ABOUT TRAINING:
Personnel training in the pharmaceutical industry is very important to ensure safety, quality, and compliance. Employees must understand how to follow good manufacturing practices (GMP) and handle drugs properly. Training helps workers learn about hygiene, equipment use, documentation, and safety rules. It also keeps them updated with new regulations and technologies. Regular training reduces errors and helps maintain high standards in production and testing. New staff must be trained before starting work, and experienced workers need refresher courses. Overall, proper training improves performance, reduces risks, and ensures that medicines are made correctly and safely for patients.
TYPES OF TRAINING:
The types of training are divided into two Major Categories as Internal Training and External Training.
INTERNAL TRAINING:
Internal Training is the Training which shall be conducted within the Organisation by the In house Qualified Trainer who have been certified and trained to impart effective training. It is also divided in to six main categories as mentioned below:
- Induction Training
- cGMP / Technical Training
- Job Specific Training (Training of New Joinee before Execution of Work)
- On Job Training
- Refresher Training
- Re-Training/Need Based Training
Induction Training:
Training, which is covering the overview of Organisation, Parent Department and Cross Functional Departments, shall be defined as Induction Training.
The Induction Training shall be imparted to every new employee, who joins the Organisation and shall be co-ordinated by Head HR or his / her designee.
The induction should be completed in minimum one working day, starting from the date of joining.
HR Department shall prepare an induction training schedule for every new joinee and communicate induction schedule to all department through verbal or telephonic/mail as per Annexure–II.
Initial Induction Training is carried out by Head HR or his / her designee. Induction training manual shall be used by HR Personnel for the training purpose which cover topics like:
Introduction about {Company Name}
- Organisational Structure.
- Entry & Exit into the factory premises
- Key Personnel and different Department Structure and details.
- Different Product Range.
- HR Policy’s w.r.t Shift Timing,
- Leave Policy and other Employee Benefit Policies.
- HR Department facilities w.r.t. Canteen, Transportation, Medical etc.
- Security system and safety measures.
The new entrant shall visit to respective department as per schedule and training (about departmental structure, departmental functions and cross functional areas) shall be given by department Head/ designee.
Job Specific Training (Training of New Joinee Before Execution of Work)
Job responsibilities shall be assigned to new entrant as per the respective SOP.
Concerned department Head/designee shall plan training of new Joinee on the basis of job Responsibility and training need identification as per Annexure-VII of SOP Training of Personnel.
- As per work requirement and competency, competency matrix shall be prepared by concerned department Head/designee and approved by QA Head as per Annexure-VIII of SOP Training of Personnel.
- Trainee shall record the details of training in their respective training log card as per the Annexure-III of SOP Training of Personnel..
- All new entrants joining organisation at designation of Assistant Head and above shall undergo the self training and no evaluation is required.
- After the completion of the training program, New Entrants shall be evaluated by the respective department Head (in case of new entrant is respective department Head shall evaluated by QA Head) and certificate of completion of training shall be issued as per the Annexure-X of SOP Training of Personnel..
- In case of all plant personnel, Certificate of training to new Entrants shall be certified by Head QA as per Annexure-X of SOP Training of Personnel. after successful completion of the training program.
- In case of Head QA, Certificate of training to new Entrant shall be certified by Managing Director as per Annexure-X of SOP Training of Personnel after successful completion of the training program.
- cGMP / Technical Training:
- cGMP Training covers the various aspects covered as per different Regulatory Guidelines of cGMP. The purpose of cGMP is to ensure that laid down system is adhered by personnel in the Organization.
- Technical Training is the Training which is designed to develop specific and cross specific skill and enhance the Technical Knowledge.
The Quality Assurance Department with concerned of different Department Head shall prepare a Annual Training Planner as per Annexure-IX of SOP Training of Personnel and Technical Training at the start of every Calendar Year.
The Internal cGMP / Technical Training shall be conducted at least once in Year and as when identified by certified Trainer. Technical training like: cGMP, GDP, GLP, Cross-Contamination, Sanitization & Personnel Hygiene, basic EHS awareness etc.
cGMP training shall be mandatory for the new joinee prior to put into the area of operation.
The cGMP Training shall be conducted by Trainer as Class Room training by the means of Power Point Slide Presentation or Module.
The scope of cGMP / Technical Training includes aspects like as follows but not limited to the followings only:
- Basic cGMP aspects of Different Regulatory Agency.
- Any revision / updation to Regulatory Guidelines etc.
- Topics cover safety aspects of the persons engaged in Manufacturing Operation.
- Other as identified during the routine Operation.
- The Training material used by the Trainer shall be distributed after the training to the employees attended the Training Programme if required.
In addition, the websites of the Regulatory Agencies (such as MHRA, EU GMP, USFDA, ANVISA etc) shall be referred by QA to gather the information for changes in the GMP regulations, audit procedures, submission requirement, variation application requirements, risk assessment etc. This tracking shall be done and circulated once to all concern departments and to operations for quality system enhancements.
On the Job Training:
The functional Heads/ Designee (Ttraining Co-ordinator) shall prepare an Annual Training Planner (covering departmental SOPs, Cross functional department SOPs cGMP/Technical Training) on annual basis as per Annexure-IX of SOP Training of Personnel and these planner shall be approved by Head QA.
One copy of Annual Training Planner shall be distributed to concern department for execution. Master copy of same document shall be retain in quality assurance department.
If a particular training has not been conducted as per the training Planner or schedule, department Head/designee shall inform to QA department for the same and shall arrange to conduct the training within one working week.
Attendance of each training session shall be recorded in training attendance record as per Annexure-V SOP Training of Personnel respectively and shall be maintained by concerned department.
All plant personnel shall attend the training according to SOP as per Annual Training Planner and same shall be record in Log Card as per Annexure-III of SOP Training of Personnel.
All plant personnel shall attend the minimum training required as per competency matrix and as required for their Job Responsibility.
All Department Head/functional Head ensure that each personnel should attend training of all job related SOPs at least once in a year.
Training of the required SOP and other related areas to the Operator / Worker shall be given by the concerned area in charge (Trainer). The Training of SOP for the worker shall be on the local regional language so that it can be easily understand by them.
If any Employee is transferred from one area of operation to other area of operation within the department then the related SOP Training shall be given to the concerned employee.
Refresher Training:
All employees shall undergo Refresher Training on the procedures of their respective functions and related processes or cross functional department. Wherever applicable.
Refresher Training shall be carried out once in a year and whenever there is a Procedural Change or Revision before Implementation.
Re-Training / Need Based Training:
Re-Training can be given on any Technical Topic and cGMP as and when required or identified by the Concerned Head.
If during any type of Training, the evaluation marks are less than 80% than the employee shall be retrained.
Need based training shall be conducted in reference to the additional requirement of incident/deviation/OOS/ Market Complaint, OOT, Self Audit, External Audits, Performance reviews and behavioural issue etc.
This is required for the specific persons, so the reoccurrence of incident, Deviation, OOS, Market complaint, OOT and behavioural issue occurring due to the personnel error can be prevented.
The details of the training shall be recorded in training Attendance Record as per Annexure-V of SOP Training of Personnel and also record in Log card as per Annexure-III of SOP Training of Personnel.
For Complete procedure of training click the below link:
TRAINING OF PERSONNEL
External Training:
The external cGMP / Technical training shall be conducted at least once in a year or as and when required.
The external training programme shall be identified by the concerned Department Head and information shall be sent to Head QA and HR.
Selection of outside training programme and identification of the employees for training shall be done by Concerned Department Head and Head QA.
After attending the External Training Programme at Outside, Trained Employee shall conduct the Training Programme on the same topic on which he / she is being Trained.
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.
The selection of External Trainer for In house Training shall be done by the concerned Department Head and Head QA. The selection of Trainer shall be primarily based on his Experience, Qualification, Skills and Expertise on the training topics.
After attending the Training Programme at outside it shall be recorded in the External Training Record shown in Annexure-XIV.of SOP Training of Personnel
Maintain the training record in training file of concerned employees who have undergone external training.
You can also read
STANDARD OPERATING PROCEDURE FOR INVESTIGATION IN PHARMACEUTICAL INDUSTRY
INVESTIGATION OF OUT OF SPECIFICATION (OOS)
STANDARD OPERATING PROCEDURE FOR THE HANDLING OF DEVIATIONS AND INCIDENTS
