Personnel validation

1. PERSONNEL VALIDATION
BY:
G.SAI SUSHMITHA
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2. CONTENTS
 VALIDATION
 PERSONNEL
-Personal qualifications
 PERSONNEL VALIDATION
- PERSONNEL RESPONSIBILITIES
- TRAINING
*Who needs training?
*Methods of training
- GOWNING
* Personnel Hygiene
- SOP
- Personnel validation report
- GMP Audit checklist
 FDA DISCUSSION
 CONCLUSION
 REFERENCES
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3. VALIDATION
 As per WHO: Validation is an essential part of good manufacturing
practices (GMP).,an element associated with QA.
 The basic principles of quality assurance have as their goal the
production of products that are fit for their intended use.
 Validation of processes and systems is fundamental to achieving
these goals. It is by design and validation that a manufacturer can
establish confidence that the manufactured products will consistently
meet their product specifications
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4. VALIDATION
 As per FDA: It is establishing documented evidence which
provides a high degree of assurance that a specific process will
consistently produce a product meeting its predetermined
specifications and quality attribute.
 For assuring the repeatability of the process, fluency of
production and decreasing the risk of manufacturing problems,
expenses, the risk of failing in cGMP : every section is
VALIDATED.
 Similar to process validation and cleaning validation, personnel
validation is also employed in a system
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5. 5

6. WHO-PERSONNEL
NEED??
 The establishment and maintenance of a satisfactory system of
QA and the correct manufacture and control of pharmaceutical
products and active ingredients rely upon people.
 For this reason there must be sufficient qualified personnel to
carry out all the tasks for which the manufacturer is responsible.
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7.  In pharmaceutical industries, for various functional departments
personnel are required, among them personnel from Quality
assurance, Quality control and manufacturing are utmost
important for maintaining the quality of pharmaceuticals.
 Individual responsibilities should be clearly defined and
understood by the persons concerned and recorded as written
descriptions.
 The manufacturer should have an adequate number of
personnel with the necessary qualifications and practical
experience.
 All personnel should be aware of the principles of GMP that
affect them and receive initial and continuing training, including
hygiene instruction, relevant to their needs.
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8. Sec. 820.25 Personnel
 Each manufacturer shall have sufficient personnel with the
necessary education, background, training, and experience to
assure that all activities required by this part are correctly
performed
 Training. Each manufacturer shall establish procedures for
identifying training needs and ensure that all personnel are
trained to adequately perform their assigned responsibilities.
Training shall be documented.
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9. Sec.211.25 Personnel qualifications
 Each person engaged or supervising in the manufacture,
processing, packing, or holding of a drug product shall have
education, training, and experience, or any combination thereof,
to enable that person to perform the assigned functions
 Training in current good manufacturing practice shall be
conducted by qualified individuals
 There shall be an adequate number of qualified personnel to
perform and supervise the manufacture, processing, packing, or
holding of each drug product
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10. PERSONNEL VALIDATION
 Personnel are trained accordingly and their work is evaluated to
ensure the quality of the products.
 Thus personnel validation came into picture and the main scope
is to cover all aspects of GMP which includes performance
dimension.
 During personnel validation, one has to demonstrate that
personnel are appropriately qualified and aware of their
responsibilities
ASPECTS:
The two major aspects in personnel validation are
 Personnel Responsibilities
 Personnel Training
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11. Sec. 211.28 Personnel responsibilities
 Personnel engaged in the manufacture, processing,
packing, or holding of a drug product shall wear clean
clothing appropriate for the duties they perform, protective
apparel, such as head, face, hand, and arm coverings, shall
be worn as necessary to protect drug products from
contamination.
 Personnel shall practice good sanitation and health habits.
 Only personnel authorized by supervisory personnel shall
enter those areas of the buildings and facilities designated
as limited-access areas.
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12.  Key personnel responsibilities include authorisation of written
procedures and other documents, including amendments
 Approval of suppliers of materials and contract manufacturers
 The inspection, investigation, and taking of samples, in order to
monitor factors which may affect product quality.
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13. TRAINING
 Training refers to the acquisition of knowledge, skills, and
competencies
Who Needs Training?
 Employees new to the company
 Existing employees — when the nature or content of their job
changes
 Existing employees whose performance at a particular task
declines below required standards
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14. MAJOR TRAINING ELEMENTS:
 Introductory, background (induction or orientation) training for
new employees
 GMP training, including training in hygienic practices
 Specific skills training
METHODS OF TRAINING:
 There are different types of delivery methods for training
 The type to be used should be determined when reviewing the
training needs.
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15. 1.NEW EMPLOYEE ORIENTATION:
 Performed within the first few days of hiring
 Requires a qualified instructor
 Follows classroom type training
 May be held off-site or in a separate area
 Often involves tests during or after training
NEW EMPLOYEE TRAINING PROGRAM OUTLINE Include few
areas that benefit new employees
 Facility overview
 Product overview
 GMP
 Documentation
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16.  General Operating Procedures
 Contamination Control
 Safety
 Operational requirements
 Materials Handling
 Equipment
2. FULL EFFECT TRAINING:
 This is a concept by which key employees are “processed”
through all job functions in the facility
 Gives the employee a full understanding of the unique
operations of each function.
 Requires a qualified individual with strong knowledge of each
area.
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17.  Unique operations include Warehousing, sampling, formulation,
manufacturing, Packaging, Labelling, Marketing overview
 Usually there are no tests after this type of training
3.READ AND UNDERSTAND:
 Employee reads the document (often a procedure) and signs
training documentation stating they read and understand the
document
4.COMPUTER BASED TRAINING (CBT):
 Web based training, Often PowerPoint presentations, or contained
in a learning, education and development system(LEADS)
 Includes online learning, live webinars may also be conducted
 Can have any tests any time during or after training.
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18. 5. CLASSROOM TRAINING (CRT):
 May be held off-site or in a separate area
 Can incorporate the following:
 Video tapes
 Speakers
 Manuals or booklets
 Tours
 Application of instructions or training subjects with company
problems or issues
 Role playing
 Case examples
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19.  The main advantage of CRT is that it provides ample opportunities for
group interaction social learning , practical experience
6. ON-THE-JOB TRAINING (OJT):
 OJT may be one of the most effective forms of training
 Usually performed by a qualified subject matter expert (SME) or
qualified supervision
 If possible, can create a training area for OJT
 Small area with representative equipment to be used for training only
 Usually involves a comprehensive test to verify understanding and
competence on the task .
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20. 7.SELF TRAINING:
 Employee usually takes the initiative and pursues additional training, May include:
 Membership in professional societies
 Training outside the company to increase understanding or knowledge on a job-
related topic .Visits to other companies
 Publications
Magazines
Manuals/booklets
Books
 There are usually no tests.
The evaluation of training could be carried out by using the following techniques:
 Conducting of interviews of the trainees by their immediate supervisor
 Filling up relevant questionnaires
 Through written tests
And finally score is given accordingly
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21. Assessment of Training:
 The effectiveness of training should be assessed during each
session by oral questions and answers, and at the end of each
by a simple, largely multiple choice and question paper.
 In the longer term, assessment should be by observation of
operator performance and adherence to systems and
procedures, as noted during periodic company self audits etc.
Retraining:
 Retraining and/or refresher training should be given whenever:
(a) Assessment of post-training effectiveness, or
(b) Changes in Company organization, systems or technologies
indicate the need.
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22. Training Records
There should be two types of
training records:
1. The personal file of
each member of staff
should contain a record
of the training received,
indicated by module
reference number
1. Departmental training
records should be
maintained, indicating in
tabular form the training
received by each
member of staff.
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23. SOP
•An SOP should be established documenting
how training will be developed, reviewed and
approved, delivered, documented, and
maintained.
•This SOP should also include how and
when employees are qualified and re-
qualified.
•Each standard operating procedure (SOP)
should specify how to complete a routine
task
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24.  SOP for training procedure for quality control
Procedure:
 Qualified individual, knowledgeable in the subject / topic who is
able to effectively communicate the information should conduct
training. A person of supervisory or managerial cadre is most often
required to give training.
 The program should include the following kinds of training:
 Orientation / general information for new and temporary employees
 GMP and GLP concepts and procedures. Theoretical knowledge
for job related training, On the job training.
 General Operations / procedures.
 Outside seminars, conference etc.
 Training should be on continuing basis and with sufficient
frequency. It should include the topics to be covered, the people to
attend and the approximate timing for each session.
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25. Program
 Conduct the training session by any of the methods.
 Evaluate effectiveness and training through questionnaires,
performance indicators direct observation or discussion / review
with supervision for job competence.
 Prepare a report containing the name of trainer, his designation,
names of trainees, subjects covered, evaluation sheets, any raw
data that may have been generated during the course of training
Evaluation of criteria
 In case of questionnaires/individual discussion if the candidate
score
90%-100% - Excellent performance
80%-90% - Very good performance
70%-80% - Better performance
60%-70% - Good performance
50%-60% - Average performance
If the candidates score below 50% they are retrained
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26. GOWNING
Proper Gowning is generally a more satisfactory way of
maintaining adequate standards of dress and the following
guidelines may be applied:
1. A sufficient amount of clean uniforms is provided so that
changes can be made at an adequate defined frequency
or whenever they became soiled.
2. Washing and sanitation procedures should be checked to
confirm their effectiveness.
3. Employees in special clean areas should wear only lint-
free garments to prevent shedding.
4. Garments should be designed and use material that
maximizes personal comfort.
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27. 5. The range of clothing available would normally include:
a. Hats or hair cover
b. Beard and moustache covers
c. Coveralls —preferably with no pockets, or pockets suitably
designed to prevent articles falling out.
d. Disposable gloves
e. Foot covers or shoes
f. Masks
g. Safety glasses or goggles
h. Appropriate clean-room suits for sterile areas
6. Employees should be shown how and when to wear the
appropriate clothing.
7. Work clothing should not be worn outside of the appropriate plant
area, and changing rooms should be available.
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28. Personnel hygiene:
 Personnel should practice good sanitation and health habits.
 Smoking, eating, drinking, chewing and the storage of food
should be restricted to certain designated areas separate from
the manufacturing areas.
 Personnel suffering from an infectious disease or having open
lesions on the exposed surface of the body should not engage in
activities where it effects product’s quality
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29.  The basic objective for personnel validation shall be to
demonstrate the capability of the trained individual to perform
the assigned task.
 Personal Validation is done using the following parameters as
described in the Personal Validation Format
 Quality of work
 Job Knowledge
 Attendance and punctuality
 Working relationships
 Dependability
 Personnel appearance (appropriate dressing)
 Work station efficiency
 Use of the equipment
 Safety practices & Sanitation
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30. During personnel validation:
 Is an organizational chart available covering personnel
 Are job descriptions available for these individuals, indicating
their specific responsibilities
 Number of personnel, their qualification, training its records,
SOP’s are checked.
 Personnel medical reports their hygiene and SOP’s for clothing
and hygiene are checked
 Complaints or remarks are provided in personnel validation
report
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31. PERSONNELVALIDATION REPORT:
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32. GMPAUDITCHECKLIST
 Company brochure
 Literature describing GMP regulations and stressing importance
of following instructions.
 Does each employee receive retraining on an SOP (procedures)
if critical changes have been made in the procedure?
 Is all training documented in writing that indicates the date of the
training, the type of training, and the signature of both the
employee and the trainer? And records readily retrievable
 Are supervisory personnel instructed to prohibit any employee
because of any physical condition
 Are consultants, who are hired to advise on any aspect of
manufacture, processing, packing or holding, of approval for
release of drug products, asked to provide evidence of their
education, training, and experience
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33. FDA's Expectations for Training: A Discussion by a Former FDA
Official & Industry Experts
A teleconference was held by a panel of Experts with FDA & Industry
experience ,it included: - Effective training is both an FDA and an
ISO requirement, and FDA routinely examines training programs
during inspections. Observations on 483s – and even warning letters –
cite drug and device firms not only for failing to have an effective
training program, but also for failing to have the necessary
documentation supporting the program. By this one knows:
 FDA's legal requirements for training personnel
 Requirements for maintaining training records
 Warning letter and EIR citations companies have received for failing to
have documented training records
 Key elements of an SOP on corporate training
There are many such warning letters based on personnel training failure
,personnel hygiene failure and documentation failure
2015 _ Mylan Laboratories Limited 8_6_15.html
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34. CONCLUSION:
 FDA, or any other food and drugs regulatory agency around the globe not only ask for
a product that meets its specification but also require a process, procedures,
intermediate stages of inspections, testing adopted and personnel involved during
manufacturing are designed or trained such that they should produce consistently
similar, reproducible, desired results which meet the quality standard of product being
manufactured
 The company should develop a policy and procedures for identifying training needs
and providing training of personnel and implementing personnel hygiene procedures
 The company should develop a short-term and long-term training plan for each person
 All the documents pertaining to training, personnel hygiene are retained in the custody
of QA department
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35. REFERENCES
 Accessdata.fda.gov. CFR - Code of Federal Regulations Title 21 [Internet]. 2016 [cited 18 February 2016].
Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.25
 Pharmaceutical training guideline [Internet]. 2016 [cited 7 February 2016]. Available from:
http://compliance-insight.com/wp-content/uploads/2013/03/20.020.2-Pharmaceutical-Training-Guideline-
E-version1.pdf
 Good pharmaceutical manufacturing practise. Boca Raton, Florida: CRC press; 2005.
 Accessdata.fda.gov. CFR - Code of Federal Regulations Title 21 [Internet]. 2016 [cited 18 February
2016]. Available from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=211.25
 http://www.compliancezen.com/compliance_zen/2013/06/fda-training-records-three-risky-challenges.html
 [Internet]. 2016 [cited 7 February 2016]. Available from:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS986annex2.pdf
 ICH Q7 guideline [Internet]. 2016 [cited 9 February 2016]. Available from:
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.p
df
 Foiservices.com. FDA’s Expectations for Training: Audio Recording Details [Internet]. 2016 [cited 19
February 2016]. Available from: http://www.foiservices.com/featuredFDATraining.cfm
 Fda.gov. Mylan Laboratories Limited 8/6/15 [Internet]. 2016 [cited 19 February 2016]. Available from:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm458363.htm
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