Documentation, Procedures and Record-Keeping
Requirements for documentation, procedures and record keeping.
5.1 Documentation Requirements
- Documentation put in place for wholesale activities must be sufficiently comprehensive to cover the scope of the wholesale activities, be readily available and be written in clear unambiguous language which is understood by all personnel. Staff must have access to the necessary documentation required for the tasks they perform.
- All documentation must be approved, signed and dated by an authorised WQP.
- Changes to the documentation must be traceable, with a record of who made the change, when the change occurred and why. The changes must be in a format that allows the original information to still be available. Version control must be implemented on all documentation to allow this to occur.
- The documentation can be paper-based or electronic, or a combination of the two, but must be retained for a minimum of five years.
5.2 Procedures
Procedures must describe the full wholesale distribution process, including:
- (i) risk management
- (ii) data security, including computerised systems breakdowns
- (iii) training
- (iv) orders to suppliers and from customers
- (v) receipt and checking of deliveries
- (vi) storage requirements and conditions, including stock rotation
- (vii) stock control, including stock audits
- (viii) management of non-conforming products, including storage and waste
- (ix) picking and packing of orders
- (x) temperature mapping of storage areas
- (xi) temperature monitoring, including recording and calibration of equipment
- (xii) cleaning and maintenance of the premises, including pest control
- (xiii) vehicle operation, maintenance and cleaning
- (xiv) security of stock, both on site and in transit
- (xv) protection of veterinary medicinal products during transport and delivery
- (xvi) handling of returned veterinary medicinal products
- (xvii) emergency supply
- (xviii) recall plans
- (xix) qualification of suppliers and customers
- (xx) disposal of unusable veterinary medicinal products
- (xxi) investigating and resolving complaints
- (xxii) monitoring and documenting deviations
- (xxiii) non-conformance investigations, including CAPAs
- (xxiv) suspect counterfeits
- (xxv) self-inspections
- (xxvi) import certificates
- (xxvii) management of outsourced activities and contracts
- (xxviii) handling and management of controlled drugs
- All site-specific wholesale procedures must be approved, signed and dated by the WQP.
- Procedures which cover multiple sites/geographical areas must be approved, signed and dated by an authorised person who has control of the document and the WQP must make a record of the procedures used to demonstrate that they have reviewed and approved their use.
- Procedures must be reviewed regularly, and version control must be implemented to prevent inadvertent usage of a superseded document. Obsolete procedures must be removed from use and archived.
5.3 Records
1.) Records must be kept for any transaction where veterinary medicines are received or supplied, including disposals. These can be in the form of purchase or sales invoices or delivery notes and can be paper based and/or electronic. Records must be kept of all incoming and outgoing veterinary medicines and they must be available for inspection. In accordance with Regulation 22 of the Veterinary Medicine Regulations 2013 (as amended) these records must include all the following:
- (i) date of the sale/receipt
- (ii) name of the veterinary medicinal product
- (iii) the pharmaceutical form and strength of the product
- (iv) the batch number
- (v) the expiry date
- (vi) the quantity
- (vii) company name and address of the supplier or recipient
2.) Records must be made at the time and be clearly legible and retained for a minimum of five years after the date of the transaction.