personnel and training slides
TRANSCRIPT
04/09/23
1PHAM 500: QUALITY ASSURANCE
PRESENTATION
ON
PERSONNEL AND TRAINING
BY: KIROJ RAJBANSHI
KUSUM SHRESTHASURUCHI NEPAL
M Pharm 1st year, Batch 2011
3 DEC. 2011KUSOM, LALITPUR
Basic Principles of GMP
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Personnel and Training
WHO Technical Report Series,908, Annex 4, WHO Technical Report Series 961
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
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
Personnel
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General - I
Adequate number of qualified people with practical experience
An individual’s responsibilities should not be so extensive as to present a risk to quality
Personnel
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General - II
•Individual written job description•Organization Chart :
it should not look like
Personnel
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Director
QA manager Production Manager Admin manager
Qc Manager
Regulatory Officer
Officer microOfficer chemicalOfficer instrumentOfficer packaging
Store managerAssistant production manager
Engineering Manager
Tablet/Capsule Officer
Liquid/ointment officer
Packaging Officer
Engineering Officer
Purchase OfficerPersonnel 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
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
Key Personnel
This include Head of Production Head of Quality Units (WHO TRS 961) Authorized Person
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Key Personnel
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
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
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Shared Responsibilities
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
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
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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 employees2.Work Specific Area training GMP training On the Job Training Training on SOPs Safety Training3. Supervisor training4.Manager training 5. Trainers Training 6.Ongoing Training7.Remedial Training8.Job Change Training9.Temporary employee and contractor training
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Table 1Amount of Training Required
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MORE TRAINING IS REQUIRED WHEN…
LESS TRAINING IS REQUIRED WHEN…
The workforce is relatively new to the job
The workforce is experienced
There is a high, rapid employee turnover rate
There is a low employee turnover rate
New products are being added No new products are being added
There are many worker performance issues
There are few worker performance issues
The technology, equipment, or process is new or changing
The technology, equipment, or process is stable
New personnel are added; the firm is expanding
Few new personnel are added; the firm is staying thesame size
The facility operates 24 hours a day using multiple shifts
The firm operates on one shift
There are gaps between what a person can do when hired and what he is required to do.
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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HIGHLY ACTIVE(anticancer, steroids)
TOXIC (formaldehyde , ethylene oxide, hydrogen sulphide)
INFECTIOUS ( therapy involving live cells )
SENSITIZING MATERIALS
AREA WHERE CONTAMINATION IS HAZARD
SPECIFIC TRAINING SHOULD INCLUDE….
chemical hygiene plan
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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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 given10.3. Focus of the safety 10.4 Focus on the discussion on QA, its
understanding and implementation10.5. Limits the reach of visitors /specifies the
need for supervision before their entrance10.6 Helps ensure that the consultant and
contract officers are qualified
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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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04/09/23
THANK YOU
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