PROCESS VALIDATION: An essential

process in pharmaceutical industry

BY : YOGITA KUMARI
LOVELY SCHOOL OF PHARMACEUTICAL SCIENCES, LOVELY
PROFESSIONAL UNIVERSITY, PHAGWARA, PUNJAB (INDIA)-
144411

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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)
http://apps.who.int/prequel/trainingresources/pq_pres/PQT_Assesment_May2014/2-4_process 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
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 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