Training Procedure, Purpose:
Training Procedure, To lay down guidelines for training of new entrants and periodic retraining of technical staff.
Training Procedure, Scope:
[][]This procedure is applicable for all employees of General block and Sterile block at XX Pharmaceuticals Ltd. for
[][]On the job training (OJT)
[][]Class room training (CT)
[][]External training
[][]Basic GMP training
Definitions / Abbreviation:
[][]SOP: Standard Operating Procedure.
Responsibilities:
[][]The roles and responsibility is as follows:
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.
Procedure:
[][]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.
New Entrants:
New entrants to the organization shall be given induction training and brief cGMP/GLP training by Head of Quality assurance or Quality Assurance within 10 days of joining.
[][]New entrants should be given technical training (need based) by the departmental manager depending upon the nature of job for one month.
[][]New entrant should be instructed to observe the activity in the recruited department for one month after the initial induction program.
[][]A written feedback is collected from new entrants after the training to ascertain his/her competence in both technical and cGMP skills.
[][]Quality Assurance shall prepare a regular annual schedule for training/retraining of technical staff.
[][]The Qualified trainer who has conducted the training should review and assess the feedback.
[][]Based on the assessment, trainer shall identify training retraining needs.
[][]Individual Training record should be maintained for each new entrant along with their feedback.
[][]Once the induction is over the new employees hand over induction training format duly filled with all required signatures to HR & Admin. Department.
Classroom training:
[][]Prepare the training schedule and circulate to all Department Heads for information.
[][]Upon finalization of training schedule, intimate to participants.
[][]Prepare required training aids and conduct the training program.
[][]On completion of the training, evaluate the training imparted by giving a questionnaire. Trainer is required to set the questionnaire.
[][]Trainer evaluates the answer & ranks them as Excellent (>90%), Very good (>80-90%), Good (>60-80%), Poor (<50%).
[][]Poor performers are retrained and re-examined.
[][]After training, trainer provides “Individual Training Record” to the trainee for getting feedback.
[][]All trainees fill the same immediately after the program gets over & submit it to the trainer.
[][]Trainer notes the contents, signs each reports & forward the same to HR & Admin. Department who keep all training related records.
[][]Maintain the training record in training file and update the Employee training card.
On-the-job training:
[][]On need base a competent person organizes on job training to concerned persons either individually or in small group preferably of 5 to 7.
[][]Trainer first explains the theoretical aspects making use of writing boards/printed literature diagram etc.
[][]Explain or demonstrate the actual operation or system to participant.
[][]Training record is maintained in the form as explained above.
External training:
[][]Upon information from various agencies nominate the person on consultation with department head.
[][]Make the necessary arrangement like tickets, hotel arrangement etc. to attend the external training.
[][]After training, trainee will submit the report in the prescribed format as per Annexure- V, to HR & Admin. Department through Department Head. Brief [][]information about the program need to be enclosed with the report.
[][]Maintain the training record in training file and update the Employee training card of concerned employees who have undergone external training as per SOP.
[][]Trainee shares the literature & knowledge gained in the program with all this colleagues.
[][]Department Head may ask the concerned employee to make a presentation on the topic concerned for the benefit of all those concerned who were not sent for training.
Training on basic GMP practice:
[][]Department Head training the new comer on following points:
Production :
[][]Importance of good manufacturing practices and requirements.
[][]Systems related to manufacturing.
[][]System related to packaging (printed and unprinted component code etc).
[][]Documentation.
Warehouse:
[][]General warehousing procedure.
[][]Function carried out by Warehouse.
[][]Document related to warehouse.
Engineering:
[][]Facilities and services
[][]Brief working of the services
[][]Documentation
Quality Assurance:
[][]General information on SOP, GMP Documentation.
[][]Activities of Quality Assurance, Product Development, Microbiology & Quality Control.
[][]Product information.
[][]Other specific activity related to the employees department.
Training schedule:
[][]New entrant: General factory rules and cGMP –10days
[][]Regular training for staff and operators
[][]cGMP – Once in 6 months
[][]GLP – Once in 6 months
[][]Technical training – Once in 3 months
[][]A training session by an External Agency shall be conducted as and need/opportunity arises.
[][]Apart from the schedule, training/retraining sessions will be conducted as and when need arises.
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.