TRAINING PROCEDURE FOR PLANT PERSONNEL IN PHARMA
OBJECTIVE: To lay down a standard operating procedure for organizing and conducting Training and need gap analysis to all the employees at all levels.
SCOPE: This SOP is applicable for organizing and conducting Training Calendar, Programmes, Schedules, Tests to do need gap analysis of all the employees at all levels.
RESPONSIBILITY:
Officer or designee of respective department shall be responsible for conducting their respective department training.
Head of the Department (HOD) or designee shall be responsible for compliance of this SOP.
QA Officer / Training Coordinator or designee shall be responsible for conducting training as per schedule, management of training documents.
ACCOUNTABILITY: Head QA shall be accountable for the compliances of this SOP.
PROCEDURE:
Training program, based on its nature are categorized as below:
Induction Training
Guideline based /Special Training such as cGMP/ GLP/ GDP etc.
On-the job training (SOP based)
Safety Training
Specific training
External Training
Induction Training:
This training is imparted to all employees who are newly joined in the organization and is conducted immediately after the employee’s reporting to duty.
This training is imparted by HR team to inform new employee about company policies, rules and regulations, does and don’t in company premises, culture of company and basic introduction of hierarchy system.
During induction training, the new freshers are made aware of basic cGMP training, safety training, on-the job training, and policy of personal hygiene and general maintenance of cleanliness in factory premises.
Induction training record is maintained as per Annexure-II.
Guideline based /Special Training:
Quality Assurance department is responsible for organizing and conducting guideline based /special training such as cGMP/GLP/GDP training.
cGMP/GLP training is based on cGMP orientation, EU Guidelines, PIC/S, MHRA guidelines, WHO guidelines etc.
Guideline based /special training shall be conducted at least one topic in a month, so at least 12 topics shall be covered in this training throughout the year.
Relevant guidelines are selected as per the job related requirements of the personnel and each of them is divided into subgroups. Each group is given one topic of guidelines to read and present to others followed by Group discussion to understand the topic well. Presenter are given freedom to present verbally or using presentations.
On the job training:
Head of the department is responsible for organizing the on-the-job training to each individual.
On-the-job training is based on the various SOPs and other work instructions related to the job.
The frequency of On-the-job training is at-least once per year and later as per frequency of new joinees.
It is decided by the head of department. It is not mandatory to provide one to one training of each new joineee immediately (unless it is a fresher) and can be considered in a group of people within three months of first new joinee.
In case of revision in SOPs, all related persons shall be trained and training is recorded in Training Attendance Sheet as per Annexure-V.
On-the-job training is effectively carried out with the help of lectures based on literature / SOPs, presentations and by the practical demonstration of the real operation as applicable.
Safety training:
To provide safety precautions include safety related to work area and general for facility.
It usually includes operation of fire extinguishers training, first aid etc.
Safety training shall be given quarterly.
Safety training shall be conducted either by Safety officer/Engineering/Quality Assurance In charge or appropriate trainer (Internal or External) to all the concerned employees in the plant on safety topics.
Training is recorded in Training Attendance Sheet as per Annexure-V.
Specific Training:
Specific training in case of Market complaints / OOS / Change Control / Deviation / Self inspection etc. shall be given to all the concerned persons who are likely to be involved in that related activity.
This training will be organized by Department Head / Quality Assurance department.
Only attendance related to such special trainings will be recorded as a proof of training as per Annexure-V.
External Training:
Management will organize the external training by technical agencies from time to time.
The periodicity of such trainings is not fixed and it depends on availability of trainers and suitability of time slot.
Training is recorded in Training Attendance Sheet as per Annexure-V.
Concerned staff of each department will attend for these training.
The above seminars will be focused mainly on the technology development, sophistication of instrumentation, other advanced process/validation aspects and other current GMP, training of auditors of self inspection and regulatory topics.
These training can be done by outside the company campus by permitted certain selected persons to attend such trainings as organized by Govt. / educational agencies. Certificate of participation of such trainings is retained in employee file.
The mode of training can be either oral or visual such as videos, slides, pictorial diagrams when within campus.
SOP Based Training:
‘Annual Training Planner’ as per Annexure-VIII shall be prepared by each department and shall cover all important SOP of each department.
Department HOD will tell about important SOP.
SOP based training shall be divided into January to December months.
It is based on Tutor and trainee principal.
All of the team members of a particular department are identified as speaker for certain SOPs and work is distributed such that for a training one speakers cover one SOP topic at the time of scheduled training and other team members (other than speaker for that day) are trainees, while in next training session the tutor of first session turn trainee and some other team member is a tutor for another SOP.
If any training cannot conduct on scheduled date then same shall be given on next working day.
Presence of HOD/Senior Staff is must in such trainings to ensure clarity of subject.
Every department Head is responsible to coordinate these SOP trainings.
At the end of each training, every trainee must ask question to trainer as a compulsory feature and trainer may also ask the cross questions to trainees to ensure thorough understanding.
Records:
All training records shall be maintained by the concerned department training coordinator and verified by Quality Assurance Department.
Training Records of employees should be retained until resigned.
If any person resigned then training record of person destroyed along with his personal file.
Requirements of Trainer:
Management with QA Head to choose expert faculty from various departments for imparting guideline training on specific topics and prepare a “List of trainers” as per Annexure for “List of Trainers for Guideline Based / Special Trainings” as per Annexure-IX.
Trainer /Subject matter expert shall be having sound technical & practical knowledge on the subject in which he is going to give training.
Apart from the subject knowledge a trainer shall also have good interpersonal communication skills.
Trainer will be trained from time to time by department head/management or external trainer on the requirement.
Note: Following formats shall be prepared in Soft Copy and printout will be signed:-
Annexure-I: Master Training Calendar
Annexure-IV: Job Responsibility of the Employee
Annexure-VI: Training Questionnaire
Annexure-VII: Training Answer Sheet
Annexure-VIII: Annual Training Planner
Annexure-IX: List of Trainers for Guideline-Based / Special Training
Training for Transferred Employee:
Inter Department Transfer:
Employee’s previous training file shall be used to understand the background of individual by concern department head along with training coordinator / designee to identify the training needs.
Training coordinator / designee shall coordinate the training as per procedure under (On the job Training procedure).
Employee’s previous training file shall be retained along with the new training record.
Inter Location Transfer:
In case a person transferred from another location, site training coordinator shall insure that copy of the training file of the transferred employee shall be provided to the site training coordinator of the transferred location.
Site training coordinator shall coordinate further training as per procedure defined for new employees.
The employee’s previous training file shall be retained along with the new training file.
Training for Assistant Manager and Above :
Induction training shall be applicable for new assistant manager and above, as described in this procedure.
Job specific training at department shall be at least “Read Only” training, however if an Assistant manager or Above personnel are intended to perform any activity directly, then he/she shall go through the given procedure “Training for new employees”.
In the case of “Read Only”, a training evaluation shall be required verbally by his/her senior / reporting personnel.
Above training details shall be recorded appropriately as per Annexure-II (On the job training record)
After successful completion of the training, he/she shall be eligible to perform the assigned responsibility as per job roll.
ENCLOSURE:
Master Training Calendar
Induction Training Program
Individual Training Record
Job Responsibility of the Employee
Training Attendance Sheet
Training Questionnaire
Training Answer Sheet
Annual Training Planner
List of Trainers for Guideline Based / Special Trainings
Record of Transferred Employee
