The document outlines guidelines for good pharmacy practice in India. It discusses responsibilities of community pharmacists which include dispensing drugs with care and accuracy, counselling patients, and ensuring legal compliance. It also covers guidelines for pharmacy facilities, personnel, quality systems, and processes like procurement, inventory management, and storage of medications. The objective is for all pharmacies in India to achieve high standards of practice over the coming years.

1. 2. PROFESSIONAL
RESPONSIBILITIES OF
COMMUNITY PHARMACISTS

2. RESPONSIBILITY OF COMMUNITY
PHARMACIST:
The main responsibilities of a community pharmacy include
compounding, counselling, and dispensing of drugs to the patients
with care, accuracy, and legality along with the proper procurement,
storage, dispensing and documentation of medicines.
The community pharmacist must be a qualified and pertinent with
sound education, skills and competence to deliver the professional
service to the community.

3. PROFESSIONAL RESPONSIBILITIES OF
COMMUNITY PHARMACISTS
Dispencing
Proper
communication
Patient
Medication
History
Legality
Sign and
stamp
Counselling

4. Narcotic
drugs
Stock and
inventory
Manage
Superwise
and train
Manage
finance and
budget
Keep up to
date data
Advice

5. GOOD PHARMACY PRACTICE
The objective of framing and implementing Good
Pharmacy Practice guidelines for India is that over
the next few years, all pharmacies in India should
achieve the standards of practice.

6. A. STRUCTURE GUIDELINES
2.1 FACILITIES
2.1.1 Premises:
The pharmacy should be easily located and identified by the public.
Exterior of the pharmacy should be maintained neat and clean.
The display should be clearly marked with the word "PHARMACY”.
The pharmacy environment should be clean with minimum dust, free
from rodents and pests/ insects and pest control measures should be
taken from time to time.

7. The pharmacy should have a constant supply of energy especially for
the refrigerator(s). There should preferably be a provision for drinking
water
The pharmacy should have a constant supply of energy especially for
the refrigerator(s).
There should preferably be a provision for drinking water.
The pharmacy should have
(1) Sufficient space for patients to stand comfortably at the dispensing
counter.
(2) Space for patient information displays, including for information
leaflets/material.

8. (3) A separate enclosure described as "counselling Area" for patient
counselling.
(4) A compounding pharmacy should also have sufficient additional
space.
(v) Separate waste collection baskets/boxes should be available.
Ambient temperature in the pharmacy should be maintained within the
stipulated range to prevent deterioration of various medicines stored at
room temperature conditions.

9. 2.1.2 Furniture and fixtures:
The pharmacy should have neat, well placed shelves with provision
for storage of medicines and other items in a neat manner, protected
from dust, moisture, excessive light.
The counselling area should be furnished with:
1) A table.
2) Chair for the Pharmacist and a couple of patients.
3) Cabinet for storing patient medication records (PMRS).

10. 2.1.3 Equipment:
The pharmacy should be equipped with refrigerated storage facilities
for products requiring storage at cold temperature.
1) The counselling area should be equipped with:
2) Reference material
3) Demonstration charts, kits and other demonstration material
4) Patient information leaflets
5) Some basic instruments for e.g. Sphygmomanometer, glucometer
etc.
6) Weight and height scale

11. (vi) The pharmacy preferably equipped with computers and
appropriate software that can
1. Manage inventory
2. Manage invoicing
3. Generate timely warning for expiring medicines4. Archive patient
medication records
4. Archive patient medication records.

12. 2.2 PERSONNEL
The Community Pharmacy should be managed under the overall
supervision of a chief pharmacist.
All staff members should be trained as per the training policy of the
pharmacy.
All personnel in the pharmacy must wear a neat apron. Pharmacists
working in the pharmacy should:
1. Be registered as a pharmacist with the Pharmacy council of the
concern state.
2. Have undergone adequate practical training in a community
pharmacy.
3. Have communication skills and capabilities to give proper advice
to the patients.

13. 4. Each Pharmacist working in the pharmacy must be competent
enough to:
• Play a professional role to assess prescriptions.
• Advise the patients on appropriate selection and use of OTC
medicines.
• Advise patients on appropriate use of prescribed medicines.
• Check and advice on drug-drug and drug-food interactions.
• Be alert for adverse drug reactions.
• Assess the patient's condition and decide when to refer him/her to
the doctor.
• Perform the role of a health care provider and a counsellor.

14. 2.3 SYSTEMS
The pharmacy should have well defined and documented systems for
each operation carried out in the pharmacy.
2.3.1 Quality Policy
It is a general declaration of the intent of the pharmacy about the level
of quality of service and products offered to the public.
The pharmacy should have a quality manual, which should state, in
detail, the necessary steps to be carried out for fulfillment of the
desired quality goals.

15. The manual should also enlist the details of the activities, routines,
distribution of responsibilities, work procedures and instructions that
are necessary for achieving the quality goals in day-to-day operations
in the pharmacy.
2.3.2 Service Policy:
The pharmacy should have a well-documented service policy based on
its patient servicing goals.
Service policy statement should include issues like home delivery of
products, the nature and level of attention to be given to patients of
various kinds like elderly patients, regular patients, etc.

16. 2.3.3 Staff Training Policy:
A well-conceived and implemented staff training policy has the
potential to determine the future of the pharmacy in the community.
Availability of adequate reference resources (books, current
periodicals, software, etc.) in the pharmacy is the fundamental
requirement of the training process.
Special emphasis should be laid on training
Pharmacists: Communication and counselling skills, handling of
prescriptions, continuing education in illnesses and drugs, latest
developments in the field of pharmacy.

17. Pharmacy assistants: Communication skills, salesmanship,
dispensing of drugs, procurement and storage of drugs, and "when to
refer to a pharmacist for counselling.
2.3.4 Complaints policy:
All complaints-oral or written must be immediately addressed by the
pharmacist, and suitable action be taken to amend the situation.
The complaint, its nature, the erring person's name and the action
taken must be documented in a complaint register Appropriate steps
should be taken in order to prevent the recurrence of the same or
similar events.

18. 2.3.5 Drug Recall Policy:
The Pharmacist should have a well-documented recall policy:
(1)The pharmacy should proactively participate in recall process
for any substandard drug.
(2) In case of any suspicion, the pharmacist should take immediate
steps to stop the sale of drug and notify the relevant parties.
(3)If the pharmacist has a suspicion or a reason to believe that short
comings have occurred in the process of delivery of medicines
from the pharmacy, immediate effective measures should be
initiated to minimize the risk of damage or danger to the
patient(s).

19. Audit Policy:
The Chief Pharmacist can evaluate the different routine processes
and the quality systems in the pharmacy, and check whether the
systems are functioning as per requirements. This is achieved by
frequent internal audit and a periodic external audit. The staff
deployed for internal audit should be adequately trained for the
purpose. Audit may be carried out once in six months, or more
frequently. An external audit must be done at least once a year by
external auditors, who are competent to do so and are appointed by
the management.

20. Documentation system:
All necessary statutory documents (eg. regulatory licenses,
registrations, permissions etc.) for operating a pharmacy must be
adequately maintained and should be 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 the law. Some of the necessary documents include:
1 Protocols
2 Standard Working Procedures 3. Operation instructions 4.Quality
Manual Cleaning and maintenance processes and records 6.
Complaint records7. Audit records (internal and external)8. Policy
documents 9. Personal details

21. Some of the necessary documents include:
1 Protocols
2 Standard Working Procedures
3. Operation instructions
4.Quality Manual
5.Cleaning and maintenance processes and records
6. Complaint records
7. Audit records (internal and external)
8. Policy documents
9. Personal details

22. B. PROCESS GUIDELINES
1. Procurement and inventory management:
• The pharmacist should ensure that the source of supply of
medicines and other items meet the standards laid down in the
law.
• The pharmacist should maintain a 'products list' where all
items approved by the pharmacy for stocking are described.
• Adequate cost-effective purchasing methods should be
followed which ensures adequate inventories leading to
optimal financial gain for the pharmacy.
• All products received from vendors should be tallied against
their invoice and checked for correctness of quality, price,
batch number and expiry date.
• The purchase records/invoices should be maintained as
stipulated under the law.

23. 2. Storage
Storage management:
• A products coming into the pharmacy should be checked
for correctness of quality, batch number, expiry, integrity,
etc. and then allowed to transfer to their respective storage
location.
• All drugs should be stored at stipulated temperature areas,
protected from excessive light, dust, and humidity.
• The medicines and shelves should be maintained clean
and dust free at all times by following cleaning schedules
and SOPs.

24. • All the drugs that are to be stored in a 'cold' temperature should
be kept in the refrigerator unless the ambient temperature in the
area is cold enough.
• Some medicines like drugs specified under the schedule X,
Narcotic drug and Psychotropic Substances Act and some other
CNS drug etc. should be kept under lock and key.
• Records of purchase and sales of such medicines should be kept
as per legal requirement.
• Shelves should be checked at a predetermined periodicity to
ensure removal of drugs whose expiry date is approaching.

25. • Some medicines like drugs specified under the schedule X,
Narcotic drug and Psychotropic Substances Act and some
other CNS drug etc. should be kept under lock and key.
• Records of purchase and sales of such medicines periodicity
to ensure removal of drugs whose expiry date is
approaching. The near expiry products should be stored
separately and disposed of either by returning to the
respective vendors or by expending their dispensing. Drugs,
which have already expired, should be stored in separate
shelf, bearing the label "Expired Goods Not for Sale".

26. • Disposal of unused pharmaceutical products and waste:
The non-saleable or expired pharmaceutical products lying in the
pharmacy should be listed and returned to the respective vendor.
However, in case this is not possible the same may be dispose as
per the pharmacy's standard operations procedures in this regard.

27. 3. Prescription handling:
Client must be made to feel attended and comfortable by friendly
gesture and ambience as soon as they come into the pharmacy.
(A) Upon receiving the prescription, the Pharmacist should
confirm:
1. Identity of the client.
2. Whether the prescription is presented by the client himself or
by someone on the client's behalf.

28. B) Prescription should be complete with regard to:
i. Name of the Doctor, his/her address and registration number
GD Name, address, age, sex of the patient
ii. Name(s) of the medicine(s), potency, dosage, total amount of
the medicines to be supplied.
iii. (iv) Instruction to the patient
iv. (v) Refill information if any
v. (vi) Prescribed doctors' usual signature.
C) The prescription should be checked for:
i. Dosage: Whether the dosage prescribed is within the standard
dose range.
ii. Double medication (same drug or different drug with same

29. pharmacotherapeutic effect)
iii. Interaction between the currently prescribed medicines, OTC
medicines being taken by the patient and the medicines being
taken from any past prescription.
iv. Contraindication: age, sex, disease(s), conditions or other
characteristics of a patient that may cause certain prescribed
medicines to be contraindicated.
v. Any handwriting legibility problem should be brought to the
notice of the prescribing Doctors.

30. 4. Dispensing:
• The medicine should be removed from the storage area, counted
and invoiced.
• As a final step, the pharmacist should personally dispense the
medicines, at which stage appropriate counselling should be given
for the patient.
• The medicines should be packed neatly so that the integrity is
maintained.

31. 5. Extemporaneous preparations:
• All such preparation should preferably be compounding by the
Pharmacist, only under direct supervision of a pharmacist.
• Only medicinal quality or better grade ingredient should be used
for compounding.
• The preparation area should be cleaned immediately before and
after compounding.
• After compounding, the product should be transferred to a suitable
container and closed securely.
• The container should be appropriately labelled stating name of the
preparation, date of preparation, and name of the patient, direction,
quantity, a reference (batch) number generated by the pharmacy,

32. storage conditions and name of the pharmacy.
6. Information for patient
Pharmacist should provide oral as well as written information about
various illness, medicines and other health care products, in order to
increase the awareness level of the client regarding his illness and his
medicines.

33. 7. Patient Counselling:
• The Pharmacist should provide professional counselling with
regard to use of medicines and related products, so as to improve
the quality of the patient's life.
• While dispensing, the patient should be explained
1. How to take the medications.
2. For how long
3. When to take the medicines.
4. What foods/beverages/tasks to avoid during the therapy.
5. What side effects to expect and how to manage them.
6. What to do if one or more doses get skipped.
7. Any other precautions

34. STANDARD OPERATING PROCEDURES
(SOPs)Standard operating procedures are often referred to as 'SOPs
and include all the written protocols and procedures in place within
a pharmacy describing how a routine task is to be carried out,
when, where and by whom.
SOPS play a fundamental role in continuous quality assurance and
ensuring best practice at pharmacy, in order to assist you in
protecting the safety of patients and members of the public.

35. The implementation of SOPs, which are specific to pharmacy, will
help to:
• ensure quality and consistency of service to patients
• ensure good practice is achieved at all times
• utilise the expertise of the pharmacy team effectively
• facilitate delegation of appropriate tasks to trained members of
the pharmacy team.
• provide role clarification for all members of the pharmacy team
• provide staff training.
• provide assurance of staff understanding of processes to be
followed in the pharmacy.

36. • provide an opportunity for pharmacists to define and assess their
practice
• facilitate communication and team work
PREPARATION OF SOPS
The preparation of SOP should be done into six stages as follows
1. Objectives: the purpose of the SOP.
2. Scope: what are the areas of work to be covered by the SOP? It
is advisable that this should not be over-complex.
3. The stages of the process: this is a description of how the task is
carried out. It is important that this description is clear and
unambiguous, preferably without the use of jargon.

37. 4. Responsibility: who is responsible for carrying out the
procedure and who ensures that staff members are suitably
trained to carry out a procedure? In a working pharmacy this
would also include contingency plans detailing what to do in
cases of sickness or holiday leave, etc.
5. Other useful information: for example, details on how the SOP
is to be audited. Auditing the processes helps maintain standards
and identifies any areas where improvement could be made.

38. 6. Review: shows how the process is monitored to ensure that it
remains up to date and relevant.
ADVANTAGES OF SOPS
1. They can assist with quality assurance, ensuring that patients
receive a service that meets certain predefined standards.
2. They ensure consistency, which helps to maintain the level of
service offered and therefore maintain good pharmaceutical
practice at all times.

39. 3. They help 'free time' for pharmacists, by enabling the delegation
of certain tasks. This in turn enables pharmacists to engage in some
of the 'new roles' and provides enhanced roles for pharmacy
technicians that recognise their specific expertise.
4. They set out clear lines of accountability, ensuring that staffs are
aware of their own responsibilities.
5. They help locum and part-time staff understand the processes
and running of the pharmacy.

40. 6. They are useful templates in the training of new staff.
7. They provide additional information for the audit process.
Different SOPs covering the day-to-day activities at the
pharmacy:
Some of the common SOPs covering the day-to-day activities are as
follows:
Dispensing: This includes the entire process from the receipt of the
prescription, through therapeutic review to the transfer of the
medicine to the patient and patient counselling.
Dispensing procedures should address the dispensing of different
types of medicines. including high-risk medicines (Methotrexate
etc.), high-tech medicines, OTC drugs and controlled drugs.

41. Stock take: To ensure the accuracy of stock records by comparing
actual stock on hand with stock records.
Ordering stock: To regulate and standardize ordering procedures.
Receiving stock: To ensure that all pharmaceutical stock invoiced is
received in good condition; to verify that stock received corresponds
with stock ordered; to ensure that undelivered stock appears on the
overdue issue list or back-order list.
Effective stock rotation: To prevent wastage and ensure a
continuous supply of medication at all times; to prevent medication
from expiring in the dispensary.
Storage of vaccines: vaccine store complies with all conditions
enlisted under general drug storage and prompt action for destruction

42. Storage of medicines:
• Ensure that pellets and shelves, steel ladder, steel cabinets and
other relevant furniture's and fittings are provided.
• Ensure that the pharmaceutical store has a good and functional
cooling system at all times in line with the recommended storage
conditions.
• Thermometer should be in place and record temperature regularly.
Ensure the pharmaceutical store has a good lightening system.
• Ensure that availability of standard stores' stationary such as
ledgers, daily issue books, antibiotic record book, disposal book
etc.
• Storage of items should be in dosage forms and arranged according

43. to their pharmaceuticaluses or in alphabetical order.
• Shelves labelling should code for ease of ensuring into a
computerized system.
Disposal of Expired Drugs: Maintain records for all expired drugs.
Determine the total cost of expired drugs. Appropriate action to be
taken towards the timely disposal of expired drugs.
Procurement, Dispensing and Distribution of Narcotic Drugs and
Poisons: Ensure accurate documentation of all proceedings. Ensure
adequate security of products at all times.

44. Ensure that all unused or expired narcotic drugs are handed over for
record and disposal.
Daily routine and working hours: To regulate and standardize the
manner in whichpharmaceutical services are rendered and to provide
for key control.
Management of emergency situations e.g. loss of electricity/power.

45. Housekeeping and cleanliness of the dispensary (including
equipment, public pharmacy area and all other areas of the pharmacy)
Temperature Control: Ensure availability of temperature control.
Monitor and record temperatures at regular intervals.
Pest control policy (as required): To provide guidance on keeping
the dispensary or medicine room pest free at all times.