Sterile Manufacturing of Pharmaceutical Products
Process orders and prescriptions, assist in compounding of sterile products and review quality of finished products
Type
Domain
Competency Area
Drug Compounding and Management
Levels
Prepare sterile products and work areas in accordance to protocols and practice standards
Pack finished sterile products in compliance with worksheet specifications
Prepare labels according to worksheet specifications
Label finished sterile products correctly in accordance with organisational guidelines, including any auxiliary labels
Place final sterile products in appropriate storage areas and/or conditions
Dispose of waste correctly in accordance with organisational guidelines
Prepare raw ingredients required for compounding
Conduct checks on compounding inventory to ensure sufficient supply
Prepare tools and equipment required for compounding in accordance with organisational guidelines
Maintain work areas before and after compounding activities
Inspect the quality of compounded sterile products (CSPs)
Perform accurate measurements of items, ingredients and drugs needed
Perform compounding using appropriate compounding techniques and in the appropriate sequence
Identify and report concerns to supervisors on compromises to the sterility of products
Manage compounding records in accordance with organisational guidelines
Gather patient information and laboratory values required for compounded drugs
Assess drug orders for drug compounding procedures
Calculate doses and volumes of chemotherapy, Total Parenteral Nutrition (TPN) and intravenous (IV) admixtures and infusions
Prepare worksheets according to orders including calculating and explaining doses and volume required
Document simple interventions performed in accordance to organisational procedures
Conduct regular internal audits on the quality and manufacturing processes of CSPs
Implement corrective actions when unacceptable standards of operation for cleanroom, LAFCs and BSCs are observed
Maintain proper documentation of audit and monitoring results
Identify potential areas of sterility compromise
Conduct environmental testing for cleanrooms and BSCs
Review current sterile manufacturing processes to meet regulatory and organisational requirements and guidelines
Identify potential areas that compromise the preparation of sterile compounded drugs
Perform visual inspection of Compounded Sterile Products (CSPs) for the purposes of quality control and ensuring that no impurities are present in the finished products
Obtain appropriate authorisations and checks at designated points according to worksheets