SOP for Training of Personnel in factory

1.0		OBJECTIVE:
		To lay down the procedure for organizing and conducting training programs in the factory for plant personnel.
2.0		SCOPE:
		This SOP is applicable for all personnel at all levels at XYZ Pharmaceuticals Ltd.,
3.0		RESPONSIBILITY:
		All department heads and training coordinator for organizing, conducting and assessing the trainees.
		HRD Personnel for conducting induction training to all new recruits.
		Head – Quality Assurance
4.0		PROCEDURE:
4.1		Training shall be given to all personnel in the production, Quality Assurances, Quality Control, Engineering, Stores and Personnel departments.
4.2		The training needs of staff employee shall be identified based on their activities by department heads and consequently the training schedule cum card shall be prepared. The Training schedule cum cards shall be prepared for individuals or groups whose job responsibilities are similar.
4.3		For operators, the training schedule cum-card shall be prepared group wise, based on the skill set requirements.
4.4		Training schedule cum card shall be prepared by the training coordinator and shall be checked by the department head and approved by Head Quality Assurance.
4.5		Training program shall consist of following five categories: Induction program cGMP / cGLP  / cGDP / cGEP / cGWP training Job related training (Standard Operating Procedures) Safety training NCR (Non conformance report) related training
4.6		Human resources Department shall be responsible for the induction program for the new recruits, which shall include the overview of the organization and its general policies.
4.7		The quality Assurance department shall be responsible for organizing and conducting cGMP / cGLP / cGDP / cGEP / cGWP training/awareness program through internal and external trainers.
4.8		The job related training shall be given by the concerned department heads his designee or external trainers having sufficient knowledge on the subject.
4.9		Safety training shall be conducted by Engineering head, his designee or external trainers having sufficient knowledge on the subject. The modules used to impart training for safety are as per the list No..
4.10		For NCR related training, appropriate training sessions shall be carried out and the same shall be recorded in unscheduled training card. Any external training or SOP revision training shall also be recorded in the similar way.
4.11		At the end of each month updated unscheduled training card  printout shall be taken & maintained in the individual’s training file.
4.12		The mode of training shall be oral, or through visual presentations or through self-reading prepared as modules. The modules for the cGMP / cGLP / cGDP / cGEP / cGWP training are as per the list No..
4.13		The trainees shall be evaluated through written questionnaire or orally. If the evaluation score is less than 80%, the trainee shall be required to undergo retraining. The operators and workers shall be evaluated orally only.
4.14		Retraining attempts shall be maximum three times for each topic. If the candidate fails to qualify the retraining in the all attempts, the concern HOD shall re-identify the training need or need for change in job profile.
4.15		Department Head shall ensure that new recruits are suitably trained for their work before assigning them with independent activities. Each new recruit shall endorse the New Recruit Induction/Training certificate after the successful completion of the training program.
4.16		If the employee is on long leave (more than 30 days) the employee shall undergo training basically on the SOP’s related to the   jobs performed on his/her re-reporting. The schedule training missed by him/her shall also be taken and all these shall be treated as unscheduled if the schedule month passed away.
4.17		A Training Manual shall also be prepared by the training coordinator which shall include the following but not limited to: Policy of training Identification of trainers Training Modules Methods of Training and Evaluation Methods of Recording The relevant annexures will be update as per requirement.
4.18		Trainers shall be certified by Head-QA based on the educational qualification and experience. A list of trainers shall be maintained as per list No..
4.19		All training activities shall be recorded in the training format with required comments from the trainees. There is no need for filling the training attendance sheet for the induction training & on job training, which shall be held for the new joinees.
4.20		At the end of the year, each employee shall be evaluated through the long-term evaluation format and any additional training requirements shall be identified for the individual during such evaluation by the department head.
4.21		The frequency of the training program is as follows: One cycle per year shall be completed in a maximum of 12 months for SOPs and cGMP / cGLP/ cGDP / cGEP / cGWP training. NOTE: Schedule of the training programs may be changed to suit work exigencies.
4.22		External trainings shall be coordinated by Quality Assurances Department along with HRD and concerned department. The training details shall also be recorded in the training format. The trainees shall handover the training materials to the training coordinator for reference.
4.23		Advanced technical training topics shall be identified by the respective department heads from recent publication, external training and Pharmacopoeial revisions. Such trainings can be conducted through classroom training or issuing materials for reading.
4.24		The training records of all existing employees shall be retained by Quality Assurance department. For resigned employees, the training records shall be retained for a period of five years after resignation.
4.25		Feedback forms shall be obtained through “Feedback about Training program and Trainer/ Facility”  only for the training programs conducted by external faculties.
4.26	To assess the technical and presentation skills of the external faculty, feedback form shall be obtained from the participants for the first program of the faculty. Evaluation shall be done by Head-QA.
4.27	The contractor shall be responsible to ensure that the contract workers are adequately trained in the basics of GMP, personnel hygiene and safety prior to entry into the work premises. For contractor worker QA and concerned department will impart verbal training on cGMP module and specific job related training respectively. A pictorial may be used for the same. A formal record to be maintained for the same
4.28	The training records shall be preserved as follows: Training Schedule cum Card Unscheduled Training Card Evaluation Questionnaires Long term Evaluation Checklist
4.29		The modules used for the imparting training to the trainees shall be revised minimum at the end of two years or as and when required for revision /updations of the guidelines.
7.0		ABBREVIATION (S) /DEFINITION (S) :
		cGLP   : Current Good Laboratory Practices cGMP  : Current Good Manufacturing Practices cGMP: current Good Manufacturing Practice cGLP : current Good Laboratory Practice cGDP : current Good Distribution Practice cGEP : current Good Engineering Practice cGWP : current Good Warehousing Practice HRD  : Human Resource Department NCR : Non conformance Report SOP : Standard Operating Procedure QA : Quality Assurance