Teva Api India

T EV A

INDI A

API

LIMI TED GAJ RAU LA J .P.NA GAR ( U.P.)

GE NERA L VEIW S OF TE VA API IND IA LMI TE D

• The employees of the Teva API India Ltd. Under go for training to carrying out their jobs. • The training needs are identified by the plant manager /Department Manager /QA Manager /HR Manager for professional and personal development of the employees. • The process of identifying the training needs is uniform for all employee in TEVA • The training needs are recorded and programme for conducting training is constructed by HR Department.

OBJ ECTI VE The purpose of this procedure is to specify the methods and means for training employees in TEVA API India Ltd and fitting them for their jobs.

SCO PE The procedure refers to training related to the following subjects. Basic Safety . Directions for working under Good Manufacturing Practices(GMP) . Standard Operating Procedures (SOP). Professional and managerial subjects.

RE SP ONSIB ILIT Y PLANT MANAGER:

DEPARTMENT MANAGER:

HUMAN RESOURCES DEPARTMENT :

Implementation of the training program.

Training the employees and accrediting them for jobs. Supplementary training in exceptional cases. Preparation of training calendar Preparing training aids. Documentation of training and accreditation Training and accreditation of instructors . Updating training material Monitoring of irregular training cases. Approval of qualification (test paper) of exams in coordination

DEF INIT IONS New employees: an employee take who has been on for regular work in the Teva API India Limited.

Authorized Instructor: An employee

who has received accreditation in training skills and has been trained in basic safety ,Basic GMP & Updating GMP.

Frequency Subject Target population

Basic GMP

All new

Basic safety

All new employees

Safety & environment Departmental SOPs

Refreshing SOPs Updating GMP Refreshing GMP Process validation Cleaning validation

employees

All employees New concerned employees Concerned

of trai ning

Maximum implementatio n time after starting Immediate Immediate Annual 1-months 6-months

Examination Required (R) Not Required (NR)

R

Pass grade (%)

75

NR

Frequen cy

One -time

One- time

NR

One-time

NR

One-time

NR

One-time

employees Asst. Manager & above

Annual

NR

One-time

All employees

Annual

NR

One-time

New employee in MCS:(QC ,QA , Engineering,production

same

6-months

R

6-months

R

75 75

One-time One-time

TRAI NI NG • • •

•

The HR Manager or appointee will prepare an annual training calendar in coordination with the Head of the Department and QA Once a month a monthly training calendar will be formulated which shall be derived form the training requirements of the departments and form training omissions in previous months. A Personal training plan will be development by department manager for each TAIL employee according to his / her qualification experience previous training and job description, which is kept in HR department. The department managers may organize professional training that did not appear in the training programs issued by HR but are required by the needs of the department.

TRA IN IN G MEA NS The training will be provided, as necessary with the following means. • A trainee booklet to be given to every participant in the course. The date of issue and edition number shell appear on every booklet. • A kit of training material to be provided for every qualified instructor. • Other means

TEST S •

An updated series of tests ,approved by Quality Assurance , Human Resource and Department manager shell be provided for those subjects requiring tests . • It is likely that there will be different target populations for the same subject. • The training program and timetable will be prepared so as to give the trainee time to prepare for his /her tests . The tests will be of the objective.

TRA IN IN G MA NAG EMEN T The training will be given for group of 15 trainee but not exceeding 20. The training will be given in classrooms equipped with chairs desks, white board, screen and slide projector, or other means.

DOC UM ENTAT ION A list of the following documents will accompany the training process for all subjects. 1st) Approval that training has been held, including a list of participants ( for courses and training held outside TAIL if possible). 2nd) Summary of the training material. 3rd) Certificates of completion of GMP 4th) Uniform com pletion certificates for quality training :updated GMP (quality policy ,failures and instructor and the participants will be sent to documentation in HR

LIST OF PRO DUCT S IN TEVA API • INTERMEDIATES/ APIs •

API s: Fomciclovir ,Fluvastatin Sodium ,Irbesartan ,Olanzapine ,Montelukast sodium ,Quetiapine Fumarate ,Ezetimibe • INTERMEDIATES: Clarithromycin-1 ,Desmethyl AZA Erythromycin ,Hydroxy NMPP ,Sertraline HCl (Racemate) ,CLD CSA Salt Pure ,Venlafaxine Free Base ,CLP-8 ,Simvastatin ammonium Salt.

Limit ation In Teva APIs India Limited there are many limitation.