This document discusses key personnel, qualifications, training, and hygiene practices for pharmaceutical manufacturing organizations. It outlines organizational structures and defines key roles such as heads of production, quality control, and quality assurance. It emphasizes the importance of having sufficient and qualified personnel to effectively perform tasks. The document also provides examples of required documentation for training programs, medical records, and standard operating procedures to ensure regulatory compliance.

2. CONTENTS:

3. Introduction Managements basic job is the effective
utilization of the people, which they have, to achieve
from organizational objectives Without human efforts,
no organization can achieve their objectives.
Organogram at overall organizational level:
Organogram at overall organizational level chairman
Managing director president / V. President (Technical
Operations) Head manufacturing Quality management
Engineering Personnel Finance & Administration

4. Qualification, Experience & Training :
Qualification, Experience & Training Why organization
fail in regulatory inspection? “ Organizers feel that
good buildings, costly equipments & few cleverly
designed formats is the key to success in inspection
but they forgot the most important factor in a success
story that is people.”
Qualification, Experience & Training:
Qualification, Experience & Training Technical /
Professional Qualification Training of Employees Number
of People Ability To Perform Task Managerial Skills.
Technical / Professional Qualification :
Technical / Professional Qualification Qualification for
relevant areas Pharma production Q.A. or Q.C. Managerial
Other areas.

5. Training of Employees:
“A person is called trained person when he has appropriate
knowledge, skill & attitude”
Knowledge – theoretical background excepted
Skill – ability to use theoretical knowledge
Attitude – behavioral trait of a person

6. Number of People :
“There should be sufficient number of qualified
personnel to carry out all the task”. “Manufacturing
plant should have sufficient number of people such
that they are able to perform all the work assign to
them so that no risk of quality because of overload of
work to any person”.

7. Ability To Perform Task :
“Organizations must identify the different level task &
sets of knowledge, skills & attitudes required to make a
person able to perform his task” . Machine operator Shop
floor supervisors Junior/ Senior managers Top managers
& directors.

8. Managerial Skills:
“Managers carry out the functions of planning,
organizing, staffing, leading & controlling”
Productivity implies effectiveness & efficiency.

10. Mind mapping
A mind map is a diagram used to
represent words, ideas, tasks, or other
items linked to and arranged around a
central key word or idea. Mind maps are
used to generate, visualize, structure,
and classify ideas, and as an aid
tostudying and organizing information, sol
ving problems, making decisions, and
writing.

12. Responsibilities & Job Description:
“A job description is an organized, factual statement of the
duties & responsibilities of a specific job, in brief, it
should tell, what is to be done, how it is done, & why it is
done”
Ideally a job description must contain knowledge about :-
Reporting relationship Individual assignments, Job
summary, Working conditions & hazards of the job.

13. Key Personnel “Key personnel can be defined as those positions in the
organization, which have a direct impact on the working of the organization &
quality of the product produced” There are six different key personnel :- Head
of production Head of Q.C. Head of Q.A. Head of sales & distribution
Authorized person Managing director
Responsibilities of head of quality control:
Responsibilities of head of quality control To approve or reject starting &
packaging material, intermediate, bulk & finished product. To evaluate batch
records. To approve & monitor analysis carried out under contract. To
approve sampling instructions, specifications test methods & other quality
control procedure. To check validation of analytical procedures & calibration
of equipment. To establish, verify & implement all quality control procedure.
Responsibilities of head of production:
Responsibilities of head of production Appropriate documentation To approve
instruction relating to production operation, including in process control &
their strict implantations. To ensure that production records evaluated &
signed by designated person. To check the maintenance of the department,
premises & equipment.

14. Personal hygiene & clothing:
Personal hygiene & clothing “ persons engaged in manufacturing of the
pharmaceuticals must be healthy & not only healthy, but they themselves have
good hygienic & sanitational habits ” Regulatory guidelines to manufacturer
High standards of personal cleanliness should be observed by all those with
production process Habit of hand washing. Hygiene programmes for
employees.
Eating, drinking, chewing & smoking or storage of food, drink, smoking
materials should not be permitted. Direct contact should be avoided. There
should be pre-employment medical check. Annual eye examination. Report skin
infection & skin lesion .

16. Detailed dress code procedure should be
implemented. Hygiene programmes should
be promoted. Requirements regarding
personal hygiene & protective clothing apply
to all persons entering production.

17. Documents & Formats:
Documents & Formats Documents for training :- Each
organization should have a training manual specifying
the policy & procedures. Types of training :- a) GMP/GLP
related training b) Job specific training c) Behavioral
training
Training manual records contains :-:
Training manual records contains :- Attendance record
Training evaluation record Format : Personnel training
records Date :- Topic :- Trainer:- Method :- Time :- Venue
:- Sr. no. Name of participants department signature
PowerPoint Presentation:
Sr. no. Name of participants Department Evaluation
Format :- personnel training evaluation records Sr.no .
Name JoiningDate Desig -nation Qualifi-cation Exper-
iance FDA approval Format :- Technical staff with
qualification, experience & F.D.A. approval

18. Forma t :- certificates of Medical Check-up Name & address of the
person examined :- Sex :- Age :- Marital status :- Blood group :- He /
she examined for the following :- Height ,Weight, Pulse Eye sight,
respiratory , Git & Cardiac diseases Leprosy & communicable diseases
He / She needs following treatment/ investigation. 1. 2. Declaration :-
He / She is medically fit / unfit for any type of job Signature of
Examining Doctor