haccp gamp .final 2015 rakesh

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Presented by:-Mr. Wani Rakesh.M.

M.Pharm, Ist Sem(QAT)

Guided by:-Prof. Mr. Bidkar A.A.

HOD Pharmacognosy

Date of Presentation:- 06/11/2015

Emerging concept in qa-haccp and gamp

Sinhgad institute of pharmacy narhe, Pune

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Contents: Introduction

Objective

History of HACCP

Pre HACCP Activities

Principal

Advantages

Application

Conclusion

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Introduction: -

The Hazard Analysis Critical Control Points (HACCP) system is

a logical, scientific system that can control safety problems in food

production.

It works with any type of food production system and with any food.

The hazards can be biological, chemical, or physical.

Used for the identification of Critical Control Points (CCP’s)

where food safety concerns can be identified.When critical limits are exceeded, corrective action must be taken

and documented.

www.usda.gov

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Prevent, reduce or eliminate hazards in food and in Pharmaceuticals.

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Objective: -

To make product safely and be able to prove it

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History of HACCP

The concept had its origin in USA.

1958-59; Concept was discussed and developed at NASA.

1971; The HACCP system was published and documented.

1985; The National Academy of Science (NSA) recommended the use of

the system.

1988; National Advisory Committee on Microbiological Criteria for

Food (NACMCF).

1989; NACMCF proposed 7 principles of HACCP.

1st revision in 1992,

2nd revision in 1997 ; published in Journal of Food protection.

www.haccp-international.com

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Need for HACCP system

Failure of inspection procedures to prevent hazards from being

present on foods.

End-product testing does not guarantee the safety of the product.

Examination of entire lots is not feasible (Sampling plans).

Allows to provide consumers with safe foods.

It is the Law…!!!

Dr. Hany Khalil, Professor of food science, California state university, California.

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Where can HACCP be used?

HACCP can be used in any food sector from production to retail

HACCP

Production

Processing

TransportRetail and food service

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The 7 Principles of HACCP

1. Conduct a Hazard Analysis

2. Determine Critical Control Points

3. Establish Critical Limits

4. Establish Monitoring Procedures

5. Establish Corrective Actions

6. Establish Verification Procedures

7. Establish Record keeping and Documentation

www.haccpindia.org

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Before starting HACCP plan one must conduct….

Pre HACCP Activities

1. Assemble the HACCP team

2. Describe the food and its distribution method

3. Identify the intended use and target consumer for the product

4. Develop a flow chart describing the process

5. Verify the flowchart

www.haccpindia.org

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7 principles cont…

Principle 1: - Conduct a hazard analysis –

Hazard identificationHazard evaluation (biological, chemical, or physical)Prepare a list of steps in the process where significant hazards

may be introduced or increased.Use the process flow chartSummarize the information in a Hazard Analysis Worksheet

Dr. Hany Khalil, Professor of food science, California state university, California.

12Almond board of California, USA

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*`

Almond board of California, USA

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2. Determine Critical Control Points –

Point, step or procedure where a control measure is applied and the

control is necessary at that point to keep a safe production.

Dr. Hany Khalil, Professor of food science, California state university, California.

15Almond board of California, USA

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3. Establish Critical limits –

Critical limits are tolerances beyond which the related CCP is out of

control and a potential hazard can exist.

A critical limit is a maximum and/or minimum value at which control

must be maintained for the CCP.

e.g. : Temperature/ Time, pH, salt concentration etc.

Dr. Hany Khalil, Professor of food science, California state university, California.

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4. Establish monitoring procedures –

Monitoring is a scheduled observation of a CCP and its

limits.

It Determines;

What will be monitored?

How it will be monitored?

When it will be monitored?

HACCP Plan Form is needed for this step.

18Almond board of California, USA

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5. Establish Corrective Action –

When there is deviation from an established CCP, corrective actions

must be taken to prevent a product that may be unsafe from reaching

consumers.

Corrective action steps taken must be documented.

Dr. Hany Khalil, Professor of food science, California state university, California.

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6. Establish Verification Procedures –

Every HACCP plan should be examined to validate its ability

to control food safety hazards that are reasonably likely to

occur, and that the plan is being effectively implemented.

CCP verification;

# Are we doing the right thing ?

# Do we do what we say ?

# Do we say what we do ?

Dr. Hany Khalil, Professor of food science, California state university, California.

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7. Establish Record keeping and Documentation –The HACCP plan must be on file at the facility.

Types of records could include:Processing records.Deviation records.Product safety records.Ingredients, ingredient certification, supplier qualification.Storage and distribution.

Dr. Hany Khalil, Professor of food science, California state university, California.

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Advantages

Enhances food safety management.

HACCP can be applied throughout the food chain.

Allows more efficient and effective use of resources.

Cost effectiveness.

Can help identify process improvements & reduced customer

complaints.

International Acceptance.

Enhances customer satisfaction / reduces dissatisfaction

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HACCP certified firms

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Conclusion

HACCP is a powerful tool in food safety management.

Ensuring food safety in industry.

It takes consistent, steady, and diligent effort to constantly

think about process/product and be ready to implement

changes to enhance food safety.

HACCP system can also be used in areas other than food

industry where product safety and purity is prime concern.

e.g. Pharmaceutical Industries

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References: -

1. www.usda.gov

2. www.haccp-international.com

3. www.haccpindia.org

4. Dr. Hany Khalil, Professor of food science, California state

university, California.

5. Almond Board of California, USA.

Thank You…!!!

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Group of pharmaceutical professional bonded together to form GAMP®

It’s a guideline not a regulation

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History and Evolution of GAMP®

Founded in 1991 in the UK

First GAMP® published in march 1995 and

partnered with ISPE®

Second GAMP® published in May 1996

Third GAMP® May 1998 Fourth GAMP® December 2001 Fifth GAMP® February 2008

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* GAMP Organization:

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ICH guidelines

• Q8-Pharmaceutical development• Q9 -Quality risk management• Q10- Pharmaceutical quality system

FDA (Good management practices)

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Why GAMP® useful now?

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Software Categories According to GAMP® Classes

GAMP Class Category Validation Action1 Operating System Record Version2 Instrument And

ControllersRecord

Configuration and calibration

3 Configurable Packages

Audit Supplier, Apply full life cycle

requirement

Table no:-1 Software categories according to GAMP® classes

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Hardware Categories According to GAMP® Classes

Sr.no Hardware category Name of category

A 1 Standard Hardware Component

B 2 Custom Built Hardware Component

Table no:-2 Hardware categories according to GAMP® classes

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Universal Approach

Applies to all type of system

Process control system

Spreadsheet

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Uniform Approach

‘V’ model is universally applicable

Plan >Check>Do>Record

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The ‘V’ Model

Fig:-1 The ‘V’ model

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Five key concept of GAMP®

Product and process understanding

Lifecycle approach within QMS

Scalable life cycle activities

Science based Quality Risk Management

Leveraging supplier involvement

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Using GAMP to Validate Continuous Monitoring System Software

Ten step process

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1) Develop URS• SMART

2) Begin building a traceability matrix• Track the requirement listed in the URS• Verify the function

3) Audit vendor and select the product• Audit and examine facility

4) Determine the software type• Off the shelf• Configured• Custom

5) Develop functions specification document• Describe the function of software and fulfill the requirement of the URS

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6)Develop detailed specification document• Perform the specification as per FS

7)Develop testing document• necessary for all the categories of the system

8)Finalise traceability matrix• time to do final check

9) Run system test• all tested the check list

10)Maintain the system under change control• GAMP approach is a lifecycle approach which

means maintaining system untill retirement

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Key maintenance step for any Automated System

SOP’S

Training

Calibration

Validation

Change control (any changed are introduced in a

controlled manner)

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Applications

Monitoring manufacturing, production and storage

environments in the pharmaceutical industry.

Monitoring the autoclaving process in the pharmaceutical

industry.

Water purification in the pharmaceutical industry.

Freeze drying in the pharmaceutical industry

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Conclusion

While there are new revolutionary concept in GAMP 5,it does

bring together the latest industry and regulatory thinking GxP

computerized system validation into one concise guidance.

Regulatory companies can reduced the time and cost necessary

for validation and maintain their system in a compliant state.

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References

Kelvin C. Martin, Risk Based Validation –The Benefits of the GAMP

Approach, Engineering Pharmaceutical Innovation ISPE,2012

GAMP 5-A brief overview ,IFF mode 2012-09-19

Keith williams,GAMP5 as suitable framework for validation of

Electronic Document Management System ‘On Premise’ and ‘in the

Cloud’

Danilio Maruccia, GAMP Guideline & Validation

Document,PQE,2006

Maas & Peither AG-GMP Publishing, The ‘v’ Model logprofile no

16 ,2012,1-3

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Thank You