Haccp hazard analysis and critical control point salman

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 ; P revented E liminated (PER) R educed 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: Identify any hazards that must be prevented, eliminated or reduced to acceptable level. 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. Establish critical limit at CCP that saperate acceptability to an acceptability for prevent of hazards. Establish and implement effective monitoring procedures at CCP. Establish corrective action when monitoring indicates that CCP is not under control. Establish procedures which shall be carried out regularly to verify that the above measures are working effectively. Establish documents and records with nature and size of the business to demonstrate effective applications.

6. STAGES

7. HACCP Includes Two Parts Good Hygiene Practices (GHP): It is vital for food and drug industry. It helps to check whether the manufacturer has reliable hygienic procedures in place before starting to apply HACCP. 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: In business where it involves preparation, manufacturing and processing hazards are controlled only by GHP. When manufacturing and processing is done for production operators can develop their own safety management procedures by following traditional HACCP or by generic HACCP. Documentation is important part of HACCP as it provides evidence of operators thinking and decision that can be audited. 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 Hazards and associated control measures are identified The analysis may identify needed modification (also known as invention) to the initial process or product so that product safety is assured 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 Product temperature. Microbial testing of incoming product. Testing for metal contamination. 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 A dvisor C ommittee O n Microbiological Criteria F or P roducts [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: Track control of the process. Determine where there is loss of control or deviation occurs. 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 Corrective Action to be taken when a deviation from Critical Limit appears. Corrective Action includes – Ensures CCP is under control after Corrective Action is taken. Ensures the measures established to prevent re- occurence . 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 specified Corrective 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 : Summary of hazard analysis. Plan. Supporting documents. Daily operation record. Documents covers the basis and justification of plan. It also contains : HACCP team and their responsibility. Description of product, intended use and consumer.

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

29. Develop HACCP Plan

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