COMPOUNDING PHARMACY COMPLIANCE & AUDIT SUPPORT

The controls should reflect the type and complexity of compounding being performed.

Premises and equipment need to be suitable for the preparation, while records should show the formulation, ingredients, quantities, preparation process, staff involved and applicable beyond-use date.

The Pharmacy Board’s pharmacy compounding guidelines and the current Australian Pharmaceutical Formulary provide guidance across simple, complex, sterile and hazardous compounding.

Start by containing the affected process and determining whether any preparations or patients may be affected.

Preserve the original records, investigate the cause and determine whether quarantine, recall, notification or other action is required. Corrective and preventive action should then address the root cause and confirm that the revised process is effective.

No. Formal GMP audit requirements depend on how the pharmacy operates and whether it is relying on a pharmacist manufacturing exemption or requires a TGA manufacturing licence.

The TGA explains that pharmacists may be exempt from manufacturing-licence requirements when the relevant conditions are met, while activities outside those exemptions can require formal GMP compliance.

Where formal GMP applies, GMP SOPs should reflect the manufacturing activities and risks involved.

This can include materials, formulations, equipment, cleaning, environmental monitoring, batch documentation, deviations, recalls, change control and Corrective and Preventive Action (CAPA).

For exempt community pharmacy compounding, procedures should instead reflect the professional and regulatory requirements applying to the pharmacy’s actual compounding activities.

For sterile compounding, investigate the result and determine whether the preparation environment or any affected medicines may have been compromised.

Document the investigation and corrective action, and do not resume affected activities until the pharmacy is satisfied that appropriate conditions have been restored. Where formal GMP applies, environmental monitoring results should also be reviewed for trends and their potential impact on product quality.

Generally, no.

The TGA defines anticipatory compounding as preparing medicine before receiving a prescription or specific request from an identified patient and prohibits it outside specified hospital circumstances.

Batch preparation is possible once prescriptions or orders have been received for all medicine being prepared in that batch. The TGA explains the distinction between extemporaneous, anticipatory and batch compounding.

A pharmacist may be exempt from holding a TGA manufacturing licence where all conditions of the relevant exemption are met. If the pharmacy’s activities fall outside those conditions, a manufacturing licence may be required.

This should be checked before changing the production model, supply arrangements or types of medicine being compounded.

Records should allow the pharmacy to trace what was prepared, for whom and how.

Depending on the preparation, this can include the prescription or patient request, formulation, ingredients and quantities, preparation process, staff involved, batch information, beyond-use date and relevant quality checks.

For sterile or more complex compounding, additional environmental, equipment and competency records may also be needed.

Staff should remain competent for the compounding activities they perform, with training and assessment reviewed as procedures, equipment or scope change.

Sterile and complex compounding require stronger competency controls than simple compounding, so the pharmacy should follow the applicable Pharmacy Board and APF requirements for its activities.