WAR-075 Example of Tablet Dispensary Procedure

Note: ‘D’ Grade Factory clothing and ‘D’ Grade footwear are to be worn.  No external clothing is to be worn inside the booths (See SOP MAN-005)

1. Risks in Dispensing/Sampling

The Dispenser must make every effort to ensure the material being dispensed is the correct Raw Material Code, Lab. Batch number and Manufacturer’s Batch number.  The tablet cartons must be counted and these are then multiplied by the amount of tablets in each carton.  This should equal the number requested on the Transfer Order (Form-055).  If not, investigate.

1.1. General Precautions

1.1.1. Isopropyl Alcohol (IPA 70%) is collected with Expiry Date clearly labelled on the container.

1.1.2. Excessively dirty pallets, packaging and other material must be cleaned before being taken into the Tablet Dispensing Booth.  Cleaning is done by spraying with IPA.

1.1.3. Ensure all implements to be used including sample jars, are clean and dry.

1.1.4. Sanitise all implements by spraying with IPA under the downflow zone.  The implements are kept under downflow until sampling is completed.

1.1.5. After sanitising sampling instruments under downflow, they are to be rested ONLY on ‘One Touch disposables’ throughout the dispensing process to prevent contamination.

1.1.6. Check Laboratory Batch Number on the TO (Material Transfer Order received with the pallet) against the Sydco label on tablet carton. Check all the Tablet cartons to be dispensed must have ‘RELEASED’ stickers on them.

1.1.7. Examine all material containers for damage before sampling.  Report any damage to the Laboratory Manager.

1.1.8. Do not touch any material with your hands.  Always use the appropriate sampling tools.

1.1.9. Dispensing staff is to observe GMP with respect to absence of watches, rings, nail polish and cosmetics.

1.1.10. Before sampling any Tablets, read carefully the sampling instructions given on the Tablet Sampling Form.

1.1.11. The air conditioning settings and timer are not to be altered in any way.

2. Dispensing Practice

Note: Only one batch of tablets is to be brought into the Safe Working Zone at any time.
This is to prevent batch mix-ups.

2.1. Ensure there is a large Waste bin for cardboard carton waste and also a bin for empty tablet bags.

2.1. Ensure the IBC (Intermediate Bulk Container) is clean with an internal plastic lining in place.  There should be a Yellow tag in the clear pocket, this will detail when, and who cleaned the vessel (see SOP MAN-070).

Ensure the bottom of the bag is sealed with a tie, this must be done whilst wearing gloves, and positioned in such a way inside the IBC that the operator, who opens the bottom cap, can access the tied end of the bag easily.  Also ensure the bottom cap of the IBC is securely in place.

2.2. The IBC and the Waste bin must be kept in separated areas with marked lines. The Waste bin on the left and the IBC on the right.  This ensures any dust generated whilst dispensing will be drawn into the filter system thus protecting the operator.

2.3. Select the first raw material to be issued according to the TO (Transfer Order). Check the Raw Material name, Code and Batch Numbers on the container against those on the Transfer Order.

2.4. If this information is correct, cut open the tablet bag and, with the forceps supplied, carefully pour the tablets in to the IBC bins. (If incorrect, inform Process Manager of Tablet Line.)

2.5. Open the MI (Manufacturing Instruction) sheet for Dispensary Phase (see SOP MAN-080) and read thoroughly before starting. Fill out each section step by step. Complete the MI sheet by signing.

2.6. At the end of the Dispensing operation for that batch number, an IBC Identification label (Form-380) is printed and fill up the section with Tablet Code, Name, Lab. Batch no, Quantity Dispensed, Manufacturer’s Batch number, IBC number, Sign and Date. This IBC ID label should be placed in the plastic pouch on the IBC.  If there are 2 or more IBC’s used then that is how many labels need to be printed.  The cleaning Tag (Form-145) from each IBC should be stapled to the rear of each printed label.

2.7. Send the IBC bins to the production WIP area (See SOP WAR-030) including the MI Sheet for Dispensary Phase and the paperwork received from the warehouse according to SOP WAR-015.

2.8. All empty tablet cartons are to be disposed of by putting in Green ”Paper/Cardboard Recycling” Bin.  These cartons are not to be crushed by hand.  After dispensing these Recycling Bins are sent in the hoist to the warehouse area. Inner bags from the tablet cartons, whether plastic or foil are to be placed in the Blue Waste Bin.  These are then taken to Waste Disposal Area.

2.9. All spillages are to be cleaned up immediately, by mopping or vacuuming.

3. Post Weighing Cleaning and Procedures

3.1. Clean booth by a one-touch disposable wipe dampened with IPA.

3.2. Clean floor by D Grade mop.

3.3. At the end of the day ensure that all walls, floors, and surrounding areas are clean and free from materials.

3.4. Turn the Booth OFF.

4. Summary of Changes