SOP for Establishment of Training for New and Existing Employee

 

 1.0           Purpose

1.1            To describe the training system of introducing a newly appointed employee & the existing employee of the Organization according to their nature & environment of the job.

2.0           Scope

2.1         This SOP is applicable to all newly appointed & existing employee of “NAME” Pharmaceuticals Ltd.

3.0           Responsibility

3.1            Head of Human Resources (Plant) is responsible for arranging an ‘Orientation Program’ for new employee and follow-up of this program.

3.2            Head of Quality Assurance or his nominee is responsible for briefing on different aspects of GMP to the employee.

3.3            Respective Departmental In-Charge / Head or Manager is responsible for briefing the new employee about his/her job responsibility and to interaction with other departments. He/ she also responsible to select the general SOPs for orientation program.

3.4            Departmental In-Charges /Head are responsible to assess the training needs and send the requirement phase wise to QAD to prepare yearly Training Calendar. He /she is also responsible to provide training as per yearly Training Calendar and on any new & revised SOP.

3.5            Head of Quality Assurance or his /her nominee is responsible to prepare & circulate the yearly Training Calendar and its follow-up.

3.6            Other departmental In-Charges are responsible for briefing the new employee about the key functions of his/her department and interaction of them with respective department.

3.7            All trainees are responsible to attend the training on time and fill-up the training record.

4.0           Abbreviations and Definitions

4.1            SOP     :           Standard Operating Procedure

4.2            QA       :           Quality Assurance

4.3            QAD     :           Quality Assurance Department

4.4            HR&A   :           Human Resource and Administration

4.5            QCD     :           Quality Control Department

4.6            No.       :           Number

4.7            c-GMP  :           Current Good Manufacturing Practice

4.8            HOD     :           Head of Department

4.9            Sign     :           Signature

5.0           Materials and Equipment

5.1            Not Appreciable

6.0           Precaution / Health and Safety Considerations

6.1            Not Appreciable

7.0           Procedure

7.1            It is necessary that all employee at the plant have an appropriate combination of education, training and

experience to enable them to perform their assigned functions. Therefore a training program covering the following

aspects shall be designed for all the employees.

7.2            cGMP training shall be given as per the nature of job to all employees.

7.3            In house qualified individuals and external faculty shall conduct training. The trainer will make the training

Material (such as powder point presentation).

7.4            The HOD shall prepare ‘Identified Training needs and schedule’ for individual employee.

7.5            Training coordinator shall maintain employee training record and the training given in the course of

employment.

7.6            For every training coordinator shall maintain attendance record duly signed by trainees.

7.7            Each training shall be concluded by written or verbal evaluation.

7.8            Training of New Employee:

7.8.1        Arrange an ‘Orientation Program’ for the newly appointed employee in consultation with QAD & the

respective departmental In-Charge of the employee for minimum 7 days.

7.8.2        Brief the employee on the organizational history, policy management, administration, and site rules, during

orientation.

7.8.3        Provide guidelines on the following topics according to orientation program :

-         Basic GMP

-         Hygiene and Health requirements

-         Safety guidelines

-         Job responsibility & some general SOPs (e.g. Dress change procedure, Change control, SOP for SOP etc.)

7.8.4        The employee reports to each department for few hours and brief him/ her about the key functions of that

department and interactions of this department with respective department.

7.8.5        Brief the employee about his/ her job description and interaction with other departments.

7.8.6        Assess the primary needs and provide training through orientation program & fill up the training record.

7.8.7        Assess the further needs for training and inform the requirement for yearly training program.

7.9            Training Program of Existing Employee

7.9.1        Assess the training needs for existing employees & inform it to the QAD or training section before

publishing the Yearly Training Calendar (YTC) / Training Schedule.

7.9.2        Prepare a training calendar after receiving the training needs from the respective department.

7.9.3        Circulate the Yearly Training Calendar into two phases (half yearly). Which includes the followings but not

limited to

-         General GMP / GLP training.

-         Hygiene & safety training.

-         Departmental SOP training etc.

7.9.4        Arrange the training program according to the schedule.

7.9.5        After completing the phase wise training program according to the YTC each department submits their

training report within 7 (seven) days after each phase including their next phase requirements.

7.9.6        Prepare next phase training schedule considering the departmental training needs & circulate after

reviewing the training report.

7.9.7        Arrange any training by any department (if necessary) beyond the training schedule with prior information

to training section (QAD).

7.9.8        Record the training according to the SOP.

7.10         Evaluation

7.10.1      The effectiveness of training shall be evaluated by written test or by verbal evaluation. Trainee shall write

the answers in the stipulated time period or can answer verbally.

7.10.2      Trainer shall evaluate the trainee based on the marks scored by him/her. The details of evaluation shall be

recorded in ‘Training Evaluation Sheet’. 

7.10.3    Criteria for evaluation                       Grades

            96-100 %                                  Excellent

            91-95.99 %                               Very good

            86-90.99 %                               Good

            80-85.99 %                               Satisfactory

            <80%                                         Poor and Retraining required 

7.10.4       Unsuccessful employees (< 80%) shall be retrained immediately.

7.11         On The Job Training  

7.11.1    After completion of induction and orientation program new employee shall be sent to respective departments for under going on job training.

7.11.2    Initially the senior technical personnel would explain the procedure, step involved, precautions to be taken and would perform the activity with new recruit observing.

7.11.3     After minimum three of such sessions or as and when trainer is confident of new recruits      performance, the new recruit would perform the activity under the observation of senior technical personnel.

7.11.4    Only successful employee shall be allowed to perform his assigned duties and responsibilities

7.11.5    In-house training or training form outside faculties including seminars shall be organized as per the training plan/card. For any training outside the scope of training card shall be given by external faculty or consultancy by training institution and shall be recorded.

 

8.0           Reference Document

8.1            WHO GMP Guideline ;TRS-986, Annex 2;

 

9.0           Annexure

9.1             Annexure-I        : Training Attendance Record

9.2             Annexure-II       : Training Evaluation Sheet

9.3             Annexure-III      : Logbook for Training Record

9.4             Annexure-IV     : Format of “Training Need Assessment”

 

 

10.0        Revision History

 

Revision No.	Brief reason for the revision	Effective Date	Remarks
01	New

 

11.0        Training

11.1       Head of Quality Assurance or his nominee is responsible to conduct a training session on this SOP.