CONTENTS:

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

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.

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

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”.

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.

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

Mind mappingA 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, solving problems, making decisions, and writing. 

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.

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.

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 .

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

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

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