1. 1

2. Our Presentation Topic: Importance Of Validation & Qualification In Pharmaceutical Industries Presented By: Md. Tanjir Islam (Group C) 2

3.  Validation - is the establishment of documented evidence, which provide a high degree of assurance that a specific process (manufacturing of pharmaceutical dosage form) will consistently produce a product meeting its predetermined specifications. 3

4.  Began in 1970’s  Originally sterilized based.  Now evolved into all Product, Process and Facility matters. 4

5.  Assures Quality  Regulatory Requirement  Reduces Cost  It’s the LAW ! 5

6. 1.Validation can reduce costs by reducing,  Rejects  Reworks  Reliance on In-process controls  Down time 2.Help timely corrective action 3.Assure consistent production performance 4.Ensure achievement of quality goal 5.Allow parametric release.etc 6

7.  Experience  Planning  Resources  Understanding & communication  Training  SOP,s instruments & methodologies.  Validation Master Plan.  Data analysis.  Validation report. 7

8. 8 Validation Prospective Concurrent Retrospective

9.  Prospective validation: The Validation that has been made before an entry of a new product or employing a new formula/process & also is been carried out if there is a change in the manufacturing process is called–PV.  Concurrent validation: validation that has to be carried out for the existing products that is taken from manufacturing line in a batch wise manner.extensive testing during validation may verify quality attributes. 9

10. Retrospective validation:  This type of validation is acceptable only for well established process where critical process parameters are able to identify & documented, which reduces excessive process failure leading to operational errors & equipment errors. 10

11.  Definition Action of proving that any premises, systems and items of equipment work correctly and actually lead to the expected results (Validation usually incorporates the concept of qualification) A process of establishing confidence that the equipment is capable of consistently operating within established limits and tolerances. Studies therefore done prior to use 11

12. 12 Design qualification Installation qualification Operational qualification Performance qualification

13. Design qualification  Design qualification (DQ) is the process of completing and documenting design reviews to illustrate that all quality aspects have been fully considered at the design stage.  User requirements should be considered when deciding on the specific design of a system or equipment.  A suitable supplier should be selected for the appropriate system or equipment (approved vendor). Installation qualification  Verifies that the correct equipment has been received and installed as per plan and protocol. Also that it is complete and undamaged (parts, services, controls, gauges and other components). 13

14. Operational qualification  Verifies that the equipment operates consistently within established limits and tolerances over the defined operating ranges.  Each of the instrument’s function are checked to ensure that they conform to the manufacturer’s specifications. Performance qualification  Verifies that the equipment performs according to design specifications and user defined requirements in a reliable and reproducible manner under normal production conditions. 14

15. 15 ValidationQualification Action of providing and documenting that any process procedure or method actually and consistently leads to the expected result. Action of providing and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Validation is conduct for an process, method, or system. Qualification is a part of validation and conduct for an equipment. Proof. Document that the process will consistently produce a predetermined outcome. Performed on one element or component of the process to be validated and determine if the component of a process has the attributes to produce a specified outcome  Before you do validation on a process, you have to be sure that the equipment has passed qualification test.

16.  Pharmaceutical Process Validation by R. Berry & Robert A. Nash.  www.fda.gov/cder/guidance/pv.htm (US FDA).  Remington’s pharmaceutical science.  Pharmaceutical preformulations by j.j. Wells.  www.emea.eu.int/ (EU Audit Agency). 16

17. 17