Good regulatory practice in Community and Hospital Pharmacy

1. GOOD REGULATORY PRACTICE.

2. CONTENT
DEFINITION
COMMUNITY PHARMACY
RETAIL AND WHOLESALE PHARMACY
HOSPITAL PHARMACY
PHARMA MANUFACTURING
IMPORT OF DRUG AND MEDICAL DEVICE
EXPORT OF DRUG AND MEDICAL DEVICE

3. DEFINITION
Good regulatory practice are
internationally recognized process,
system, tools and method for
improving the quality of regulation.

4. COMMUNITY PHARMACY
Community Pharmacy includes all the establishments that are
privately owned and their function is to serve the society’s need
for drug products and pharmaceutical services.
The pharmaceutical wholesaler act as intermediary between
pharmaceutical industry and customer by purchasing and
distrubuting medicine to their customer.

5. GRP IN COMMUNITY PHARMACY& WHOLESALE BUSINESS
(RETAIL SALE)

13.  Application submission of document, verification, payment of fee
through GRAS system, grant and renewal of retail, wholesale
manufacturing, import licenses etc are processed through online only.
 Document can be maintained electronically to have easy traceability.

14. HOSPITAL PHARMACY
It is a health care service department of hospital which receives,
supplies, store and dispense drugs and medical devices to
inpatient and outpatient under the supervision of legally
qualified Registered Pharmacist.
It also play the role of advising patients, doctors, nurses and
other healthcare professional on drug safety, effective and
efficient use.

15. GRP IN HOSPITAL PHARMACY
Good Regulatory Practice in Hospital Pharmacy includes: Documentation,
Licensing, Renewal, E-governance.
DOCUMENTATION:
such as regulatory license, registration, permission etc.
such as purchase invoice, sales invoice.
such as;
I. Protocols
II. Standard Working Procedure
III. Operation instructions
IV. Quality manual
V. Cleaning and maintenance record

16. VI. Complaint record
VII. Audit record
VIII. Policy document
IX. Personal Document- Patient health profile & Patient medication record.
Prescription must contain- Patient’s name, age, sex,
address and name of the institution /hospital, drug name with its strength
(especially in paediatric age group), dose frequency, duration in days and total
quantity (number of tablet and capsule).

17. Always keep carbon copy of referral note especially
in case of critically ill patient. In referral note the date and time and the
treatment given to be mentioned.
It shows conditions of patients on the admission,
investigations done, the treatment given and detail advice on discharge
should be written in the discharge card.
issued as written evidence and accepted.

18. Licenses:
i. For drug other than specified in schedule C, C(1) and X :Form
20.
ii. For drug those specified in schedule C and C (1) :Form -21.
iii. For schedule X drug :Form -20 F.

19. Renewals :
The license can be renewed by available online application
submission in the PCI website.
The PCI portal shall open the link for Payment Gateway to submit
the applicable fee for renewal.
In failure of renewal of license it becomes delinquent, once
pharmacy license expires permanently, a new license must be
obtained before operating a pharmacy.

20. E-governance:
EMR (Electonic Medical Record) system can be used to bring all the
patient related data to single platform. Along with patients medical
history, prescription can be maintained electronically.
Licensing authority of state has presented the guideline manual for
the easy understanding of processing of various application through
online system.

21. THANK YOU!