Quality Policy

1.  Purpose

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This Quality Policy establishes the foundational commitment of ALEMÈ Compounding Pharmacy ("the Pharmacy") to delivering safe, effective, and high-quality compounded preparations to every patient we serve. It defines the principles, standards, and regulatory obligations that govern all compounding activities and quality management practices within our facility.

2.  Scope

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This policy applies to all personnel, operations, processes, and activities conducted at ALEMÈ Compounding Pharmacy, including but not limited to:

• All compounding activities
• Procurement, handling, and storage of raw materials and active pharmaceutical ingredients (APIs)
• Quality control procedures
• Documentation, record-keeping, and change control
• Dispensing, labelling, and patient counselling
• Equipment calibration, maintenance, and environmental monitoring
• Personnel training, competency assessment, and continuing professional development
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3.  Regulatory and Standards Framework

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ALEMÈ Compounding Pharmacy is committed to full compliance with all applicable regulatory requirements and voluntary quality standards. Our operations are governed by the following framework:

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3.1  Good Pharmacy Practice (GPP) - SAPC
All pharmacy operations are conducted in accordance with the Good Pharmacy Practice standards promulgated by the South African Pharmacy Council (SAPC) under the Pharmacy Act 53 of 1974 and its associated regulations. GPP compliance ensures that the Pharmacy upholds professional, ethical, and operational standards required for the registration and ongoing operation of a licensed pharmacy in South Africa.

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3.2  USP <795> - Non-Sterile Compounding
The Pharmacy adopts the United States Pharmacopeia General Chapter <795> as the primary technical standard for all non-sterile compounding operations. USP <795> provides detailed guidance on:

• Responsibilities of compounding personnel
• Compounding facilities, equipment, and environmental controls
• Component selection, handling, and quality evaluation
• Compounding procedures and beyond-use dating (BUD) assignment
• Labelling requirements and patient counselling
• Quality control and assurance activities
• Documentation and record-keeping requirements

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Implementation of USP <795> reflects our commitment to internationally recognised compounding standards that prioritise patient safety and preparation quality.

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3.3  Good Laboratory Practice (GLP)
Quality control and in-process testing activities within the Pharmacy are conducted in accordance with GLP principles. GLP ensures that all laboratory operations are performed with scientific rigour, reproducibility, and integrity. Key GLP principles applied include:

• Defined and documented test methods and procedures
• Qualified, trained, and competent laboratory personnel
• Calibrated, maintained, and validated equipment and instruments
• Traceability of raw data, test results, and reports
• Proper handling, storage, and disposal of test articles and reference standards
• Management oversight and quality assurance auditing

4.  Quality Commitment

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ALEMÈ Compounding Pharmacy is unconditionally committed to the following quality principles:
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4.1  Patient Safety First
Every compounded preparation leaving our pharmacy shall be safe for the patient for whom it is intended. Patient safety is non-negotiable and supersedes all commercial or operational considerations.

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4.2  Accuracy and Precision
All compounding activities shall be performed with meticulous attention to accuracy in ingredient selection, weighing, measuring, and preparation. We operate within defined specifications and limits as prescribed by USP <795> and applicable literature references.

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4.3  Purity and Traceability
Only pharmaceutical-grade ingredients from approved, reputable suppliers shall be used in compounding. Full traceability of every batch component, from supplier certificate of analysis to dispensed preparation, shall be maintained.

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4.4  Continuous Improvement
The Pharmacy is committed to a culture of continuous quality improvement. Deviations, complaints, and near-misses are documented, investigated, and used as drivers of systematic process enhancement.

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4.5  Qualified Personnel
All personnel engaged in compounding and quality-related activities shall be adequately qualified, trained, and assessed as competent prior to independent practice. Ongoing training requirements shall be documented and fulfilled.

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5.  Quality Objectives

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ALEMÈ Compounding Pharmacy shall pursue the following measurable quality objectives:

1. Maintain 100% documentation completeness for all compounding batches, including raw material certificates, compounding records, and beyond-use dating rationale.
2. Achieve zero critical compounding errors attributable to process failure; investigate and close all deviations within 14 working days of detection.
3. Ensure all active compounding personnel complete a minimum of 20 hours of continuing professional development related to compounding practice per annum.
4. Complete scheduled equipment calibration and maintenance within defined intervals, with no overdue calibrations at any time.
5. Review and update related SOPs at a minimum annually, or following any significant regulatory change, incident, or process modification.
6. Address all patient or prescriber complaints within 1 working day of receipt, with a documented investigation and corrective action where required.
7. Conduct a minimum of two internal quality audits per calendar year against GPP, USP <795>, and GLP requirements.
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6.  Roles and Responsibilities

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6.1  Responsible Pharmacist (RP)

• Holds overall legal and professional accountability for pharmacy operations under the Pharmacy Act 53 of 1974.
• Ensures all GPP requirements are met and maintained.
• Approves this Quality Policy and any revisions thereto.
• Reviews quality metrics and approves corrective and preventive actions (CPAs).‍

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6.2  QA Manager

• Responsible for day-to-day implementation and oversight of this Quality Policy.
• Ensures all compounding activities comply with USP <795> and GLP standards.
• Manages the SOP library, training records, and deviation management system.
• Leads internal quality audits and facilitates external inspections.
• Reviews and authorises all compounding batch records prior to release.‍‍

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6.3  All Compounding Personnel

• Comply with this Quality Policy and all related SOPs at all times.
• Report any deviation, error, or near-miss immediately to the QA Manager.
• Maintain personal training records and attend all mandatory training.
• Follow proper gowning, hygiene, and aseptic/clean compounding techniques as applicable.

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6.4  Support Personnel

• Adhere to relevant sections of this policy applicable to their role (e.g., reception, procurement, administration).
• Escalate quality concerns to the Pharmacist-in-Charge without delay.
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7.  Key Quality Requirements

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7.1  Standard Operating Procedures (SOPs)

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Comprehensive, written SOPs shall be maintained for all critical pharmacy operations, including but not limited to compounding procedures, cleaning and sanitation, equipment operation and calibration, material receipt and inspection, weighing and measurement, labelling, dispensing, and complaint handling. All SOPs shall be version-controlled, reviewed annually, and accessible to relevant personnel.

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7.2  Compounding Records

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A Master Formulation Record (MFR) shall be prepared and approved for every compounded preparation. A Compounding Record (CR) shall be completed for every batch prepared, capturing all ingredients used, quantities weighed, lot numbers, expiry dates, in-process checks, quality control results, beyond-use dating assigned, and personnel responsible. Records shall be retained for a minimum of five (5) years, or as required by regulation.

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7.3  Raw Material Control

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All raw materials, APIs, and excipients shall be sourced from approved suppliers. A current certificate of analysis (CoA) shall be obtained and reviewed against specifications for every lot received. Materials failing to meet specifications shall be quarantined and returned or disposed of in accordance with documented procedures. Storage conditions (temperature, humidity, light) shall be monitored and recorded.

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7.4  Facility and Equipment Standards

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The compounding area shall be maintained in a clean, orderly, and fit-for-purpose condition at all times. Equipment shall be qualified, calibrated on schedule, and operated only by trained personnel. Environmental monitoring (temperature, humidity) shall be documented. Preventive maintenance programmes shall be in place for all critical equipment.

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7.5  Beyond-Use Dating (BUD)

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BUDs shall be assigned to all compounded preparations in accordance with USP <795> requirements, supported by physicochemical stability data, published literature, or conservative default limits. BUD rationale shall be documented in the Master Formulation Record.

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7.6  Labelling and Dispensing

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Every compounded preparation shall be labelled accurately and completely in accordance with SAPC regulations, including the patient's name, prescriber's name, preparation name and strength, quantity, directions for use, BUD, storage conditions, and any relevant cautionary warnings. A pharmacist shall verify all preparations prior to dispensing.

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7.7  Deviation and Complaint Management

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All deviations from approved procedures and all complaints received from patients or prescribers shall be documented on the prescribed form, investigated using root cause analysis principles, and resolved through documented corrective and preventive actions. Trends shall be reviewed at quality management meetings.

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7.8  Quality Audits

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Internal quality audits shall be conducted at least twice per year against the requirements of this Policy, relevant SOPs, GPP standards, USP <795>, and GLP principles. Audit findings shall be formally reported, assigned owners, and tracked to closure. External regulatory inspections shall be facilitated openly and cooperatively.

8.  Quality Statement

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At ALEMÈ Compounding Pharmacy, quality is not a department - it is our culture. We are committed to compounding every preparation with precision, integrity, and compassionate care, meeting and exceeding the expectations of the patients and prescribers who trust us. We comply fully with the Good Pharmacy Practice standards of the South African Pharmacy Council, implement USP <795> as our technical benchmark for non-sterile compounding, and apply Good Laboratory Practice principles in all quality control activities. Every person at ALEMÈ is empowered and expected to uphold this commitment.

9.  Policy Review and Revision

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This Quality Policy shall be reviewed at a minimum annually, or whenever triggered by a change in regulatory requirements, operational scope, organisational structure, or following a critical quality event. All revisions shall be approved by the Responsible Pharmacist, version-controlled, and communicated to all relevant personnel. Superseded versions shall be retained in the controlled document archive.