GMP Observations in Production-Does Standard Operating Procedure are followed and displayed.

GMP Observations in Production

1]              General procedure:

1.1 Quality Assurance personnel shall make plant round to check adherence of cGMP and fill up the checklist.

1.2     AMQA/Executive/Designee shall review the plant audit observation and after compliance/discussion with plant Incharge audit report shall be closed.

 1.3     QA Executive or Designee shall ensure the compliance of the observations

1.4   There is no need to have advance intimation or area permissions for plant audit.

1.5      Abnormalities/discrepancies can be complies online by production personnel

1.6     bnormalities/discrepancies except check list shall be reported and same shall be attached.

1.7              In case of following critical noncompliance observed during plant audit AMQA/Executive/Designee shall be inform through GMP incidence report.     

a)           Breakdowen of equipment/instrument during production.

b)           Missing /non availability of controlled document.

c)           Non availability of material status label.

 1.8              GMP incidence report having ten digit  i.e. GIR/XX/YYY.

a.           Where first 3 digits is for GMP –Incidence Report GIR fallowed by slash.

b.          Forth and fifth digit XX represents last two digit of the current year. e.g. (01, 02…99),with slash.c.           Sixth, seventh and eight digits (YYY) is sequential no. (001 to 999).

1.9              Filled GMP incidence report along with corrective& preventive action shall be review and approved by site quality head.

1.10          Incidence of GMP due to any discrepancies shall be reported.

 2]               During plant audit Inspect /Check following points  Following Check points shall be thoroughly considered during plant audit.

2.1         Calibration status of temperature indicators, pressure gauge, online pH meter, vacuum gauge, flow meters.

2.2          Preventive maintainace records of all manufacturing equipment.

2.3         Weighing balance calibrated and observations are recorded as per SOP; ensure standard weights are calibrated by authorized laboratory.

2.4         Manufacturing process is strictly fallowed as per controlled BMR and check for online recording. 

2.5         Samples from relevant stage are sent to Q.C.

2.6         Dispensing of Raw Material is done as per BMR for quantity, label status and ensure material is kept at defined place according to storage condition

.2.7         Calibration status of equipment displayed near the equipment?

2.8         Are the status boards of equipment updated? e.g. ready for use, to be cleaned, under maintenances, current status of process

2.9          Usage log book for the equipments available and updated on routine basis2.10     Does a manhole of reactors covered?

2.11     Check the centrifuge bag, filter cloth, Nutch filter cloths stored with proper identification as per their respective SOP.

3]               Check for House keeping:-

3.1          Review the area cleaning record as per schedule and SOP

3.2          Cleaning and maintenances records of air handling system and filters updated

3.3          Ensure that Floor, Walls, Ceilings and High level surfaces, Light fittings, window/ doors, AC, Air inlet/outlets properly maintained and cleaned.

3.4          Processing area have restricted entry i.e. Entry exit procedure is followed.

3.5          Ensure that all employee must fallow the gowning procedure.

3.6          Does Standard Operating Procedure are followed and displayed.