PHAM 500: QUALITY ASSURANCE

PRESENTATION
ON

PERSONNEL AND TRAINING

BY:

KIROJ RAJBANSHI KUSUM SHRESTHA SURUCHI NEPAL M Pharm 1st year, Batch 2011

3 DEC. 2011 KUSOM, LALITPUR

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Basic Principles of GMP

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Personnel and Training

WHO Technical Report Series, 908, Annex 4, WHO Technical Report Series 961

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Personnel and Training

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Objectives
To review general issues related to personnel To review requirements for key personnel To review the training of personnel

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Personnel
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Principle
Establishment and maintenance of satisfactory system of QA and manufacturing of products and actives rely on people. Must be sufficient qualified personnel to carry out tasks Individual responsibilities must be clearly understood by individuals concerned All personnel should be aware of the principles of GMP that affect them
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Personnel
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General - I
Adequate number of qualified people with practical experience An individuals responsibilities should not be so extensive as to present a risk to quality

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Personnel
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General - II
Individual written job description Organization Chart :
it should not look like

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Personnel
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Director

QA manager

Production Manager

Admin manager

Store Engineering manager Manager Qc Manager Assistant production manager Regulatory Officer Officer micro Officer chemical Officer instrument Officer packaging
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Tablet/Capsule Officer Engineering Liquid/ointment officerOfficer Packaging Officer

Purchase Officer Personnel Officer

Personnel
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General - III Individuals must receive training in GMP:

initial

training continuing training including hygiene standards

Motivated to
support

the establishment maintain high-quality standards

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Personnel
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General - IV
Prevent unauthorized access to production, storage, quality control Stop personnel who do not work in these areas using them as passageways

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Key Personnel
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This include Head of Production Head of Quality Units (WHO TRS 961) Authorized Person

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Key Personnel
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Usually must be a full timer Should possess appropriate qualifications for handling the post Should have practical experience Should possess scientific education

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Shared Responsibilities
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Head of the Production and Quality Units may share some responsibilities relating to quality: Authorization of written procedures and other documents Monitoring and control of manufacturing environment While carrying out Validation and Qualification Personnel Hygiene and Environmental Monitoring Training Monitoring compliance with GMP Internal Audits 1/14/2012

Shared Responsibilities
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Approval and monitoring of Suppliers and contract acceptors Retention of Records Performing and evaluating In-process Controls Designation and monitoring of storage conditions for materials and products

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Responsibilities of Head of Production

Production of finished products and their appropriate storage Production Planning Responsible for allocating Officer and Staffs to different sections Approval and implementation of production instructions, In process controls Ensure that procedures are followed as per the written procedures and report deviations if any. Ensure production records are effectively documented, evaluated and signed by the designated person
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Responsibilities of Head of Production

Ensure that Process Validation, Equipment Qualification and Instrument Calibration are performed timely and all the records are maintained Responsible for carrying out initial and continuous training of the production personnel and their motivation Ensure that the production premise and equipments are maintained properly

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Responsibilities of Head of Quality Unit

Approval and rejection of starting materials, bulk products, intermediate products, finished products and packing materials Ensure that required testing are done in accordance with the established procedures Ensure that Analytical Method validation and Instrument Calibration are performed timely and all the records are maintained Responsible for carrying out initial and continuous training of the QC personnel and their motivation Ensure that the QC premise and equipments are maintained properly Approval of Quality control procedures like sampling and testing; specifications
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Responsibilities of Head of Quality Unit

Ensure that all the required equipments and reagents for carrying out analysis are adequately available and are correctly utilized, cleaned and are in good condition Organize duties of analysts effectively, efficiently and handle analytical technical problems Implementation and control of documents as per GMP requirements Establishment, implementation and maintenance of quality system Supervision of regular internal audits or self inspection Participation in the external audits (vendor audit) Participation in validation programmes
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Responsibilities of Authorized Person

Compliance with technical or regulatory requirements related to quality of finished products Approval of release of finished products for sale In certain countries, by law, batch release is the task of authorized person from production together with the authorized person from QC

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Authorized person who is responsible for batch release should ensure that following requirements have been met
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Marketing authorization and manufacturing authorization requirement for the product have been met The principles and guidelines of GMP have been followed The principle manufacturing and testing procedures have been validated, if different Any planned changes or deviation in manufacturing or quality control have been notified with well defined reporting system All the necessary tests and checks have been performed Approval have been given from head of QC All necessary production and QC documentation have been completed Appropriate audits, self inspection have been carried out by experienced and trained staff
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The function of approval of release of finished batch can be delegated to a designated person with appropriate qualification and experience. This is normally done by QA by means of batch review

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GMP Requirements for Training

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10.1. The manufacturer should provide training in accordance with a written programme for all personnel whose duties take them into manufacturing areas or into control laboratories (including the technical, maintenance and cleaning personnel) and for other personnel as required.

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The Written Programme

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POINTS THAT CAN BE INCLUDED IN SOP Scope of the procedure Types of training covered Responsibilites of training Programme WHO is to be trained, WHEN training to be conducted Quality Unit Involvement Learning Plans and Curricula Qualification of Instructors Documentation of participation in training Maintainance of training materials Retention of training materials Reports to Mangement etc..
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GMP Requirements for Training

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10.2. Besides basic training on the theory and practice of GMP, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness periodically assessed. Approved training programmes should be available. Training records should be kept.

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Types of Training
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1. Orientation training for new employees

2.Work Specific Area training  GMP training  On the Job Training  Training on SOPs  Safety Training 3. Supervisor training 4.Manager training 5. Trainers Training 6.Ongoing Training 7.Remedial Training 8.Job Change Training 9.Temporary employee and contractor training
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Table 1Amount of Training Required

MORE TRAINING IS REQUIRED WHEN
25 The

LESS TRAINING IS REQUIRED WHEN The workforce is experienced There is a low employee turnover rate No new products are being added There are few worker performance issues

workforce is relatively new to the job

There is a high, rapid employee turnover rate New products are being added There are many worker performance issues

The technology, equipment, or process is new The technology, equipment, or process is or changing stable New personnel are added; the firm is expanding The facility operates 24 hours a day using multiple shifts There are gaps between what a person can do when hired and what he is required to do. Few new personnel are added; the firm is staying the same size The firm operates on one shift There is a close match between knowledge and skills of and what he is required of them
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GMP Requirements for Training

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10.3 Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitizing materials are handled, should be given specific training.

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SPECIFIC TRAINING SHOULD INCLUDE.

chemical hygiene plan

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HIGHLY ACTIVE (anticancer, steroids) TOXIC (formaldehyde , ethylene oxide, hydrogen sulphide) INFECTIOUS ( therapy involving live cells ) SENSITIZING MATERIALS

Location and availability of known reference material on the chemical hazards, and their safe handling, storage, and disposal including, but not limited to, Material Safety Data Sheets (MSDSs) received from chemical suppliers.

Measures that workers and their employers can take to protect employees from hazards Know the toxic effects of the chemicals Protective clothing etc
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AREA WHERE CONTAMINATION IS HAZARD

GMP Requirements for Training

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10.4 The concept of quality assurance and all the measures which aid its understanding and implementation should be fully discussed during the training sessions.

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GMP Requirements for Training

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10.5 Visitors or untrained personnel should preferably not be taken into the production and quality control areas. If this is unavoidable, they should be given relevant information in advance (particularly about personal hygiene) and the prescribed protective clothing. They should be closely supervised.

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GMP Requirements for Training

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10.6 Consultant and contract staff should be qualified for the services they provide. Evidence of this should be included in the training records.

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Example of Impact of Training

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One firm found that people were washing their hands much more frequently after a training course in which people put their hands one washed and the other unwashed on culture media plates (Petri dishes). The dramatic difference that hand washing made became a motivating factor.

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Example
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A firm provided extensive training to key technical, production and quality personnel on how to investigate problems (i.e. deviations) and write reports. After a period of two years, because the investigation teams knew how to determine root causes to problems and recommend and implement corrective actions, they had a significant reduction in recurring deviations. WHO/IVB/05.24 5
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Training: In Nutshell as per GMP

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10.1 Focuses on training to the personnel in manufaturing area , QC (including technical and maintainance) 10.2. Focus on the types of training to be given 10.3. Focus of the safety 10.4 Focus on the discussion on QA, its understanding and implementation 10.5. Limits the reach of visitors /specifies the need for supervision before their entrance 10.6 Helps ensure that the consultant and contract 1/14/2012 officers are qualified

CONCLUSION
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In conclusion, training is an investment in people that pays its dividends in a more skilled workforce, improved productivity, and higher levels of product and service quality.

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REFERENCES
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WHO TRS 908 WHO TRS 961 A WHO guide to good manufacturing practices .Part 3: Training Defining your GMP training programme with a training procedure ; James L Vesper www.osha.gov
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THANK YOU

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