Check Points for shop Floor Improvement –
- Online Documentation
- Daily calibration status and its record
- Environmental Records / Differential Pressure as per SOP.
- Physical cleanliness of the area / equipment / instruments.
- Status labeling of area / equipment / instruments
- Cleaning and Sanitization records.
- Area cleaning records.
- Training records of the employees performing the activity.
- Availability of job description of employee performing the activity.
- Procedures are being followed as per SOP.
- Effective date and review period of SOP.
- Doer and checker system.
- Qualification status of new / existing area / equipment / instrument and their records
- Equipment / instrument operation / Cleaning records.
- Verification of safety checks of the instruments / equipment and their records.
- Solution preparation and destruction records.
- General Maintenance records.
- Calibration / revalidation records
- Data storage and sample storage condition and records.
- Material issuance and distribution procedure and records.
- Current effective vs available SOPs / specification / guideline status.
- Written approved procedure vs actual practices followed.
- Issuance and destruction records.
- Availability of approved layout of the area.
- Pest control measures.
- SCM related procedural checks.
- Collection of in-process samples.
- Reconciliation procedure.
- Critical manufacturing and processing steps.
- Yield and other calculations.
- Standardization records of volumetric solutions.
- Glassware calibration records.
- Storage conditions of standard and working reagents / solution /indicators /impurity /
raw and packing material.
- Records of primary standards, secondary standards and reference material.
- Records of microbiological media / standard cultures.
- Labeling procedures.
- Procedure for the handling and disposal of chemical and biological Waste.
- Calibration calendar and its compliance.
- Preventive maintenance calendar and its compliance.
- Building maintenance records.
- Work orders.
- Cleaning and Sanitization of the containers for API and /or excipient.
- Physical segregation of approved / under test / rejected materials.
- Procedure for verification of gross weight, tare weight and net weight.
- Types of documents and records to be checked shall vary for area to area and Equipment
to equipment.