The pharmaceutical industry is an important component of health care systems

throughout the world; it is comprised of many public and private organizations that
discover, develop, manufacture and market medicines for human and animal health
(Gennaro 1990). The pharmaceutical industry is based primarily upon the scientific
research and development (R&D) of medicines that prevent or treat diseases and
disorders. Drug substances exhibit a wide range of pharmacological activity and
toxicological properties

The manufacturing of pharmaceutical products has to be maintained at high standards to ensure the
strength of the active ingredients, quality and purity of the final products. These standards ensure safe
and effective products for patients. Minute changes in any of these factors can have serious
consequences for patients, therefore the controls and checks put in place need to be far more stringent
than, for example, the food industry.

The medical profession and patients expect medicines to be consistently produced to a high level of
precision and safety with every new batch. But it is virtually impossible for the medical or pharmacy
professional, much less the consumer, to tell if a pharmaceutical product as supplied by the
manufacturer is safe, or if it contains what it is supposed to contain.

The major burden for ensuring consumer safety, lies firmly at the manufacturing stage, where it is
essential to use industry-accepted Good Practices to maintain safety and efficacy.

Good practices for drug manufacturing

Both regulatory authorities and Pharmaceutical industry itself puts great emphasis on manufacturing

pharmaceutical products using practices and processes that ensure high levels of quality and safety built
into every step. 

Sanitation and hygiene GMPs

Good Manufacturing Practices form part of a pharmaceutical quality system. It aims to minimise the
risks in manufacture to ensure safety, quality and efficacy.

 A manufacturer has responsibility to ensure the pharmaceutical products are fit for use, comply
with marketing authorisation requirements and have adequate safety, quality and efficacy.

 Senior management has the responsibility to ensure that the pharmaceutical quality system is
adequately resourced, roles, responsibilities and authorities are clearly defined and
communicated.

 Pharmaceutical manufacture requires high levels of sanitation and hygiene at every point of the
process, covering personnel, premises, equipment, materials, containers, and cleaning and
disinfection products.
  It also requires elimination of potential sources of contamination, both for hygiene purposes
and for medical effectiveness, which could be affected by, for example, dust from other product
ingredients or cleaning compounds.

The basic sanitation and hygiene GMPs below are derived from WHO guidelines (WHO, 2011):

Personnel

There should be sufficient numbers of qualified personnel who should be aware of the principles of GMP
applicable to their role, including hygiene practices.

Personal hygiene

 Health checks: personnel should undergo health checks before and during employment.

 Hygiene practices: all personnel involved in the manufacturing process should practice a high
level of personal hygiene.

 Illness: staff having an illness or open wounds that could affect product quality must not handle
starting materials, packaging, in-process materials or medicines, until they have recovered and
are no longer a risk. Staff and contractors who may be suffering from a food-borne
illness (symptoms include diarrhoea, vomiting, hepatitis) must inform the customer site contact
and determine whether they may enter the pharmaceutical company premises.

 Handling goods: there should be no direct contact between hands and starting materials,
primary packaging materials, and intermediate or bulk products.

 Clothing: persons in the production areas should wear clean body coverings as appropriate,
including production staff, contractors, employees, visitors, managers and inspectors.

 Personal habits: eating, drinking, chewing, smoking should not be allowed in the production,
laboratory and storage areas. Food, drink, smoking products and personal medicines should not
be allowed in these areas also.

Premises

 Location: premises should be located in an environment that minimises the risk of

contamination of materials and products.

 Design and layout: the design and layout of the premises must facilitate good sanitation and
allow effective cleaning and maintenance to prevent cross-contamination and build-up of dirt.
As well as being appropriate for the activities for which the premises are used, the design and
construction of pharmaceutical premises should not permit the entry of pests and not provide
harbourage for pests.

 Pest control: there should be pest control procedures that encompass Integrated Pest

Management (IPM) to reduce or eliminate pests.
  Cross-contamination: measures should be taken to prevent cross-contamination from dust
generated during manufacturing operations from handling of ingredients.

 Cleaning: premises should be cleaned and disinfected according to written procedures and

records kept.

 Services: lighting, temperature, humidity, ventilation and electrical supply should not adversely
affect pharmaceutical products or the functioning of equipment.

 Staff facilities: facilities for changing, washing, toilets, eating and rest should be separate from
production and storage areas. Facilities should be appropriate for the number of users.

 Storage areas: these should be designed to ensure suitable conditions: dry, clean, well lit, and
maintained within suitable temperature limits.

 Delivery and dispatch areas: these should be designed to protect products from the weather
and be designed and equipped to allow cleaning of delivery containers.

 The layout of production areas: premises should be designed to allow production to take place
in a logical order and with required cleanliness levels.

 Surfaces: interior surfaces of walls, floors, ceilings should be smooth, free of cracks and loose
materials, and allow effective cleaning and disinfection.

 Fittings: pipework, light fittings, ventilation fittings should be designed for ease of cleaning and
maintenance.

 Drains: drains should be of sufficient capacity and designed to prevent back flow

 Ventilation: production areas should have suitable ventilation to prevent contamination from

external and internal sources, and control temperature and humidity as appropriate.

Equipment

 Layout and design: the layout and design of equipment should allow effective cleaning and
maintenance and prevent cross-contamination and build-up of dirt or dust. Layout and design
should not permit pest harbourage.

 Cleaning: equipment should be cleaned using validated procedures, according to a suitable

schedule and records kept of the procedures, times and results of tests.

 Equipment for cleaning: equipment for washing, cleaning and drying should be suitable for use
and not contaminate products.

Materials
  Cleaning: materials used for cleaning should be of the appropriate grade for use with
pharmaceutical equipment and should not come into contact with products.

 Pest control: pest control materials, including rodenticides, insecticides and fumigation gases,

should not contaminate equipment, starting materials, packaging materials, materials in process
or finished products.

 Water: water used in the manufacturing process should be of suitable quality.

Waste disposal

Waste should be removed from production areas and properly stored in suitable containers in
designated areas and disposed of in a timely manner.

Standard operating procedures and records

Standard operating procedures, with appropriate records should include:

 maintenance, cleaning and sanitization, including for each piece of equipment;

 relevant personnel matters including qualifications, training, clothing and hygiene;

 pest control: the pest control contractor should have a Standard Operating Procedure (SOP) that
complies with HACCP and is designed by the pest manager in conjunction with the
pharmaceutical business. The program should support the GMP for the pharmaceutical business
and include all legislative requirements and ensures Industry best practices.

Good production practices

Pharmaceutical products need particular care to prevent contamination and cross-contamination from
materials and other products such as living microorganisms, hormones, toxic substances, and other
active substances.

 Cross-contamination: this can occur from the release of dust, gases, particles, vapours, sprays or
organisms from materials and products in production processes. Appropriate measures to
prevent this include:

o self-contained production areas;

o airlocks, pressure differential, air supply and extraction systems, as appropriate for the
required cleanliness levels;

o wearing protective clothing;

o using effective cleaning and decontamination procedures;

  Contamination: any foreign object or material found in the finished product could also
introduce disease or cause poisoning of consumers. Contamination can be physical, biological
and chemical e.g. insects, rodents, rodent droppings, pathogens such
as Salmonella, Listeria, E.coli. Contamination can occur from:

o residues on equipment;

o insects and other pests;

o operators’ clothing, skin, jewellery etc. Staff and contractors must have a documented
clothing and jewellery policy.

o particles from the building structure and fittings;

o pipework supplying water, including distilled or deionised water; these should be free of
defects and cleaned appropriately;

o containers in the production line should be cleaned before filling and any physical
contaminants removed.

That is why distribution is an essential activity to ensure that these populations as well as other end-
users can acquire safe and effective medications for the improvement of their health outcomes. To
attain this, only persons or entities which are authorized to do so and/or which hold the appropriate
licence should be entitled to distribute pharmaceutical products. All personnel involved in distribution
activities should be trained and qualifi ed in the requirements of GDP, as applicable. Training should be
based on written standard operating procedures (SOPs). Personnel should receive initial and continuing
training relevant to their tasks, and be assessed as applicable, in accordance with a written training
programme. In addition, training of the personnel should include the topic of product security, as well as
aspects of product identifi cation, the detection of counterfeits and the avoidance of counterfeits
entering the supply chain. A record of all training, which includes details of subjects covered and
participants trained, should be kept.

The nature of the risks involved is likely to be similar to that for risks encountered in the manufacturing
environment, e.g. mix-ups, adulteration, contamination and cross-contamination. When the distribution
chain is interrupted by manufacturing steps such as repackaging and relabelling, the principles of good
manufacturing practices (GMP) should be applied to these processes

There are requirement for the personnel in the distribution process, the quality system,
premises, warehousing, or storage, vehicles and equipment, and shipment containers and
labeling, 
Based on the personnel, All  involved in the distribution activities should be trained initially and
continually in accordance with the written standard operating procedures and qualified in the
requirements of the Good Distribution Practice. In addition, training of the personnel should
include the topic of product security, as well as aspects of product identification, the detection of
counterfeits and the avoidance of counterfeits entering the supply chain. A record of all training,
which includes details of subjects covered and participants trained, should be kept. There
should be an adequate number of competent personnel involved in all stages of the distribution
of pharmaceutical products in order to ensure that the quality of the product is maintained.
Appropriate procedures relating to personnel hygiene, relevant to the activities to be carried out,
should be established and observed. Such procedures should cover health, hygiene and
clothing of personnel.

1. efficient and effective regulatory capacity, procurement and 

management of supplies and logistics

Philippine-WHO cooperation for health and development

The design and use of vehicles and equipment must aim to minimize the risk of errors and permit
effective cleaning and/or maintenance to avoid contamination, build-up of dust or dirt and/or any
adverse effect on the quality of the pharmaceutical products being distributed. There should be
procedures in place for the operation and maintenance of all vehicles and equipment involved in the
distribution process, including cleaning and safety precautions.