Pharmaceutical validation, calibration & qualifications

Pharmaceutical qualifications, calibration and validation
Quality Assurance
Quality control
Validation

1. PHARMACEUTICAL VALIDATION 1 Name- Suraj B. Ghorpade M. Pharm 1 st year (Quality Assurance) Guided by- Pro. Neha R aut Institute: SKBCOP, Kamptee, Nagpur

2. Contents: Definition Scope of calibration Scope of validation Frequency of calibration Importance/ purpose of calibration Importance/ advantages of validation Difference between calibration & validation Pharmaceutical validation 2

3. Definition: Validation: A “documented programme”, which provide a high degree of assurance that a specific process will consistently produce, a product meeting its pre-determined specification and a quality attributes. Types of validation: Process validation: C l e a n i ng validation V a l i d a t i on o f a n a l y t i cal m e t h o d s Pharmaceutical validation 3 Prospective validation Concurrent validation re-validation Retrospective validation

4. Calibration: Definition: Calibration is a process where a comparison is made between two entities, one whose value has to be measured and the other entity, known as the standard , which is used as the reference in the comparison. Methods for calibration: Standard Calibration Calibration with Data ISO 17025 Accredited Calibration Pharmaceutical validation 4

5. M e t h o d s u s e d f o r c a l i b r a tion : S t a n d a r d C a l i b ration : T h i s method i s m o s t l y p r e f e r red f o r c a l i b r a t i n g i n s t r u m ent t h a t a r e n o n - c r i t ical t o q u a l i t y o r n o t r e q u i red f o r a ccreditat i on a n d l i c e n s e p u r p o ses Calibration W i t h D a t a : P r o c e d ure f o r c a l i b r a tion with d a t a a r e s i m i l a r t o t h a t o f a c c r e dited c a l i b r a t ion . O n l y e x c e ption being that t h e s e p r o c e d u r e a r e n o t a c c r e dited to t h e I S O s t a n d a r d . Moreover , t h e y n o t a c c o m p a n i e d b y d a t a o n m e a s u r e ment uncertainties . I S O 1 7 2 5 A c c r e dited C a l i bration : T h i s h a s t o b e a stric t e s t method of c a l i b r a tion . G e n e r a lly i t r e q uires a m e a s u rement r e p o r t s w h i ch h a s t h e d e tails o f t h e m e a s u r e ment t h a t a r e m a i d a g a i nst t h e s t a n d a rd o f " a s f o u n d " ( b e f o r e c a l i b r a tion i s s t a r t e d ) & " a s l e f t " ( o n c e t h e c a l i b r a t ion i s c o m p l e t e d ) . I f t h e c a l i b r a tion i s d o n e b y e s e r v i ce provider t h e y m u s t i s s u e a c e r tificate o f t h e s a m e . 5 Pharmaceutical v a l i d a tion

6. Qualification Definition: Qualification is a process of assurance that the specific system, premises or equipment are able to achieve the predetermined acceptance criteria to confirm the attributes what it purports to do. Qualification can be considered to be a part of the validation process. It can be further divided into: Design qualification(DQ) : It is documented evidence that proposed design of the facilities, system and equipment is suitable for intended use. Purpose : To ensure that all the requirements for the final system have been clearly defined at the start . Pharmaceutical validation 6 Design qualification Installation qualification Operation qualification Performance qualification

7. Continue… 2. Installation Qualification (IQ) : It is documented evidence that the premises, supporting utilities, the equipment have been built and installed in compliance with design specifications. Purpose : To check the installation site/ environment & verifies the condition of installed equipment. Also to ensure t hat all aspect of equipment installed correctly and complies with the original design. Operation Qualification (OQ) : It is the process of demonstrating that an instrument will function according to the its operational specification in the selected environment. Purpose: To ensure that all the dynamic attributes comply w ith original design. Pharmaceutical validation 7

8. Continue … Performance Qualification (PQ) : It is the process that ensure the process under anticipated conditions, consistently produces a product which meets all pre-determined requirements. Purpose: It is ensure that the instrument is performing within specified limits. Pharmaceutical validation 8 Scope/ Purpose of calibration: Calibration can be perform for the following purpose: To make sure that the readings of equipment or instruments are consistent with other measurements and display the correct readings every single time .

9. To determine the accuracy, precision, reliability and deviation of the measurements produced by all the instruments. A c c u r a c y : C l o s e n e s s t o t h e test r e s ults o b t a i n e d b y t h a t m e t h o d t o the t r u e v a l u e . Precision : D e g r e e o f a g r e e ment a m o n g i n d i v idual r e s u l ts w h e n t h e m e t h od i s a p p l i e d r e p e a t e dly t o m u l t i p le s a m p l i n g o f a h o m o g e neous s a m p l e . R e l i a b ility : Degree t o w h i c h a n a s s e ssment t o o l p r o d u c e s t a b l e & c o n s i s tent r e s u l t u n d e r t h e s a m e c o n d ition . Pharmaceutical validation 9 Continue…

10. Continue… D e v i a tion : I s a m e a s u r e d d i f f e r e n ce b e t ween o b s e r v e d v a l u e & e x p e c t ed o r s t d . v a l u e f o r a p r o c e s s o r p r o d u ct . To establish the reliability of the instrument being used and whether it can be trusted to deliver repeatable results each time. To map the ‘drift’ as documented. Instruments have a tendency to produce inaccurate measurements over a period of time, following repeated use. 10 dddddd

11. Frequency of calibration: Calibration interval may be based on calendar. The frequency of calibration depends on following factors: What is level of accuracy desired? What is the recommendation of manufacturer? The interval between calibration varies as: Weakly Monthly or bi-monthly Annually or semi-annually After every heavy usage of equipment or instrument. Pharmaceutical validation 11

12. Importance of calibration: Calibration is responsible for defining the accuracy of any measurement and its quality that is recorded by any instrument. Regularly calibration of any equipment can eliminate the draft at its building stage instead of allowing it to grow till it affects the measurement in significant ways. Calibration helps in quantifying and controlling errors and uncertainties within various measurement process to an acceptable level. Further, it helps in improving the accuracy of the measuring device, which in turn improves the quality of the FPP. Pharmaceutical validation 12

13. Continue… In short regular calibration allows pharmaceutical companies to have confidence in there result which they can record monitor and control. Calibration are not optional but needed for regulatory compliance Pharmaceutical validation 13

14. Scope of validation: Analytical test methods : ( e g . A c c u r a cy , precision , s p e c i f i c i t y , limit o f d e t e c t i o n , linearity e t c . . . ) Instruments calibration : ( e g . T e m p . , W e i g h t , p H , h u m i d i t y e t c ) Process utility services : ( e g . W a t e r , s t e a m , HVAC s y s tem e t c ) Raw materials & Packaging materials : ( e g . S p e c i f i c a t ion , v e n d o r c e r t ificate ) Equipment : E q u ipment q u a l i f i c a t i o n p r o g r a m m e start with User s Requirement S p e c i f i c a t i o ns & F u n c t i o n a l R e q u i r e m e n t S p e c i f i c a t ions t h e s e t w o r e q u i r e m ents will result in to t h e Design Q u a l i f i c a tion . Pharmaceutical validation 14

15. Continue… Facilities : ( eg . C o n s t r u ction , b u i l ding m a i n tenance , c e r t ificat e o f constricted f a c i l ities e t c ) Manufacturing operations : ( e g . T a b l e t m f g . ) Product design : ( F & D , p a c k a g e c o m p a t i b ility , d e f i n e s p e c i f i cation f o r R M / P M , D e f i n e p r o c e s s & t e s t m e t h o d e t c ) Cleaning : ( e q u i p ment & p r o c e s s containe r s , p r o d u c t c o n t a i n ers & c l o s u r e s , f a c i l i t y e t c ) O p erators : ( knowledge , s k i l l s & attitude ) 15 P h a r m a c e utical validation

16. Importance/ advantages of validation: The four major advantages of validation includes: Reduction of quality cost Process optimization Assurance of quality & safety Pharmaceutical validation 16 16

17. Difference in Calibration & Validation Pharmaceutical validation 17 17 Calibration Validation 1 Calibration assures accuracy of measurements. Validation provides proof of consistency across all the processes, batches of products or methods being used. 2 Calibration is a process that ensures that accuracy is maintained in the measurements produced by your equipment. Validation is a documented process that provides assurance that a product, service or system consistently provides results within the acceptable criteria. 3 Calibration performance of any equipment is compared against a reference standard. There are no reference standards used in validation. 4 It should be performed as per calibration SOP. It should be performed as per the validation protocol. 5 You must periodically calibrate your instruments. Identify if there is a ‘drift’ in the measurements and eliminate it through calibration. There are no such requirements for validation. It should be performed when you make any change in the existing system or when the revalidation period has reached.

18. Thanks . . . 18 P h a r m a c e utical v a l i d a t i o n