SOP Title: Training
- Objective:
To lay down procedure to ensures that personnel engaged in the manufacturing, processing, packaging, Quality Control and storage of drug products have the proper education and/or training to perform their responsible function. In addition, the theory and practice of GMP must be addressed.
- Scope:
It covers all employees involved in the effective implementation and maintenance of quality system.
- Responsibility:
Plant Head : Identifying and approving training needs of HODs.
HODs : Identifying training needs of personnel reporting to him and down below. On Job training of personnel in his department.
Concerned Department: To identify, initiate, evaluation and document the training.
- Accountability:
Head – Quality Assurance
- Procedure:
- Definition:
Training: Training is defined as a process of teaching or learning a skill through interaction.
On-the-Job Training: is a form of training taking place in a normal working situation in their respective areas of operation according to the training need identification of individual departments.
Training Need Identification: is the procedure before going to operation of any job in individual department trainee/trainer shall identify the procedure/SOP in which he/she needs training.
- Procedure:
| 5.2.1 | Requirements: | ||
| 5.2.1.1 | It is necessary that all the employees at the Plant shall have an appropriate combination of
Education, Training and Experience to enable them to perform their assigned functions. |
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| 5.2.1.2 | Therefore a training programme covering the following aspects shall be designed for all the employees. | ||
| 5.2.1.3 | Training shall cover the specific operation that the employee performs and the relevant aspects of GMP & hygiene. | ||
| 5.2.1.4 | In house qualified individuals and external faculty shall conduct training. | ||
| 5.2.1.5 | Individual employee shall maintain training record given in the course of employment. | ||
| Training of New Recruits: | |||
| 5.2.2 | Induction Programme: | ||
| 5.2.2.1 | Every new employee shall be given Induction Training with a view to facilitate entry into the organization and to acquaint with the systems and procedures as applicable. During the induction training, all new employees shall be formally inducted to the company. | ||
| 5.2.2.2 | Training need of new recruit shall be determined and the trainer shall be responsible for training the employees at this stage. | ||
| 5.2.2.3 | During induction training, the employees shall receive general information in the following department as appropriate. Administration Department, Quality Assurance, Quality Control, Production, Warehouse, Engineering and Purchase and Accounts. | ||
| 5.2.2.4 | The Induction Training shall be carried out in accordance with the format specified in SOP. | ||
| 5.2.3 | SOP/On-the-Job Training: | ||
| 5.2.3.1 | SOP/On-the-job training shall be given to the employees in their respective areas of operation according to the training need identification of individual departments as per “Training Need Identification” format. | ||
| 5.2.3.2 | During on-the-job training period, employees shall be trained for usage of equipment, unit operations, safety norms to be followed, Quality Assurance Procedures and Standard Operating Procedures, Validation and Calibration procedures, Preventive Maintenance as applicable. Adequate time shall be allotted to complete SOP training and on the job training. | ||
| 5.2.3.3 | Training Log shall be maintained for each training as per “Training Log Sheet”. | ||
| 5.2.4 | Evaluation: | ||
| 5.2.4.1 | Evaluation shall be done by preparing a questionnaire based on the topics covered during the training. The Evaluation sheet shall be filled by the trainee by writing answers of the questions asked. | ||
| The details of evaluation shall be recorded in ‘Training Evaluation Sheet’.
1. Trainee shall have to secure minimum 80% marks to qualify. 2. Maximum marks will be 100%. 3. If any employee obtain less than 80% marks, he/she shall be considered as disqualified for that topic and retraining shall be given. 4. Evaluation questionnaire shall be generally objective type e.g. multiple choice questions, true and false or fill in the blanks etc. 5. If by- mistake wrong answer selected can be cross cut with single line with sign and date and select or write correct answer. |
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| 5.2.4.2 | After completion of induction training and SOP training, new employee shall be directed to Concerned Department for assessment and certification as per “Training Certificate” form. | ||
| 5.2.4.3 | Calculation for % marks obtained:
No. of correct Answers Percentage (%) Of Mark Secured = ————————————- x 100 No. of Questions
= ________________ x 100
= _________ % |
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| Training in the Course Of Employment: | |||
| 5.2.5 | Training by in House and External Faculty:
In-house training or training from outside faculties including symposia and seminars shall be organised as per need. |
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| 5.2.5.1 | An “Annual Training Plan” shall be drawn as per SOP and it shall be imparted on a periodical basis throughout the year covering GMP aspects. | ||
| 5.2.6 | In Addition to the Training Imparted Based on the Annual Plan, Training shall be given in the Following Events: | ||
| 5.2.6.1 | Introduction of new standard operating procedure. | ||
| 5.2.6.2 | Change in SOP content, observation of audit, laboratory testing error, manufacturing error, document error and packing error etc. | ||
| 5.2.6.3 | The trainer shall intimate the concerned persons for attending the training programme. | ||
| 5.2.6.4 | The SOP which has been revised to do some minor changes and will not have impact on procedure content or meaning like grammatical correction, typo error, footer change or formatting in that case no need to fill evaluation sheet. Information shall be given to concern regarding changes. | ||
| 5.2.6.5 | The details of training shall be updated in the individual “Training Need Identification”. The Training Evaluation Sheet shall be maintained in individual training file. Evaluation sheet is not required for the trainer for that particular topic. | ||
| 5.2.6.6 | As and when required, the personnel shall be sent for attending training programme conducted by external training institutions, manufacturers for machinery and equipment etc. | ||
| 5.2.6.7 | Separate training record shall be maintained as “Outside Training Record” for external training. | ||
| 5.2.7 | Re-training of employees : | ||
| 5.2.7.1 | If an employee has been absent from the company or is returning to a specific task after a period of greater than six months, the need for re-training must be evaluated in association with the employee. This evaluation shall be documented and the decision recorded as per “Retraining Assessment” format. Where applicable questionnaire relevant to the employees job description may be used as part of the evaluation process. |
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| 5.2.8 | Training for contract employee: | ||
| 5.2.8.1 | Training shall be conducted for workmen, housekeeping personnel and contract workmen of Specific working areas. | ||
| 5.2.8.2 | Wherever required SOP shall be converted to vernacular language or training shall be imparted in vernacular language for better understanding of procedures to contract workers. | ||
| 5.2.8.3 | Evaluation sheets are not required for contract workers. | ||
| 5.2.8.4 | Contract workers shall work under supervision of trained staff. | ||
| 5.2.8.5 | Training Attendance Log shall be filled for contract workers. | ||
| 5.2.9 | Trainer Certification: | ||
| 5.2.9.1 | Trainer shall be assessed for skills like subject matter expert, subject understanding, presentation skill, training skills, communication skills, interaction skill, voice clarity etc. | ||
| 5.2.9.2 | Training topic shall be prepared and a trial presentation shall be held in front of Department Head and QA Head for training skill assessment. | ||
| 5.2.9.3 | If training skills found appropriate the trainer shall be certified as per “Trainer Certificate” form. | ||
| 5.2.9.4 | If training skills found not appropriate then give suggestion for training skills improvement and call back for re-trial. | ||
| 5.2.9.5 | After successful completion of training assessment training shall be conducted. | ||
- Abbreviation:
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| GMP | current Good Manufacturing Practice |
| HOD | Head of the Department |
| e.g. | Exempli gratia |
| etc | etcetera |
*Note – Ready to use SOP available in “DOWNLOAD” Section.