SOP on Training Procedures
Objective: To lay down a procedure to conduct training of working personnel and its evaluation.
Scope: This Standard Operating Procedure is applicable for the training of personnel working in all pharmaceutical formulation plants/operations.
Responsibility:
Head, QA or his/her designee for co-ordination on training of the personnel.
Head of every department or training coordinator shall ensure that each individual in his or her department has been imparted required training, which shall be relevant to the activities performed by the individual, as per this SOP.
Head of each department shall ensure compliance of this SOP and shall maintain training records annually.
Head, QA or his/her designee shall co-ordinate with head, HR for the preparation of cGMP Training Calendar in conjunction with other departments.
Head, HR or Designee shall provide Staff training record
Abbreviations and Definitions:
cGMP Training : Training pertaining to Current Good Manufacturing Practices which are supposed to be followed at different stages of design, development and manufacturing of drug product. This type of training shall be given to all those who are directly or indirectly associated with the quality of the drug product. cGMP training shall also cover the safety aspects of the personnel engaged in manufacturing operations.
SOP/OG Training : Training on Standard Operating Procedures and Operating Guidelines applicable in the different department for the adequate and accurate operations. This training shall be imparted to those, who directly or indirectly fall in the scope of execution of a SOP or an OG.
On the Job Training : This type of training is a departmental training which shall be imparted to all staff members whose functioning affects the productivity of various departments. The staff shall be trained with respect to his or her area of working in the department.
Procedure :
Training : Following types of training shall be imparted to the personnel to upgrade their skills and knowledge.
- cGMP Training
- SOP/OG Training
- On job Training
Training need identification
Department heads or his/her designee shall do the gap analysis of the job description of the employee and available skill on the technical knowledge of the person. Thereafter the topics on cGMP training, SOPs, OGs etc. shall be identified for the respective employee by the department head.
Note: – Names provided in the training need identification format shall be tentative and Head of each department shall send the concerned personnel for training depending upon the availability and viewing their operational aspects.
Training on identified topics shall be organized through the training Department training need matrix and training calendars shall be initiated by training coordinator and shall be recorded. Same shall be approved by department head and head QA. Master copy shall be given to QA for distribution purpose.
cGMP Training : cGMP Training Calendar for the Staff and Workers shall be prepared by QA department in conjunction with the HODs of various departments and shall be circulated.
cGMP Training (training by a designated person of the organization) shall be conducted as per the scheduled calendar.
External training imparted by outside faculty through workshops, seminars shall be recorded in the ‘Staff Training Record’ . The evaluation criteria for such program may not be applicable; however the proof of attendance like certificate etc. shall be maintained by QA or by respective department.
SOP / OG Training : All staff members shall be given training on various SOPs or OGs relevant to their area of work. As required training on relevant SOPs / OGs, to the workers shall also be imparted.
Respective department shall impart the SOP / OG training, and the concerned department shall maintain the training records.
Revision of any SOP / OG or introduction of a new SOP / OG shall require training of the concerned personnel.
Concerned training coordinator of respective department shall ensure the training and shall maintain all training records.
On Job Training
Staff and Workers shall be given training before they are allowed for the proper execution of an activity being performed in the operation area.
Concerned training coordinator shall maintain training records of ‘on job training’. Training shall be imparted by making group of workers within departments.
Training Evaluation:
Training evaluation shall be done by training coordinator of the respective department.
Training evaluation shall be recorded on ‘Training Attendance and Evaluation Record’.
Evaluation of training shall be done by means of a questionnaire as per the respective SOP, OG or Training topics.
Note: A questionnaire, normally based on training contents, shall be prepared by the Trainer to evaluate the training to be imparted to the staff and any other appropriate means of recording and / or evaluation of training shall also be acceptable.
The training, in case of evaluation through written test, shall be scored on a scale of 0 to 10 and a score not less than 8 shall be required for successful completion of training.
In event of score less than 8, re-training shall be given. Evaluation of re-training shall be done and same shall be recorded in training record.
A person shall be allowed to work in the respective area after successful re-evaluation.
HR shall provide a Staff Training Record card having the provision of recording on both sides of it, to every employee for recording the trainings imparted to trainee during his or her induction training.