Mr. S. N. Mavchi.

Sampling, Inspecting, Testing, Monitoring,

Releasing/Rejecting of starting materials,

Packaging materials, Intermediates,

Bulk products Finished products.

Quality control is a day to day process of controlling the quality

within an organization by technically competent and

qualified staff responsible for the acceptance or rejection of raw

materials and finished products.

Functions of Quality Control:1.Quality control department of pharmaceutical

company responsible for sampling of raw materials.

2.This department is also responsible for decision maker that may affect the quality o product.

3.This dept. also responsible for documentation of all the batches in the organization.

4.Q.C. dept. has to decide the release of final product to the market.

5.Q.C. dept. helps in keeping the quality of the product during manufacturing by taking samples.

Def.: Quality assurance refers to the responsibility of an organization to

ensure or assure that systems, facilities and written procedures, Standard

operating procedures, Current good manufacturing practices are followed in

order to ensure that the final product will meet all the applicable

specifications.

QA InspectorQA ExecutiveDocument Controller

QMS - Co-ordinator

Validation Co-ordinator

QA Manager

“Quality assurance is wide ranging concept that includes all matters that individually or jointly influence the quality of product.

It is the sum of all practices which performed to maintain quality of drug.

Therefore Q.A. incorporate good manufacturing practices in addition to other factors.

Q.A. dept. is responsible for/functions of Q.A:

Quality assurance must be supported by team effect.

Responsible for Process design.

Process Design Is The Design Of Processes For Desired Physical And/Or Chemical Transformation Of Materials

Responsible for space.

Responsible for Ventilation. Responsible for cleanliness. Responsible for environmental control and

sanitation. Validation.(It is the documented act of

demonstrating that a procedure, process, and activity will consistently lead to the expected results.)

Sources of Impurities:1)Raw Material.2)Reagents used in the manufacturing process.3)Intermediate products in the manufacturing

process.4)Defects in the manufacturing process.5)Solvents.6)Action of solvents and reagents with reaction

vessels.7)Atmospheric contamination during the

manufacturing process.8)Defective storage of final products.9)Adulteration.

1) Raw Material:Eg. Copper turnings do contains iron and arsenic as impurities.Cu + 2H2SO4 CuSO4 + 2H2O + SO2

When zinc as taken as raw material for the manufacturing of zinc sulphate then it may contain Aluminum, copper, magnesium, manganese, Nickel, arsenic as impurities. Zn + H2SO4 ZnSO4 + H2.

2) Reagents used in the manufacturing process:

Eg. If final product i.e. Ammoniated mercury is not washed then ammonium hydroxide will remain as impurity.HgCl2 + 2NH4OH NH2HgCl + NH4Cl.

3) Intermediate products in the manufacturing process:Eg. Potassium iodine is intermediate product and if it is not completely converted into KI then it may be present as an impurity.KIO3 + 3C KI + 3CO

4) Defects in the manufacturing process:Eg. If CaCO3 and HCl are not mixed then some hydrochloric acid may till remain unreacted form which will act as an impurity.CaCO3 + 2HCl CaCl2 + H2O + CO2.

5) Solvents:Eg. Water contains Cl-, Ca+2, Na+, SO-2 & HCO-3 impurities.

6) Action of solvents and reagents with reaction vessels:Some solvents and reagents may react with the metals of the reaction vessels during the manufacturing processes and may dissolve these metals which appear as impurities in the final products.

7) Atmospheric contamination during the manufacturing process:Eg. During crystallization of odium hydroxide as final product exposed to air containing CO2. NaOH readily absorbs CO2 and forms sodium carbonate, therefore sodium hydroxide should not be exposed to atmosphere for a long time during it’s manufacturing.2NaOH + CO2 Na2CO3 + H2O.

8) Defect storage of final product:Eg. i. When iodine is stored in contact with rubber cork it reacted with it.ii. KI is deliquescent should stored in air tight container.iii. Ferrous sulphate is converted into ferric sulphate which is brown in colour.

9) Adulteration: Addition of cheaper chemicals or

substances.Eg. Potassium bromide may be adulterated with sodium bromide. Potassium bromide is more expensive than sodium bromide.

Effect of Impurities in a medicinal substance:

1.Have a toxic effect and be dangerous when present beyond certain limits.

2.Cause a change in the physical and chemical properties of

the substance.

3.Cause an incompatibility with other substances.

4.Lead to technical difficulties in the formulations.

5.Decrease the shelf life of the formulations.

6.SHOWS cumulative /toxic effects.

“Assay”Def.: Assay is the quantitative determination of

the compound in the given product to asses whether it confirms to the stated standards or not. i.e percentage purity.

Assays are;1.Gravimetric methods.2.Volumetric assay.

a) Acid-Base titration.b) Redox titration.c) Iodometric titration.d) Precipitation titration.e) Complexometric titrations.f) Diazotization titration.g) Non-aqueous titrations.

“Limit Tests”Limit tests are:1)Limit test for Chlorides.2)Limit test for Sulphates.3)Limit test for Iron.4)Limit test for Lead.5)Limit test for Heavy Metals.6)Limit test for Arsenic (Gutzeit’s apparatus).

“Identification Tests”

# Assays, Limit tests and Identification tests: Refer to Pharmaceutical chemistry practical manual in detail.

LIFETRANSFORMER PROF.SANDIP MAVCHI 20