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AgVetLink: Number 1M, January 2007

Questions and answers

Notification of changes

Q1: What if I change premises or processes?

Approved manufacturers of veterinary medicines and vertebrate toxic agents must notify the ACVM Group of any changes to their premises, plant or processes that is different from the manufacturing information provided at the time of the registration. Such changes are likely to require an application to make a change to the registered trade name product (TNP) to be lodged and approved prior to the change being implemented.

Q2: We have only changed the firm we use to pack our product. Do we have to notify the ACVM Group about this change?

Yes, notifiable changes include changes to contract labellers, packers and quality control laboratories. This will also result in the need to lodge an application to change/add the manufacturer(s) of the TNP.

Q3: When should we notify changes?

Notification should be made before changes are implemented. If in doubt, ask. The proposed changes may not result in an additional inspection but will be placed on the manufacturing file to ensure information held by the ACVM Group is current at all times. The regulator and the auditors do not like surprises!

Q4: We have leased a manufacturing site that was GMP approved for the previous tenant. Is the GMP approval still valid?

The approval and GMP certificate links an organisation with a specific site for the manufacture of specific categories (types) of products. If a manufacturer vacates a site, the approval automatically lapses. Another manufacturer cannot move into a vacated site and assume GMP compliance because the previous tenant had approval.

Q5: We are GMP approved but we are moving to a new manufacturing site. What do we need to do to keep our approval?

Any new site has to be inspected and approved before any product can be released for sale from the site. This approval must be for both the site (GMP approval) and for the product (product registration).

Q6: What do we have to do if we want to extend the range of products we manufacture?

Manufacturers must apply for an extension to their GMP certificate if they intend to extend the types of products they manufacture. This includes both an additional category and dose form of product (liquid/powder/cream etc.). If you are just adding another product in the same category, another approval is not required.

Inspection programme

Q7: What is the purpose of GMP inspections?

Inspections of manufacturers of registered veterinary medicines are carried out to confirm that the registered veterinary medicines are being manufactured in accordance with the information and processes that were notified at the time of registration and in appropriate facilities. Users of veterinary medicines and vertebrate toxic agents expect them to be safe, effective and of high quality. To achieve this, products must be manufactured consistently, by a specified and approved process by appropriately trained staff to meet the registered specification – that is using Good Manufacturing Practices (GMP). Manufacturing a product in accordance to the ACVM Standard for Good Manufacturing Practice is a condition of registration of particular TNPs registered under the ACVM Act 1997.

Q8: What is the basis of the inspection?

The basis of the inspection is the assessment of a manufacturer’s level of compliance for the range of products manufactured with the ACVM Standard for Good Manufacturing Practice and, where appropriate, the ACVM Guideline for Good Manufacturing Practice for manufacture of specific categories of products.

Products vary in complexity from high risk veterinary pharmaceuticals to low risk dietary products. The scope and intensity of the inspections are matched to the risk levels of the products being manufactured.

Q9: How often do inspections take place?

Regular inspections (at least once every two years but likely to be more often if there are significant non-compliances) of manufacturers of agricultural compounds that are registered under the ACVM Act are required to provide assurance to users of veterinary medicines and vertebrate toxic agents that risks from manufacture are being managed. This frequency is in line with international practice.

Q10: Who does the inspections?

GMP inspections are carried out by trained inspectors in a third party agency, AgriQuality New Zealand, under contract to the ACVM Group. The costs of the inspection are recovered from the manufacturers by the ACVM Group. Members of NZFSA Verification Agency (VA) staff are undergoing training to perform Category 1 inspections in the future.

Q11: My product is exempt from registration. Will I be inspected?

Manufacturers of exempt products do not have to be ACVM-approved manufacturers in compliance with the ACVM Standard for GMP and they are not subject to regular inspection. Exempt manufacturers must comply with the conditions of exemption in the ACVM Regulations 2001. For some types of exempt products (e.g. topical preparations), there is a condition to manufacture to the principles of good manufacturing. These principles are defined by the manufacturer to ensure that the product is fit for purpose (for the type of the product).

However, all aspects of the ACVM Act are covered by at least ‘level 1 responsive compliance’. This means that any allegation or suspicion of non-compliance with the legislation by a manufacturer of exempt products will be investigated and may result in inspection of the manufacturer.

Q12: Is there an inspection programme for vertebrate toxic agent (VTA) manufacturers?

Manufacturers of vertebrate toxic agents are included in the GMP inspection programme, but the standard used is the ACVM Standard for Vertebrate Toxic Agents.