Philippine Drug Regulations and Manufacturing Standards Quiz

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

Which law was enacted on June 22, 1963?

RA 5921 Pharmacy Law

RA 7432 Senior Citizen Act of 1992

RA 3720 Food, Drugs and Cosmetics Act (correct)

RA 6675 Generics Act of 1988

What is the common name for RA 9257?

Special Law on Counterfeit Drugs

Expanded Senior Citizens Act of 2003 (correct)

Comprehensive Dangerous Drugs Act of 2002

The Dangerous Drugs Act of 1972

Which law is also referred to as the 'Generics Act of 1988'?

RA 6675 (correct)

RA 9994

RA 7581

RA 9711

Which law is related to the 'Price Act'?

RA 9502 Signup and view all the answers

What is the date of enactment for RA 8423?

May 7, 1992 Signup and view all the answers

Which law is associated with the 'Comprehensive Dangerous Drugs Act of 2002'?

RA 9165 Signup and view all the answers

Which executive order is related to the reorganization of the Bureau of Food and Drugs?

EO 174 Signup and view all the answers

Which type of water is used for the preparation of parenteral solutions?

Water for Injection Signup and view all the answers

What does Bacteriostatic Water for Injection contain?

One or more antimicrobial agents Signup and view all the answers

How many classes are drugs categorized into based on solubility and permeability in biopharmaceutics classification?

Four Signup and view all the answers

What does Type I glass refer to in USP definitions?

Borosilicate glass Signup and view all the answers

What is emphasized in the text regarding certain drugs?

Prohibition Signup and view all the answers

What are the basic actions involved in comminution, as described in the text?

Cutting, compression, impact, and attrition Signup and view all the answers

What is the specific gravity of potassium dichromate (K2Cr2O7) if its weight in air is 5.76g and its weight in oil is 3.08g, with the specific gravity of the oil being 0.86?

1.85 Signup and view all the answers

How long should an ordinary prescription be preserved?

3 years Signup and view all the answers

What type of glass is soda lime glass?

General purpose soda-lime glass Signup and view all the answers

Which equation describes the general behavior of gases with variations of pressure, volume, and temperature?

Ideal gas law Signup and view all the answers

What is the alcohol content range of elixirs?

10-40% Signup and view all the answers

Which type of gelatin is prepared from acid hydrolysis?

Type A Signup and view all the answers

In the Biopharmaceutics Classification System, which class has high permeability and low solubility?

Class II Signup and view all the answers

What is the most preferred container for aerosols?

Aluminum Signup and view all the answers

Which government agency issues national identification cards and purchase slip booklets to senior citizens?

OSCA Signup and view all the answers

What is the sequence of the drug development process outlined in the Philippines?

Pre-clinical studies, investigational new drug trials, clinical trials, new drug application, and post-marketing surveillance Signup and view all the answers

What are the specified storage conditions outlined for drugs in the Philippines?

Cold places, freezers, refrigerators, cool rooms, controlled room temperature, warm conditions, and protection from excessive heat Signup and view all the answers

What are the ethical principles in drug use emphasized in the Philippines?

Non-maleficence, beneficence, respect for autonomy, confidentiality, veracity, and role fidelity Signup and view all the answers

What type of containers are specified for drug packaging in the Philippines?

Well-closed, tight, hermetic, and light-resistant containers Signup and view all the answers

What are the penalties for unlawful acts related to dangerous drugs in the Philippines?

Imprisonment ranging from 1 day to life and fines ranging from 10k to 10M Signup and view all the answers

What type of regulations has the Philippines adopted for drug manufacturing?

Good Manufacturing Practice (GMP) regulations, including the adoption of PIC/s GMP as the standard Signup and view all the answers

What materials are specified for drug packaging in the Philippines?

Glass and plastic, with specific types and tests for each material Signup and view all the answers

Study Notes

Philippine Drug Regulations and Manufacturing Standards

The Philippines has established various regulations and standards for drug registration, labeling, licensing, and manufacturing establishments through executive orders and guidelines issued in different years.
Ethical principles in drug use, including non-maleficence, beneficence, respect for autonomy, confidentiality, veracity, and role fidelity, are defined and emphasized.
Unlawful acts related to dangerous drugs carry severe penalties, including imprisonment ranging from 1 day to life and fines ranging from 10k to 10M.
Possession of specified amounts of dangerous drugs or chemical precursors can lead to imprisonment and fines.
The drug development process involves pre-clinical studies, investigational new drug trials, clinical trials, new drug application, and post-marketing surveillance, following a specific sequence and regulatory compliance.
The Philippines has adopted Good Manufacturing Practice (GMP) regulations for drug manufacturing, including the adoption of PIC/s GMP as the standard, mandating strict compliance for drug manufacturers.
Different types of containers are specified for drug packaging, each with specific characteristics and uses, such as well-closed, tight, hermetic, and light-resistant containers.
Packaging materials for drugs include glass and plastic, with specific types and tests for each material, ensuring safety and quality of drug products.
Specific storage conditions are outlined for drugs, including cold places, freezers, refrigerators, cool rooms, controlled room temperature, warm conditions, and protection from excessive heat.
Solubility terms for drugs are defined in parts of solvent, ranging from very soluble to very slightly soluble, indicating the drug's solubility characteristics.
The text includes detailed information on drug delivery systems, manufacturing pharmacy, new chemical entity, and the regulatory process for drug approval and monitoring.
The document provides comprehensive details on the regulations and standards for drug manufacturing, packaging, storage, and ethical principles in the Philippines, ensuring the safety, efficacy, and quality of pharmaceutical products.

Studying That Suits You

Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

Description

Test your knowledge of Philippine drug regulations and manufacturing standards with this quiz. Explore topics such as drug registration, ethical principles, unlawful acts, drug development process, Good Manufacturing Practice (GMP) regulations, drug packaging, storage conditions, solubility terms, and more. Gain insights into the stringent regulations and standards in place to ensure the safety, efficacy, and quality of pharmaceutical products in the Philippines.