Emerging concept in QA HACCP and GAMP

1. Presented by:-
Mr. Wani Rakesh.M.
M.Pharm, Ist Sem
(QAT)
Guided by:-
Prof. Mr. Bidkar A.A.
HOD
Pharmacognosy
Dateof Presentation:-06/11/2015
Emerging concept in qa-haccp and gamp
Sinhgad instituteof pharmacy narhe, Pune1

2. 2
Contents:
 Introduction
 Objective
 History of HACCP
 Pre HACCP Activities
 Principal
 Advantages
 Application
 Conclusion

3. 3
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

4. 4
Prevent, reduce or eliminate hazards in
food and in Pharmaceuticals.

5. 5
To make product safely and be able to prove it

6. 6
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

7. 7
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.

8. 8
Where can HACCP be used?
HACCP can be used in any food sector from production to
retail
Production
Processing
Transport
Retail and
food service

9. 9
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

10. 10
Pre HACCPActivities
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

11. 11
Principle 1: - Conduct a hazard analysis –
Hazard identification
Hazard 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 chart
Summarize the information in a Hazard Analysis Worksheet
Dr. Hany Khalil, Professor of food science, California state university,
California.

12. 12Almond board of California, USA

13. 13
*
Almond board of California, USA

14. 14
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.

15. 15Almond board of California, USA

16. 16
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.

17. 17
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.

18. 18
Almond board of California, USA

19. 19
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.

20. 20
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.

21. 21
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.

22. 22
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

23. 23
HACCP certified firms

24. 24
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

25. 25
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.

26. Thank You…!!!

27. 27

28. 28

29. Group of pharmaceutical professional
bonded together to form GAMP®
It’s a guideline not a regulation
29

30. 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 200830

31. 31
* GAMP Organization:

32.  ICH guidelines
• Q8-Pharmaceutical development
• Q9 -Quality risk management
• Q10- Pharmaceutical quality system
 FDA (Good management practices)
32

33. 33
Why GAMP® useful now?

34. 34

35. 35
Software Categories According to GAMP® Classes
GAMP
Class
Category Validation Action
1 Operating System Record Version
2 Instrument And
Controllers
Record
Configuration and
calibration
3 Configurable
Packages
Audit Supplier,
Apply full life cycle
requirement
Table no:-1 Software categories according to GAMP® classes

36. 36
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

37. Universal Approach
 Applies to all type of system
 Process control system
 Spreadsheet
37

38. Uniform Approach
 ‘V’ model is universally
applicable
Plan >Check>Do>Record
38

39. The ‘V’ Model
Fig:-1 The ‘V’ model
39

40. 40
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

41. 41
Using GAMP to Validate Continuous
Monitoring System Software
 Ten step process

42. 42
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

43. 43
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

44. 44
Key maintenance step for any Automated System
 SOP’S
 Training
 Calibration
 Validation
 Change control (any changed are introduced in a
controlled manner)

45. 45
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

46. 46
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.

47. 47
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

48. 48
Thank You