PROCESS VALIDATION: An essential
process in pharmaceutical industry
BY : YOGITA KUMARI
LOVELY SCHOOL OF PHARMACEUTICAL SCIENCES, LOVELY
PROFESSIONAL UNIVERSITY, PHAGWARA, PUNJAB (INDIA)-
144411
1
DEFINITION
The collection and evaluation of data, from the process design stage
through commercial production, which establishes scientific evidence
that a process is capable of consistently delivering quality products.
(FDA-food and Drug Administration)
Documented evidence which provides a high degree of assurance that a
specific process will consistently result in a product that meets
predetermined specifications and quality characteristics. (WHO-World
Health Organization)
The documented evidence that the process , operated within established
parameters , can perform effectively and reproducibly to produce a
medicinal product meeting its predetermined specifications and quality
attributes.(EMA-European medicines Agency)
[Link] validation. 2
BASIC PRINCIPLES OF PROCESS VALIDATION
INSTALLATION OPERATIONAL PERFORMANCE RE-
QUALIFICATION QUALIFICATION QUALIFICATION QUALIFICATION
(IQ) (OQ) (PQ)
Health Canada / Health Products and Food Branch Inspectorate Validation guidelines for pharmaceutical Dosage Forms 3
(GUI-0029) / December, 2009
CONSIDERATIONS OF IQ
Equipment design features
Installation conditions
Calibration, preventive maintenance, cleaning schedules
Safety features
Supplier documentation, prints, drawings, and manuals
Software documented
Spare part list
Environmental conditions
Health Canada / Health Products and Food Branch Inspectorate Validation guidelines for pharmaceutical Dosage Forms
(GUI-0029) / December, 2009
4
CONSIDERATIONS OF OQ
Process control limits
Software parameters
Raw material specifications
Process operating procedures
Material handling requirements
Process change control
Training
Short term stability and capability of the process
Potential failure modes, action levels and worst-case conditions
The use of statistically valid techniques
Health Canada / Health Products and Food Branch Inspectorate Validation guidelines for pharmaceutical Dosage Forms 5
(GUI-0029) / December, 2009
CONSIDERATIONS OF PQ
Actual product and process parameters and procedure
established in OQ
Acceptability of the product
Assurance of process capability as established in OQ
Process repeatability, long term process stability
Health Canada / Health Products and Food Branch Inspectorate Validation guidelines for pharmaceutical Dosage Forms
(GUI-0029) / December, 2009 6
CONSIDERATIONS OF
RE-QUALIFICATIONS
Modification
Relocation
Minor changes
Changes having no direct impact on final or
in-process product quality
Health Canada / Health Products and Food Branch Inspectorate Validation guidelines for pharmaceutical Dosage Forms
(GUI-0029) / December, 2009 7
TYPES OF PROCESS VALIDATION
TYPE 1- PROSPECTIVE VALIDATION
TYPE 2- CONCURRENT VALIDATION
TYPE 3- RETROSPECTIVE VALIDATION
TYPE 4- PROCESS REVALIDATION
Guidelines for Process Validation of Pharmaceutical Dosage Form- Saudi Food &Drug Authority; Version 2;
February ,1992 8
PROSPECTIVE
VALIDATION It is carried out during the development stage by means of
a risk analysis of the production process , which is broken down into
individual steps : these are then evaluated on the basis of past experience to
determine whether they might lead to critical situations.
CONCURRENT
VALIDATION A process where current production batches are used to
monitor processing parameters . It gives of the present batch being studied ,
and offers limited assurance regarding consistency of quality from batch to
batch.
Guidelines for Process Validation of Pharmaceutical Dosage Form- Saudi Food &Drug Authority; Version 2;
February ,1992 9
Retrospective
validation Conducted for a product already been marked , and
is based on extensive data accumulated over several lots and over
time.
Re-validation Required when there is a change in any of the
critical process parameters, formulations, primary packaging
components, raw material fabricator, major equipment or premises.
Guidelines for Process Validation of Pharmaceutical Dosage Form- Saudi Food &Drug Authority; Version 2; 10
February ,1992
Validation master plan
Introduction
Organizational structure
Plant/process/product description
Specific process considerations
Revalidation activities
Key acceptance criteria
Documentation format
Reference to the required SOP’s
Time plan for each validation project and sub project
Note for Guidance on Process validation- The Europe Agency for Evaluation of Medicinal products
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;CPMP/QWP/848/96;EMEA/CVMP/598/99
