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PERSONNEL VALIDATION

BY:

G.SAI SUSHMITHA

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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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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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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WHO-PERSONNELNEED??

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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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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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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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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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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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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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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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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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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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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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.  1

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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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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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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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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 testsAnd finally score is given accordingly

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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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Training RecordsThere 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

2. Departmental training records should be maintained, indicating in tabular form the training received by each member of staff.

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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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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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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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GOWNING Proper Gowning is generally a more satisfactory way ofmaintaining adequate standards of dress and the followingguidelines 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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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 areas6. 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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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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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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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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PERSONNEL VALIDATION REPORT:

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GMP AUDIT CHECKLIST 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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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 trainingThere are many such warning letters based on personnel training

failure ,personnel hygiene failure and documentation failure2015 _ Mylan Laboratories Limited 8_6_15.html

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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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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.pdf

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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