M.PHARM, QUALITY ASSURANCE TECHNOLOGY

1. HACCP- Hazard Analysis And Critical
Control Point.
SALMAN LATIF
M.PHARM(QAT)

2. INTRODUCTION
■ All operators in pharmaceutical industry are
responsible for making sure that the product
produced are safe for consumption i.e product is not
harmful to health.
■ To obtain such results operators must implement
and maintain permanent procedures based on
HACCP principle.

3. ■ To produce safe formulations for the
consumers, all the important safety hazards
that are associated with production of medicine
viz. biological, physical and chemical hazards
needs to be ;
1. Prevented
2. Eliminated (PER)
3. Reduced
To an acceptable level.

4. PRINCIPLE
■ 7 HACCP Principles provides systematic way for identifying
food and drug safety hazards making sure that these hazards
are being managed responsibly showing that this is being done
continuously.
7 Principles are:
1. Identify any hazards that must be prevented, eliminated or
reduced to acceptable level.
2. Identify the critical control point (CCP) at step/steps at which
control is essential to prevent or eliminate hazards or to
reduce it atacceptable level.

5. 3. Establish critical limit at CCP that saperate acceptability to
an acceptability for prevent of hazards.
4. Establish and implement effective monitoring procedures
at CCP.
5. Establish corrective action when monitoring indicates that
CCP is not under control.
6. Establish procedures which shall be carried out regularly to
verify that the above measures are working effectively.
7. Establish documents and records with nature and size of
the business to demonstrate effective applications.

6. STAGES
• CHECKTHATYOU ARE
DOING EXACTLYTHE
SAMETHING WHATYOU
HAVE PLANNED
• TO CORRECT ANY
PROBLEMMTHAT WOULD
HAVE ARISE DURINGTHE
PROCESS AND NOTE
DOWNTHE SAME.
• DOWHATYOU HAVE
PLANNEDTO MAINTAIN
SAFETY.
• WHAT NEEDSTO BE DONE
TO MAINTAIN SAFETY.
PLAN DO
CHECKACT

7. HACCP Includes Two Parts
■ Good Hygiene Practices (GHP):
1. It is vital for food and drug industry.
2. It helps to check whether the manufacturer has reliable
hygienic procedures in place before starting to apply
HACCP.
3. Management is achieved when Good Hygiene
Practices (GHP) and operational process both are
based on HACCP for controlling hazards throughout
production.

8. ■ Flexibility in Implementation:
1. In business where it involves preparation, manufacturing and
processing hazards are controlled only by GHP.
2. When manufacturing and processing is done for production
operators can develop their own safety management
procedures by following traditional HACCP or by generic
HACCP.
3. Documentation is important part of HACCP as it provides
evidence of operators thinking and decision that can be
audited.
4. Flexibility gives us possibility for exception reporting of visual
monitoring checks.

9. Principle 1:- Conduct a Hazardous
Analysis
■ A through hazard analysis is the key to preparing an
effectively designed HACCP plan.
■ It is important to consider in the hazard analysis the
ingredient and raw material, each step in the process,
product storage and distribution and final preparation
and use by consumers.
■ When conducting a hazard analysis, safety concern
must be differentiated from quality concern.

10. ■ A hazard is defined by NACMCF as a biological,
chemical/ physical agent that is reasonable likely to
occur and will cause illness or injury in the absence of its
control.
■ Establishment must be considered all three types of
hazard – biological, physical and chemical at each step
of the production process.
■ A step is a point or activity in an operation within the
production process that is essential to the proper
production of the finished product.

11. ■ A food safety hazard that is reasonable likely to occur is
one for which a prudent establishment world establish
control because the hazard has historically occurred in
in the product / process or because there is a reasonable
probability that the hazard would be occur in the
absence of these controls.

12. OBJECTIVES
1. Hazards and associated control measures are identified
2. The analysis may identify needed modification (also known as
invention) to the initial process or product so that product safety is
assured
3. The analysis provides a basis for determining Critical Control Points
CCP in Principle 2

13. Principle 2- Determine critical
Control Points
■ The hazard that were analyzed in the hazard analysis must be
addressed in the HACCP Plan.
■ Hazard is controlled by one or more critical control point (CCP).
■ CCP is defined as “any point, step, procedure in the production at
which control can be applied as a result safety can be attained.
■ CCP are locations in the process at which control can be applied.

14. ■ Examples of CCP includes
1. Product temperature.
2. Microbial testing of incoming product.
3. Testing for metal contamination.
4. Concentration of carcass (dead body of rodents) etc.
■ The step of the process at which critical control point is
located does not need to be a point where hazard is
introduced.
■ They may be placed in any location deemed adequate to
prevent ,eliminate or control the hazard.

15. ■ The control point for hazard may be later in the
process than the point at which the hazard occurs .
■ Eg ; the cooking step is common control for biological
hazard that have been introduced in the product at
previous step.

16. Principle 3:- Establish Critical Limits
■ The next step in the development of a HACCP plan is to
establish critical limits for each critical control point.
■ Critical Limit [CL] are the parameter that indicate whether the
control measure at the CCP is in or out of control.
■ The national Advisor Committee On Microbiological Criteria For
Products [NACMCF] states that a Control Limit is a maximum/
minimum value to which a biological, physical and chemical
parameter must be controlled at CCP to prevent, eliminate or
reduce to an acceptable level.

17. ■ The establishment must consider the product safety standard
that must be met at each CCP.
■ Critical limits are designed to ensure applicable target or
performances standards pertaining to the specific process or
product.
■ Critical Limit design should be based on applicable FSIS
regulation/ compliance guidelines, FDA tolerance, specific and
technical literature, experimental studies or the
recommendation of recognized experts in the industry,
academia or processing authorities.
■ Critical Limits should not be confused with operational limits
which are established for reasons other than product safety.

18. Principle 4- Establishing monitoring
procedure.
■ Once critical limit is set for each CCP during HACCP plan
development.
■ Procedures must be established to monitor CCP and
determine whether the control limits are met.
■ Monitoring is the planned sequence of observation or
measurements to assure whether the CCP is under control
and to produce accurate record for future verification.

19. ■ Establishments are responsible for determining the procedure
of measurement and observations.
■ Critical limit is a numerical value and the process of monitoring
involves the measurement of limits.
■ Monitoring involves defining the critical limits as present or
absent.
■ Monitoring also involves the determination if any deviation
occurs from central limit so that appropriate corrective actions
can take place.

20. ■ It involves three step:
I. Track control of the process.
II. Determine where there is loss of control or deviation
occurs.
III. To provide a written document to be used in
verification.

21. Principle 5:- Establishing Corrective
Action
■ Specific corrective action depends upon the process used
and type of formulation manufactured.
■ Establishing corrective action must be determined at each
step or CCP in cases where Critical Limit is not met.
■ When there are deviation from Critical Limit.
■ Corrective Action required to prevent potentially hazardous
product from reaching the consumer.

22. ■ HACCP plan must include CorrectiveAction to be taken
when a deviation from Critical Limit appears.
■ Corrective Action includes –
1. Ensures CCP is under control after Corrective Action is
taken.
2. Ensures the measures established to prevent re-
occurence.
3. Ensures that no product affected by deviation is shipped.

23. ■ HACCP plan should specify what is to take place
when deviation occurs who is responsible to take
Corrective Action.
■ Corrective Action must be documented as a part of
specifiedCorrective Action.
■ It takes place when deviation will occur.
■ Here Expert may be required or consulted to review
the information available.

24. Principle 6- Establishing Record
Keeping And Documentation
Process
■ When HACCP plan is made it must be ensured that there is
effective record keeping.
■ Record is a written evidence that documents the operation of
HACCP.
■ All measures taken at Critical control points and any corrective
action is been documented and kept in file.
■ If any question arises record is used to trace history of finished
product.

25. ■ Records include :
I. Summary of hazard analysis.
II. Plan.
III. Supporting documents.
IV. Daily operation record.
■ Documents covers the basis and justification of plan.
■ It also contains :
1. HACCP team and their responsibility.
2. Description of product, intended use and consumer.

26. Principle 7:- Establish Verification
Process
■ Establish verification process is systematically verified.
■ 4 procedures:
1. Scientific and technical process known as validation for
determining the CCP and Critical Limit.
2. Initially and an ongoing bars that the HACCP functions
properly.
3. Documented periodic assessment/ reassessment of HACCP
plan.
4. Government verification for establishing HACCP functioning
properly.

27. ■ It ensures that plan ios implemented as written.
■ It confirms accurate monitoring of CCP.
■ It ensures that HACCP system is adequately controlling food and
drug safety hazard.
■ After initial validation system must be checked regularly.
■ If HACCP plan do not meet the need modification and
revalidation is done.
■ Contains minimum calibration process that frequently involves
direct observation for monitoring and determine monitoring is
done correctly.

28. ■ Record view ensures records are correctly kept and
ensures that activities were performed according to
plan within Critical Limits and no activity were
missed.
■ Not all CCP required calibration of equipment and
monitors other type of verification process can be
used
■ Eg: MicrobialTesting

29. Develop HACCP Plan
EstablishVerification Process
Establish Record Keeping Procedures
Establish Corrective Action
Establish Monitoring Procedure of CCP
Establish Critical Limit
Determine CCP
Conduct A Hazard Analysis