Principles of GCP, GPP, and Scope of Practice in Compounding

Specific Learning Objectives

  • Explain the scope of practice of a pharmacist's assistant (basic) in compounding.
  • Describe the role of the pharmacist or pharmacy technician in compounding.
  • Explain the GCP and GPP principles.
  • Explain the importance of ethical principles in compounding.
  • Explain the general guidelines in compounding.

Scope of Practice of Pharmacy Support Personnel in Compounding

  • Pharmacy support personnel can perform compounding actions under direct personal supervision of a pharmacist, following good pharmacy practice rules.
  • There are varied scopes of practice depending on the qualifications:
    • Pharmacist's Assistant (Basic):
      • Assist with the preparation of non-sterile medicines (S1 to S4).
      • Responsibilities include cleaning equipment, receiving formulas, preparing and mixing ingredients, labeling, and documenting processes under pharmacist supervision.
    • Pharmacist's Assistant Post:
      • Similar responsibilities as basic, but may involve sterile preparations as well.
    • Pharmacy Technician:
      • Further responsibilities, typically including additional compounding levels (S1 to S6), and a higher level of independence in operations.

Role of the Pharmacist's Assistant (Basic) in Compounding

  • They assist pharmacists in compounding, manipulating, and preparing non-sterile medications from Schedule 1 (S1) to Schedule 4 (S4).
  • Pharmacists must be physically present in the pharmacy to supervise the work of pharmacy support personnel.

Good Compounding Practice (GCP)

  • Quality Assurance System:
    • Compounded medicines must be of high quality, safe, and effective with a well-designed Quality Assurance (QA) system.
    • QA ensures safety throughout the compounding process and includes regular effectiveness assessments.
  • Quality Control:
    • Ensures medicines meet quality standards through correct preparation and documentation of processes.
  • Basic Requirements for Quality:
    • Pharmacists are responsible for quality assurance and control.
    • Adequate training for personnel, cleanliness and hygiene standards, equipment suitability, and well-defined processes for compounding.
    • A self-audit program should verify compliance with GCP principles.

Good Pharmacy Practice (GPP)

  • Minimum Requirements:
    • Direct supervision of a pharmacist during compounding.
    • All processes must adhere to Standard Operating Procedures (SOPs).
    • Proper training, adequate premises, and equipment must be in place for effective operations.
    • Documentation of all procedures and maintaining high cleanliness standards.
    • Personnel must practice good hygiene and sanitation.

Ethical Principles in Compounding

  • Guidelines:
    • All compounding must be supervised by a pharmacist.
    • Only compound upon receiving a prescription from a qualified prescriber.
    • Use approved pharmacopoeia as a reference; avoid unsafe, ineffective, or difficult-to-compound ingredients.
    • Ensure proper labeling and prevention of cross-contamination, particularly for active pharmaceutical ingredients (APIs).
    • Maintain thorough documentation of all compounding activities.

Training and Continued Education

  • Training:
    • New personnel should receive comprehensive training for their roles.
    • Continuous education is necessary to maintain competencies and hygiene awareness.

Premises, Facilities, and Equipment

  • Facilities should minimize contamination risks and facilitate thorough cleaning.
  • Compounding areas must have clear segregation from other activities, with well-defined storage conditions to maintain quality.
  • Equipment should be designed for easy cleaning and maintenance, with strict control of storage conditions.
  • Quality control areas should ideally be separate or employ strict measures to prevent errors.