Memo from QA to Production Head

To,

MR.XXXXXXXXX

From,

Quality Assurance Manager

During my morning round to your department the BMR of XXXXX capsules was reviewed it is observed that the manufacturing details of Lot B is not entered in BMR though the process is already carried out.
On inquiry it is known that the details are entered in raw data notebook to avoid any correction in BMR.
This is a gross GMP violation. QA department instructs you not to transcript the raw data details in the BMR until thorough investigation is carried out along with the Production Manager. Until then the raw data book will be under QA’s custody.

You are instructed not to get involved in any entry of any manufacturing document until you qualify the retraining program. After training a senior person will counter sign all your entries for verification of genuineness.

This is a warning for you not repeat such bad practice in future, which may be viewed very seriously.


Thanks,



Quality Assurance Manager