Hazard Analysis and Critical Control Point – HACCP

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Hazard Analysis and Critical Control Point – HACCP

1.0 OBJECTIVE

To lay down the procedure for conducting Hazard Analysis and Critical Control Point (HACCP) study to identify, evaluate, and control hazards that may affect the safety, quality, and efficacy of products.

2.0 SCOPE

This procedure is applicable to all products manufactured at the facility and covers HACCP study during validation of new processes as well as review of existing processes.

3.0 RESPONSIBILITY

3.1 Concerned Department Head

3.1.1 Identify hazards associated with activities performed in their respective departments.
3.1.2 Ensure appropriate Critical Control Points (CCPs) are established to manage identified hazards.

3.2 Technical Team

3.2.1 Conduct HACCP study with a multidisciplinary approach including members from QA, Production, Warehouse, and Engineering.
3.2.2 Ensure all aspects of the manufacturing process are considered and appropriate control measures are established.

4.0 ACCOUNTABILITY

Head – Quality Assurance shall be accountable for implementation, review, and approval of HACCP studies.

5.0 DEFINITION & ABBREVIATION

5.1 Definition

Not Applicable.

5.2 Abbreviations

Abbreviation Description
QAD Quality Assurance Department
SOPs Standard Operating Procedures
cGMP Current Good Manufacturing Practices
HACCP Hazard Analysis and Critical Control Point
N.A. Not Applicable
CCP Critical Control Point

6.0 PRECAUTIONS, SAFETY & EHS

Not Applicable.
(Refer to relevant Safety and EHS SOPs where applicable.)

7.0 MATERIAL & EQUIPMENT REQUIRED

7.1 Materials: Not Applicable
7.2 Equipment: Not Applicable

8.0 PROCEDURE

8.1 Formation of HACCP Team

8.1.1 HACCP study shall be carried out by a multidisciplinary Technical Team consisting of representatives from:

  • Quality Assurance

  • Production

  • Warehouse

  • Engineering

8.1.2 The team shall ensure all aspects of the process are evaluated.

8.2 Purpose of HACCP

8.2.1 HACCP is a systematic tool used to evaluate processes and determine whether they are adequately controlled to eliminate or minimize risks to the end user to an acceptable level.

8.2.2 It documents and reviews risks related to safety, quality, and efficacy of the product.

8.2.3 HACCP study shall be considered as part of process validation.

8.2.4 HACCP may also be performed on existing processes to review current control levels and implement improvements where necessary.

8.2.5 HACCP studies shall be documented and periodically reviewed.

8.3 Steps for Conducting HACCP Study

8.3.1 Identify the Product

Identify the specific product for which HACCP study is to be conducted.

8.3.2 Identify Processing Steps

List all steps involved in manufacturing and handling of the product.

8.3.3 Prepare Process Flow Diagram

Prepare a sequential flow diagram covering the entire process, including but not limited to:

  • Receipt of material

  • Sampling of material

  • Storage of material

  • Testing and release for use

  • Dispensing

  • Manufacturing

  • Filling

  • Storage of bulk product

  • Sampling of bulk product

  • Testing of bulk product

  • Release of bulk product

  • Primary packing

  • Secondary packing

  • Storage of finished product

  • Sampling of finished product

  • Testing of finished product

  • Release of finished product

  • Transfer to warehouse

  • Distribution

8.3.4 Hazard Identification

Identify hazards at each processing step, including:

  • Microbiological hazards

  • Chemical hazards

  • Physical hazards

8.3.5 Identify Causes of Hazards

Determine and document the possible cause(s) for each identified hazard.

8.3.6 Identify Existing Control Measures

For each hazard, verify whether control measures are available to eliminate or minimize the risk. Control measures may include:

  • Approved SOPs or batch documentation

  • Personnel training

  • Line clearance procedures

  • Process validation

  • Cleaning validation

  • Dedicated equipment usage

  • Testing and release controls

  • Environmental controls

  • Document control systems

  • In-process checks

8.4 Identification of Critical Control Points (CCP)

8.4.1 After documenting significant hazards and control measures, identify Critical Control Points (CCPs).

8.4.2 A CCP is a process step that reduces or eliminates a hazard having a direct impact on product safety or quality.

8.4.3 Determine whether each process step is a CCP using the Decision Tree (Annexure-I: Critical Control Point Decision Tree.

8.5 Monitoring of CCP

8.5.1 Each identified CCP shall be subjected to stringent monitoring and recording of process parameters.

8.5.2 Establish Critical Limits for each CCP to ensure hazard control.

8.5.3 For each processing step:

  • Identify hazard

  • Verify control measure

  • Define critical limit

  • Establish monitoring procedure

8.5.4 Monitoring procedures shall be clearly documented and performed by authorized personnel.

8.6 Corrective Action

8.6.1 In case of failure to meet a Critical Limit, appropriate corrective action shall be taken as per defined procedures.

8.6.2 Corrective actions shall be documented and reviewed by QA.

8.7 Verification and Review

8.7.1 After completion of HACCP study, verify that:

  • All significant hazards are identified

  • Control measures are adequate

  • CCPs are correctly identified

  • Monitoring procedures are effective

8.7.2 HACCP study shall be reviewed:

  • Whenever there is a proposed process change

  • In case of major deviation or product failure

  • At defined periodic intervals

8.7.3 An annual audit of the process and associated batch records shall be conducted to ensure continued compliance with the HACCP study and existing documents.

9.0 ENCLOSURES

Annexure – I: Critical Control Point Decision Tree

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