WAR-080 Example of Tablet Sampling Procedure as Raw Material

1. Before Start to Sampling

1.1. 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.

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

1.3. Prior to sampling goods, observe the relevant information from the GRS (Form-075) and notify supervisor of any discrepancies.

– Material Number

– Material Description

– Supplier

– Quantity

– Number of containers

– Manufacturer’s Lot No.

– Number of labels

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

– Approved Supplier

– Approved Manufacturer

– Supplied Containers

– Sampling procedure

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

– Conforms

– Initials

– Date sampled

– Quantity Sampled.

2. Tablet Sampling

2.1. Ensure the appropriate Bulk Tablet Sampling Form (Form-035) is printed and the required fields are filled in.  There are different forms for each Raw Material Code.

Print and fill out one Tablet Sampling Form for each Lab. Batch number.  Each IBC bin must contain only one lab number of tablets.  Mixing of different lab numbers in one bin is not allowed.

2.2. Precaution when sampling

2.2.1.  The tablet bags contain a small silica gel bag inside to keep out the moisture.  This is placed on the top of the tablets inside the tablet bag.  The bag must be cut as follows:

– Pinch tablet bag to form raised section for cutting.

– Make a small cut to ensure that the silica gel bag was not cut.

– While continuing to pinch the tablet bag continue the cut so that the tablets inside may be taken for samples.

– When there is more than one bag in the opened container, take samples as one tablet from each bag.

NOTE: Partial bulk containers that have been previously sampled during a previous BPN must also be re-sampled.

2.3. Compare the sampled tablet to the Appearance description and picture given in the appropriate Tablet Sampling form.  Check the tablet for the correct:

– Shape

– Colour

– Intagliations on Side 1

– Intagliations on Side 2

If any tablet is different from what is stated in the Tablet Sampling Form, notify your Area Manager immediately.

2.4.  Place the tablet into a sample jar labelled with Form-105.

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

2.6.  Specific containers from which samples are taken must be labelled with “SAMPLED” (Form-090) stickers.

2.7. Attach the Sydco ID labels (Form-080) 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.

2.8. 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.

3. Raw Material Sampling Logbook

3.1.  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

a. Date sampled

b. Booth number

c. Material code

d. Lab. Batch number

e. Date sample delivered to Analytical Lab.

f. Number of sample jar / containers delivered.

g. Signature of sampler.

4. Movement to Bulk Store or Reject Cage

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

4.2. 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.

4.3. 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.

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

5. Re-sampling of Tablets for Re-testing

A Laboratory request to resample of tablets 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 3).

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.

6. Summary of Changes