Operations

Operational requirements.

6.1 Requirements for Operations

  1. The WQP must ensure that;
  • (i) the premises is authorised for the wholesale supply of veterinary medicinal products, and the authorisation covers all activities performed at that site
  • (ii) the identity of the veterinary medicinal products is not lost during the wholesale activities and that traceability is maintained throughout the entire process
  • (iii) measures are in place throughout the wholesale process to minimise the risk of counterfeit veterinary medicinal products entering the legal supply chain
  • (iv) veterinary medicinal products are distributed in accordance with the information on the products’ SPC
  • (v) for products intended for the GB market, the veterinary medicinal products have a UK or GB marketing authorisation or have been imported in accordance with a Wholesale Dealer Import Certificate (WDIC) for supply against a valid WDIC or Special Import Certificate (SIC) from the customer
  • (vi) for products intended for export to Northern Ireland, the veterinary medicinal products have a UK or NI marketing authorisation or have been imported in accordance with a WDIC for supply against a valid WDIC or SIC from the customer
  • (vii) for products intended for export to a third country, the veterinary medicinal products can be legally supplied into that country
  • (viii) the operations of the WQP and other key personnel are described in the quality system.

6.2 Supplier Validation

  1. Wholesale dealers must obtain their supplies of veterinary medicinal products only from another wholesaler distributor or a holder of a valid manufacturing authorisation which covers the product in question. A wholesale dealer can only supply the type of veterinary medicinal product that they are authorised to supply, as stated in their WDA document.
  2. Due diligence checks must be performed for new suppliers, to assess their suitability, competence and reliability. There must be a documented check that the supplier complies with the principles and the requirements of GDP and that they hold the correct authorisation, for example by using the online VMD registers or obtaining a copy of the supplier’s authorisation document.
  3. Supplier authorisations must be re-checked periodically. This must be controlled by a procedure and the results documented. The checks must be based on risk management principals, but as a minimum must occur at least once annually.

6.3 Customer Validation

  1. Wholesale dealers must ensure they supply veterinary medicinal products only to a person who is entitled to supply that product under the VMR, either by wholesale or retail.
  2. All supplies must only be made to a registered/authorised premises, and if the supply is to a veterinary surgeon, a pharmacist or a suitably qualified person then checks must also be made that the person to be supplied is appropriately qualified.
  3. Customer authorisations must be re-checked periodically. This must be controlled by a procedure and the results documented. Checks and periodic rechecks may include requesting copies of customer’s authorisations, verifying status on the VMD website or RCVS website, requesting evidence of qualifications or entitlement according to national legislation. The checks must be based on risk but as a minimum, at least once annually.
  4. There must be monitoring in place on transactions and investigations made into any irregularity in the sales patterns of narcotics, psychotropic substances or other dangerous substances. Unusual sales patterns that may constitute diversion or misuse of veterinary medicinal products must also be investigated and reported to competent authorities where necessary.

6.4 Receipt of Veterinary Medicinal Products

  1. It is critical to ensure that any new consignment is checked on arrival to confirm that it is correct, originates from an approved supplier and has not been visibly damaged during transport. The receiving area must be separate from the storage area and the goods must be checked for counterfeits, product defects and that there is sufficient shelf life.
  2. Any activities performed on the incoming goods must not impact on the quality of the veterinary medicinal products. Veterinary medicinal products requiring special storage or security measures must be prioritised and once appropriate checks have been conducted, they must be immediately transferred to appropriate storage facilities.

6.5 Storage

  1. Veterinary medicinal products must be stored in accordance with the terms of the summary of product characteristics for each product, in segregated areas which are clearly marked and have access restricted to authorised personnel. Any system replacing physical segregation, such as electronic segregation based on a computerised system, must provide equivalent security and must be validated.
  2. Veterinary medicinal products must be stored separately from other products likely to alter them and must be protected from the harmful effects of light, temperature, moisture and other external factors. Veterinary medicinal products must not be stored directly on the floor unless the package is designed to allow such storage.
  3. Special attention must be paid to the storage of products with specific handling instructions as specified in national law. Special storage conditions (and special authorisations) may be required for products such as controlled drugs, chemotherapy medicines, hormonal products and those that are temperature sensitive.
  4. Warehousing operations must ensure appropriate storage conditions are maintained and allow for appropriate security of stocks. Storage areas must be clean, free from litter and pests.
  5. Stock must be rotated according to the ‘first expiry, first out’ (FEFO) principle. Exceptions must be documented.
  6. Veterinary medicinal products must be handled and stored in such a manner as to prevent spillage, breakage, contamination and mix-ups. Veterinary medicinal products must not be stored directly on the floor unless the packaging is designed to allow for such storage. If there is any damage, broken seals or suspected possible contamination, these products must be removed immediately and quarantined pending disposal.
  7. Veterinary medicinal products that are nearing their expiry date/shelf life must be withdrawn immediately from saleable stock. Expired products must be neither sold nor supplied and must be disposed of appropriately.
  8. Products pending a decision as to their disposition or have been removed from saleable stock must be segregated either physically or through an equivalent electronic system.
  9. Any counterfeit product, expired product, recalled product and rejected product found in the supply chain must be immediately physically segregated and stored in a dedicated quarantine area away from all other veterinary medicinal products. These areas must be clearly identified.
  10. Stock inventories must be performed regularly, and a full audit must be conducted at least once annually. Stock irregularities must be investigated and documented.

6.6 Destruction of Obsolete Veterinary Medicinal Products

  1. Destruction of obsolete veterinary medicinal products must be in accordance with the applicable requirements for the handling, transport and disposal of such products, and in accordance with local requirements.
  2. Records of all destroyed veterinary medicinal products must be retained to allow traceability and inspection of the annual stock audit. All records pertaining to veterinary medicinal products must be held for a minimum of five years.

6.7 Order Picking and Supply

  1. Controls must be in place to ensure the correct product is picked. The product must have an appropriate remaining shelf life when it is picked.

  2. For all supplies, the documentation accompanying the consignment (e.g. delivery note) must be enclosed stating:

    • (i) the name of the medicine
    • (ii) the strength and pharmaceutical form
    • (iii) the date on which the veterinary medicinal product was supplied
    • (iv) the quantity of product supplied
    • (v) the batch number
    • (vi) the expiry date
    • (vii) the name and address of the wholesale dealer supplying the product
    • (viii) the means by which the product was transported and the required conditions of storage
    • (ix) the name of the person to whom the product was supplied and the address to which it is to be delivered.

  3. This documentation can be paper based and sent with the delivery or sent electronically directly to the customer. If sent electronically then the documentation must not arrive at the customer after the delivery has occurred.

  4. Records of all deliveries must be kept so that the location of the veterinary medicinal products are known throughout the distribution process.

6.8 Export

  1. When exporting veterinary medicinal products outside of Great Britain then the wholesale dealer must only supply those products to persons who are authorised or entitled to receive veterinary medicinal products for wholesale distribution or for supply to the public in accordance with the applicable legal and administrative provisions of the third country concerned.
  2. Evidence that the checks have been made, including any documentation provided by the customer, must be retained for inspection.