Basics on Pharmaceutical Process Validation

1. Presented by-
Diksha Kumari
Anurag Chanda
Anindita Biswas
B.pharm ,4thyr,7th Semester
Guru Nanak Institute of Pharmaceutical Science and Technology

2. What is Process validation?
Process validation is defined as the collection and
evaluation of data, from the process design stage
throughout production, which establishes scientific
evidence that a process is capable of consistently
delivering quality products.

3. Objectives
 More confidence in quality system
 More confidence in product quality
 More confidence in manufacturing process
 Increase in product output
 More rapid investigation

4. Basic Principles For Validation
 Establish that the process equipment has the capability of operating
within required parameters;
 Demonstrate that controlling, monitoring, and/or measuring
equipment and instrumentation are capable of operating within the
parameters prescribed for the process equipment;
 Perform replicate cycles representing the required operational range of
the equipment to demonstrate that the processes have been operated
within the prescribed parameters for the process and that the output or
product consistently meets predetermined specifications for quality and
function; and
 Monitor during routine operation for requalify and recertify the
equipment.

5. TYPES OF PROCESS VALIDATION
 Prospective Validation
Prospective validation is conducted before a new product is released for
distribution or, where the revisions may affect the product's
characteristic.
 Retrospective Validation
Retrospective validation is the validation of a process based on
accumulated historical production, testing, control, and other
information for a product already in production and distribution. This
type of validation makes use of historical data and information which
may be found in batch records, production log books, lot records, control
charts, test and inspection results, customer complaints or lack of
complaints, field failure reports, service reports, and audit reports.

6.  Concurrent validation is a subset of prospective validation
and is conducted with the intention of ultimately distributing
product manufactured during the validation study.
 Revalidation is needed to ensure that changes in the process
and/or in the process environment, whether intentional or
unintentional, do not adversely affect process characteristics
and product quality.
 Revalidation may be divided into two broad categories:
 Revalidation after any change having a bearing on product quality.
 Periodic revalidation carried out at scheduled intervals.

8. Approach to Process Validation
Process Validation activities in three stage
1. Process Design -The commercial process is defined during
this stage based on knowledge gained through development
and scale-up activities.
2. Process Qualification - Process Design is evaluated to
determine if the process is capable of reproducible commercial
manufacturing.
3. Continues Process Validation - Ongoing assurance is
gained during routine production that the process remains in
a state of control.

9. VALIDATION PROTOCOL
Validation Protocol Should Contain Minimum Following Things-
 Objectives, scope of coverage of the validation study.
 Type of validation: prospective, concurrent, retrospective, re-validation.
 Number and selection of batches to be on the validation study.
 A list of all equipment to be used; their normal and worst case operating parameters.
 Requirements for calibration of all measuring devices.
 Critical process parameters and their respective tolerances.
 Description of the processing steps: copy of the master documents for the product.
 Sampling points, stages of sampling, methods of sampling, sampling plans.
 Statistical tools to be used in the analysis of data.
 Training requirements for the processing operators.
 Specifications for raw and packaging materials and test methods.
 Forms and charts to be used for documenting results.
 Format for presentation of results, documenting conclusions and for approval of study
results.

10. MASTER VALIDATION PLAN
The format and content should include:
 Introduction: validation policy, scope, location and schedule.
 Organizational structure: personnel responsibilities.
 Plant/process/product description: rational for inclusions or
exclusions and extent of validation.
 Specific process considerations that are critical and those requiring
extra attention.
 List of products/ processes/ systems to be validated, summarized in a
matrix format, validation approach.
 Re-validation activities, actual status and future planning.
 Key acceptance criteria.
 Documentation format.
 Reference to the required SOP’s.
 Time plans of each validation project and sub-project.

11. THANKYOU
References-
•Pharmaceutical Process Validation: Second Edition, edited by Robert A.
Nash,Alfred H. Wacter;399-436.
•Industrial process validation on solid dosage form : a review; Singh
Harsimranjit et al.IRJP 2012 3(4).
•Industrial process validation of solid dosage form: an overview;
Satyabrata Jena et al., Volume 4, Issue 2, September – October 2010.

12. CELEBRATE
BE PROUD TO BE A PHARMACIST