / her in-charge, who is responsible for helping the new recruit through the induction period and beyond.

On–the–Job Training

• On-the-job training shall include in-depth training in the parent department and cross-functional department of the new employee.
• The on-the-job training program shall include training related to the specific aspects of an individual’s role including the use of equipment, unit operations, safety norms to be followed, adherence to cGMP, assigned responsibilities, etc.
• The mode of imparting training shall be through a combination of one or more of the following: reading procedures, presentation, practical training, discussion, and questionnaire.
• If a person is transferred from one department to another, the training in charge/Department in charge shall be informed, and separate on–the–job training shall be initiated by the head of the new department.

cGMP Training

• This program shall be mandatory for all employees (New and Existing).
• cGMP Training for New Employees: This program covers all new employees for the manufacturing, processing, packing, or distribution. This program shall cover the basics of cGMP and be conducted as classroom training.
• cGMP Training for Existing Employees (Refresher program)

1. This training shall be conducted once in 6 months covering cGMP requirements. cGMP Programme for a calendar year shall be prepared by the Training in-charge/Quality Assurance (Refer to Attachment-II).
2. For a refresher, cGMP Training programs employees shall be divided into 2 groups.

       Group-I comprises of Workmen & other operating staff

       Group-II comprises of Supervisor, Chemists, Officers, Executives 

       and above.

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External Training

• The external training programs shall include the training conducted by external institutions or training conducted by external faculty in the organization.

Evaluation and certification of training

• Training shall be imparted through the QA-approved training modules/materials.
• The effectiveness of the training program shall be evaluated to ensure that it fulfills the intended requirements.
• On completion of the Internal Training program, the Trainer shall evaluate through an oral test, written test or a discussion or using workout sessions. Where necessary like SOP training, an objective type questionnaire shall be prepared to determine the understanding as detailed in the Assessment record (Refer to Attachment-III).
• Wherever evaluation is done through questionnaires, the Trainee shall be certified, if he has scored a minimum qualification mark, which shall be 70% of the total marks allotted to the questionnaires.
• If the trainee fails to obtain the minimum qualification marks or incorrectly answers the compulsory questions, retraining (remedial) shall be conducted and the same shall be recorded in the Assessment Record (Refer to Attachment-III).
• After every training session, participants will be required to fill out the Trainer’s Evaluation Form (Refer to Attachment VI) to evaluate the trainer.

Documentation

• All records pertaining to the training of employees shall be maintained by the concerned Training in charge.
• Employee Training Card: The employee training card shall be issued to each employee at the time of joining, by the training in charge.
• All the training as mentioned above, attended by the employee shall be entered in the Employee Training Card (Refer to attachment-IV).
• For all internal training programs (On Job Training, SOP Training, cGMP Training, Specific Training, and Retraining), the trainees shall enter their attendance in the Training Log. (Refer to Attachment-V).
• The trainer shall enter the comments and summary on the training conducted.

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Personal Training File:

• At the time of joining, a training file shall be opened for each employee by the HOD of the specific department.
• Induction reports, training cards, evaluated reports/questionnaires, post-training reports (for external training), certificates, and any other training-related document of an employee shall be filed in the Personal Training File.
• All the training files shall be maintained by the Quality Assurance department.
• All the training documents shall be retained for a period of one year after the date of resignation or retirement. After one year the documents shall be destroyed.

ABBREVIATIONS

SOP - Standard Operating Procedure

Q.A - Quality Assurance

Q.C - Quality control

No. - Number

e.g. - Example

HOD - Head of the department

HRD - Human Resources and Development

cGMP - Current Good Manufacturing Practices

OOS - Out of Specification

ATTACHMENT

Attachment-I - Format of Induction Training Schedule

Attachment-II - Training Schedule

Attachment-III - Format of Assessment Record

Attachment-IV - Format of Training Attendance Sheet

Attachment-V - Format of Employee Training Card

Attachment-VI - Trainer’s Evaluation Form

REVISION HISTORY

Nil

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