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Tony Gould Qualification and Validation

Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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Page 1: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

Tony Gould

Qualification and Validation

Page 2: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

2 | PQ Workshop, Abu Dhabi | October 2010

TopicsTopics

General overview

Qualification vs validation

Validation principles

Approaches to validation

Cleaning validation

Page 3: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

3 | PQ Workshop, Abu Dhabi | October 2010

WHO referenceWHO reference

WHO Technical Report Series, No. 937, 2006 - Annex 4

"Supplementary guidelines on good manufacturing practices: validation"

General guidance

7 Appendices covering specifics– HVAC, water systems, cleaning, analytical methods,

computerized systems, systems and equipment, non-sterile processes

Page 4: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Introduction

Validation is an essential part of GMP, and an element of QA

Basic principles include:– Safety, quality and efficacy of products– Built into the product – as it cannot be "inspected or tested

into a product"– Critical steps in the process need to be validated

Need for confidence that the product will consistently meet predetermined specifications and attributes

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ValidationValidation

Introduction (2)

Documentation associated with validation:

SOPs

Specifications

Validation Master Plan (VMP)

Qualification protocols and reports

Validation protocols and reports

These will be discussed later

Page 6: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Introduction (3)

Validation work requires considerable resources such as: Time:

– work is subject to rigorous time schedules Money:

– may need specialized personnel and expensive technology People:

– collaboration of experts from various disciplines

– a multidisciplinary team, comprising quality assurance, engineering, production, quality control (other disciplines, depending on the product and process to be validated)

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ValidationValidation

Scope WHO guideline focuses mainly on the overall concept of

validation

It serves as general guidance only

Principles may be useful:

– in production and control of active pharmaceutical ingredients (APIs) and finished pharmaceutical products

Validation of specific processes and products (e.g. sterile product manufacture) requires much more consideration and a detailed approach beyond the scope of the guideline

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ValidationValidation

Scope Many factors affecting the different types of validation Manufacturers should plan validation to ensure

– regulatory compliance and – product quality, safety and consistency

The general text in the guideline may be applied to validation and qualification of:

– premises, equipment, utilities and systems – processes and procedures

More specific principles addressed in the appendices (parts 2 to 7)

Semi-automatic or fully automatic clean-in-place (CIP) systems and other special cases should be treated separately.

Page 9: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Qualification and Validation

Qualification and validation are essentially components of the same concept

The term qualification is normally used for equipment, utilities and systems

The term validation is normally used for processes

In this sense, qualification is part of validation

Page 10: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Validation: Approaches to validation

Two basic approaches: 1. Evidence obtained through testing (prospective and

concurrent validation), and 2. Analysis of accumulated (historical) data (retrospective

validation)

Whenever possible, prospective validation is preferred.

Retrospective validation is no longer encouraged

Retrospective validation is not applicable to sterile products

Page 11: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Validation: Approaches to validation (2)

Both prospective and concurrent validation, may include:

– extensive product testing, which may involve extensive sample testing (with the estimation of confidence limits for individual results) and the demonstration of intra- and inter-batch homogeneity;

– simulation process trials;

– challenge/worst case tests, which determine the robustness of the process; and

– control of process parameters being monitored during normal production runs to obtain additional information on the reliability of the process.

Page 12: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Scope of validation

Validation requires an appropriate and sufficient infrastructure including:

– organization, documentation, personnel and finances

Involvement of management and quality assurance personnel

Personnel with appropriate qualifications and experience

Extensive preparation and planning before validation is performed

A specific programme for validation activities in place

Validation done in a structured way according to documentation including procedures and protocols.

Page 13: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Scope of validation (2)

Validation should be performed: – for new premises, equipment, utilities and systems, and

processes and procedures;– at periodic intervals; and – when major changes have been made.

Can periodic revalidation/requalification be substituted? Validation in accordance with written protocols. A written report on the outcome to be produced. Validation over a period of time, e.g.

– at least three consecutive batches (full production scale) to demonstrate consistency. (Worst case situations should be considered.)

Page 14: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Scope of validation (3)

Distinction between in-process controls and validation

– In-process tests (performed during the manufacture of each batch; their objective is to monitor the process continuously)

Demonstrate suitability for new manufacturing formula or method Process, materials and equipment to prove consistent yield of a

product of the required quality Manufacturers to identify what validation work is needed Significant changes (facilities, equipment, processes) - should be

validated Risk assessment approach used to determine the scope and

extent of validation needed

Page 15: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Qualification

Qualification should be completed before process validation is performed

A logical, systematic process followed

Start from the design phase of the premises, equipment, utilities and equipment

Major equipment and critical utilities and systems normally require IQ, OQ and PQ

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ValidationValidation

Qualification (2)

Some equipment, utilities and systems require only IQ and OQ as the correct operation could be considered to be a sufficient indicator of its performance

The equipment, utility and system should then be maintained, monitored and calibrated according to a regular schedule

Page 17: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Calibration and verification

Performed at regular intervals

Responsible personnel with appropriate qualifications and training

Calibration programme available including information, e.g.– calibration standards and limits, responsible persons,

calibration intervals, records and actions to be taken when necessary

Page 18: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Calibration and verification (2)

Traceability to standards used– (e.g. national, regional or international standards)

Calibrated equipment, instruments and other devices to be labelled, coded or otherwise identified

– indicate status of calibration and recalibration due date

If not used for a certain period of time– function and calibration status to be verified– shown to be satisfactory before use

Page 19: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Documentation

Validation Master Plan (VMP)

Protocols

Reports

SOPs

Others?

Page 20: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Validation Master Plan (VMP)

Contains key elements of the validation programme.

Concise, clear, contain at least:– a validation policy– organizational structure of validation activities– summary of facilities, systems, equipment and processes

validated (and to be validated)– documentation format (e.g. protocol and report)– planning and scheduling– change control and references to existing documents

Page 21: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Qualification and validation protocols

Describe the study to be performed and include as a minimum:– the objectives of the study– the site of the study– the responsible personnel– description of SOPs to be followed– equipment to be used– standards and criteria for the products and processes– the type of validation

Page 22: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Qualification and validation protocols (2)

Protocol contents (2):– the processes and/or parameters– sampling, testing and monitoring requirements– predetermined acceptance criteria for drawing conclusions

Description (how results will be analysed)

Protocol approved prior to use - changes approved prior to implementation of the change

Page 23: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Qualification and validation reports

Written reports on the qualification and validation performed

Reflect protocols followed and include at least:– title and objective of the study; reference to the protocol;

details of material– equipment, programmes and cycles used; procedures and

test methods

Results evaluated, analysed and compared against the pre-determined acceptance criteria

Page 24: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Qualification and validation reports (2)

The results should meet the acceptance criteria

Deviations and out-of-limit results should be investigated. If these are accepted, this should be justified. Where necessary further studies should be performed

Responsible departments and QA to approve completed report, including the conclusion

Page 25: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Qualification stages

There are four stages of qualification:– design qualification (DQ);– installation qualification (IQ);– operational qualification (OQ); and– performance qualification (PQ).

All SOPs for operation, maintenance and calibration should be prepared during qualification

Training provided and records maintained

Page 26: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Design qualification: Provides documented evidence that the design specifications were met

Installation qualification: Provides documented evidence that the installation was complete and satisfactory

During IQ: – Purchase specifications, drawings, manuals, spare parts

lists and vendor details should be verified– Control and measuring devices should be calibrated

Page 27: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Operational qualification: Provides documented evidence that utilities, systems or equipment and all its components operate in accordance with operational specifications

Demonstrate satisfactory operation over the normal operating range as well as at the limits of its operating conditions (including worst case conditions)

Operation controls, alarms, switches, displays and other operational components should be tested

Page 28: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Performance qualification: Provides documented evidence that utilities, systems or equipment and all its components can consistently perform in accordance with the specifications under routine use

Test results collected over a suitable period of time to prove consistency

Page 29: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Requalification

In accordance with a defined schedule

Frequency to be determined (e.g. on the basis of factors such as the analysis of results relating to calibration, verification and maintenance)

Periodic and after changes – e.g. changes to utilities, systems, equipment; maintenance

work; and movement

Part of change control procedure

Page 30: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Revalidation

Processes and procedures - to ensure that they remain capable of achieving the intended results

Periodic revalidation, as well as revalidation after changes

In accordance with a defined schedule

Frequency and extent determined using a risk-based approach together with a review of historical data

Page 31: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Periodic revalidation

To assess process changes that may occur gradually over a period of time, or because of wear of equipment

Consideration given to:– master formulae and specifications– SOPs– records (e.g. of calibration, maintenance and cleaning) – analytical methods

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ValidationValidation

Revalidation after change

After change that could have an effect on the process, procedure, quality of the product and/or the product characteristics. (Considered as part of the change control procedure.)

Extent depends on the nature and significance of the change(s)

Changes should not adversely affect product quality or process characteristics

Page 33: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Changes requiring revalidation should be defined in the validation plan and may include:

– changes in starting materials

– change of starting material manufacturer

– transfer of processes to a different site

– changes of primary packaging material

– changes in the manufacturing process

– changes in the equipment

– production area and support system changes

– appearance of negative quality trends

– appearance of new findings based on current knowledge

– support system changes

– e.g. including physical properties, such as density, viscosity or particle size distribution that may affect the process or product

– e.g. change of facilities and installations which influence the process

– e.g. substituting plastic for glass

– e.g. mixing times or drying temperatures

– e.g. addition of automatic detection systems, installation of new equipment, major revisions to machinery or apparatus and breakdowns

– e.g. rearrangement of areas, or a new water treatment method

– e.g. new technology

Page 34: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Revalidation after change (continuation)

Changes of equipment which involve the replacement of equipment on a “like-for-like” basis would not normally require a revalidation

For example, installation of a new centrifugal pump to replace an older model would not necessarily require revalidation

Page 35: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Change control

SOP followed - as changes may have an impact on a qualified utility, system or piece of equipment, and a validated process and/or procedure

Describe the actions to be taken, including the need for and extent of qualification or validation

Changes should be formally requested, documented and approved before implementation

Records should be maintained

Page 36: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Choice of approach:– Prospective

• Concurrent– Retrospective

Page 37: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Prospective validation

Critical factors or parameters possibly affecting finished product quality to be identified during product development

– Breakdown of production process into individual steps– Evaluate each step

Determine the criticality of these factors through a “worst-case” challenge where possible

Page 38: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

(continued) Prospective validation protocol should include:

– description of the process and of the experiment– equipment and/or facilities to be used including measuring

or recording equipment (and its calibration status)– variables to be monitored– details of the samples to be taken– product performance characteristics/attributes to be

monitored, together with the test methods– acceptable limits and time schedules– personnel responsibilities– details of methods for recording and evaluating results,

including statistical analysis

Page 39: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Concurrent validation

May be appropriate to validate a process during routine production

– Can you give any examples?

Decision made by appropriately authorized personnel

Premises and equipment previously qualified

Done as per validation protocol; and results documented in the validation report

Page 40: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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ValidationValidation

Retrospective validation

Comprehensive review of historical data

Requires a protocol and a report with a conclusion and a recommendation

Not the preferred method of validation, and used in exceptional cases only:

– e.g. for well-established processes

Inappropriate in case of changes (e.g. equipment)

Sufficient data to be reviewed to provide a statistically significant conclusion

Page 41: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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Part 2

Cleaning Validation

Page 42: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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DefinitionDefinition

Cleaning validation is documented evidence that an approved cleaning procedure will provide equipment which is suitable for processing of pharmaceutical products or APIs.

Food labels sometimes say “may contain traces of peanuts” – we can’t say “may contain traces of other medicines”!

Page 43: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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IntroductionIntroduction

Cleaning validation – performed in order to confirm the effectiveness of a cleaning

procedure– rationale for selecting limits of carry over of product residues,

cleaning agents and microbial contamination should be logically based on the materials involved.

– limits should be achievable and verifiable.

Page 44: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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General approachGeneral approach

For similar products and processes – OK to select representative range – “bracketing”

Can do single “worst case” if critical issues taken into account

Typically 3 successful consecutive applications of cleaning procedure

“Test until clean” not alternative to validation

Can do simulation using material with same physiochemical properties if toxic or hazardous

Page 45: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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Points to considerPoints to consider

At what point does a piece of equipment or system become clean? What does visually clean mean? Does the equipment need to be scrubbed by hand? What is accomplished by hand scrubbing rather than just a solvent

wash? How variable are manual cleaning processes from batch to batch

and product to product? What is the most appropriate solvent or detergent? Are different cleaning processes required for different products in

contact with a piece of equipment? How many times need a cleaning process be applied to ensure

adequate cleaning of each piece of equipment?

Page 46: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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BracketingBracketing

Cleaning procedures for products and processes which are very similar, do not need to be individually validated.

Select “worst case” to represent a range of similar products

Base on risk

Page 47: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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Selection of productsSelection of products

Consider the following when selecting products for product residue cleaning validation:

– Potency and toxicity, e.g. LD50

– Solubility– Ease of cleaning, e.g. oily, sticky– Other risk factors, e.g. sensitising materials

Page 48: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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LimitsLimits

Typical criteria used, as appropriate:– a) Not more than 0.1% carry over.– b) No more than 10ppm of any product will appear in another

product.– c) Visually clean

Rationale for selecting limits should be logically based on consideration of the materials and their therapeutic dose

Page 49: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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Setting limitsSetting limits

“Visually clean”– Always a criteria – May be sensitive enough – needs verification– Often used between batches of same product– Illuminate surface before checking– Spiking studies

Page 50: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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Setting limitsSetting limits

“10 ppm”– Mostly historical– In some poisons regulations– Limit test in pharmacopoeias– Based on assumption that residue is as harmful as heavy

metals– Useful for materials with no toxicity data– Shouldn’t be used for potent materials

Page 51: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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Setting limitsSetting limits

“Not more than 0.1%”– No more than 0.1% of the normal daily dose of product carried

over into the maximum daily dose of the next product

Page 52: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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Sampling methodsSampling methods

Swabbing vs rinse sampling

Measures 2 different things– Swabs sample a small area– Rinses sample a large area– Swab measures worst case (if location properly selected)– Rinse measures average

Results may not correlate

Page 53: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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Documents and recordsDocuments and records

Validation done according to protocol approved in advance

Proper records of validation activities must be maintained

Records must include a conclusion

Page 54: Tony Gould Qualification and Validation. 2 | PQ Workshop, Abu Dhabi | October 2010 Topics General overview Qualification vs validation Validation principles

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Thank you for listening!