Welcome

Process Validation

Presented by:-

Mr. Avinash ManeM.Pharm (Q.A.- 1)

Guided by:-

Mr. S.G.Killedar Asso.Prof.in Pharmacognosy

Bharati Vidyapeeth College of Pharmacy Kolhapur

Seminar on

IntroductionDefinitionScope of validationImportance of validationTypes of validationLimitation of validationProcess validationTypes of process validationConclusionReferences.

Content

Introduction

The proof of validation is obtained through the collection and evaluation of data .

Beginning from the process development phase and continued through in to the production phase.

validation is necessary include Process qualification, material, equipment, system, personnel.

The control of the entire process for repeated batches or runs.

Definition

“ Validation is a documented program which provide a high

degree of assurance that a specific process will consistently

produce a products to meeting it’s Pre-determined Specification

and quality attributes”

Scope of validation

Pharmaceutical validation is vast area of work and it practically cover every aspect of pharmaceutical process activities. Following area or operation will point out for pharmaceutical validation,

Analytical test method.

Instrument calibration.

Raw material.

Packaging material.

Equipment validation.

Facilities.

Manufacturing operation

Product design.

Cleaning validation.

operator.

Process utility services.

Importance of validation

Every activity in any business unit is done to get some benefit from that.

Validation activity must give the industry some advantages, some benefit & Some added value.

Reduction ofQuality cost

Process optimization

Assurance of Quality

Safety

Reduction of quality cost :

Preventive cost : To prevent failure or reduce the appraisal cost 1. Quality planning. 5. Process validation 2. Training. 6. Self inspection. 3. Calibration. 7. Documentation. 4. Sanitation 8. Review of data.

Internal failure cost : Non-confirming material . 1. Reject. 3. Re-inspection. 2. Rework. 4. Re-test. External failure cost : Non- confirming condition after the product

left the company ownership.1.Recall. 2. Complaints. 3.Return due to Quality problem

process optimization :

Make the process effective, efficient, perfect or useful as possible at the minimum cost.

Trained qualified people are the key element in any process, thus greatest impact on improving efficiency and productivity.

In this content GMP training program that include how to do the job correctly, easily and repeatedly.

Assurance of quality :

Validation is a extension of quality assurance, in other words validation and process control are the heart of GMP.

Without validated and controlled process it is impossible to produce quality product consistently.

Safety :

Validation can also result in increased operation safety.

e.g. gauges used in equipment that is designed to operate at certain temperature, and pressure must be reliable i.e. they must be calibrated.

Limitation of validation

Validation has a practical limit and related cost, hence while deciding the limit of validation, we need to balance between the process cost and the benefits derived from such limit.

e.g. The cost of controlling weight variation in tablet or capsule, if 1 person keep limit of 5% & other person keep at limit 0.5% using high tech.& high cost. We must see what benefit, benefit is not much then we decide the limit.

Process validation

Definition:- “The collection and evaluation of data from the process design stage throughout production which establishes evidence that a process is capable of consistently delivering quality product”

Process validation involves a series of activities taking place over the lifecycle of the product and process.

Phases of validation

Phases Of validation

Design Qualification

Installation Qualification

Operational Qualification

Performance Qualification

Design qualification :

Design qualification is the responsibility of the authorized project team.

Responsible for the creation of the facility. People should be consist of various area like engineering, production

quality management, project, person etc. Senior knowledgeable and mature person should head of this team.

E.g. Typical room data sheet contain following information.

1. Name of the room 6. Lighting intensity. 2. No. of the room. 7. Sound level. 3. Normal human population. 8. List of equipment. 4. Temp, Humidity. 9. Doors,window,surface. 5. Class of air. 10. Vacuum, steam, drainage.

Installation Qualification:

The protocol is insure that the system equipment and its component are installed correctly and to the original manufacturer specification.

Major calibration of equipment, accessory equipment, or utilities should be performed in this step.

Operational Qualification:

This step proceed after the installation qualification.

This should be done mainly to see if there is any problem related to the lighting, drainage, men and material movement, sewage and sanitation, cleaning and maintenance .

Performance Qualification:

This is the final step of validation. Evaluate the premises suitability with :

Equipment in operation.

Material being handled.

People working.

Various sound may be produced.

Dust is getting generated.

Heat is getting generated.

Filtered getting chocked.

Take care of all possible practical problems.

Types of Process validation

Prospective Validation

Concurrent Validation

Revalidation

Retrospective validation

Prospective Validation :

Prospective validation is done during the Product development stage.

When we developed a new mfg process and formula each step will be validated to achieve desire result.

On the basis of past experience to determine whether they might lead to critical situation.

Unsatisfactory process must be modified & improve until the validation exercise prove them to be satisfactory.

Essential in order to limit the risk of error occurring on the production scale.

Every aspect from laboratory scale to commercial scale is documented on record of Process validation.

e.g. Injectable preparation.

Conti…

Concurrent Validation :

Concurrent validation is carried out during production.

This time the in-process quality control parameter are also decides & monitor for use of regular production, final control & stability.

If initial batches use same type of equipment then revalidation may not be required only IPQC test are enough.

IPQC test should be carried out for every batch to see the process is moving forward in the excepted direction.

Conti…

Process & procedure should undergoes periodic critical revalidation to ensure that achieving the desire result.

The verification of process parameter are evaluated for the mfg. facilities batch after batch if any changes is required.

The premises and equipment to be used have been validated previously and then decision to carry out concurrent validation.

Revalidation :

“Revalidation is needed to ensure that changes in the process and in process environment whether intentional or unintentional do not adversely affect process characteristics and product quality” e.g. Change in : Formula. Equipment. Procedure. Quality of raw material. Physical variation.

May required revalidation process.

Revalidation after any changes bearing on product quality.

Periodic revalidation carried out at schedule interval.

Types of Revalidation :

Revalidation after any changes bearing on product quality.

Change in Starting material.

Density Viscosity. Particle size. Crystal type. Modification of

active ingredients.

Change in Packaging material.

Replacing plastic by a glass.

Change in Process.

Mixing time Drying temp. Cooling regimen.

Change in Equipment.

Conventional granulator Replaced by

Rapid mixer granulator or

Fluid bed processor.

Periodic revalidation carried out at schedule interval.

It is well known that the process changes may occur gradually even if experienced operator works correctly, similaraly equipment may also causes gradually changes.

Periodic revalidation is based on review of historical data. i.e. data generated during in process & finished product testing.

Any change in master formula & method, batch size etc.

Has preventive maintenance been performed in accordance with the

Program & time schedule.

Have the (SOPs) been properly updated.

Have the (SOPs) been implemented.

Have the cleaning & hygiene program been carried out.

Retrospective validation:

Establishing documented evidence that a system does what if purpose to do based on a review and analysis of historical data and information obtained during production of marketable products.

This validation includes:

Batch documents.

Process control chart.

Maintenance log book.

Record of personnel changes.

Finished product data.

Storage stability result.

Conclusion.

Validation is obtained through beginning from the process development Phase and continued through in to production phase. which provide high degree of assurance that will consistently produce a product meeting its predetermine specification and quality attributes. may used to achieve reduction of cost, process optimization, assurance of quality and safety. Process validation involves series of activity taking place over the Lifecycle of the product and process.

Thank you