STANDARD OPERATING PROCEDURE of PROCEDURE FOR TRAINING
1. Purpose:
To lay down guidelines for training of new entrants and periodic retraining of technical staff.
2. Scope:
This procedure is applicable for all employees of --------- for
• On the job training (OJT)
• Class room training (CT)
• External training
• Basic GMP training
SOP for Pharmaceuticals Water Handling System
3. Definitions / Abbreviation:
• SOP: Standard Operating Procedure.
• On the job training: Employee training at the place of work while he or she is doing the actual job. It is a one-on-one training or in small group preferably of 5 to 7 located at the job site, where someone who knows how to do a task shows another how to perform it. On-the-job training takes place in a normal working situation, using the actual tools, equipment, documents or materials that trainees will use when fully trained.
• Class room Training: Classroom training is the most familiar training delivery mechanism. It should be used when there are a number of learners all requiring the same training at the same time, when the learners can profit from getting together with peers and sharing experiences, and when the course developer wants learners to have the opportunity to hear and experience other points of view. There is wide variety of classroom training techniques e.g. Lectures, Discussions, Quizzes, Case Studies etc.
• External Training: In this process, an external trainer from a training company or a freelance trainer is invited to conduct a 1 or 2 day workshop for the employees. This is external training. All Trainings employees are nominated to attend outside the organization and they are segregated into 2 groups’ Local training & overseas training.
• Local Training: All trainings attended by employees outside the organization but in a local training provider i.e. in the employee’s country
Overseas Training: When the employees is sponsored to travel outside his country to attend a training program
• Basic GMP training: GMP training is part of quality assurance (QA) and all employees need to be aware of the regulations. Basic training consists of two or three hour’s explanation of the purpose and consequences of GMP applications. At the end of the session, a questionnaire will be completed by employees to demonstrate their understanding of GMP.
Basic HPLC for Pharmaceutical Quality Control Department
4. Responsibilities:
The roles and responsibility is as follows:
Roles Responsibility
Executive, HR & Admin.
• To ensure that this procedure is followed.
• To maintain the records properly as per SOP.
• To check the records of training filled by trainee.
• To maintain employ training record.
• To prepare list of training given to the employees.
• To file all records of training in their individual training file.
• Training is given in all departments as per the induction form.
Manager, Human Resources
• To preserve all training record
• To co-ordinate in all training program
General Manager, Plant • To ensure that this procedure is kept up to date.
• To ensure implementation of the training as per SOP.
• To assess the training requirement.
Manager, Quality Assurance
• Approval of the SOP.
5. Revision Details:
Sl. No. Version no. Effective date Change History
6. Annexure:
• Annexure-I: Individual Training Record.
• Annexure-II: Training Log.
• Annexure-II: Induction Training Format.
• Annexure-IV: Employee Training Card.
• Annexure-V: Training Program Report.
Purified Water Test Procedure in Pharmaceuticals
7. Procedure:
7.1 The manufacturer should provide training for all the personnel whose duties take them into production
Areas or into the control laboratories (including the technical, maintenance and cleaning personnel) and for other personnel whose activities could affect the quality of the product.
7.2 New Entrants:
7.2.1 New entrants to the organization shall be given induction training and brief cGMP / GLP training by Manager, Quality assurance or Quality Compliance within 10 days of joining.
7.2.2 New entrants should be given technical training (need based) by the departmental manager depending upon the nature of job for one month.
7.2.3 New entrant should be instructed to observe the activity in the recruited department for one month after the initial induction program.
7.2.4 A written feedback is collected from new entrants after the training to ascertain his/her competence in both technical and cGMP skills.
7.2.5 Manager, Quality Assurance shall prepare a regular annual schedule for training/retraining of technical staff.
7.2.6 The Qualified trainer who has conducted the training should review and assess the feedback.
7.2.7 Based on the assessment, trainer shall identify training retraining needs.
7.2.8 Individual Training record should be maintained for each new entrant along with their feedback.
7.2.9 Once the induction is over the new employees hand over induction training format duly filled with all required signatures to HR & Admin. Department.
7.3 Classroom training:
7.3.1 Prepare the training schedule and circulate to all Department Heads for information.
7.3.2 Upon finalization of training schedule, intimate to participants.
7.3.3 Prepare required training aids and conduct the training program.
7.3.4 On completion of the training, evaluate the training imparted by giving a questionnaire. Trainer is required to set the questionnaire.
7.3.5 Trainer evaluates the answer & ranks them as Excellent (>90%), Very good (>80-90%), Good (>60-80%), Poor (
