Good practices in pharmacy
Rivers have always been essential for human life and settlement. A source for drinking, the source of food, and a way to transfer goods from one place to another. They are essential in the environment of rainforest and wetlands.
Good distribution practice
What is comprises of
Effective recall system
Full traceability in the distribution chain
FIFO system in stock movement
Right Product, Right Place, Right Time
Avoid cross contamination
safe and secure storage conditions in warehouse as well as during transport
Authorized/quality products
A concept that covers the assurance of the safety and efficacy of pharmaceuticals from the time they leave the factory gates to the point at which they are used by the patients
Good dispensing practices
What it comprises
counting devices must be kept clean daily and electronic counting equipment must be maintained for accuracy for accuracy
equipment for extemporaneous preperations
Appearance: lab coat, hair, professional
storage
Documenting procedures and result
Cleanliness of drug, premises/bench/equipment/store
Ensure quality of dispensed or compounded product by covering areas such s cleanliness, appearance, documentation, equipment, manipulative techniques, ingredients, calculations, counting etc
Good laboratory practice
North America
In the 18th century, the river was the primary western boundary of the young United States, and since the country's expansion westward, the Mississippi River has been widely considered a convenient dividing line between the Eastern, Southern, Midwestern United States, and the Western United States.
South America
Amazon River, the greatest river of South America and the largest drainage system in the world in terms of the volume of its flow and the area of its basin.
what is it?
Its source is Lake Itasca in northern Minnesota and it flows generally south for 2,320 miles (3,730 km) to the Mississippi River Delta in the Gulf of Mexico.
The main stem is entirely within the United States. Tributaries - St. Croix River, Wisconsin River, Rock River, Illinois River, Kaskaskia River, Ohio River, Minnesota River, Des Moines River, Missouri River, White River, Arkansas River.
The river either borders or passes through the states of Minnesota, Wisconsin, Iowa, Illinois, Missouri, Kentucky, Tennessee, Arkansas, Mississippi, and Louisiana.
proper storage and retention of records that allows for traceability
Proper receipt, handling, sampling and storage of all test and reference materials
Qualified Personnel with training
Physiological and biologicla testing system
A tributary, also called an affluent, is a stream or river that flows into and joins a main river. The place where the tributary and the main river meet is called a confluence.
Name as much tributaries as you can.
main area of activity must be covered by SOP
The mouth of a river refers to the end of a river, the place where it drains into a larger body of water - another river, a lake, the sea or the ocean.
Apparatus/ reagents must have validation, maintenance and proper storage
The source of a river, also called headwaters, is the original point from which the river flows. There are different types of sources: lake, marsh, spring or glacier.
Adequate facilities
Try to state the length either in miles or in kilometers.
Good manufacturing practices
Comprises of
Product complaints
Product process- proper handling of materials throughout process
Documentation of specifications for raw materials/ packaging materials/finished products
Self inspection audit
Premises and equipment
Sufficient no. of qualified, experienced personnel, with proper training and hygiene
Quality management/ Quality System
QA should be appropriate to the intended use of product
Applies rights from purchase of starting materials from approved suppliers until finished products leave factory
Preventive measures tat is designed to ensure things happen in the correct manner
part of quality assurance
A process of preventing cross-contamination and mix-ups
The requirements to cover such topics as quality management, personnel, documentation, premises and equipment, materials handling, validation, contract manufacturing, and self inspection
Concept that covers the assurance of the safety and effectiveness of pharmaceuticals during all the stages of manufacturing
Good clinical practice
What it comprises of
conducted by a medically qualified person who have the training and experience in clinical trials and skill needed for any new procedure being investigated
Subject should be informed of the details of the study, potential risks, benefits and rights to withdraw at a later stage
Physical, mental integrity and privacy of the subject should be protected
Study results should always be reported accurately
Potential benefits must be in proportion with risks
Design and conduct should be scrutinized by a person unconnected with the investigator and sponsor
Based on good scientific investigation including pre-clinical studies
Drug should be tested rigorously in labs in cell cultures and animals and healthy volunteer first
What it is
It acts as a major control on the quality of clinical studies and the protection of human subjects
For clinical trials
Clinical trials in Singapore
IRB
A committe that ensures health and safety of patients
Purpose
Serves as an assurance that results obtained from clinical trials are credible
Set ethical and scientific standards for the conduct of clinical trials
Because of
A need to grant appropriate protection to ensure the safety and well-being of trial subjects
Increase in clinical research activities in Singapore
The HSA through its Health Products Regulation Group, provides advice on the licensing of clinical drug trials
Requests for CTC extensions
Serious adverse event report
Amendments to clinical trials protocols and informed consent documents
New applications for clinical trials certificates
All clinical trials on medicinal products conducted in Singapore requires a clinical Trail Certificate
Additional info
