Description:
- cGMP and compliance review in the GMP area as per cGMP guideline.
2 Machine and area clearance.
3 Sampling of blend, intermediate stages, AQL finished product, ANSI sample, reserve sample, stability sample and In-process checks during execution of batch manufacturing & Packaging as per Process Study Protocol (PSP), Process Validation Protocol (PVP), Batch Manufacturing Record (BMR), Batch Packaging Record (BPR) & miscellaneous protocol based study.
4 Issuance of Bottle label, Outsert and Medication guide for commercial batch.
5 Documents and records review like equipment logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record etc.
6 Calibration of IPQA instruments.
7 Supervision of dispensing activity of raw material and packaging material.
8 Review of executed Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR) and release for next stage.
