Australian CODE OF GOOD WHOLESALING PRACTICE FOR MEDICINES IN SCHEDULES 2, 3, 4 AND 8.
Good Wholesaling Practice is important in the supply chain for medicines in Schedules 2, 3, 4 and 8. Wholesalers are responsible for the safe handling, storage and distribution of the medicines. The Code of Good Wholesaling Practice ensures that quality is maintained during the process. There are 10 sections of this Code; sections 1-9 applies to all medicines, and section 10 applies to medicines classified as Controlled Drugs (CD) and Goods with High Illicit Value (GHIV).
How the Good Wholesaling Practice came into being
Prior to 1989 the health surveillance was the responsibility of each state of Australia. In 1989 the passage of the Therapeutic Goods Act 1989, the Code of Good Manufacturing Practice gave jurisdiction for "Health"to the Commonwealth Government; creating the Therapeutic Goods Administration (TGA).
Unfortunately when the TGA was formed their scope of authority did not include the storage and distribution activities. These remained with each state Health department.
In 2011 a group of stake holders (TGA, State Health representatives and Industry) and produced the Good Wholesaling Practice document. It's curated by the TGA but the regulatory authority remains with each state Health department.
Section 1 Buildings and Grounds
Buildings used for warehousing should have in place good housekeeping and protection measures for all medicines stored within them. There should be sufficient space provided to store, receipt and despatch medicines, including a quarantine area. Buildings should be kept clean and well maintained, so as to protect the medicines from contamination or deterioration. The facility should have appropriate security systems to prevent unauthorised access.
Section 2 Storage Facilities
The storage facilities must provide conditions that ensure the maintenance of quality and safety of stored medicines. Facilities where temperature sensitive medicines (TSM) are stored must be monitored, using calibrated temperature recording devices.
Section 3 Personnel
Policies and procedures should be in place to train staff to maintain the quality, safety and security of the medicines. Specific training should be carried out for certain medicines or tasks, such as medicines requiring special storage conditions or tasks requiring the evaluation of goods.
Section 4 Stock Handling and Stock Control
Stock handling and stock control should be in accordance with procedures to prevent contamination or deterioration of the goods. Storage areas should be organised with a system in place to ensure stock rotation. Inwards goods should be inspected upon receipt to ensure correctness against order, period of time before expiry date and absence of damage.
Section 5 Transport
Adequate methods of transportation must be in place to achieve safe, secure and timely delivery of all medicines from their origin to their destination. Containers for the transportation of medicines must be clean and provide adequate protection from damage or deterioration of the medicines. Procedures should be in place to give assurance of the trustworthiness of delivery personnel.
Section 6 Management of Complaints, Return of Unused and/ or Damaged Goods and Product Recalls
Policies and procedures should be in place to provide adequate methods of handling complaint content, including evaluating the complaint content and prevention of a recurrence. Return of unused and/ or damaged goods from customers must be accounted for and stored in the appropriate areas until disposal occurs. All product recalls must be documented and accounted for until disposal occurs. Damaged stock and stock unsuitable for sale must be correctly accounted for and quarantined.
Section 7 Management of Records, Documentation and Standard Operating Procedures
Accurate records must be kept, that are readily retrievable and securely stored to prevent damage or loss. Systems should be in place for the design, preparation, review and distribution of Standard Operating Procedures (SOP). Policy documents should also be maintained and reviewed.
Section 8 Cold Chain Medicines
Throughout the receipt, storage and distribution of cold chain medicines, the integrity of the cold chain must be maintained according to the recommended conditions. Inwards cold chain medicines should be moved promptly to storage within the defined temperature range. Packaging of cold chain medicines should be performed under conditions that minimise the risk of medicine temperature excursions. Cold chain medicines should be transported under conditions that have been validated, using validated temperature-control systems, or by monitoring; to ensure integrity of the cold chain is maintained between wholesaler and customer.
Section 9 Security Arrangements and Procedures
There must be an appropriate level of protection and security of the facility, and for stored medicines, to prevent their theft and illegal distribution. Management should carry out a security risk assessment and maintain a security risk management plan for the business, which should be reviewed periodically. An authorised waste collector must carry out collection and destruction of waste medicines.
Section 10 Additional Measures for Management of Controlled Drugs (CD) and other Goods with High Illicit Value (GHIV)
There are additional risks to wholesalers who handle CD and/ or GHIV. Therefore, the security risk assessment and security risk management plan must detail secure storage, such as in a vault or safe, and handling methods for CD and GHIV. There must be control and administration of all transport movements of CD and/ or GHIV from wholesalers to product recipients. Detailed records of transactions in respect to CD and/ or GHIV, such as formal stock counts, including waste, must be maintained.
More information on Good Wholesaling Practice can be found here:
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