Organization & Personnel

1. ORGANIZATION AND PERSONNEL
Personnel responsibilities Training
Hygiene Personal Records

2. Personnel
• To carry out various tasks in manufacturing unit-
sufficient no. & qualified personel
• Individual responsibilities of persons concerned
& to be recorded
• All must be aware of GMP
• Therefore, training, hygiene instructions required

3. Guidelines as per Sch M of D&C act 1945
• Mfg. must be under supervision of technical staff
with req. qualification & practical experience in
relevant field
• Head, QC lab should b independent of Mfg. Dept.
• QA, QC personel- req. qualification & practical
experience
• Written duties to be laid down & followed strictly
• Regular in service training programmes for
personnel of production area as per duty assigned
to b ensured by licensee

4. Health clothing & sanitation
• Handing of beta lactum antibiotics- persons to be tested
for penicillin sensitivity before employment
• Handling of cytotoxic substances & potent drugs- regular
examination for adverse effects
• Persons should be moved from these sections on
rotational basis for health safe guard
• Before employment- medical examination including eye,
communicable, contagious diseases testing
• Medical examination once a year, with proper record
• Training in practices of mfg. to ensure personnel hygiene
• Person with apparent illness must not b allowed to handle
starting, packaging, in process materials & drug products
which may have adverse affect on quality of products.
• Personnel must report about their illness to supervisor

5. • Direct contact to b avoided between unprotected
hands of personnel & raw materials, intermediate or
finished products
• Must wear clean body coverings for their concerned
duties.
• Before entering mfg. area, changing rooms for each
gender with facilities of cleanliness like wash basin
with running water, clean towels, hand dryers,
soaps, disinfectants etc. Cabinets for storage of
personnel belongings.
• Smoking, eating, drinking chewing not be permitted
in production and testing areas.

6. WHO GMP guidelines for personnel involved in the mfg
of Pharmaceutical products
Head of production & quality unit have following responsibilities:
• Authorization of written procedures
• Monitoring of manufacturing environment
• Maintenance & evaluation of personnel hygiene
• Conduction of process validation & calibration of analytical instruments
• Organizing personnel training
• Evaluation of in process controls
• Documentation of records
• Checking status of compliance with GMP requirements
• Performing self inspection
• Approval or rejection of starting materials, packaging materials &
finished products in relation to their specs.
• Evaluation of batch records
• Monitoring of analysis carried out under contract
• Checking of maintenance of premises & equipments
• Implementation and maintenance of quality system

7. Responsibility of Authorized personnel to release a
batch
• To ensure that principles of GMP have been
followed
• Mfg. and testing procedures have been validated
• All necessary test have been performed
• All required Production and QC documentation
have been completed & certified by supervisors
trained in appropriate disciplines
• Relevant audits & self inspections are carried out
by experienced and trained staff

8. KEY PERSONNEL
• Includes Head of Production/Quality unit or authorized
person
• Quality unit Head: To observe QA & QC functions
• Full time basis
• Should be independent heads
• Good Scientific education and Practical experience to
perform independent professional judgement
Education includes
• Chemistry or biochemistry
• Chemical engineering
• Microbiology
• Pharmaceutical sciences
• Pharmacology
• Toxicology

9. KEY PERSONNEL- Training
• Approved Training programmes as per written programme &
relevant to allotted duties for all personnel must be conducted
• Written records of all trainings to be maintained
• Concept of hygiene, sanitation, quality audit etc to be discussed
• Must be trained on Theory & Practice of GMP
• Regular trainings with periodic assessments of practical
effectiveness
• Special training for those working in hazardous area like clean
areas, or areas with highly active or toxic or where infectious
materials are handled
• Concept of QA & others that help to understand the
implementation of GMP must be discussed during training
• Visitors/ untrained personnel must not be permitted into production
or QC areas or else relevant information to be given in advance on

10. Personal hygiene
1. Periodic health and eye examination for all
2. Instructions for hand wash before entering Mfg area
3. Person with open lesions/illness which might affect the quality of
product should not be allowed to handle starting materials, in-
process materials, or finished products until at risk
4. Automated/semi automated Mfg. process to be used to avoid
direct contact of personnel with materials/bulk products
5. Should wear clean body coverings during duties in Mfg
6. Used cloths if reusable to stored separately & laundered,
disinfected, sterilized
7. Smoking, eating, drinking, chewing or keeping food, drinking &
smoking material not permitted in Production lab/store room etc.
8. Personnel hygiene procedures, wearing of protective clothing to
be followed strictly in production areas

11. WHO GMP requirements for API’S
PERSONNEL
1. Sufficient no./qualified personnel- education/
training/ experience to perform Mfg of API
2. Responsibilities of all the personnel must be
recorded and documented
3. Training must be conducted regularly by qualified
individuals & must cover the operations conducted
by employees. Record of training
4. Periodic assessment of training

12. Personnel Hygiene
1. Good health habits to maintain personel hygiene
and sanitation
2. Should wear clean clothing
3. Protective apparels like head, face, hand arm
coverings to be worn when required to protect
API’s / intermediates from contamination
4. Avoid direct contact with intermediates or API’s
5. Smoking, eating, drinking, chewing storage of food
must be prohibited in designated areas
6. Personnel with infectious contagious disease or
with open lesions on exposed surface should not be
involved in activities so as to effect the quality of
API’s

13. CONSULTANTS
• To advise on Mfg. & control of intermediates
of API’s
• Must be qualified, trained, experienced
• Records to be maintained with names, address,
qualification, types of services provided by
consultants

14. WHO GMP guidelines for Mfg. of Sterile
Products
Personnel
1. Minimum no. in sterile areas particularly during
aseptic processes.
2. Inspections, controls should be conducted outside
such areas
3. Persons concerned with cleaning & maintenance in
sterile areas to be given initial & regular training
relevant to correct mfg. of sterile products,
including hygiene & basics of microbiology
4. Staff engaged in processing of animal tissue
material, cultures of microorganisms other than
used in Mfg process should not enter in sterile
product areas until rigorous and defined
decontamination procedures have been followed

15. Personnel
5. Proper standards of personnel hygiene & cleanliness should be
maintained by personnel involved in mfg of sterile product
6. Personnel working should be instructed to report any abnormal
conditions that may be cause of contaminant
7. Periodic health checks for all personnel are desirable
8. Preventive & remedial actions must be taken by designated
competent person with respect of personnel introducing undue
microbial hazards in working area
9. Changing & washing should follow a written standard procedure
designated to minimize contamination of clean area clothing or
carry through contaminants to clean areas.
10. Clothing & its quality should be proper as per process & grade
of working area
11. Clothing of personnel working in sterile area should be made of
such fibres that no shedding from clothing is made
12. Clothing should be laundered or cleaned in such way that it
does not gather additional particulate contaminants

16. Personnel
13. Clothing should be worn such that it protects the product
from any contamination
14. Protective clothing like one piece jumpsuit, facemask etc &
shoes/ shoe covers to be worn
15. Only disinfected gloves & masks should be used during
working in the sterile area. Footwear should be disinfected or
sterilized. Garment sleeves must be tucked into gloves
16. Personnel working in different grade areas should wear
sanitized eye protector
17. Protective clothing must not shed any fibers/ particulate
matter & must be able to retain particles shed by body.
18. Washing & sterilization process as SOP
19. Wearing of watches, jewellary or any kind of extreme
fancy/cosmetic item by personnel should be prohibited
20. Hair, beard, moustache should be covered