Expiry date , calculation of yields, production record review, change control
- 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 product x 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
- 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,updated on 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