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.