Here in this presentation includes personnel qualification, responsibilities, training, and Personnel Hygiene to be followed in the Pharma Industry

1. R DEEPTHI
Assistant professor
Vignan institute of pharmaceutical technology
visakhapatnam
PERSONNEL
QUALIFICATION, RESPONSIBILITIES,
TRAINING & HYGIENE

2. QUALIFICATIONS
 There shall be an adequate no. of qualified personnel to perform and supervise
the manufacture, processing, packing, or holding of each drug product.
 Each person responsible for supervising the manufacture, processing, packing, or
holding of a drug product shall have the education, training, and experience, or
any combination thereof to perform assigned functions in such a manner as to
provide assurance that the drug product has the safety, identity, strength, quality,
and purity that it purports to represent.
 Each person engaged 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 the assigned functions. Training shall be in the
particular operations that the employee performs and in current good
manufacturing practice as they relate to the employee’s functions.
 Training in current good manufacturing practice shall be conducted by qualified
individuals on a continuing basis and with sufficient frequency to assure that
employees remain familiar with cGMP requirements applicable to them.

3. The consistent achievement of quality standards requires understanding of, and
compliance with, established procedures.
Consequently, initial screening should select only those individuals who have such
basic skills as reading, writing and numeracy.
An employee who cannot understand written instructions will find it difficult to follow
procedures, an inability to write coherently will inhibit the recording of typical
situations, while a lack of numeracy could make it impossible to perform certain
in-process testing such as statistical process controls. For certain positions
color vision may also be important.
In addition to these basic skills required of every employee, there are specific
requirements for certain jobs, such as qualifications in pharmacy, engineering,
chemistry, microbiology, etc.
In order to define these additional requirements it is important to perform a
knowledge and skills assessment for each job category.
Because of the changing environment in which we work it is essential to re-evaluate
these needs from time to time.

4. Pre-employment screening for the purpose of identifying potential security risks
is of special importance when the pharmaceutical manufacture involves the
handling of controlled substances.
This screening must not only include careful scrutiny of the potential employee’s
personal and previous employment references, but also whether review of
possible criminal background as may be possible.
While the dangers of insecurity with respect to controlled substances are of
concern to the official government bodies as they may involve criminal acts and
frustrate accountability, the effect of loss or diversion of any ingredient or
product will also reflect as a cGMP failure.

5. 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 covering, 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.
 Any person shown at any time (either by medical examination or by supervisory
observation) to have an apparent illness or open lesions that may adversely
affect the safety or quality of drug products, shall be excluded from direct
contact with components, drug product containers, closures, in-process
materials and drug products until the condition is corrected or determined by
competent medical personnel so as not to jeopardize the safety or quality of
drug products. All personnel shall be instructed to report to supervisory
personnel any health conditions that may have an adverse effect on drug
products.

6. The wearing of the uniforms for manufacturing and control operations is not mandated,
only that clothing shall be clean and appropriate for the duties being performed.
In defining what clothing is appropriate, it is necessary to consider the end purpose.
For ex, it would be inappropriate to require hair covering to protect the product from the
inadvertent ingress of hair and then to allow employees to wear clothing that
incompletely covered the hair, did not cover beards or moustaches, or left the arms
uncovered. Yet situations do exist.
The use of plant uniforms 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.

7. 5. The range of clothing available would normally include:
a. Hats or hair cover
b. Beard & 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.

8. The continued wearing of such clothing in cafeteria areas during breaks should also
be evaluated.
Obviously operators in sterile areas will change prior to leaving the area, and this
may be desirable for some others areas, especially to minimize the potential for
cross contamination.
Compliance with the requirements that production processes should not be
exposed to employees who are sick starts with the pre-employment medical
examination.
This will normally include chest x-ray, wassermann test, and tuberculosis test.
Employees should require a fitness statement from a physician, either company or
personnel, for return to work after sick leave greater than a specified period. Annual
medical re-examinations are sometimes required.

9. There should be a liberal policy for those who feel fit for work but show
symptoms of the common cold or other non-disabling illness.
Employees will be reluctant to report these conditions if they are punished by
being sent home, having their pay reduced, or being told to continue work since
“ it doesn’t really matter”.
Ideally, these employees should be allowed to work at tasks in which they
cannot contaminate products and at their usual rate of pay.
Separating an ill worker or one with open lesions from the product by use of
gloves, masks, or special clothing is not recommended.

10. PERSONNEL TRAINING
Introduction
Training is a dynamic process to ensure that personnel are capable of
performing their assigned functions.
Training has far reaching impact on product quality and hence should be given
its due importance.
The trainer must not only explain how to do it but also why to do it because
“telling why” will lead to higher conformance with the specified procedure or work
instructions to SOPs (standard operating procedures) and cGMP (current Good
Manufacturing Practices).
Training is an integral part of cGMP.
Sufficient training must be given to keep the cGMP knowledge updated and to
cover any gap areas in the knowledge.

11. Scope
The policy applies to the training of all the employees, including contract and
temporary staff, involved in the production, testing, distribution (including those
in related support activities) and marketing of products produced by the
company.
Policy
1. Requirement
The company must identify the jobs in their organizations where the
performance of the job holder may affect product quality or safety or
environment. Management is responsible for ensuring that the persons
employed in these positions have an appropriate combination of:
I. Education
II. Training
III. Experience
So as to enable the persons to perform their assigned function. Until these
requirements have been met, additional supervision must be provided.

12. 2. Training must cover:
I. The specific operations that the employee performs.
II. Relevant aspects of current Good Manufacturing Practices (cGMP) and the
company’s Business Policy and Philosophy.
III. Training must be conducted by appropriately qualified and trained individuals.
a. SCOPE
1. Training must cover not only specific tasks but also Good Manufacturing
Practices and the importance of personal hygiene, safety and environment
awareness and procedures.
2. Training of production, quality assessment, engineering and service staff (ex.
Cleaning staff, whether employed by the company or by contractors) should be
in accordance with written programmes, and must be administered on
recruitment, and repeated with sufficient frequency to ensure that the
employees remain familiar with current requirements of GMP.
Training should be designed to ensure that employees understand at least the basic
principles behind the operations that they are expected to perform.

13. 2. Training records for individual employees must be maintained.
3. Special attention must be given to the training of staff working in aseptic areas
including relevant cleaning and engineering staff who enter these areas. Special
instruction must also be given to staff working with highly potent, toxic, reactive,
inflammable or sensitizing materials.
4. Special training and handling instructions must be given to employees
handling material with carcinogenic potential and to men and women of
reproductive age group for handling hormones.
5. Training must support the quality improvement as well as environment, health,
and safety programmes instituted by the company.
I. It should monitor and evaluate the effectiveness of training and the
competency of all personnel.
II. Emphasize on retention of production records and documents for the
required period of time.
III. Monitor and make sure that validation of production processes and
equipment are adequate.

14. iv. Must ensure that all significant changes to a validated process including
changes to facilities, equipment, materials, process steps, computer control
systems, utilities are subject to a comprehensive review and approval by
competent authorities, including Quality Personnel.
b. REQUIREMENTS
1. Identification of training needs is a continuous, on-going activity. All
individuals working at supervisory grade and above should identify training
needs for individuals working under them.
2. All personnel involved in the processing of a pharmaceutical product should
have appropriate level of education, training and experience to enable them
to perform their job responsibilities. The training must be in the specified job
functions the individual oversees.
3. In addition to specific job training, all personnel involved in the processing of
a drug product must be trained in GMPs before they perform their job
functions. It is recommended that all personnel must also receive periodic
GMP training at least three times in a year.

15. 4. All personnel involved in the processing of a drug product must be trained in
safety and environment procedures before they perform their job and receive
periodic safety and environment training.
5. Personnel performing jobs in hazardous areas or controlled environments (
such as clean rooms or sterile areas, handling toxic materials etc.) must receive
specific training to minimize the risk to personnel and drug products.
c. FREQUENCY
There must be induction and follow-up training at sufficient frequency to ensure
that employees are familiar with current GMP requirements and have the
knowledge and skills necessary to perform their assigned duties and
responsibilities. A schedule or calendar should be documented and established
for each employee for every year.
d. FORMAT
Training needs are different for different personnel. A training format must be
prepared in order to cover all the customised training programmes for personnel
functioning at various levels.

16. e. EFFECTIVENESS
The effectiveness of the training programme must be evaluated to ensure that it
fulfills the intended requirement. Evaluation is closely tied to the other steps that
should be undertaken to plan, implement, pilot, conduct and then evaluate a
training programme. Training given should be documented.
f. DOCUMENTATION
1. Training programmes must be documenented and records kept to
demonstrate that
- All personnel are capable of performing their assigned duties.
- All processes are carried out by appropriately qualified and trained personnel
Additionally, there must be records of:
- Content of training programme
- The in-house and external training received by individual employees
- Bio-data & experience details of trainer with training material where
available.

17. 2. The documentation and records must be retained for a definite period of time
depending upon the company’s policies.
g. MANUAL OF INSTRUCTIONS
1. The training manual should be updated from time to time incorporating the
additional requirements of the company.
2. A person should be designated to oversee the training needs of the company
and he should be the person responsible for updating and issuing
instructions to the participating department.

18. PERSONAL HYGIENE
1. GENERAL REQUIREMENTS & RESPONSIBILITIES
Drugs are intended for the treatment of disease and the protection of health.
Drug manufacturers, therefore, have a special responsibility to ensure that their
products are free from any kind of contamination.
A major contributory factor in contamination is the human body which carries
very many organisms and particulate matter.
Every person who produces a drug or handles drug substances and other
components has to comply with certain minimum requirements of health,
personal cleanliness, hygienic operations and clothing to protect himself and the
product.
It should be clearly understood that requirements regarding personal hygiene
and protective clothing apply to all persons entering production areas. This
includes visitors, maintenance staff, senior management staff and government
and other inspecting authorities.
It is the responsibility of the factory management to ensure that the minimum
requirements shown hereunder are observed by all persons entering production
areas.

19. 2. HEALTH
 It would be advisable to put in writing the minimum health requirements of
personnel who work in the factory and in the laboratory.
 A pre-employment medical examination inclusive of eye testing must be
insisted upon, this is applicable even to the employment of temporary
operators.
 Yearly health checks should be carried out on all factory personnel and
special attention should be paid to persons with any disease in a
communicable form.
 If an employee is suffering from an infectious disease like conjunctivitis or
severe cold, then he should not report to work.
 When employees report for work after an absence due to illness involving a
communicable disease, they should not commence work till their health has
been assessed by a competent medical officer or nurse.

20.  Staff should be encouraged to report infectious diseases, particularly enteric
(stomach) disorders and respiratory diseases. Similarly, they should be
asked to report any infectious diseases which occur at their homes. This will
enable the supervisor to arrange for their temporary transfer to other work
areas.
 Staff should be trained to report any boils, carbuncles, open wounds, or
rashes on exposed surfaces of the body. Personnel with these conditions
must be excluded from operations involving direct contact with materials and
equipment until the condition is corrected.
 Supervisory staff should look for signs and symptoms of unhealthy conditions
of persons working in their areas.

21. 3. PERSONAL CLEANLINESS
Strict attention to personal hygiene is essential to stop the spread of bacteria.
 Staff should be advised and encouraged to have regular baths and to change
their underclothes frequently.
 Hands should be cleaned regularly and certainly always after visiting the
toilet. Nails should be clipped regularly. Staff should be trained in the use of
a soap and other hand washing facilities.
 Hair should be kept clean and well controlled at all times. Male operators
should be encouraged to be clean shaven and not keep beards. Beards, if
maintained, should be covered.
 Wearing of jewellery such as bracelets, pendants, rings, ear-rings etc. should
be discouraged. Women operators should wear the minimum make-up.
 False eye lashes, false nails, hair pieces, wigs or any other beauty aids that
are likely to fall into the product must not be permitted.
 Staff should be suitably advised regarding cosmetics and jewellery permitted
at the place of work.

22. 4. HYGIENIC OPERATIONS
A satisfactory level of hygiene can be achieved only if every one makes it a
personal responsibility by following these elementary rules:
 Food and drinks must not be consumed in the manufacturing, packing,
storage and laboratory areas. This includes the chewing of paan, betel nuts,
by personnel in any production/ storage area.
 Smoking must not be permitted in any processing, storage or laboratory
areas. ‘No smoking’ signs should be displayed in prominent position at points
of entry to those areas.
 Food, drink and smoking material should not be stored in manufacturing
areas and in any other area where they might adversely affect product
quality. Likewise, personal medication should not be permitted in such areas.
The protective clothing pockets should not be used for storing food.
 Staff should be trained to keep working areas clean and uncluttered and to
clean down and clear away all items from one job before starting another.
 It must be ensured that staff keep their lockers in a clean and tidy condition.
Unclean lockers are a big source of contamination.

23. 5. PROTECTIVE CLOTHING
The purpose of protective clothing is not only protection of the individual but also
protection of the product from the individual. The use of protective garments
does not in any way obviate the need for clean clothes, underclothes and
footwear.
 No person should ever enter the production area wearing only street clothes.
They should always be supplemented or replaced by protective garments as
decided by the individual company.
 Clean working garments and protective apparels such as head, face, hand,
shoe and arm coverings must be worn as directed.
 While handling dangerous or volatile materials, personnel must be protected
by suitable clothing and additional devices such as head coverings, anti-dust
masks, safety goggles etc.
 Protective garments should not be worn outside factory premises. The
practice of going out into the streets and back to the place of work in the
same factory garments should be prohibited.

24.  Protective clothing should be clean at all times and should be changed
regularly after frequent laundering (at least twice a week).
While deciding upon the laundering contractor, attention should be paid towards
his method of washing and the source of water being used for laundering.
Contractors having washing/drying machines should be employed. Contractors
doing washing on the banks of the river should not be employed.
 Clothing must be worn correctly, where buttons are provided they should all
be fastened. Damage to protective clothing should be repaired.
 Particular care should be taken to ensure that the headgear covers the hair
completely. Beards should be covered completely.
 Protective clothing should preferably have no pockets above waist level as
any articles kept in pockets are likely to fall into the product in the course of
work.

25. PERSONAL HYGIENE – STERILE PRODUCTS
a. GENERAL REQUIREMENT
During and after the manufacture of sterile products, particularly injectable,
special precautions and procedures are essential because of the dangers of
contamination.
Operators working in sterile processing areas and their clothing could become a
source of contamination if they do not pay attention to matters of hygiene and
cleanliness and the right habits of working. The requirements of personal
hygiene have been detailed in the document entitled ‘Personal Hygiene’.
The following guidelines deal with the additional precautions necessary for
personnel involved in the manufacture of sterile preparations.

26. b. HEALTH
1. Staff with open wounds, rashes , boils or any skin ailment must not be
permitted to work in clean and aseptic areas.
2. Staff suffering from upper respiratory tract infections, colds, coughs, hay
fever etc. must not be allowed to work in clean and aseptic areas.
3. Periodic health checks for the aforementioned conditions should be done.
4. All the operators working in aseptic areas and taking part in the manufacture
of products should be monitored by taking their swab tests.
Weekly swabs of the persons working in the sterile area should be taken.
Swabs of nose, ear, skin, throat may be taken.

27. c. PERSONAL CLEANLINESS
1. Nails of persons working in clean and aseptic areas should be regularly trimmed.
2. Staff should be encouraged to keep their hair short and clean, shave their beards
and moustaches in order to minimize the hazards of contamination from hair.
3. Jewellery and cosmetics particularly rings and watches should not be allowed in
sterile working areas.
4. Attitude of cleanliness should be instilled in staff by training in basic elements of
microbiology.
d. HYGIENIC OPERATIONS
1. The no. of persons working in aseptic areas should be kept to the minimum
practicable.
2. Staff should not move about unnecessarily in aseptic areas, movements should not
be jerky, because movement increases particulate and bacterial shedding.
3. Persons engaged in maintenance work or process adjustments or rectification of
minor faults of equipment must observe the same precautions and hygienic
standards as production personnel.

28. e. PROTECTIVE CLOTHING
1. Staff working in clean or aseptic areas should change into special garments
which include head and footwear. Such garments should be comfortable to
wear and with loose fitting.
2. Edges of the garments should be sealed and the seams should be all
enveloping. The garments should not have external pockets and
unnecessary tucks or belts.
3. Sterile area garments should shed virtually no fibres or particulate matter
and should retain particles shed by the body. They should be cleaned and
sterilised in such a way that they do not gather contaminants which can later
be shed while working.
4. Personnel working in aseptic areas should wear sterilised single or two piece
trouser suits, with high necks and gathered at the wrists and ankles.

29. THANK U…