Doc No: SOP 01

Revision No: 1

Revision Date:

Created By:

SECTION TITLE: STANDARD OPERATING PROCEDURES Approved By:

DOCUMENT TITLE: RECEIPT AND STORAGE OF MATERIALS Pages: 2

PURPOSE: This SOP outlines the procedure for the proper receiving and storage of raw and packaging materials.

PERSON RESPONSIBLE

FREQUENCYMONITORING

ACTIVITYCORRECTIVE ACTIONS RECORDS

Receiving Personnel /QA Designate

According to QA Audit Schedule /As Required

Daily GMP Audit / Monthly GMP Audit

When findings deviate from written standards the QA designate will document findings on the Daily / Monthly GMP Audit Form and notify the General Manager of the deviation.

Short term action will be initiated and recorded on the Daily / Monthly GMP audit form. Long term action required, will be discussed by management and corrective actions / responsibilities and time frames will be agreed and documented.

Daily GMP Audit / Monthly GMP Audit /Receiving Log Sheet /Non-compliance Product and /or Transport Truck Rejection form Hold Form / Log

PROCEDURE DESCRIPTION:

1. Note the outside condition of the carrier and inspect for:

Holes, cracks or broken panels (permitting the passage of other sources of contamination). Doors or hatches that do not close adequately. Refrigeration unit not working (when applicable).

2. Open the door and inspect for:

Temperature out of specification. Foreign / off-odors (e.g. chemical/solvent smell, fishy odor, rotten/spoilage odor). Insect / pest activity Molds. The condition of the shipment e.g. damaged or dirty packaging, exposed product. Water damage. Non-food items e.g. previously carried goods that are non-compatible with food. Contaminated product (when you have reason to believe that the product is contaminated). Unlabeled products (labels, production date, best before date etc.). Government seal broken/missing (when applicable). Products from unapproved suppliers (check supplier list or check with purchaser). Pesticides Any other material or contaminant which could effect finished, raw or packaging material

3. If you suspect a problem like damage, contamination, filth or odors, notify your supervisor and/or QA manger immediately. All materials shipped in damaged, dirty, or infested vehicles will be rejected. Record the non-compliance on the Non-compliant product and / or Transport Truck rejection Form (See ‘Reasons to reject a shipment note’).

4. Unload the shipment and transfer to raw material staging area.

5. Inform QA Designate of the shipment.

6. Record the details of the received materials on the – Receiving Log Sheet.

7. Ensure the number of items, product type, product code, and shelf life match the packing slip. If the shelf life is less than 75%, inform the QA designate for further action, which may include rejecting the shipment or accepting based on shelf life and production requirements.

8. Material deemed unacceptable (out of specification) will be tagged as such with a “HOLD” sign by the QA designate (SOP 04).

9. The product will be unloaded and staged in the receiving area. Identify ingredients deemed as “Allergens”, refer to Active Ingredients List if unsure if ingredient is an allergen and tag it with a RED sticker. Ingredients Tagged with RED stickers are deemed as Allergens and are stored in a segregated “Allergens Only” area.

10.Store ingredients, finished goods, packaging and other items off the floor and at least 18 inches (50 cm) away from walls and ceilings. Maintain adequate space between the rows of stored products for cleaning, monitoring, and inspection. Store ingredients deemed as ‘Allergens” separately from non-allergen ingredients in controlled ‘Allergens Only’ locations.

11.Undertake proper rotation of all ingredients, packaging supplies and other materials on First In, First Out basis.

12.Use clean pallets; use slip-sheets between pallets and bags of ingredients and between double stacked pallets to protect pallets from damage by pallets.