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Professor (PHARMACOGNOSY)
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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KEY PERSONNEL
Production
Packaging
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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.
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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
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
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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
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ORGANIZATION CHART
CEO
MANAGING DIRECTOR
HEAD OF PRODUCTON
ATHORISED PERSON
SECURITY MANAGER
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HEAD OF ENGINEERING
KEY PERSONNEL
DECISION MAKER
CEO
LEADER
MANAGER
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Managing Director
QUALIFICATION:
RESPONSIBILITIES :
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FINANCIAL MANAGEMENT
MANAGING DIRECTOR
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
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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,
Approval or rejection of materials E.g. packing materials, intermediates, bulk products & finished
products.
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.
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MAINTENANCE
ENERGY CONSERVATION
COMMUNITY SERVICE
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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
Cold area
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SECURITY MANAGER
Is capable of handling of
Security Manager
Updating the various security technology for safety. Responsible for planning, developing and implementing
Contd.
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VALIDATION
Validation manager
Production manager
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SUMMARY
KEY PERSONNEL
RESPONSIBILITY
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.
REFERENCES
1. Potdar, M.A., 2006. Personnel, In: Pharmaceutical Quality
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