Philippine Drug Regulations and Manufacturing Standards Quiz

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.