Activities Responsibility

Rejection/Sample codes PHPL and Rpwyz

Shift field mandatory in COR6N Rpwyz
Partial Confirmation provision Rpwyz

Utilities consumption based on time PHPL and Rpwyz

Codes description in COR6N Rpwyz
Deleting fields Mould,CIP in other important screen Rpwyz
Last operation confirmed yield quantity should propes as goods r Rpwyz
Results Recording for sterilisation PHPL
Manufacturing date of sfg should be mixing phase start date Rpwyz
Changes in BMR/BPR issuance,SRS form Rpwyz and PHPL
Water for injection release PHPL
Greay out batch number field in COR2 Rpwyz
WFI Release Sample - COR6 PHPL
Zero Sample - COR6 PHPL
Terminal Sterilization- COR6 PHPL
Remarks
List of codes need to be provided by puniska
Enhancement
Configured and working fine

Standard solution provided decision expected from PHPL for development

Changes in enhancement
Changes in enhancement
Enhancement
Standard system working fine decision need to be taken by puniska
Enhancement
Changes in enhancement
Standard system working fine decision need to be taken by puniska
Enhancement
Different Inspection lot shall be generated for WFI release sample at start of manufacturing.
Recording For Zero Sample at filling stage to be incorporated but should not restrict during filling stage entry
1. Finished Sample shall be withdraw at Terminal sterilization stage but should not restrict for result recording. 2. Inspection
 Status Action Dtae
Open 03.04.2019
Closed 03.04.2019
Closed 02.04.2019

Open 03.04.2019
Open 04.04.2019
Closed 03.04.2019
Open 05.04.2019
Open 04.04.2019
In progres 04.04.2019
Open 03.04.2019
Open 05.04.2019
Open 04.04.2019

ing. 2. Inspection Lot generation date shall be same as Finished prouduct sample withdrawal date