Expiry date , calculation of yields, production record review, change control

The responsibility of the pharmaceutical manufacturer is that the drug product should have the stated potency and therapeutic effectiveness till the end of the shelf life of the product This shelf life should be based on t

1. A presentation on
Expiry date , calculation of yields, production record
review, change control
By
Santosh Kumar-MPH/10019/22
Department of pharmaceutical science and Technology
Birla institute of technology, Mesra
Ranchi-835215(Jharkhand)
2022

2. CONTENTS
❑Expiration dating
❑calculation of yields
❑Production record review
❑change control

3. ❑Expiration dating
➢The responsibility of the pharmaceutical manufacturer is that
the drug product should have the stated potency and
therapeutic effectiveness till the end of the shelf life of the
product This shelf life should be based on the stability
studies data of the product concerned.
➢For this purpose a detailed SOP on carrying out drug stability
studies is required. The data so obtained should be used to
establish the shelf life of each product; before it goes into the
market.
➢The expiration dates shall be related to any storage conditions
stated on the labelling as determined by stability studies
carried out.

4. ❑Expiration dating
➢Shelf life of product -Determine -Stability
studies.
➢Expiration date -Storage condition -Stated on
label.
➢If drug is reconstituted product-Label should
include expiration-both reconstituted and un
constituted product.

5. ❑Factors affecting stability of drugs
➢Moisture, hydrolysis and pH
➢Oxygen and Oxidation
➢Light
➢Temperature
➢Microbes

6. ❑Production record review
➢The main principle of cG.M.P. is that "The quality of a product is built into it
and cannot be just tested in it".
➢Quality control or testing can test only certain testable parameters only in
the final product, but it cannot assure the quality of the product. Testing has
certain limitations.
➢Hence, the concept of Q.A. has come into existence. Q.A. not only believes in
testing, but it also tries to assure that the entire process of manufacturing
has been actually followed, the way it should have been followed. This
activity is done with the help of following:
✓Carry out in process quality check and record them.
✓Collect samples throughout the manufacturing process on different times.
✓Check all the documents related to the batch production, along with quality
control documents

7. ➢In this connection the regulatory literature gives certain important
guidelines, which are very important.
➢All drug product production and control records, including those for
packaging and labelling shall be reviewed and approved by the quality
control unit.
➢Any unexplained discrepancy (including percentage of theoretical yield
exceeding the maximum or minimum percentage established in
M.P.C.R.) or the failure of a batch or any of its components to meet any
of its specifications shall be thoroughly investigated.
➢The investigation of such batches shall extend to other batches of the
same drug product and other drug products that may have been
associated with the specific failure or discrepancy.
➢A written record of such investigation shall be made and shall include
the conclusion and follow up.
❑Production record review

8. ❑calculation of yields
Theoretical yield
➢An amount of product calculated from the complete reaction of the
limiting reagent is called theoretical yield.
➢Theoretical yield of product = quantity of productx MW of product
MW of reactant
Actual yield
➢The amount of product obtained when the reaction takes place.
Percent yield
➢The ratio of actual yield to theoretical yield.
percent yield = actual yield (g)x 100
theoretical yield (g)

9. ❑change control
➢Change Control is the process of handling proposed alterations
to items that have been previously designated as fixed, and the
procedure that controls change is called change control.
➢Changes refers to any modification in equipment,
manufacturing materials, facilities, utilities, design,
formulations, processes, packaging, labeling, computer system
and all associated documentation.
➢According to WHO, "Change control is a formal system by
which qualified reprenstatives of appropriate disciplines
reviews proposed or actual changes that might effect at
validated status. The intent is to determine the need for the
action that would ensure that the system is maintained in a
validated state.

10. ➢Change control is a procedure that ensures changes are
implemented in a controlled and coordinated manner.
➢The change control program evaluate all changes that
could affect the production and control of the drug
product, intermediate or API. It is the most critical
element in the overall quality management of
pharmaceutical industry.
➢A change control system provides checks and balances in
the quality system by tracking, reviewing and approving
the changes. In adequate change control procedures ends
up in regulatory non compliance
❑change control

11. Functional group involved in change control

12. CHANGES IN PHARMACEUTICAL OPERATIONS INCLUDE
➢Production:change in location, equipment, batch size, process control
parameters.
➢Engineering:changes in Any part of equipment, design &layout, facility.
➢Research & development:Change in specifications of raw materials, Quantity
of raw materials, Change in shelf life, environmental conditions, stability
protocols, stability conditions etc.
➢Quality control: Change in Method of analysis, change in sampling plan,
➢change in Hardware /software of computerized: instruments.
➢Quality assurance: change in validation protocols, Sop's and documents and
sampling.
➢Cleaning procedures: change in cleaning aids, agents and procedures

13. Change control procedure

14. SOP for Change Control Program
➢Purpose: To provide instruction for change control
Procedure.
➢Objective:To provide a documented procedure for
change control procedure.
➢Scope:This procedure is applicable for change control
procedure.
➢Responsibility:Primary: Officer / Supervisor of
respective department. Overall: Respective department
Head.

16. REFERENCES
▪U.S. Food And Drug Administraton, current good manufacturing
practices,updatedon 10/06/2017 available
onhttps://www.fda.gov/drugs/developmentapprovalprocess/manufact
uring/nem169105.html
▪Code Of Federal Regulation, title 21, volume 4, revised as of April
1,2017, sec. 211.103 Calculation Of Yield. Available
onhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSea
rch.cfm?fr-211.103

17. Thank you