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Good Pharmacy Practice
1. GOOD COMMUNITY PHARMACY PRACTICE
Good Pharmacy Practice (GPP) defines pharmacists
provide quality pharmacy service to every patient. It
is the practice of pharmacy that responds to the
needs of the people, who use the pharmacists’
services to provide optimal, evidence based care.
2. Good Pharmacy Practice (GPP) organizes following
major roles for pharmacists:
1. Prepare, obtain, store, secure, distribute,
administer, dispense and dispose of medical
products.
2. Provide effective medication therapy
management.
3. Maintain and improve professional
performance.
4. Contribute to improve effectiveness of health
care system and public health.
3. National Good Pharmacy Practice standards was initiated at
Department of Drug Administration (DDA) in 2003
supported by WHO. This responsibility was given to Nepal
Pharmacy Council.
Nepal Pharmacy Council has prepared the guidelines of
Good Pharmacy Practice (GPP). It has stated various
requirements for the Good Pharmacy Practice (GPP):
• Premises/layout
• Furniture
• Equipment
• Manpower
• Material
• Documentation
• Inventory control
• Storage
• Services
4.
5. REQUIREMENTS OF PREMISES/LAYOUT
• The location of pharmacy should be such that it is easily
identified by the public.
• The environment in the pharmacy should be neat and clean.
• It should have clearly marked word “PHARMACY-फार्मेसी”
(औषधी पसल) written in English as well as Nepali.
• The pharmacy should also be accessible to disabled people or
people using wheel chairs.
• It should have display counter, shelves for medicine storage,
counselling area, waiting area, billing area, adequate space
for movement and waste collection boxes.
• Counselling area should have furnitures (table and chairs) for
comfortable conversation or communication and cabinets for
keeping Patient Medication Records (PMR).
• It should have telephone service, electronic supply,
refrigerator, drinking water, etc.
• A compounding pharmacy for extemporaneous preparations
should have additional space and necessary equipments.
6. REQUIREMENTS OF EQUIPMENTS
• The pharmacy should be equipped with refrigerator for
storage of medicines in cold temperature and validated from
time to time.
• Counselling area should be equipped with demonstration
charts, patient information leaflets (PILs), reference materials
and other required materials.
• It should contain basic instruments like sphygmomanometer,
glucometer, thermometer, stethoscope, weight and height
scale.
• The pharmacy should be preferably equipped with computer
and appropriate softwares that can manage inventory, manage
invoicing, generate timely warnings for expiring medicines and
archive patient medication records.
• Compounding pharmacy should be equipped with appropriate
apparatus required for the preparation.
7. REQUIREMENTS OF MANPOWER
• The pharmacy should be managed under the
supervision of pharmacist and other personnel
working in the pharmacy should be well trained.
• The pharmacy should have well documented
guidelines and procedures for personnel set by
management with pharmacist consultation.
• The personnel in the pharmacy should wear neat
apron/coat and wear a badge displaying name and
designation.
• All pharmacy personnel should be medically
examined and adequately immunized periodically
and their health data should be archived.
8. • Pharmacist working in the pharmacy should hold at least
a bachelor degree in pharmacy and registered as
Pharmacist in Nepal Pharmacy Council. Pharmacist should
also have done adequate practical training in community
pharmacy and have adequate communication skills for
patient counselling.
• Pharmacy Assistant working in the pharmacy should hold
at least a diploma in pharmacy and registered as
Pharmacy Assistant in Nepal Pharmacy Council. Pharmacy
Assistant should also have done adequate practical
training in community pharmacy and have adequate
communication skills.
• Professionalist working in the pharmacy should hold the
qualification specified by Drug Advisory Committee and
recognized by that committee.
9. REQUIREMENTS FOR STORAGE
• All medicines coming into the pharmacy should
initially be quarantined and then checked for
quantity, batch number, expiry, integrity, etc. After
checking they should be transferred to their
respective storage location.
• All medicines should be stored at appropriate
temperature protecting from excessive light, dust
and humidity. Record of daily temperature should be
kept in record sheet and preserved for future record.
• The medicines and shelves should be clean and dust
free following Standard Operating Procedures (SOPs).
• All medicines that are to be stored in cold
temperature should be kept in the refrigerator.
10. • Narcotics and Psychotropic drugs that fall into
Group “Ka” should be kept in a separate safe with
lock and handled only by the Pharmacist. Records
of such drugs should be maintained as per legal
requirements.
• Shelves should be checked periodically for expiry
of medicines and expired medicines should be
kept separately labelling “Expired Goods-Not For
Sale”.
• Near expiry medicines which can expire during the
prescribed time should not be sold. Expired
medicines, unused or unopened medicines are
either returned to the supplier or destroyed as per
in house protocol.
11. REQUIREMENTS OF INVENTORY CONTROL
• The pharmacy should develop and maintain safe,
effective, operational and socioeconomically
acceptable procurement and inventory management.
Pharmacist should ensure medicines and health care
products are readily available in the pharmacy in
sufficient quantities.
• Suppliers and Purchasing
The pharmacist should ensure quality supply of medicine
by purchasing from supplier that meets the standard laid
down by the law. Details of suppliers (name, address,
contact number, licenses, etc.) should be kept. A list of
trusted suppliers should be maintained and visited from
time to time for audit of premises and system. Any errors
made by the supplier should be reported and rectified in
timely manner.
12. • The pharmacist should inform regulatory authorities if
any deliberate dubious activity by the supplier is
found.
• The pharmacy should have written procedure for the
selection of medicines and maintain product list with
retail price including essential and life saving
medicines. The product list should be reviewed from
time to time and updated by the pharmacist.
• All the medicines received from the supplier should
be checked for quantity, price, batch number and
expiry date.
• Cost effective purchasing method should be followed
and the purchase records/invoice should be
maintained.
13. REQUIREMENTS OF SERVICE
• The pharmacy should have well documented
service strategy based on its goals.
• Service strategies includes home delivery of
medicine, special care and attention to patients
like elderly patients, regular patients, etc.
• Service manual should state in detail service
offered, service time and pharmacy operation
schedule.
• Service manual should enlist details of activities,
routines, delegations, work procedures and
instructions for day to day activities in pharmacy.
14. REQUIREMENTS OF DOCUMENTATION
• Documentation is one of the core activities for
maintaining and achieving quality.
• Pharmacist should maintain all necessary statutory
documents like regulatory licenses, registrations,
permissions, etc. for operating a pharmacy and
displayed if required under the law.
• All operational documents like purchase invoices,
sales invoices and other statutory documents
should be maintained and archived as prescribed
by law.
15. • Some of the necessary documents includes:
Quality manual and policy documents
Protocols
Standard Operating Procedures
Cleaning and maintenance processes and
records
Training manual and training records
Complaint records
Audit records
Personnel details and job descriptions
Record of narcotics and psychotropics
16. • Additionally, documents for pharmaceutical care
should be adequately maintained and stored.
These documents includes:
Patient’s health profile
Patient’s medication record
Record of counselling, follow-ups, etc.