Report on Nuvista Pharma Ltd (Part-16)

COMMENTS

v  Comments about Tablet & Capsule Department:-

1.      Highly sophisticated HVAC system and AHU are used to condition, monitor and supply clean air to the working zone.

2.      Temperature and moisture levels are maintained at the desired level

3.      All modern, effective and necessary equipments required for granulation are available.

4.      Efficient and experienced production officers.

5.      Well trained manpower.

6.      Quality is maintained by Quality Compliance unit.

Opportunities:-

1.      Productivity may be increased by proper utilization of granulation machinery.

2.      All the hand filling process must be replaced by automatic filling process

v  Sterile Department:-

1.      Highly sophisticated HVAC system and AHU are used to condition, monitor and supply clean air to the working zone.

2.     Neat and clean working area.

3.     Particle and organisms are strictly controlled specially in sterile area.

4.     Clean room class is maintained each and every area of sterile section.

v  Quality Assurance Department:

1.      Quality Assurance Department is really proper oriented.

2.      Space for the quality control section is really inadequate. It needs to be expanded urgently in order to keep up the quality of the product.

CONCLUSION

Man is the best creation of God. He gained this rank and position by dint of education. Education makes a man a perfect human being. Education aware him of his duty to the family, to the society and there by to the nation. Having    had the pharmaceutical education, we now realize that we shall be able to tender our services to man kind to some extent.

The objective of the industrial training was the partial fulfillment of courses and for achievement of practical experience about manufacturing of quality drugs.

We are fortunate enough to be gainer of the opportunity to receive training from a company like ‘Nuvista Pharma limited’. We would like to express our sincere gratitude to ‘Nuvista Pharma limited’ for their constant professional guidance, conceptual teaching and proper training.

‘Nuvista Pharma limited’ has been manufacturing pharmaceutical finished products and market leader of hormonal contraceptives. Quality of Nuvista Pharma products have gained widespread trust and confidence due to

v     Commitment to the highest quality products.

v     Stringent quality control procedures.

v     Highest cGMP standards.

v     Raw materials from the best source.

v     Highest quality packaging materials.

v     World class formulation technology.

v     Diversified and sophisticated dosage forms.

In conclusion, I hope that, Nuvista Pharma Ltd. has succeeded to achieve all the objectives of its establishment and continue its success in future by taking all necessary steps which should be required for its growth

Report on Nuvista Pharma Ltd (Part-15)

WAREHOUSE

Ware House is the large area where all the raw materials, packaging materials and the finished products are stored. From the Ware House the raw materials are sent to the production unit. Again the finished products are stored in the Ware House.

Warehousing is normally the largest in terms of area special attention is paid which is focused on maintaining cleanliness freedom form infestation and order orderliness.

Different Units of Warehouse:

v    Storage for Raw material.

v    Storage for Packing material.

v    Storage for Finished product.

v    Storage for Thermolabile product (Foster/cold storage).

Areas of Warehouse:

1.    Quarantine area: After receiving, raw materials and packaging materials are kept here for QA approval. Area is located in the front portion of the building.

2.   Released area: Approved raw materials and packaging materials are generally stored in the central place of the warehouse with great safety.

3.  Rejected area: Rejected raw materials, packaging materials, finished products are stored             here with great care. The rejected area is located at corner portion of the warehouse in a       separate room, where entry is strictly regulated.
4.   Finished Products area: Finished products are stored here for delivery.

5.   Special area: It includes cold room, freeze room for poisonous materials, room for flammable materials.

Activities of Warehouse:

Warehouse activities can be stated as follows: (related to raw and packaging materials)

ü    Arrival of materials.

ü    Invoice checking.

ü    Physical inspection & receipt/discrepancy report.

ü    Quarantine storage.

ü    QA sampling.

ü    Leveling in the container.

ü    Entry in SAP.

ü    QA release/ rejected materials.

ü    Dispensing of released/ rejected materials.

ü    Dispensing / Distribution.

Objectives of proper receiving, issuing and storage of goods in Nuvista Pharma –

Measures Target:

Ø  Proper entry of all receipts & issues into the computer / Kardex 100 %

Ø  Timely issue of goods to production department & central warehouse as per requisition. 100 %

Ø  To minimize handling loss of issuing materials

            Raw Materials NMT.500 %

            Packaging Materials NMT.500 %

            Finished Goods (Glass Bottles) NMT.500 %

Ø  Maintain FEFO (1st expelled 1st output) / FIFO (1st input 1st output) 100 %

Ø  Sometime maintain LIFO (last in first out) in case of raw material.

Ø  To follow guidelines as per cGMP / GSP 100 %

Ø   

Objectives of smooth receiving & supplying of packing materials, Raw materials (Solids, Liquids) in Nuvista Pharma -

Measures Target:

Ø  Timely unloading ½ hour after receiving the documents

Ø  Tallying the quantity with delivery challan against ½ hour after receiving purchase order / L / C & preparing G.R.N. the challan.

Ø  Orderly placement of received materials immediately after at quarantine area of the store receiving the materials

Ø Shelving passed materials at respective shelves quickly transferring of the packing materials store from quarantine.

Ø  Proper entry of all receipts & issues into the Bincard 100 %

Ø  Timely issue of packing materials to production department as per requisition. 100 %

Ø  To minimize handling loss of issuing materials

       Packaging 98 %

             Solid materials 99.5 %

             Liquids 99.5 %

Ø  Maintain FEFO (1st expelled 1st output) / FIFO (1st input 1st output) 100 %

Ø  To follow guidelines as per cGMP / GSP 95 %

Objectives of smooth receiving & supplying of finished goods in Nuvista Pharma:

Measures Target:

Ø  Tallying the goods mentioned in quickly after receive finished goods transfer note goods transfer note.

Ø  Proper entry of all receipts & issues into Cardex / Bincard 100 %

Ø  Timely delivery of goods as per prescribed vat challan & gate pass of custom authority 100 %

Ø  Preparing daily statement 100 %

Ø  Maintain FEFO (1st expelled 1st output) / FIFO (1st input 1st output) 100 %

Ø  To follow guidelines as per cGMP / GSP 95 %

Some common terms of Ware house:

Sampling

As the process of taking a small portion from a lot for test and analysis to show the quality of the whole lot. The purpose of sampling and subsequent testing is to provide an effective check on the quality of the product or substances being processed.

Sampling quantity

Sampling quantity should be the double of one complete test.

Lot

A batch or number of batches in a consignment.

Batch

A quantity of the product or material which is processed in one run following manufacturing USP. ]

Campaign

A campaign means number of batches manufactured without any interruption or product change.

Handling

The term handling means checking according to invoice/challan and other documents during receiving of the materials.

Preservation

The term preservation means the materials are stored in different conditions according to its nature of stability i.e. to maintain a specific temperature and relative humidity.

Dispensing

Dispensing means the materials are supplied to the production areas by weighing according to the proper document and release it from the RM Store.

Quarantine  The term quarantine means the material is not ready for use and it is under test after received. So a quarantine label is attached to the container.

FIFO The term FIFO stands for First In First Out.

Re-test The term re-test means the samples are needed to be repeated analysis for identify vs. previous documentation and it has been done either 3/6/12 months.

Report on Nuvista Pharma Ltd (Part-14)

MICROBIOLOGY

Microbes such as mold bacteria, viruses etc. can freely exist in an uncontrolled environment. Microbiology section will just determine the microbial contamination monitoring.

Organization of the Microbiology department:

Microbiological assay and other tests:

The department of Microbiology performs the role of immense importance to follow the GMP and to formulate as well as to implement the SOPS.
The overall activity profile of the microbiological section of Q.C department of Nuvista Pharma can be presented briefly in the following way


Instruments used in Microbiology Laboratory:
▪ Particle counter
▪ Air sampler (RCS)
▪ Incubator
▪ Anaerobic jar
▪ Centrifuge machine
▪ Water bath
▪ Freeze to preserve bacteria
▪ PH meter
▪ Colony counter
▪ Microscope
▪ Laminar flow machine
▪ Hot oven
▪ Dust collector
▪ Autoclave
▪ Balance
▪ LAL Testing Kit

TECHNICAL SERVICES DEPARTMENT

The engineering department is responsible for regular maintenance of the plant, machines, services and sanitation to help achieve smooth production and safe environment.

The were some function of this department-

¨                   Installation of production equipment.

¨                   Performance of equipment.

¨                   Machine capabilities.

¨                   Maintenance of the building.

¨                   Maintenance of the fire alarming system.

¨                   Validation of laboratory equipment’s.

¨                   Calibration of laboratory equipment’s.

¨                   Maintenance of heating, ventilation and air conditioning system  (HVAC).

¨                   Maintenance and supply purified water for treatment.

¨                   Well controlled of drainage system.

¨                   Supply of electricity of its own arrangement.

¨                   Maintenance of effluent water treatment plant.

Nuvista Pharma Limited has a well-equipped engineering department. It is divide into three sections.

v   Civil

v   Electrical and

v   Mechanical

Civil: All Construction works (any new construction and repairing) is done under this section.

Electrical: Daily electric supply to the industry is the main job of this section arises to the supply of electricity, and then this section takes emergency measurements. Mechanical: This section does Installation and validation of production machinery and their machinery’s. The following services are also under the control of mechanical section. 

              1. Air conditioning

              2. Vacuum.

              3. Steam supply.

              4. Compressed air.   5. Water supply.

Cooling system of Nuvista Pharma Limited:

Report on Nuvista Pharma Ltd (Part-13)

QUALITY CONTROL

Quality control is that part of GMP which is concerned with sampling specification and testing and with organization documentation and release procedures which ensures that the necessary and relevant tests are infact carried out and that materials are not released for sale or supply untill this quality has been judged to be satisfactory.

Activities of the Quality Control Department:

1.         Receiving of the samples to be tested from QA department.
2.         Issuing release, reject or quarantine advice for each batch of raw material and final product.
3.         Assessment of the intermediate products & bulk products for further            
            processing.
4.         Performing all tests procedure for all incoming samples according to the        schedule.
5.         Maintaining batch wise full quality control tests records & signature of the 

            Person(s) who perform the test.
6.         Performing environmental monitoring tests.
7.         Calibrations and standardization of laboratory equipment’s.
8.         Ensuring precision and accuracy of all testing methods.
9.         Control of all laboratory reagents.
10.       Research & development of any new method & its validation.
11.       Testing of any return goods.
12.       Stability tests for finished products
Working Division of Quality Control Department:
Quality control (QC) department can be further divided into four corresponding sections:

ü  Microbiological section.

ü   Packaging section.

ü  Finished product.

ü  Raw Material.

Lab Facility: Lab facility of Nuvista Pharma Limited is so excellent. Their lab can be described in the following way.
1. Analytical lab

2. Instrumental lab

3. Microbiological lab

Quality control department serves the following functions-

1. Before purchasing of raw materials QC department test the all B.P.& U.S.P specifications of raw materials from the sending sample
2. When raw materials are sent by the source in terms of invoice Q.C. department collects the sample on the basis  invoice & labeled an under test sticker.
3. If it meets all E.P., U.S.P., B.P. specification then a passed sticker is labeled.
4. After manufacturing of pharmaceutical preparation Q.C department collects sample from bulk product & test its physical & chemical parameters
5. Q.C department also tests the packaging materials & inspects its printing name corresponding to the product.

6. Q.C department tries to recover tests the quality after final packaging.
7. If any finished product is damaged during transfer to CWH Q.C department try to recover the product as a return goods.
8. After market complain Q.C department tests the product whether the complain is justified or not in respect to the keeping sample
9. Any new products or raw materials supplied by the source is tested by the Q.C respectively for 3 batches' & set its clear information for monitoring or keeping studies
10. The Q.C department tests water that is used for manufacturing process as it meets its specification.

Quality control department does following tests:

           ª For Raw Materials:

                            Physical test:

v    Appearance

v    Identity

ü  IR

ü  Melting point

ü  HPLC.

v    Clarity of solution.

v    Color of solution.

v    P^H (Acidity/Alkalinity).

v    Specific optical rotation.

v    Refractive index.

v    Viscosity.

v    Bulk density.

v    Sieve test.

v    Assay.

v    Loss on drying or moisture or water content.

v    Total impurities.

v    Related substances (HPLC).

Chemical test: potency.

          ªFor Bulk product:

                              A. Solid

                                         Physical test:

                                                  1.Dissolution test

                                                  2. Disintegration test

                                                  3. Uniformity weight

                                                 4. Average weight

                                                  5. Hardness

                                                  6. Thickness

                                                7. Friability

                             B. Liquid:

   Physical test:

                                                       1. Appearance

                                                       2. Weight per ml

                                                       3. Refractive index

                                                       4. Viscosity

                                                       5. Color

                 Chemical Test:                           Active ingredient

                                Potency

                    

                                                                                             Preservative

                            C. Dry Granulation Powder:

                Physical test:

                                      1. Appearance of dry granules.

                                      2. pH of prepare syrup.

                                      3. Water content.

                                      4. Reconstitution time.

                                      5. Seive test.

                                      6. Inspection of test syrup.

                                      7. Appearances of prepare syrup.

                                           Chemical test:    Potency.

             D. Semisolid:

                          Physical test:

                                      1. Apparaence

                                      2. PH   

                                      3. Particle size

                                      4. Water content.

                                            Chemical test: Potency.

 ª For packaging Material

The following tests of the packaging material are performed in QC department:
Items                                                       Tests          
Carton                              Appearance, weight, moisture content.       
Shipping carton                Weight, dimension, thickness, appearance             
In Process Control (IPC):

IPC test are designed to ensure that the process is under control throughout the manufacturing to have the right things happens at every stage to make a successful batch at the first attempt. The full benefits of IPC come from getting the things’Right the First Time’

. Major advantage of IPC:

¨       Allows timely action.

¨       Improves productivity.

¨       Reduces rejection cost.

¨       Reduces batch testing at the end.

¨       Reduces the chance of batch failure.

Stability Testing: The quality control department of Nuvista Pharma Limited also performs stability testing for both the marketed product and the development products.