1. Introduction

These guidelines are prepared to assist veterinary practices and other veterinarians in understanding and implementing the requirements of the Code of Good Veterinary Practices.

Therefore, they should be read in conjunction with the Code.

The purpose of these guidelines is to provide some more information as to what is required in the code and how compliance with the requirements can be shown.

The certification body shall look for these items during the audit.

Throughout this document the same order as in the Code is used, but some requirements might be explained in more than one section.

2. How to use these guidelines

These guidelines are written in tables. In the left column the clause reference of the Code of Good Veterinary Practices is given. In the second the requirements are given in short. In the third column you will find what things are expected to be seen to be able to show compliance with the requirement.

General principles:

• Where the guidelines state that a protocol is needed, this means that a protocol will have to be present in the quality manual, covering the requirement of the Code. It is however possible to cover more than 1 requirement in a protocol. Practices could for instance opt to write one protocol dealing with all medicine-depot requirements. Separate procedures will however be necessary.
• Where they state a procedure is needed, this means a procedure will have to present in the quality manual
• Where a record/logbook/etc is stated, this means records/logbooks/etc have to be kept. For every record/logbook/etc a blank copy should be present in the quality manual, together with a list stating all records and their current issue.
• Where equipment is mentioned, it means that certain equipment is necessary to comply.
• Where lay-out is stated, this means that there are certain requirements regarding the practice or office buildings.

3. Veterinary surgeons

	Clause reference		Requirement		How
	3		General requirements for veterinarians Create a mission statement stating all these requirements. Ensure that all acts performed as a veterinarian are according these statements.

4. Veterinary practice

	Clause reference		Requirement		How
	4 Part A		GVP-Veterinary practices shall:   Have a documented system in place to ensure that all requests for consultations, visits, re-visits, post-mortem examinations or any other service requested are logged. by using a daybook, protocol, procedure Have a documented system in place to ensure that all telephonecalls are answered. receptionist/answering machine/company + protocol, procedure Have a documented system in place to ensure a 24-hour service. protocol, procedure/contract with other practices Have a documented referral system in place, for cases beyond its abilities or capacity. protocol, procedure/contracts Clearly display tariffs protocol, procedure, record Have detailed bills stating all services and products with price protocol, procedure, record format Have written contracts with the farmers for the farms where it provides the animal health controls or the veterinary herd management. keep copies on file Have a documented system to ensure all requirements regarding animal health controls and veterinary herd management are met. in a separate folder per farm, or on PC Have a file for every farm under contract. protocol, procedures, records (see also Schedule 2, clauses 2.2 and 2.3) Have a yearly planning for these farm visits. create a planner Have a documented system in place to ensure all relevant documentation is kept on clients and patients. create a record on which all details are kept; on paper or PC Ensure confidentiality. protocol Have documented systems in place to ensure the safekeeping of drugs. protocols and procedures, see also schedule 1 Have documented systems in place to ensure drugs are ordered, received, stored, administered, dispensed, prescribed and destroyed according to the relevant legislation. protocols and procedures, see also schedule 1 Only administer, dispense or prescribe medicines, especially antibiotics and hormones after a thorough clinical examination of the animal(s) involved. protocols and procedures Have documented procedures to ensure surgery is performed as sterile as possible. protocol, procedure, records Have sufficient infrastructure for the type of services offered. practice lay-out Have a cleaning and disinfection schedule in place incorporating all rooms of the practice, the medicines depot, the practice car and the instruments. create a plan, state who, when, how, where, insert a page on products used and safety precautions Have documented procedures to ensure different types of waste are kept separate and disposed of as appropriate. Categories kept separate List hazardous and non-hazardous clinical wastes Storage clinical waste Removal Storage and removal of carcases protocol, procedures list lay-out, equipment protocol, procedures, contract, record protocol, procedures, contract, records Have a quality system in place that meets the requirements of this Code. see point 6 Comply with the requirements of the schedules relevant to the practice. ensure all relevant requirements of this Code are met.
	4 Part B		GVP-Veterinary practices shall:   Be clean and hygienic. Protocols and procedures Always perform a thorough clinical examination on every patient. This encludes taking the history, observations, a full clinical examination, any necessary additional examinations. Protocols and procedures Based on these examinations come to a probable diagnosis. Protocols and procedures Discuss all treatment options and give a reasoned prognosis. Protocols and procedures Be free in choice of therapy, as long as he is able to show its justification. Protocols and procedures Use drugs with prudence and according to all relevant legislation. Protocols and procedures Keep records of all examinations and treatments. Protocols, procedures, create a record with all relevant data, on paper or PC Ensure all records comply with the requirements of this Code. Protocols and procedures Comply with all GVP-requirements for veterinarians. Protocols and procedures Be a member of the College of Veterinary Surgeons. keep copy of document on file

5. Medicines Control

	Clause reference		Requirement		How
	5		All veterinary staff understand and comply with their legal obligations in relation to the prescription, safekeeping, use and supply of veterinary medicinal products. CPD, training, protocol, procedure Veterinary medicines are used with the greatest prudence. CPD, protocol, procedure Veterinary medicines only administered, dispensed or prescribed after a complete clinical examination. Protocol, procedure, internal audit Depot:   Regional Pharmaceutical Society advised in writing. File copy of letter Depot manager and deputy manager. Appoint staff, keep record Non-registered drugs and/or drugs not licensed to be traded not present in the depot. Protocol Documented procedures for the ordering, the receiving, the storage, the administration, the dispensing and the prescribing of veterinary medicines. Protocol, procedures, records At least yearly all medicines stocks are controlled. Protocols, procedures, records Documented procedures to guarantee that first in - first out principles are adhered to. Protocol, procedure, checklist Documented procedures to guarantee no medicines are used after their use by-date. Protocol, procedures, checklists Documented procedures to ensure no veterinary medicines residues are present in food for human consumption. Protocol, procedures All requirements of schedule 1 to this Code are met. See guidelines to schedule 1

6. Quality system requirements

	Clause reference		Requirement		How
	6.1		6.1. Management responsibility    6.1.1. Quality policy  policy document 6.1.2. Organization  Organogram, job descriptions, responsibilities sheets 6.1.3. Management review  protocol, procedures, records
	6.2		6.2. Quality system    Establish, document and maintain a quality system Protocol Quality manual: Protocols Procedures Structure and lay-out of documentation This is the general requirement, see further for details All protocols and procedures effectively implemented. See internal audit
	6.3		6.3. Contract review  protocol, procedure, records
	6.4		6.4. Document and data control    6.4.1. General    Documented Procedures Procedures 6.4.2. Document and data approval and issue    Assigned personnel Protocol, record Master list Protocol, record All documents:   Dated and signed Record format Issue version Protocol, procedure Printed or typed Protocol, procedure Centrally available and accessible to all personnel Protocol, procedure Available at the workstations Protocol, procedure All invalid or obsolete documents are removed from the system.   6.4.3. Document and data changes
	6.5		6.5. Purchasing / subcontractors    6.5.1. General  protocol, procedures, records Specific requirements documented and agreed.   Procedures.   6.5.2. Evaluation of subcontractors  protocol, procedures, records 6.5.3. Purchasing data.  protocol, procedures, records 6.5.4. Verification of purchased product / delivered services.  protocol, procedures, records
	6.6		6.6. Product identification and traceability    Procedures. protocol, procedures, tags, labels, records
	6.7		6.7. Process control    Documented work-instructions protocol, work-instructions Suitable equipment, maintained and, where applicable, calibrated equipment, protocol, procedure, instructions, records Compliance with legislation, standards, codes, procedures protocol, procedures
	6.8		6.8. Control of non-conforming product and waste    Procedures for the disposition of nonconforming products and waste materials. protocol, procedures
	6.9		6.9. Corrective and preventive action    6.9.1. General    Documented procedures. protocol, procedures Records. protocol, procedures, records 6.9.2. Corrective action  protocols, procedures, records 6.9.3. Preventive action  protocols, procedures, records
	6.10		6.10. Handling, storage, packaging, preservation and delivery  Protocol, procedures, checklists
	6.11		6.11. Control of quality records    Documented procedures Protocol, procedures All records legible and easily retrievable. Format, storage procedure Retention times. Protocol, procedure Available to the customer or a representative. Protocol
	6.12		6.12. Internal quality audits  Personnel appointed, protocol, procedures, audit schedule, record, follow-ups
	6.13		6.13. Training  Personnel appointed, protocol, procedures, audit schedule, record, follow-ups

Schedule 1: GVP-requirements regarding the depot of veterinary medicines

	Clause reference		Requirement		How
	Sch. 1 Clause 1.1		1.1. Ordering medicines    a pharmacist open to the public Protocol, contract / statement vaccines mentioned in the Ministerial Ruling of 10 July 1964 Protocol, ordered as appropriate using the medicines ordering document required format used returned signed copy kept for a period of 10 years protocol, procedure, file the forms will be filed chronologically protocol, procedure all medicines present in the depot of GVP-veterinary practices shall be reconcilable with the order forms. protocol, procedures Computerised system: information is available on a printout upon request. check with software-supplier
	Sch 1, clause 1.2		1.2. Incoming medicines    Checked for damaged packaging, delivered quantities, use-by date and identity of the pharmacist protocol, procedure, checklist Identification of GVP-veterinary practice put on the primary packaging protocol, procedure Documented procedure to return non-conforming products protocol, procedure, agreement with pharmacist Returned products stated on order forms, with the reason. protocol, procedures, forms Accepted products entered in incoming medicines logbook. protocol, procedure, logbook Register easily readable and accessible, if computerised printout possible at all times. format, check with software-supplier
	Sch 1, clause 1.3.1		1.3. Medicine depot    1.3.1. General    Associations have one central depot protocol, procedure
	Sch 1, clause 1.3.2		1.3.2. The depot    Closed lay-out Easily cleanable lay-out Clean and orderly cleaning protocol Vermin- and dust-free vermin control (baitstations) + checking regime, cleaning protocol Categories of products stored physically separated lay-out Separate register for sedatives, anaesthetics and euthanasia drugs lay-out, registers Closed cabinet for narcotic drugs with a separate register lay-out, register medicines to be returned to pharmacist lay-out stored as required by producer protocol, procedures, fridge, dark closet min/max thermometer in all depot-rooms thermometers medicines in primary packaging protocol, procedure, internal audit stocked so they cannot contaminate other products or materials and vice versa lay-out, regular checks: checklist, procedure measures to prevent spillage, breakage and theft lay-out, protocol, procedure, regular checks: checklist classification orderly, hygienic and according to the keeping requirements, written down in a protocol protocol, procedure, regular checks: checklist lots with the nearest use-by-date are used first protocol, procedure, regular checks: checklist Documented procedures to ensure that products beyond their use-by date are removed from the depot and disposed of as appropriate protocol, procedure, regular checks: checklist Handling, storage, packaging, preservation and delivery procedures in accordance with section 6.10 of the Code of Good Veterinary Practices protocol, procedure
	Sch 1, clause 1.3.3		1.3.3. The surgery depot-extension    Stock as small as possible protocol, procedure, checklist Stored as required by producer protocol, procedure, checklist Classification orderly, hygienic and according the keeping requirements protocol, procedure, checklist Date of first opening or first use of bottle written on the packaging protocol, procedure, checklist In use flacons or unsealed packages used maximum 3 months protocol, procedure, checklist Products beyond their use-by date or broken into more than 3 months removed from the depot and disposed of as appropriate protocol, procedure, checklist Medicines protected from spillage, breakage and theft lay-out, protocol, procedure, checklist
	Sch 1, clause 1.3.4		1.3.4. The car depot-extension    Stock as small as possible protocol, procedure, checklist Medicines stored as required by producer protocol, procedure, checklist, carfridge Classification orderly, hygienic and according to the keeping requirements protocol, procedure, checklist in primary packaging protocol, procedure, checklist identifiable protocol, procedure, checklist cannot contaminate other products or materials or vice versa lay-out, checklist sufficient measures against spillage, breakage and theft lay-out, protocol, procedure, checklist date of first opening or first use of bottle written on the packaging protocol, procedure, checklist in use flacons or unsealed packages used for maximum 3 months protocol, procedure, checklist products beyond their use-by date or broken into over 3 months removed from depot and disposed of as appropriate protocol, procedure, checklist dustbin and a needle-container equipment, checklist
	Sch 1, clause 1.4 and subclauses		1.4. Outgoing medicines    Outgoing medicines registered with relevant data protocol, procedure, register Registered per vet protocol, procedure, register 1.4.1. Administering    Relevant data are registered protocol, procedures 1.4.2. Dispensing    In primary packaging protocol, procedure Practice identification on primary packaging protocol, procedure, labels Any other required information on primary packaging protocol, procedure All relevant data registered protocol, procedure 1.4.3. Medicines for destruction    Documented procedures protocol, procedure All these medicines clearly and irreversibly marked that they are no longer to be used protocol, procedure, label Registered in logbook protocol, procedure, register
	Sch 1, clause 1.5		1.5. Stock controls    At least once a year protocol, procedure Differences on a report protocol, procedure, form Kept for a period of 10 years protocol, file
	Sch 1, clause 1.6		1.6. Administration    All administered/dispensed drugs specified on the outgoing bills protocol, procedure, form Recent veterinary medicines compendium present compendium Compendium on legislation on veterinary medicines present and kept up-to-date compendium with contract or similar Clear job descriptions job descriptions, protocols, procedures adhered to
	Sch 1, clause 1.7		1.7. Personnel requirements    Continuous professional development file
	Sch 1, clause 1.8		1.8. Waste control procedures    Documented procedures protocol, procedures, records Containers materials Room separated from living rooms, inaccessible for unauthorised persons and sign lay-out Removal company contract, records

Schedule 2: GVP-requirements regarding the veterinary practice on food-producing animals

	Clause reference		Requirement		How
	Schedule 2 clause 2.1		2.1. Practising
	Schedule 2 clause 2.1.1		2.1.1 All veterinary practices
	Sch 2 Clause 2.1.1		2.1.1.1 Administration    Daybook see GVP-code clause 4 Telephone service   On-call service   Referrals   Contracts: Contracts with farms: Copies of all contracts with farmers shall be sent to the College Of Veterinary Surgeons and the Local Veterinary Inspector. Folder kept per farm keep a copy of the letter to the College keep contracts on file have a folder for every farm with all information stated Other contracts: GVP-veterinary practices shall ensure that a copy of a contract is sent to the College of Veterinary Surgeons if required by the Code of Professional Conduct of the College. keep a copy of the letter to the College keep contracts on file Yearly planning see GVP-code clause 4 Logbooks protocols and procedures Accounts protocols and procedures
	Schedule 2 clause 2.1.1.2, 2.1.1.3, 2.1.1.3.1, 2.1.1.3.2		2.1.1.2. Clinical examination  2.1.1.3. Treatment  2.1.1.3.1. Drug therapy  use of medicines administering drugs dispensing drugs prescribing drugs pharmacovigilance 2.1.1.3.2. Surgical procedures  Protocols and procedures, records, registers as required
	Schedule 2 clause 2.1.1.4		2.1.1.4. The veterinary practice    General requirements:   GVP-veterinary practices shall be clearly recognisable as such from the outside. Have a veterinary cross or similar at the premises; display GVP-certificate The consultation hours shall be clearly visible, as well as contacts outside these hours. Paper or similar at entrance A room to see clients or representatives shall be present. This room shall be worthy of the profession. The same room can be used as the practice office, but all measures are to be in place to safeguard discretion regarding client data. Lay-out; keep records on PC or in separate files per client; do not leave any windows open on PC or files open on desk unattended. If food-producing animals are seen at the veterinary practice, the following rooms have to be present:   a consultation and treatment room; with all the necessary equipment relevant to the type of services provided. Documented procedures shall be in place to ensure that any equipment that has to be sterile, will be such prior to use Lay-out, equipment, protocols and procedures A waiting room for the clients with sufficient seating. A toilet has to be available for the clients. Lay-out An operation room; the necessary equipment relevant to the operation services provided is present and sterile. There are documented procedures to guarantee this Lay-out, equipment, protocols and procedures The following conditions have to be met if the relevant services are offered at the veterinary practice:   Own lab Lay-out, equipment, protocols and procedures equipment for bloodtesting, urine, faeces, skin etc: The necessary equipment for testing. Calibration records. A separate fridge. Records per test. An instructions manual. Lab-waste materials. Equipment, protocols and procedures, records, instructions manual, waste controls Radiology:   The equipment has to be ready for use at all times: The positioning of the equipment All walls and doors of the room adequately protected Hazard light Personal protection Dosimeters + register. Register of tests. Maintenance logbook. A separate room for development of films, with the necessary equipment. Verbal instructions, safety sheet, safety instructions. No entrance for pregnant women Radiation protection officer + procedures. Protocols and procedures Lay-out Lay-out Lay-out Equipment Equipment, protocol, procedures, register Protocol, procedure. Register Protocol, procedure, register Lay-out, equipment, protocol, procedure Protocol, procedures, sheets Personnel, protocol, procedure Observation stables and pens: easily cleanable and disinfectable. Hygiene stations. Register. Pens/stables chart. Lay-out Lay-out, protocol, procedure Register, protocol, procedure Chart, protocol, procedure post-mortem room: adequately separated from the other rooms. easily cleanable and disinfectable. Procedures equipment separation. Register. Lay-out Protocol, procedure Protocol, procedure Register, protocol, procedure A separate room to store waste from the sections, cooled. Protocol stating the collection details. Layout, protocol, procedure
	Schedule 2 clause 2.1.1.5		2.1.1.5. The practice car(s)  Equipment, protocol, procedure
	Sch 2, clause 2.1.2		2.1.2. Specific requirements for multivet practices    The contract approved by the College of Veterinary Surgeons and present. Keep letter of approval. A clear daily schedule. Schedules, protocol, procedure Work and holiday schedules. Schedule, protocol, procedure
	Sch 2, clause 2.2		2.2. Practices and official animal health work    a compendium on all legal requirements and guidance issued by the authorities regarding animal health controls is present and kept up-to-date. Compendium, contract regarding keeping it up-to-date Contract, 4 copies, sent to College of Veterinary Surgeons and Local Veterinary Inspector. Contract, protocol, procedure, keep copy of letter A list is present stating all farms for which the practice is responsible regarding animal health controls. create list, keep up-to-date and on file All official tasks are performed conform the guidance/instructions received from the Ministry. protocol, procedure On all official documentation, the inspectorate is notified in case of delegation of the official work to a colleague of another GVP-practice. This has to be double signed. protocol All documents and certificates according to clause 2.5 of Schedule 2. Protocol, procedure
	Sch 2, clause 2.3		2.3. Practices and veterinary herd management    A compendium on all legal requirements and guidance issued by the authorities regarding the veterinary herd management is present and kept up-to-date. Compendium, contract regarding keeping it up-to-date There are no more than 150 farms under contract, per GVP-veterinarian. Protocol All contracts with farms are submitted to the College of Veterinary Surgeons and the relevant veterinarian-inspector. Report to state animal health status and welfare status. Keep letter of approval on file All farms under contract are visited 6 times a year with a maximal period of 2 months between 2 visits. Protocol, procedure, record All farms under contract are inspected every 4 months (every 2 visits) for a global evaluation. Records of these evaluations shall be made in double and shall be kept for 5 years. Report to state animal health status and welfare status. Protocol, procedure, records, record format All farms under contract with more than 6 production rounds per year, are visited every production round. Protocol, procedure, record When medicines are administered or dispensed the logbook kept by the person responsible for the animal(s) is completed with the necessary details. Then both parties sign the logbook. Protocol, procedure, protocols agreed with farms under contract, record All farms under contract, with a medicine depot on farm: Keep their medicines as requested by the GVP-veterinary practice, thereto the GVP-veterinary practice shall agree protocols and procedures with farms under contract on what medication can be used by the person responsible for the animals and under what conditions. These protocols and procedures shall always respect the legal requirements. Have no more medicines in stock than necessary for the period between 2 visits. Have their medicines logbook inspected on every visit. Protocol, procedure, record All documents and certificates according to clause 2.5 of Schedule 2 Protocol, procedure
	Sch 2, clause 2.4		2.4. Emergency slaughter    Emergency slaughter follows all requirements stated in the Regulations. Protocol, procedure Any certification relating to it is only based on own ante-mortem findings and own therapies and according clause 2.5. Protocol (see also certification) Welfare: unfit to travel Protocol, procedure, equipment
	Sch 2, clause 2.5		2.5. Certification  Protocol, procedure
	Sch 2, clause 2.6		2.6. Legal responsibility    GVP-veterinary practices shall ensure that the practice as well as all staff are insured for legal and professional responsibility Keep contract with insurance company on file

Schedule 3: GVP-requirements for GVP-veterinarians working for third parties

	Clause reference		Requirement		How
	Sch 3, Clause 3.1