calculation yield, calculation of shelf life, quality control and quality assurance, tablet

1. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Subject : Quality control and quality
assurance
Topic : : Calculation of yield
Presented By,
VENKATESAN R
(Reg No : 22PA023) (2nd Sem)
M. Pharm Pharmaceutical analysis,
Presented to,
Dr. C. Sreedhar,
Professor and HOD,
Department of Pharmaceutical analysis,

2. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
What is Yield ?
Yield is a number which generally quantifies the success.
Example : If I put 10 hours of work and got a work done which is worth 8
hours. Then my work yield is 8/10 that is 80%. Or if I am a manufacture of
pens. I started making 1000 pens. 50 broke while adding ink refills in them,
50 broke while moving the box of ready pens to quality check and finally,
quality department threw 100 pens as they were not writing. At the end, I
could sell only 800 pens. My production yield is 800/1000 that is 80%.
2

3. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
The most basic definition of yield in a manufacturing plant is the ratio of
the amount of primary product output to the amount of raw material input,
expressed as a percentage.
3

4. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
How do I improve Yield ?
This is a very important task yet very difficult to accomplish.
Actions contribute in keeping up good yield are,
 Defining critical areas.
 Keeping and updating the ideal or golden data.
 Reporting collected data in a right form.
 Analyzing periodic reports.
It is always beneficial to find the problem sooner.
The manufacturing cost increases towards the final steps of production.
4

5. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
General steps towards yield improvement can be as follows:
 Collect data at every critical step of production cycle.
 Compare data with ideal data or expected values.
 Analyze the findings and pin point the possible causes of failures.
 Identify the most effective solution.
 Apply the solution to a controlled material.
 Collect the data and verify the results.
 Roll out the solution to production.
Use of data analysis tools is very helpful in these situations.
Choosing the right tool is very important. To capture all the aspects of
manufacturing, integration of the tool is critical.
5

6. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
CALCULATION OF YIELD :
“The actul yield and percentage of theoretical yield shall be
determined at the conclusion of each appropriate phase of manufacturing,
processing, packaging, or holding of the drug product. Such calculations shall be
performed by one person and independently verified by a second person”.
To meet these requirements each critical stage of the manufacturing
process should be identified and theoretical yield at the end of that stage should
be established. The actual yield at the end of these stage should be calculated,
recorded in B.P.C.R. and compared. Any abnormal deviation should be recorded
and investigated to find out reasons. Steps should be taken to avoid them in
future.
6

7. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
For the common formulations such critical stages are follows:
(A) Tablets : Granulations.
: Compression.
: Coating.
: Packing.
(B) Capsules : Mixing.
: Filling.
: Packing.
(C) Liquid oral : Bulk preparation and filtration.
: Filling.
: Packing.
(D) Ampoules : Bulk preparation and filtration.
: Washing of ampoule.
: Filling and sealing of ampoules.
: Sterilization of filled ampoules.
: Visual inspection.
: Packing etc.
7

8. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Theoretical and Actual Yields:
Reactants not completely used up are
called excess reagent, and the reactant
completely reacts is called limiting reagent.
This concept has been illustrated for the
reaction:
2 Na + Cl2 = 2 NaCl
An amounts of products calculated from the
complete reaction of the limiting reagent is
called theoretical yields.
8

9. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Whereas the amount actually produced of a product is the actual
yield.
The ratio of actual yield to theoretical yield expressed in percentage
is called the percentage yield.
Actual yield
Percent yield = ----------------- x 100
Theoretical yield
9

10. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
CALCULATION OF PERCENTAGE YIELD:
At the end of each specific packing of a batch or part-
batch, the printed components and product will be tailed by the
machine operator, e.g: label, cartons, leaflets, tablets, etc.
These components will be reconciled as a % yield, comparing
the number at the start with the number at end of the process
including all waste that occurred during the process.
% yield =
No. of goods produced at the end of process +
Rejects + sample + Returned x 100
No. of goods received at the start of process
10

11. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
All components and products should reconcile 100%, however,
allowances are made (tolerance limit) to allow for counting error and/or
minor inconsistencies.
Any unusual situtation and out-of-tolerance tally must be investigated
immediately on checking the reconcillation.In the case of the out of the
range result a recount must be done and the entires corrected. If the % yield
is still outside the allowable limits a through investigation must take place to
ensure the cause of such a deviation to establish that no mix up has
occurred.
Percent yield is a calculation of your success of producing
a product compared to the total amount if product that can be produced.
11

12. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Percent Yield in Manufacturing Plant:
Irrespective of the product, % yield for bottled foods, drinks,
beverages and other related foods should range between 98-100%.
Anything below this is not okay. In some cases(beverages) you can
have yield above 100% depending on the efficiency of the equipment
and operation process.
Your yield % is calculated from the following formula:
Yield% = (Actual quantity of goods produced/Theoretical quantity of
goods expected)%.
12

13. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Percent yield is used to calculate the success in actually
producing a product, compared with the maximum amount you can
possibly produce. The process is evaluated to save resources and
produce more output with the same input.
The equation that represents the yield is:
Fractional yield = [(actual yield)/(theoretical yield)] When you get this
answer, you need to multiply by 100 to convert it to a percentage.
13

14. Thank you 
14