Compounded Preparations Quiz

Good Compounding Practice

• Published August 1, 2018, 1st Edition
• Document provides guidance on compounding practice for the preparation of medicinal products for individual treatment or aesthetic purposes.
• Used as a reference for inspection of compounding facilities.

Acknowledgements

• Advisor: Director of Pharmaceutical Regulatory, National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia
• Editorial Committee: Centre for Compliance and Licensing, National Pharmaceutical Regulatory Agency
• Special thanks to various sections and centres of the NPRA for their contributions, including Licensing Section, Pharmacy Enforcement Division, Pharmaceutical Services, Centre of Product Registration, Centre of Post Product Registration & Cosmetic Control, Centre of Quality Control, Centre of Investigational New Product, and Centre of Development & Strategic Planning.

Table of Contents

• Lists of chapters and annexes with corresponding page numbers.
• Includes Introduction, Glossary, General Principles, Quality Assurance System, Personnel, Premises and Equipment, Documentation, Compounding Process, Quality Control, Complaints and Recalls, Self Inspection, Annex 1, and References.

Glossary

• Defines key terms in compounding practice such as Active ingredient, Batch, Batch number, Beyond-use Date (BUD), Clean area, Closed Procedure, Critical Zone, Cross contamination, Deviation report, Dispensed Medicine, In-use expiry date, and Packaging.
• Each definition gives a precise meaning to the specific compounding term for clarity and avoiding ambiguity in the field.

Chapter 1 - General Principles

• Compounded preparations should be safe and appropriate for the individual patient.
• Compounding must adhere to international pharmacopoeias or references recognised by the Drug Control Authority (DCA).
• Compounded preparations are permitted only in specific circumstances, such as when a registered product is unavailable, unsuitable, or when a unique patient need requires tailored dosage, for research, or when a patient is a child.
• Compounded preparations may include hormones, topical drugs (with appropriate clinical data), modified release medicines, and certain precursor/psychotropic drugs.
• Compounding should not involve substances prohibited by the DCA or Poisons Act 1952.
• Prohibited compounding includes parenteral mixtures with no compatibility data or substances intended for non-therapeutic purpose.

Chapter 2 - Quality Assurance System

• Quality assurance ensures that compounded preparations meet quality and safety standards.
• Compounding procedures must follow the latest information to guarantee product quality to the patient when it is received.
• Compounded preparations are completed according to the defined procedures/ guidelines.
• The process of preparation must be tracked according to required standards.
• Adequate measures are required to ensure the quality of compounded preparations until their Beyond-Use Date (BUD).
• Documentation systems must be in place and maintained.

Chapter 3 - Personnel

• Compounding should be performed by a responsible person, i.e. pharmacist or person supervised by a pharmacist.
• Responsible Person must possess adequate knowledge, training and competency.
• Individuals must have qualifications for relevant tasks, experience, and keep up-to-date with new developments.

Chapter 4 - Premises and Equipment

• Defined compounding areas are required.
• Equipment should be appropriate to activities and easily available.
• Compounding area should be separate from other areas.
• Adequate lighting, temperature, humidity and ventilation are critical.
• Cleanliness and safety precautions are paramount.

Chapter 5 - Documentation

• Comprehensive documentation is essential for quality assurance.
• Documentation should permit tracing of batch history, and ensure the integrity, availability, and legibility of documents.
• Relevant laws and regulations must be followed.
• Specific documentation details are included, such as Master formula, compounding records, standard operating procedures (SOPs), relevant certificates, and data sheets, and retention periods.
• Records should be available for inspection.

Chapter 6 - Compounding Process

• The quantity of prepared medicine must be appropriate for individual needs.
• Responsible Person evaluates dosage, safety and intended use of components.
• Compounding procedures must follow standards.
• An appropriate compounding record should be completed.
• Equipment must be inspected before use.
• A reliable Beyond-Use Date (BUD) should be established before preparation.
• Preparation should be in accordance with international pharmacopoeias or relevant references.
• Review and testing should ensure quality.
• Labelling with required information according to laws.

Chapter 7 - Quality Control

• Quality control systems for each compounding process should be present.
• Compounding records should be reviewed and checked for accuracy.
• Compounding procedures should be documented.
• Each step of the process (weighing and measuring) should be checked and monitored.
• Checking of the compound for stability and stability data, including BUD, is required in specific cases.

Chapter 8 - Complaints and Recalls

• Reporting of errors, defects, complaints, and other quality issues should be handled according to a written procedure.
• Processes for dealing with complaints and recalls must be efficient.
• Recalled products should be stored separately.
• Adverse drug reactions (ADRs) must be immediately reported to the relevant authority.

Chapter 9 - Self Inspection

• Self-inspection is part of the quality assurance system.
• Personnel, premises, equipment, documentation, production, and related processes should be inspected regularly for conformity.
• Regular self-inspections should be scheduled and documented.

Annex 1 - Guidelines for Sterile Compounded Preparations

• Provides specific guidelines for sterile compounding.
• Highlights high-risk sterility operations because of inherent risks of contamination in sterile preparations.
• Covers topics such as Personnel, Premises, Equipment.
• Includes considerations for particular product types, such as Cytotoxic, Radiopharmaceuticals, Infusion, total parenteral solutions, Eye preparations, and Biologicals.

References

• Lists publications on compounding practice, law, regulation, standards, and guidelines for the document's content and creation.

Test your knowledge on the critical aspects of compounded preparations. This quiz covers important factors such as labeling, storage conditions, and sterilization processes. Assess your understanding of regulations and best practices in compounding.