ORGANIZATION

AND
PERSONNEL
ASHURA FAHIDAT.R
III B.PHARM. III B.PHARM
 PERSONNEL
RESPONSIBILITTES
. In a pharmaceutical industry different jobs are performed by different persons
and, hence it becomes more important that each employee have a clarity and
understanding of the job description.
. A detailed job description or responsibilities should be prepared in writing,
explained and assigned the same to the Person who is going to Perform the job and
his acceptance must be sought in writing by the person to the Authority person to
whom he is going to report.
. A job description is an organized and factual statement of the responsibilities of a
specific job, in brief, it should tell the work, tasks, duties and responsibilities of a job.
. Basically the job description should indicate what is done, why it is done,
where it is done, and in brief how it is done, and then it will result in satisfactory
performance and
results.
 Ideally a job description may include:
(i) Organizational positions and operating relationships clearly mentioning job description
and reporting.
(ii) Individual assignments.
(iii) Job summary in detail.
(iv) Working conditions and hazards related to the job.
(v) Jobs/Duties, roles, responsibilities and accountability.
All the important positions in pharmaceutical industry/organization must have written,
authorized and accepted job descriptions.
 KEY
"It is PERSONNEL
de fi ned as those positions in the organization, which have a direct impact on
the
working of the organization and quality of the products produced".
Some key personnel and their
responsibilities
The Head of Quality Control
department
Head of Quality Control department generally has the following responsibilities:
. To approve or reject starting packaging material.
. To approve or reject intermediate, bulk and fini shed products.
. To evaluate records related to batch.
. To ensure that all necessary testing related to product is carried out.
. To approve sampling instructions, specifications, test methods, and other quality control
procedure related to products.
. To check the maintenance of the department, premises and equipments etc
. To ensure that the appropriate validations, including those of analytical
procedures and calibration of control equipments are done according to procedures.
. To ensure that the required training of quaity control personnel is carried out and
adopted according to need.
. To establih, verify and implement all quality control procedures and protocols.

The Head of Production

Head of Production department generally has the following responsibilities:
department
. To ensure that products are produced and stored according to the appropriate
procedures and documentation in order to obtain the required quality.
. To approve the instructions relating to production operation, in process controls, and
to ensure its strict implementations according to procedures.
. To ensure that productions records are evaluated and signed by a designated person
before they are made available to the quality control department for further use.
. To check the maintenance of the production department, its premises and equipment.
. To ensure that appropriate process validations and calibrations of all control
equipments are performed and recorded.
. To ensure that the required training of production personnel is carried out and adapted
according to need.
TRAINING
Knowledge: It refers to the theoretical background expected in a person regarding the job
to be performed and also the knowledge about the principles which may affect his area of
work.

Skill: It refers to the practical experience he has and his abiity to use his theoretical
knowledge to perform a particular task give.

Attitude: Attitude is a behavioral trait of a person who is performing a task. He must

have knowledge, skill and positive attitude towards performing work assigned to him by
authority.
 Under a quality system, managers are expected to establish training
programs for staff that include:
. Evaluation of training needs.
. Provision of training to satisfy these
needs.
. Evaluation of effectiveness of training.
. Documentation of training and/or re-training.
. Developing, maintaining, and administering the facility training plan.

In Pharmaceutical industries there are different levels of operations and jobs,

they may start from production to formulation and lastly release of product.
The different abilities are required at different levels by Personnel.
Personnel must be trained in all these levels to perform the designated jobs.
Organization must identify the different level tasks, sets of knowledge, skills and
attitudes required to make a person able to perform his task and train them accordingly.
 Authorities must Design and conduct training programs according to tasks and jobs to
enhance the Knowledge, skills and abilities of personnel.
Where contamination is a hazard including clean areas or Areas where highly
active, toxic, infectious, sensitizing materials are handled, specific should be provided
to the staff.
Training may include: Training
. Concepts and Elementson:
of GMP, GLP and other regulatory
guidelines.
. Standards of drugs
. Calibration and validation
. Handling of materials
. Sampling.
. Personal Hygiene
. Hazards and Safety measures
. Test Procedures and methods.
. Basic principles and methods of analysis
. Instruments handling, operating and their calibration and validation etc.

HYGIENE
To avoid any kind of contamination of pharmaceutical products, it has to be produced
with clean materials, equipments and human beings.
. All the persons involved in manufacturing must be healthy and should practice good
sanitation.
. All the persons involved in manufacturing should have good personal hygiene
. Organization should develop detailed hygiene programs for their employees and
programs must be implemented.
. Eating, drinking, chewing and smoking or the storage of food, drink, smoking materials
and personal medication should not be permitted within mànuracturing areas or in other
area where they might adversely in fluence product quality.
. There should be pre-employment medical checks and at regular intervals
. Steps should be taken to see that no person with disease in a communicable form or
with open lesion on the exposed surface of the body is engaged in the manufacture of
pharmaceutical products.
. Direct contact should be avoided between the operators hands products (other than
when they are in closed containers), as well as with any part of the equipment that comes
in contact with the product.
. Staff should be required to report infections and skin lesion and de fi ned
procedure followed when they are reported. Supervisory staff should look for the signs and
symptoms of these conditions.
. Habit of hand washing must be inculcated in all the employees.
. A detailed Dress-code procedure should be implemented. This should also cover use of
other accessories used for human body protection.
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