Inspection

Purpose

[SAMPLE ONLY. You may customize this template based on your business requirements]

The purpose of this SOP is to ensure that the correct steps are taken when using the tablet press to perform tablet compression.

Scope

The scope of a manufacturing SOP answers the following questions:

1. Where is the SOP to be used? e.g. area, process, department, stage? --- (chemical manufacturing lab)
2. Who is the SOP for? e.g. operator, manager, QA --- (lab personnel and tablet press operators)
3. Are there any specific limitations or exceptions to this SOP? (This only applies to the production of pharmaceutical tablets)

Cleaning of tablet press

Compression machine was cleaned as per separate SOP (use 70% isopropyl alcohol)

Dust extractors, pipes, racks, door frames, and return filters of the Air Handling Unit have all been cleaned

Performed visual check for absence of leakage

After receiving approval from quality control department, put "cleaned" label on equipment

Operation

Remove "cleaned" label prior to operating tablet press.

Affix label to tablet press with PRODUCT NAME and BATCH DETAILS

Issue the punch set suitable for the compression as per separate SOP.

Set the machine as per tablet parameters given in BMR.

Destroy tablets from first few rotations before starting the machine for the first batch.

Collect tablets generated per batch then pack and label

Stop compression as material in the hopper reaches the lowest level.

Clean all outside containers and store them with labels that show batch details.

Remove punch sets and clean as per separate SOP.

Completion
Full Name and Signature of Employee