Quality
In STLB, Quality Assurance department is associated with all matters / functions that directly / indirectly, individually or collectively affects the quality of the product.
This function of the organization is well established with:
- Qualified and trained personnel.
- Personnel computers with software for Statistical Control wherever required.
Quality Assurance participates in & has final authority in following functions carried out as a part of Total Quality Management.
| Function | QA Role |
|---|---|
| Receiving | Routine checks on receiving operations |
| Quarantine | Quarantine Routine checks to ensure controlled movement & status labeling |
| Sampling & Testing | Approval of sampling plans, Specifications, Testing methods., Review of Certificate of Analysis of Final product, Authorisation of changes in plan, specifications and methods. |
| Inventory | FIFO, Verification for balance material after dispensing, Approval or returned material from production by store. |
| Dispensing of raw materials | Verification of weight and identity of the material dispensed, labeling of containers and its subsequent movement. |
| Line clearance and Start-up operations | Verification for absence of any possibility of mix-up or cross contamination from pervious operation. Equipment & Area cleanliness, its status labeling. Verification of Air and wash water samples for compliance. |
| Cleaning | Verification of cleanliness right from equipments, floors, walls, change rooms to door tops is done by QA personnel. |
| Processing, Packaging & labeling operations | Online inspections as per written IPQC programs. Review of records during operation. Handling deviations, Verification of yield & reconciliation. |
| F. P. Release | Production Record Review, Authorisation for release. |
| Complaint Handling | Investigations with QC, Classification, Reporting, Corrective action and Follow-up, Managing records & Trends |
| Recall | Pre-recall investigation, Notification, Classification, Liasoning with marketing, Reconciliation of returned Goods. |
| Handling of Reprocessing & Reworks | Exercises control on reprocessing & rework issues. |
| Change Control | Approving New or Changes in Facility, Equipment, systems & procedures after QA review for compliance. Approval for changes in specification, method, vendor. |
| Document control | As an approving authority for creation, revision and distribution of documents including BMR & BPR. |
| Scrap Disposable | QA monitoring controlled disposal of scrap and rejected goods |
| Control samples | Control samples collection, management and destruction after expiry. |
| Self Inspection audits | Periodic inspection of facility, systems for compliance to GMP Ensuring corrective action for compliance, Reporting to management. |
| Batch Records | Storage of batch records with adequate traceability |
| Training | Continual training on cGMP |
| Personnel | Approval for job descriptions |
| Stability Studies | Co-ordination with Q.C. & Product Development to ensure compliance. |
Quality Control:
In order to complement the Quality Assurance function, STLB has well equipped Quality Control Laboratory. The control function as a whole is divided into:
- Chemical
- Instrumental
- Microbiological
- Packaging
List of the major instruments is as follows::
A. General Equipment:
- Glass Vessels
- Measuring Cylinders
- Test Tubes
- Erlenmeyer Flasks
- Graduated Pipettes
- Separating Funnels
- Weighing Bottles
- Mortar & Pestle
- Porcelain Dishes
- Tongs
- Reagent Bottles
B. Equipment for Volumetric Analysis
- Karl-Fischer Titrator
- Burettes
C. Equipment for Spectrophotometric Analysis
- UV-Visible Spectrophotometer
D. Equipment for Chromatographic Analysis
- TLC
- GC
- HPLC
E. Measuring Equipment
- Analytical Balance (0.1 mg Least Count)
- Thermometer / Hygrometer
- pH Meter
- Potentiometer – digital
- Refractometer
- Boiling Point Apparatus
- Melting Point Apparatus
- Polarimeter
- Viscometer
F. Supporting Equipment
- Oven
- Microscope
- Dessicator
- Refrigerator
- Stirrer / Homogenizer
- Bunsen Burner
- Water Bath
- Water Distillation Unit
G. Equipment for Microbiological Analysis
- Laminar Air Flow
- Incubator
- Autoclave
- Petri Plates
- Culture Media Tubes
- Syringes
- Forceps
- Colony Counter
H. Others Equipment in QC:
- Hot Air Oven
- pH Meter
- Magnetic Stirrer with hot plate
- Water Bath
- Distillation Plant
- Melting Point Apparatus
- Analytical Balance
- Bulk Density Apparatus
- Disintegration Test Apparatus
- Muffle Furnace
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