PRINCIPLE
High level or sanitation and hygiene should be
practiced in every aspect of manufacturing pharmaceutical products. The scope
of sanitation and hygiene covers personnel, premises, equipment and apparatus,
production materials and containers and anything that could become a source of
contamination to the product. Potential sources of contamination should be
eliminated through an integrated comprehensive program of sanitation and
hygiene.
PERSONAL HYGIENE
Every person entering the manufacturing areas should wear protective
garments appropriate to the operations to be carried out.
Personal hygiene procedures including
requirement of using protective clothing should apply to all persons entering
production areas, whether they are temporary or full-time employees or
non-employees on company property, e.g. contractor’s employees, visitors,
senior management and inspectors.
To assure protection of the product from
contaminations as well as the safety of the personnel, they should wear clean
body-coverings appropriate to the duties they perform, including appropriate
hair covering. Soiled uniforms and soiled cleaning cloths (if reusable) should
be stored in separate closed containers until properly laundered.
Detailed hygiene programmes should be
established and adapted to the different needs within the manufacturing area.
They should include procedures relating to the health, hygiene practices and
clothing of personnel. These procedures should be understood and followed in a
very strict way by every person whose duties take him into the production and
control areas. Hygiene programmes should be promoted by management and widely
discussed during training sessions.
All personnel should receive medical examination
upon recruitment. It must be the manufacturer's responsibility that there are
instructions ensuring that health conditions that can be of relevance to the
quality of products come to the manufacturer's knowledge. After the first
medical examination, examinations should be carried out periodically for the
work and personal health. Visual inspectors should also undergo periodic eye
examination.
All personnel should practise good personal
hygiene. They should be trained in the practices of personal hygiene. A high
level of personal hygiene should be observed by all those concerned with the
manufacturing processes.
Any person shown at any time to have an apparent
illness or open lesions that may adversely affect the quality of products
should not be allowed to handle starting materials, packaging materials,
in-process materials, and pharmaceutical products until the condition is
improved.
All personnel should be instructed and
encouraged to report to their immediate supervisor any condition (plant,
equipment or personnel) that they consider may adversely affect the products.
Direct contact should be avoided between the
operator's hands and the exposed starting materials, intermediate and bulk
products as well as with any part of the equipment that comes into contact with
the products.
Personnel should be instructed to use the
hand-washing facilities and to wash their hands before entering production
areas. Signs to this effect should be posted.
Smoking, eating, drinking, chewing or keeping
plant, storage of food, drink, smoking material or personal medicines should be
restricted to specific areas and not permitted in production, laboratory,
storage areas and other areas where they might adversely influence product
quality.
Special requirements for sterile products are
covered in Annex 1.
PREMISES SANITATION
Premises used for manufacturing pharmaceutical
products should be suitably designed and constructed to facilitate good
sanitation.
Adequate employee’s washing and well ventilated
toilet facilities should be provided and easily accessible to manufacturing
areas.
Suitable facilities should be provided in
appropriate locations, for storage of employee clothing and personal property.
The preparation, storage and consumption of food
and beverages should be restricted only to specific areas, such as lunch room.
These facilities should meet sanitary standards.
Waste material should not be allowed to
accumulate. It should be collected in suitable receptacles for removal to
collection points outside the buildings and disposed of safely and in a
sanitary manner at regular and frequent intervals.
Rodenticides, insecticides, fumigating agents
and sanitizing materials should not be permitted to contaminate equipment,
starting materials, packaging materials, in-process materials or finished
products.
There should be written procedures for use of
suitable rodenticides, insecticides, fungicides, fumigating agents, and
cleaning and sanitizing agents. Such written procedures should be designed to
prevent the contamination of equipment, components, pharmaceutical product
containers, closures, packaging, labelling materials, or finished products and
should be followed. Rodenticides, insecticides, and fungicides should not be
used unless registered and used in accordance with the relevant regulation.
There should be written procedures assigning
responsibility for sanitation and describing in sufficient detail the cleaning
schedules, methods, equipment, and materials to be used in cleaning the
buildings and facilities; such written procedures should be followed.
Sanitation procedures should apply to work
performed by contractors or temporary employees as well as work performed by
full-time employees during the ordinary course of operations.
Any unhygienic practice within the manufacturing
areas or in any other area where the product might be adversely affected,
should be forbidden.
Special requirements for sterile products are
covered in Annex 1.
EQUIPMENT CLEANING AND
SANITATION
Equipment should be cleaned both inside and
outside after use according to established procedure and should be kept or
stored in a clean condition and be checked for cleanliness prior to each use to
ensure that all products or materials from the previous batch are removed.
Vacuum or wet cleaning methods are to be
preferred. Compressed air and brushes should be used with care and avoided if
possible, as they increase the risk of product contamination.
Cleaning and storing of mobile equipment and
storing of cleaning materials should be done in rooms separated from processing
areas.
Written procedures in sufficient detail should
be established, validated and followed for cleaning and sanitizing equipment
and containers used in the manufacture of pharmaceutical products. These
procedures should be designed to prevent equipment contamination by cleaning or
sanitizing agents and should at least include responsibility for cleaning,
cleaning schedule, method, equipment and materials used in cleaning operations,
the method of disassembling and reassembling equipment as appropriate to assure
proper cleaning and where necessary sterilization, removal of previous batch
identification, protection of clean equipment from contamination prior to use.
Record of cleaning, sanitizing, sterilization
and inspection prior to use should be kept properly.
Disinfectants and detergents should be monitored
for microbiological contamination; dilutions should be kept in previously
cleaned containers and should only be stored for defined periods unless
sterilized.
VALIDATION OF CLEANING AND
SANITATION PROCEDURES
In all instances, the cleaning, sanitation and
hygiene procedures should be validated and periodically assessed to ensure that
the effectiveness of the procedures meet the requirements.