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AgVetLink: Number 1M, January 2007

Inspections: Common Deficiencies

Site master files

Inspectors have noted that not all manufacturing sites visited have complete and current site master files even though this is a requirement under section 2.4.4 of the ACVM Standard for Good Manufacturing Practice. Guidelines for the preparation of a comprehensive site master file can be obtained from the ACVM website.

For a small manufacturing operation it is appropriate that the form ‘Application for Authorisation to Manufacture Agricultural Compounds and Veterinary Medicines’ is kept up to date, and provided to the Inspector or the ACVM Group prior to, or at the time of, the inspection. This form contains the minimum information that is considered acceptable as a site master file for a small or uncomplicated manufacturing operation. For more complex manufacturing operations, the PIC/s guidance document should be used as a template (http://www.tga.gov.au/docs/pdf/siteinfo.pdf).

Others

Other deficiencies being noted regularly include:

• the lack of secure storage of pre-printed packaging components and lack of reconciliation of the product specific printed items at completion of the pack job

• the lack of any evidence that a line clearance had been performed prior to the start of a new packing operation

• the lack of a formal system to handle reject material that incorporates a secure location and a log for recording its fate.