Sterile Manufacturing of Pharmaceutical Products

Process orders and prescriptions, assist in compounding of sterile products and review quality of finished products



Competency Area

Drug Compounding and Management


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