WAR-010 Incoming Raw Materials and Components-Handling by QC Sampler

1. Receipt

On receipt of goods by the Receiving Store person, a Goods Receipt Slip (GRS Form-075) and Site ID Labels (Form-080) are printed for the consignment. Sampler has to collect the GRS, ID Labels and C of A from the receiving warehouse office. Ask for extra ID labels to warehouse personnel if needed for sampling of Printed components (SOP WAR-050).

2. Label Requirement

2.1. Site Identification Label

2.1.1. RAW MATERIAL (Actives and Excipients) – 1 label on each container.

2.1.2. IMPORTED FINISHED GOODS (i.e. Tablets) – 1 label on each container.

2.1.3. CHEMICALS – 1 label on each bag, jar, drum, etc. Do not place labels on lids of drums.

2.1.4. PRINTED CARTONS – 1 label on each container.

2.1.5. PRINTED PACKAGING MATERIALS – 1 label on each container.

Paper leaflets/PVC/Foil – have 1 label each roll.

2.1.6. PRINTED LABELS – 2 labels for each container – 1 on outside container and 1 on the top roll.

2.2. The Code Number of the Raw material (WAR-065) is checked against the GRS and Sydco ID labels.

2.3. The appropriate Laboratory Batch Number must be matching with the GRS and the printed Sydco labels.

2.4. Check Manufacturer’s lot number is matching with the C of A, GRS, and the manufacture’s label on the container.

3. Before Start to Sampling

3.1. Sampler to print out a blank Raw Material Specification and Test Report (TEM-005) for the corresponding raw material code number. Write down the Laboratory Batch Number on the RM Specification and Test Report.

3.2. Inspect containers and/or goods for any damage, if there is then notify Supervisor.

3.3. Prior to sampling goods, observe the relevant information from the GRS and notify supervisor of any discrepancies.

Material Number

Material Description

Supplier

Quantity

Number of containers

Manufacturer’s Lot No.

Number of labels

3.4. On the RM Specification Form the following must be checked

Approved Supplier

Approved Manufacturer

Supplied Containers

Sampling procedure

3.5. For each of these the following information must be written on the RM Specification Form

Conforms

Initials

Date sampled

Quantity Sampled.

4. Sampling

4.1. Transfer the goods from the Quarantine to Dispensary area. Complete movement item 2 on the GRS.

4.2. Sampling procedures for Raw Materials and Chemicals are described in SOP WAR-045 and for labels, packaging items and leaflets are described in the SOP WAR-050.  Sampling procedures for imported Tablets are described in SOP WAR-080. Specific containers from which samples are taken must be labelled with “SAMPLED” (Form-090) stickers.

4.3. Attach the Sydco ID labels one per each container. Write the qty. of goods after sampling on the GRS. When sampling is completed, transfer the goods from the Dispensary to Quarantine area. Update the movement item 3 on the GRS. Attach a copy of GRS, Raw Material Specification and Test Report (TEM-005) and C of A and deliver to the Laboratory with the physical samples.

4.4. Write the exact quantity after sampled at the top section of the Bin Sheet (Form-020), attached on to the pallet being sampled, so that it will reflect the correct quantity on the GRS. Keep the original GRS Form for warehouse to file.

5. Raw Material Sampling Logbook

5.1. All samples are to be delivered to the Laboratory. Write the details of the raw material into the “Raw Material/Component Sampling Logbook” (Form-545) and keep it in the Dispensary office.

Date raw material received from Warehouse

Date sampled

Booth number

Material code

Lab. Batch number

Date sample delivered to Analytical Lab.

Number of sample jar / containers delivered.

Signature of sampler.

6. Movement to Bulk Store or Reject Cage

6.1. Laboratory analyst will advise the warehouse staff whether a shipment of material is released or rejected after a laboratory test. In either case laboratory will produce Released or rejected stickers respectively one for each container.

6.2. If the shipment is released for production use, the warehouse staff will attach all released stickers on to each container under laboratory test. Warehouse staff will check available storage bin in the Bulk Store for the designated raw material or component types. Move the released pallets from storage bin in Quarantine to Storage bin in the bulk store and update the movement item 4 on the GRS.

6.3. In the case the shipment is rejected, warehouse staff has to raise a Deviation Report (QMS-035) and send to Quality Assurance Department. Attach the rejected stickers immediately onto each container involved and transfer the pallet/s in the reject cage. A comment should be made on the GRS regarding the rejection and inform the purchasing team.

6.4. The Reject stickers are placed on all sides of all containers of the rejected material in prominent positions.

7. Re-sampling of Raw Materials for Re-testing

A Laboratory request to resample of Raw Materials is sent to the Samplers via a sample request form (Form-010) and GRS number. Sampler to:

Collect the original GRS for the material from warehouse office.

Write the adjusted quantity after re-sampled on the copy of GRS.

Write the re-sampled details in the Raw material/component sampling log book (See section 5).

The container is marked with a “Sampled Partial” (Form-100) sticker and the Bin Sheet is adjusted again.

The Sampler then returns the adjusted copy of GRS with the physical sample to the Lab.

The Sample Request Form is kept in the dispensary office. The adjusted GRS form is kept in warehouse and use to update the inventory stock.

8. Appendix- Flowchart Raw Materials and Component Incoming Handling

9. Summary of Changes