Packaging Material Vendor Audit Checklist

Is an organization chart available?

Is the manufacturing facility certified (e.g., ISO 9001 / ISO 14001)? Are certificate numbers and expiry dates provided?

Are there other products manufactured in the same facility? What are these products?

How long has the vendor been manufacturing the product?

What is the lead time for delivery from the date of the purchase order?

Is any material supplied of animal origin? Are TSE/BSE certificates requested?

Are standard operating procedures (SOPs) available and followed?

Is adequate space provided for quarantine, approved, and rejected areas? Are these areas clearly demarcated?

Are materials properly segregated to avoid mix-ups?

Is an inventory record maintained for each material?

Is the First-In-First-Out (FIFO) system followed?

Are SOPs available for production processes?

Is a housekeeping schedule followed? Check records.

Are preventive maintenance schedules available and followed?

Are batch manufacturing records available and approved?

Is there an appropriate area designated for packing finished products?

Is there a documented procedure for packaging and labeling of final products?

Do labels contain necessary information such as product name, batch number, quantity, tare weight, gross weight, manufacturing date, and storage conditions?

Are there procedures for document preparation, control, review, approval, and distribution?

Are there procedures for managing changes in processes or specifications?

Are there procedures for handling complaints and deviations?

How are vendors approved? Is there a documented procedure?

Are training records available for staff involved in packaging processes?