SOP ON HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP)

SOP ON HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP)

1.0 OBJECTIVE

To lay down the procedure for conducting Hazard Analysis and Critical Control Point (HACCP) study to systematically 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.
It covers HACCP studies conducted during process validation as well as periodic 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 that appropriate Critical Control Points (CCPs) are established to control identified hazards.

3.2 Technical Team

3.2.1 Conduct HACCP study using a multidisciplinary approach including representatives from:

• Quality Assurance

• Production

• Warehouse

• Engineering

3.2.2 Ensure that all aspects of the manufacturing process are considered and suitable control measures are established.

4.0 ACCOUNTABILITY

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

5.0 DEFINITION & ABBREVIATION

5.1 Definition

Not Applicable.

5.2 Abbreviations

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 shall be carried out by a multidisciplinary Technical Team comprising members from QA, Production, Warehouse, and Engineering.

8.1.2 The team shall ensure that all process aspects are reviewed comprehensively.

8.2 Purpose of HACCP

8.2.1 HACCP is a systematic tool used to evaluate whether a process is adequately controlled to eliminate or minimize risks to the end user to an acceptable level.

8.2.2 It is a structured method of documenting and reviewing risks related to product safety, quality, and efficacy.

8.2.3 HACCP study shall form part of process validation activities.

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 documentation shall be maintained and reviewed periodically.

8.3 Conducting HACCP Study

8.3.1 Product Identification

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

8.3.2 Identification of Process Steps

List all processing steps involved in the manufacturing lifecycle of the product.

8.3.3 Preparation of Process Flow Diagram

Prepare a sequential flow diagram covering the complete 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 of finished product

The flow diagram shall be verified at the shop floor for accuracy.

8.3.4 Hazard Identification

Identify hazards at each processing step, including:

• Microbiological hazards

• Chemical hazards

• Physical hazards

8.3.5 Identification of Causes

Determine and document the possible causes of each identified hazard.

8.3.6 Identification of Control Measures

Verify whether control measures are available to eliminate or reduce the likelihood of each hazard. Control measures may include:

• Approved SOPs or batch documentation

• Personnel training

• Line clearance procedures

• Process validation

• Cleaning validation

• Use of dedicated equipment

• Testing and release of materials

• Environmental controls

• Document control systems

• Release control procedures

• In-process checks

8.4 Identification of Critical Control Points (CCP)

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

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

8.4.3 Determine whether a process step is a CCP using the Decision Tree provided in Annexure–I.

8.5 Establishment of Critical Limits and Monitoring

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

8.5.2 Establish Critical Limits for each CCP to ensure effective 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 implemented by trained personnel performing the process.

8.6 Corrective Action

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

8.6.2 The deviation, investigation, and corrective action shall be documented and reviewed by QA.

8.7 Verification and Review

8.7.1 After completion of the HACCP study, verify that:

• All significant hazards are identified

• Control measures are adequate

• CCPs are appropriately defined

• Monitoring procedures are effective

8.7.2 HACCP study shall be reviewed:

• Whenever there is a proposed change in process

• In case of major deviation, complaint, 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 approved HACCP study.

9.0 ENCLOSURES

Annexure – I: Critical Control Point Decision Tree