Compounded Preparations Quiz

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Questions and Answers

What is a critical factor to consider when using ingredients from registered products for compounded preparations?

The color of the ingredient

The cost of the ingredient

The potential effect on efficacy (correct)

The brand name of the product

Which of the following criteria is NOT important when selecting a container for compounded preparations?

Inertness

Moisture protection

Visibility

Brand recognition (correct)

What information must be included on the label of compounded preparations according to the regulations?

Price of the product

Generic names of main active ingredients (correct)

Pharmacy address

Date of preparation

Why is it necessary to continuously monitor storage temperatures of compounded preparations?

To maintain potency during storage Signup and view all the answers

What should be avoided in labelling compounded preparations to minimize errors?

Using a short name for the patient Signup and view all the answers

What should be performed before commencing another activity in a work area where compounded preparations are made?

Line clearance to remove all materials Signup and view all the answers

When preparing different concentrations of a compounded preparation, what should be emphasized to prevent errors?

Particular care to avoid cross contamination Signup and view all the answers

What is essential to ensure during the sterilization process of compounded preparations?

All material must be subjected to required treatment Signup and view all the answers

Why is a documented risk assessment necessary when multiple workstations are in use?

To take appropriate measures for handling compounded preparations Signup and view all the answers

How should temperature and pressure be managed during sterilization cycles?

They should be documented and periodically checked Signup and view all the answers

What should be minimized in clean areas to prevent contamination during compounding?

Materials that are prone to generate fibers Signup and view all the answers

Which method is recommended to ensure validated loading patterns in sterilization?

Using photographs or detailed drawings Signup and view all the answers

What is the main method recommended for transferring materials into the Grade A workstation?

Disinfection or sanitisation Signup and view all the answers

How should components for the Grade A zone be purchased?

Bulk gamma irradiated or sterile in double/triple wrapped form Signup and view all the answers

Which of the following statements about compounded preparation testing is true?

Compounding for a single patient usually does not require testing. Signup and view all the answers

What should the cleaning procedure effectively remove from the workstation surfaces?

Viable organisms and compounded preparation residues Signup and view all the answers

How is the extent of quality control tests defined?

Based on a risk assessment Signup and view all the answers

Which sample types can be obtained for microbiological analysis?

Unused compounded preparations and additional specially prepared samples Signup and view all the answers

What is the importance of having a written, validated Standard Operating Procedure for transferring materials?

It ensures effective removal of viable organisms from surfaces. Signup and view all the answers

When is microbiological analysis necessary?

It is not necessary on each batch Signup and view all the answers

What practice is considered more effective for sanitizing surfaces?

Spraying and wiping Signup and view all the answers

Which of the following tests should be performed frequently on the autoclave's chamber with porous load cycles?

Air removal tests Signup and view all the answers

What is the significance of using clean steam in the sterilization process?

It ensures that critical surfaces are not contaminated. Signup and view all the answers

Which of the following is NOT a key element of the aseptic process?

Using non-sterile materials in grade A areas Signup and view all the answers

How should compounded preparations and waste materials be handled in an aseptic processing area?

They should be immediately removed from the processing area. Signup and view all the answers

Which of the following is a recommended practice for sterilizing product solutions that are non-sterile?

Filtration through a sterile filter of 0.22 micron or less. Signup and view all the answers

What is the recommended limit for the number of personnel present in a sterile or aseptic processing room?

Only essential personnel should be present. Signup and view all the answers

What type of testing should be periodically performed to assess steam quality?

Superheat and dryness value testing Signup and view all the answers

Which of the following practices is crucial for maintaining aseptic integrity when handling materials?

Not touching critical surfaces. Signup and view all the answers

Who should perform aseptic processing tasks?

Competent staff authorized by the Responsible Person. Signup and view all the answers

Study Notes

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.

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.

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Description

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.