VALIDATION METHODOLOGY

Slides:



Advertisements
Similar presentations
Supplementary Training Modules on Good Manufacturing Practices
Advertisements

World Health Organization
Radiopharmaceutical Production
© WHO – PSM Quality Control Laboratory Pharmaceutical Quality, Good manufacturing Practice & Bioequivalence Kiev, Ukraine October 2005 Maija Hietava.
ISO 9001:2000 Documentation Requirements
EQUIPMENT VALIDATION.
Overview of Validation Requirements Pharmaceutical Industry
PRESENTATION ON CLEANING VALIDATION INDEX  INTRODUCTION SIGNIFICANCE SELECTION OF SAMPLING TECHNIQUES ESTIMATION OF ACCEPTANCE CRITERIA RE-VALIDATION.
A Seminar on 1.  Validation vs Qualification  Why to validate?  Who should do Equipment Validation?  Parts of Equipment Validation  Validation of.
Establish Verification Procedures (Task 11 / Principle 6)
World Health Organization
World Health Organization
SAE AS9100 Quality Systems - Aerospace Model for Quality Assurance
Validation Part 2: Cleaning validation
Supplementary Training Modules on Good Manufacturing Practice
Prepared by Long Island Quality Associates, Inc. ISO 9001:2000 Documentation Requirements Based on ISO/TC 176/SC 2 March 2001.
A seminar On Validation Of Ampoule Filling & Sealing Machine
EQUIPMENT/INSTRUMENT CALIBRATION
Water | Slide 1 of 16 January 2006 Water for Pharmaceutical Use Part 4: Commissioning, Qualification and validation Supplementary Training Modules on Good.
Validation SAPRAA March 2013.
World Health Organization
QUALITY CONTROL OF PHYSICO-Chemical METHODS Introduction :Validation توثيق المصدوقية.
WHO Supplementary Training Modules GMP
A Seminar On Validation Master Plan(VMP) & Calibration Master Plan(CMP)
QC | Slide 1 of 16 June 2006 Good Practices for Quality Control Laboratories P art 4: Inspecting the laboratory Supplementary Training Modules on Good.
Qualification and Validation
MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS
EQUIPMENT QUALIFICATION/VALIDATION
World Health Organization
Basic Principles of GMP
 A central concept is that quality cannot be tested for! ◦ Testing programs are based on testing a statistically significant number of samples  However.
Introduction to Equipment
Rocky Mountain RAPS Process Validation Presentation 6/7/06 By Clay Anselmo.
1 Importance of Instrument Validation for Accredited Food Export Testing Labs.
Water | Slide 1 of Water for Pharmaceutical Use Part 3: Operational considerations Supplementary Training Modules on Good Manufacturing Practice.
Equipment Management Audience – Local lab responsibilities.
FDA Recommendations: Sampling Plans for Blood Establishments Lore Fields MT(ASCP)SBB Consumer Safety Officer OBRR/CBER/FDA October 19, 2012.
Leukocyte-Reduced Blood Components Lore Fields MT(ASCP)SBB Consumer Safety Officer, DBA, OBRR, CBER September 16, 2009.
Module 1,, Part 5: Review and summary Slide 1 of 13 © WHO – EDM Validation Part 5: Review and summary Supplementary Training Modules on Good Manufacturing.
Validation | Slide 1 of 27 August 2006 Validation Supplementary Training Modules on Good Manufacturing Practice WHO Technical Report Series, No. 937, 2006.
VALIDATIONS: TOWARDS RELAIBLE QUALITY OUTCOMES DR. SHIVPRAKASH MANAGING DIRECTOR SYNCHRON RESEARCH SERVICES PVT. LTD., INDIA.
Validation Validation: A systematic study which ensures that systems, facilities and processes are working adequetly and precisely. Validation is an integral.
Validation Defination Establishing documentary evidence which provides a high degree of assurance that specification process will consistently produce.
MANUFACTURING AND PRODUCTION OF BIOLOGICAL PRODUCTS (ERT 455)
Module 4Slide 1 of 23 WHO - EDM Validation Basic Principles of GMP.
The world leader in serving science Validation and Qualification Overview Mike Garry Software Product Manager Spectroscopy Software Platform Team.
Sterile product validation
Pharmaceutical Quality Control & current Good Manufacturing Practice
AIQ Analytical Instrument Qualification. AIQ – Analytical Instrument Qualification Varian, Inc.’s Analytical Instrument Qualification documentation has.
ISO 9000&14000 and validation. INTRODUCTION I S O I S O International Standard Organization ISO in Greek means “equal” and ISO wanted to convey the idea.
M ODULE 8 – Q UALITY S YSTEMS IN A P RODUCTION L AB Shelley O’Grady, M.S. Associate Professor, Biotechnology Dept. Austin Community College.
SEMINAR ON PRESENTED BY BRAHMABHATT BANSARI K. M. PHARM PART DEPARTMENT OF PHARMACEUTICS AND PHARMACEUTICAL TECHNOLGY L. M. COLLEGE OF PHARMACY.
EQUIPMENT and METHOD VALIDATION
1. Our Presentation Topic: Importance Of Validation & Qualification In Pharmaceutical Industries Presented By: Md. Tanjir Islam (Group C) 2.
means to “TO CHECK OR PROVE THE VALIDITY OF” According to FDA – “ The goal of validation is to establish a documented evidence which provides a high degree.
Qualification And Validation In Pharmaceutical Manufacturing
World Health Organization
World Health Organization
Pharmaceutical Quality Control & current Good Manufacturing Practice
VALIDATION OF PHARMACEUTICAL PROCESSES
Author: Nurul Azyyati Sabri
Water for Pharmaceutical Use
World Health Organization
EPA Method Equivalency
Quality Systems in a Production Facility
Theresa Dunning, MT(ASCP)SBB, MSQA, CMQ/OE(ASQ)
This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya). You can freely download,
יוסי שדמתי רק איכות מניהול סיכונים לאימות ותיקוף תהליכי הרכבה From Risk Management to Processes Validation יוסי.
World Health Organization
Computer System Validation
Presentation transcript:

VALIDATION METHODOLOGY Validation is defined as the establishment of documented evidence which provides a high degree of assurance that, a planned process will consistently perform according to the intended specified outcomes. Once the system or process has been validated, it is expected that it remains in control, provided no changes are made. Incase of any modifications, or problems or equipment replacement/ relocation, Re – Validation is performed.

VALIDATION ACTIVITIES Validation Activities Mainly consists of : Utilities & Equipment Qualification Cleaning Validations Analytical Instrument & Method Validations Process Validations The Utility/Equipment Qualification consists of Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ).

Equipment, Utility Qualification Some equipment, whose correct operation itself is a measure of its performance and which is calibrated at regular intervals, may need only Installation Qualification (IQ) & Operational Qualification (OQ). Example : pH meter IQ, OQ & PQ on major equipment, systems and Utilities must be completed and approved prior to the use of the same for manufacturing purpose. Protocols shall be prepared, reviewed & approved for IQ, OQ &PQ studies.

INSTALLATION QUALIFICATION (IQ) Installation Qualification is the documented evidence that the installed equipment conforms to the purchase specifications, manufacturer’s literature. The IQ should list and document all the Identification information of all major components, their locations, utility requirements, connections and any safety features of the equipment. IQ is intended to verify that the installed equipment matches with purchase specifications, drawings, manuals, spare parts list, supplier address and contact numbers etc.

OPERATIONAL QUALIFICATION (OQ) Operational Qualification is the documented evidence that all the components of a system or piece of equipment operate according to the specifications. The OQ should provide a listing of SOPs for Operation, Maintenance and Calibration. Before initiation of OQ of an Equipment or Utility, its IQ must be completed.

PERFORMANCE QUALIFICATION (PQ) Performance Qualification is the documented evidence that a system/ piece of equipment can consistently perform and meet the required specifications under routine operation and, where appropriate, under worst-case situations. The PQ document should include a description of the preliminary procedures required, the detailed performance tests to be performed, and the acceptance criteria for each test.

PROCESS VALIDATION Process Validation is the  documentary evidence that processes are capable of repeatedly and reliably producing a Finished Product of the required Quality. Process Validation studies examine a process under normal operating conditions to prove that the process is in control. Once the process has been validated, it is expected that it remains in control, provided no changes are made.

Types of Process Validation Process validation consists of either of Prospective Validation Concurrent Validation Retrospective Validation Prospective Validation : The execution and documentation of pre – approved test protocol, which is designed to prove that a process performs as intended, prior to the release of a manufactured product for distribution.

CONCURRENT VALIDATION Concurrent Validation is based on data collected during actual performance of a process already implemented in the manufacturing facility. Validation data are collected during several runs of the on-going process and evaluated to determine if the process is valid. A Protocol should be written to define the information to be collected and evaluated.

RETROSPECTIVE VALIDATION Retrospective Validation is performed whenever a product has been in production since a long time, and has not been validated either prospectively (or) concurrently. A minimum of 10 to 12 Consecutive batches will be evaluated for Consistency of Test results, Quality & Yield against Acceptance Criteria.

ANALYTICAL INSTRUMENT VALIDATION The Validation of Analytical Instruments consists of Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ). Some Instruments, whose correct operation itself is a measure of its performance, may need only Installation Qualification (IQ) & Operational Qualification (OQ). Example : pH meter, Incubator, Freezer IQ, OQ & PQ of the Analytical instruments must be completed and approved prior to the use of the same for other validation activities/ product testing purpose. Protocols shall be prepared, reviewed & approved for IQ, OQ &PQ studies.

ANALYTICAL METHOD VALIDATION Analytical Method Validation is to be conducted for all identification, quantitative analytical procedures such as product strength/assay, impurity and degradation analysis etc. Validation of Analytical Method is the process of establishing any four or more of : Accuracy, Precision, Linearity, Range, Limit of Detection, Limit of Quantitation, Specificity and Ruggedness as appropriate to the type of Assay/Test. The results of Validation must be documented in an Approved Method Validation Protocol.

CLEANING METHOD VALIDATION Cleaning validation program is to be conducted for each product/ for each grouping of products to ensure that the cleaning procedures effectively remove residual products and cleaning agents from the equipment that is in contact with the product (the cleaned equipment contains an acceptable limit of previous product only). SWAB Samples / RINSE Samples are obtained & analyzed in order to prove that the cleaned equipment contains an acceptable limit of previous product only). The method of sample drawing, no. of samples to be drawn, location &equipment for sampling etc. must be documented in an Approved Method Validation Protocol.