SOP on In process Checks by IPQA

SOP on In process Checks by IPQA

Objective : To lay down a procedure for carrying In-process checks by IPQA personnel.

Scope : This standard operating procedure is applicable at formulation plant of Panacea Biotec Limited, Baddi.

Responsibility

Officer /Executive IPQA shall be responsible to perform in-process checks as per this SOP.

Head – QA or designee: To ensure the compliance of this SOP.

Procedure

IPQA personnel shall perform the in-process checks during the manufacturing and packaging operations as per respective BMRs.

Frequency of in-process checks by IPQA personnel shall be at least twice in a shift / and at starting of a new batch.

In-process check sheet shall be part of BMR.

Training Evaluation Questionnaire

1. Who is responsible for performing in-process checks during manufacturing? IPQA  /Stores/Production/QC.
2. Is in-process check sheet is a part of BMR? True  / False .
3. Who is responsible for the compliance of this SOP? Head-Production /Head-QA /Head-QC /None of these.
4. What is the frequency of checks? Once  /At starting of new batch /Twice in shift.