GUIDE BY: Prof.(Mrs. )P S. ADATE Asst.

Professor (PHARMACOGNOSY)

PRESENTED BY: Ms.MAYURI .B.KALE M.Pharm Sem-I ( QUALITY ASSURANCE)

Sinhgad Institute of Pharmacy Narhe Pune-41

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INDEX
Objectives

Principle
Introduction

Key personnel
Roles & responsibilities

Summary
Conclusion
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References

Objectives
To review general issues related to personnel

To review requirements for key personnel To concentrate on training of personnel To handle some specific issues

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Purchasing & storage

Sampling & testing NEED OF KEY PERSONNEL

Production

Packaging

Sale & distribution

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PRINCIPLE
Establishment and maintenance of satisfactory system of QA, correct manufacture and control of products and active ingredients rely upon people. Must be sufficient qualified personnel to carry out tasks.

Responsibilities must be clearly defined .

All personnel should be aware of the principles of GMP .

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QUALITY ASSURANCE
According to W.H.O QA is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. OR It is wide ranging concept covering all the matter which collectively or individually influence the quality of product.

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GMP
Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use.

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QUALITY CONTROL
According to W.H.O

QC is that part of GMP which is

Sampling Specifications

Testing
Documentation, and Release procedures which ensure that the necessary and relevant tests are carried out.
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Personnel
According to W.H.O guidelines :

Personnel must be
Qualified, experienced, trained, Sufficient in number, Follow hygienic practices, Highly motivated.
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TRAINING
All personnel should be aware of GMP Must receive training in GMP: Initial training

Continuing training
In special areas : Clean areas Working with highly active, toxic, sensitizing materials The concept of QA and its understanding and implementation.
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Personnel
Must be highly motivated to Support the establishment Maintain high-quality standard Their job responsibilities must be well explained. Ability to perform the given task at given level at given time.
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Key personnel

According to FDA guidelines , key personnel

are those positions in the organization, which have

a direct impact on the working of the organization

and quality of the products produced.

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REGULATORY GUIDLINES Sr.No POSITIONS HEAD OF PRODUCTION HEAD OF Q.C HEAD OF Q.A HEAD OF SALES &DISTRIBUTION ATHORISED PERSON MANAGING DIRECTIOR INDIA N N N N N N UK AUST W.H.O S.A

1
2 3 4 5 6

Y Y
N N N N

Y Y
N N N N

Y
N

Y Y
N N

Y Y
N

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Key Personnel
Should possess the qualifications of Scientific education such as Degree or Post graduation in pharmacy

Ph.D
Practical experience

Responsibilities should not be so extensive.

Appropriate managerial skills.

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ORGANIZATION CHART
CEO

MANAGING DIRECTOR

HEAD OF PRODUCTON

HEAD OF QUALITY CONTROL

HEAD OF QUALITY ASSURANCE

ATHORISED PERSON

SECURITY MANAGER
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HEAD OF ENGINEERING
KEY PERSONNEL

HEAD OF STORE DEPARTMET

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Chief Executive Officer(CEO)

COMMUNICATOR

DECISION MAKER

CEO
LEADER

MANAGER

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Managing Director
QUALIFICATION:

postgraduate in management, M.pharmacy, PhD.

Documentation

RESPONSIBILITIES :

Annual product review

Identify corrective action

Reporting to the management

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FINANCIAL MANAGEMENT

MANAGING DIRECTOR

DESIGN &DEVELOP STRATEGIC PLAN

MOTIVATIONAL ROLE

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HEAD OF PRODUCTION
Qualifications :B.Pharm ,M.Pharm,M.SC(Tech),PhD
Experience: Minimum 5 years experience in a managerial role

within pharmaceutical manufacturing.

High level understanding of sterile and pharmaceutical work and process flows, equipment, etc

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HEAD OF PRODUCTION
Responsibilities

1) To ensure that products are produced and stored according to appropriate documentation. 2) Approval and implementation of production instructions, in-process control and ensure their strict implementations. 3) Ensures that production records are evaluated and signed by designated person.

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Head of Production
4) Check the maintenance of production department, premises and equipment. 5) To ensure that: Appropriate process validation and calibrations performed,

recorded, and reports are made available.

Initial and continuous training of production personnel is

Carried out or not.

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Head of Quality Control

Qualification and experience : M.Pharm, M.sc,Ph.D.

Minimum 3 years experience in Q.C Dept.

Responsibilities :

Approval or rejection of materials E.g. packing materials, intermediates, bulk products & finished
products.

Evaluation of batch records.

Ensures that all necessary testing is carried out .
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Head of Quality Control

He also has other responsibilities:
.

Approval of quality control procedures, e.g. sampling instructions , specifications, test methods. Approval and monitoring of all contract analysis. Check maintenance of quality department, premises and equipment.

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Authorized person
Approved by the drug regulatory authority.

Responsibilities : Compliance with regulatory requirements. Approval of the release of finished product for sale. Supervision of the regular self-inspections.

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Authorized person:
Oversight of the QC department .
Participation in external audits and vendor audits.

Establish good working relations with inspectors.

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Head of quality assurance

Responsibilities: Responsible for approving a batch for release. should always ensure that the : The marketing authorization requirements for the product have been met for the batch concerned. The principles and guidelines of GMP have been followed or not.

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Head of QA Also ensure that-

All necessary production and quality control documentation

has been completed or not.

Evaluation of Batch Documentation and Release for Sale. Involvement in developing SOPS .

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Head of Engineering Department

MAINTENANCE

COORDINATE WITH GOVERNMENT AGENCIES

ENERGY CONSERVATION

COMMUNITY SERVICE

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Head of Engineering Department

1.Maintenance : To organize preventive maintenance of equipment, utilities and plants ,e.g water purification system, Tablet machines.

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2. Coordinate with regulatory and government agencies for compliance with applicable Acts and Rules of Electricity Boards. 3. Energy Conservation : Implement energy conservation measures and water management procedures to minimize waste and cost control. 4. Community Service : Interact with local community to maintain good rapport and public relations.

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RESPONSIBILITIES

Purchasing of raw material

Head of store department

Checking of each consignment

Storage

Cold area

Categories the material

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STORAGE AREA FOR RAW MATERIALS

STORAGE AREA FOR FINISHED PRODUCT

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SECURITY MANAGER

Appointed by the management .

Trained person in the area of security technique.

Experience in police,defence service or industrial

security. SITE plant
Internal security
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Is capable of handling of

Security Manager

Updating the various security technology for safety. Responsible for planning, developing and implementing

various security plans and programs.

For example:

Physical Security, Information Protection.

Thumb impression machine
.
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Contd.

Prevent unauthorized access in

To production areas Storage areas Quality control

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IMPORTANT ROLE OF KEY PERSONNEL IN

VALIDATION

Head of quality assurance Head of engineering Manufacturing department

Validation manager
Production manager

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SUMMARY
KEY PERSONNEL

RESPONSIBILITY

Production Manager QC Manager Maintenance Manager Production Executive QA Manager

Responsible for manufacturing of batches and review of protocol and report. Responsible for analysis of samples collected. Providing utilities and maintenance of premises. Responsible for preparation of protocol and Manufacturing of validation batches. Responsible for protocol authorization and preparation of summary report.

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CONCLUSION Without human efforts ,no organization can achieves their objectives.

For this reason there must be sufficient qualified

personnel to carry out all tasks for which manufacturer is responsible.

The quality of medicines depends upon the quality

of people who produce them. Individual responsibilities should be clearly defined and understood by the persons.
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REFERENCES
1. Potdar, M.A., 2006. Personnel, In: Pharmaceutical Quality

Assurance, Nirali Prakashan, Pune, pp.1-17.

2. Gryna, F. M., Chua, C.H, Defo, J. A. 2010. Quality Assurance Audit,In:jurans Quality Planning & Analysis For Enterprise

Quality, 5th ed.Tata Mc graw Hill, Delhi, pp.525.

3. Joseph, M., Feo,D.,1999, Jurans Quality Handbook, 6th ed . RSC publisher, Delhi,pp.241. 4. Carleton.F.J.,Agalloco.J.P, 2006.Validation Of Pharmaceutical Processes, 2nd ed. Marcel Dekker ,Newyork, pp.10.
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6. Stephen. A., Bennett, Nathan., 2006, Second In Command The

Mis-understood Role Of The Chief Operating Officer. pp.7079.

7. http://hbr.org/2006/05/second in-command/1. (Accessed on 16/11/2011) . 8...http://www.securitymanagement.com/sites/securitymanagement.c om/files/annualIndex_2010.pdf. (accessed on 14/11/2011). 9. http://apps.who.int/prequal_applicants/Guidelines/QA_Pharmaceu ticals -Vol2.pdf.(Accessed on 16/11/2011).

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