1) Proposal - Deblistering activity shall not perf...

Completed item 1. I updated the documents to state that de-blistering/manual de-foiling shall not be performed in the blistering area and that all de-foiled tablets/capsules shall not be reused and shall be transferred for destruction. This revises the current SOP provisions that place the activity in the packing area and allow inspected tablets/capsules to be reused. (SOP-PT-001-04.pdf) (SOP-PT-001-04.pdf) (SOP-PT-001-04.pdf)

• Updated Change Control - SOP/PT/001/05
• Updated Change Comparison Sheet
• Updated SOP/PT/001 Version 05

The SOP is prepared as a Version 05 draft, with the existing cleaning procedure and Annexure-I retained. The change control number remains CC/PL3/P/26/0XX, and effective/review dates remain to be assigned because final values were not provided. The original draft already proposed discontinuing reuse of de-foiled tablets/capsules. (CC_SOP-PT-001-05.docx)

Your item 2) was blank; send the second requirement and I can update these documents further.