Training

Training is the process of learning the skills you need to do a particular job or activity:

Training is important part of any industry to improve skill set of employee to increase productivity, and Quality. Similarly in pharmaceutical industry training is mandatory requirement is given in different GMP guidelines. Every organization provide training to all the employees irrespective of their qualification and skill.

Below are some important requirements related to training given in guidelines:

• The manufacturer should provide training in accordance with a written programme for all personnel who work into manufacturing area, storage area or into control laboratory (including technical, maintenance and cleaning personnel) . 

• Newly recruited personnel should receive training as per their duties assign to them. Approved training programmes should be available.  Continuing training should also be given, and its practical effectiveness should be periodically assessed.

• All the training should be document which cover minimum these details. Title of training, Date and time period training was imparted, Trainer details, trainee details etc. The training record should be archived and easy to retrieval as an when needed.

• Specific training plan/ module to be prepared and provide to the person working in area where contamination is a hazard e.g. clean area or areas where highly active, toxic, infectious or sensitizing materials are handled.

• The concept of Quality Assurance its understanding and implementation should be discussed during the training sessions.

• Un-trained personnel (e.g. Visitors) should preferably not be taken into the production and QC areas. If  this is unavoidable, in that case they should be given relevant information in advance. The information cover about personal hygiene, protective clothing and entry& exit procedure. The visitor should  be closely supervised by the trained person.

• Training should be provided to Consultant and contract staff for the services they provided. All such training should be recorded and training record should be available as an evidence.

• All personnel should be periodically trained, at least once on GMP. Training must be repeated as necessary and appropriate in light of observation or information indicating that personnel are not meeting the established standard.