Standard Operating Procedure for Hazard Analysis and Critical Control Points (HACCP)

1) Purpose

This SOP outlines the procedures for implementing and maintaining a Hazard Analysis and Critical Control Points (HACCP) system to identify, evaluate, and control hazards related to food safety within the pharmaceutical manufacturing process.

2) Scope

This SOP applies to all personnel involved in the handling, processing, packaging, and storage of pharmaceutical products where potential hazards could impact product safety and compliance.

3) Responsibilities

The Quality Assurance Manager or designated personnel are responsible for overseeing the implementation and maintenance of the HACCP system. Production, quality control, and quality assurance personnel are responsible for implementing HACCP principles in their respective areas.

4) Procedure

4.1 Hazard Analysis

1. Identify potential biological, chemical, and physical hazards that may occur in each step of the pharmaceutical manufacturing process.
2. Conduct a hazard analysis to assess the likelihood and severity of each identified hazard.

4.2 Critical Control Points (CCPs)

1. Determine critical control points (CCPs) where control measures are essential to prevent, eliminate, or reduce identified hazards to an acceptable level.
2. Establish critical limits for each CCP, which are measurable criteria to ensure hazard control.

4.3 Monitoring Procedures

1. Develop monitoring procedures to verify that CCPs are under control and critical limits are maintained during production and processing.
2. Specify monitoring frequency, methods, responsibilities, and documentation requirements.

4.4 Corrective Actions

1. Establish corrective actions to be taken when monitoring results indicate that a CCP is not under control or critical limits are exceeded.
2. Assign responsibilities, establish timelines for corrective actions, and document all corrective actions taken.

4.5 Verification Procedures

1. Verify the effectiveness of the HACCP system through periodic reviews, audits, and validations.
2. Review and update the HACCP plan as necessary based on verification results, changes in processes, or new hazards identified.

4.6 Record Keeping

1. Maintain accurate and complete records of all HACCP activities, including hazard analyses, CCP determinations, monitoring results, corrective actions, and verifications.
2. Ensure records are readily available for review by regulatory authorities during inspections.

5) Abbreviations, if any

SOP: Standard Operating Procedure
HACCP: Hazard Analysis and Critical Control Points
CCP: Critical Control Point

6) Documents, if any

HACCP Plan Template, Hazard Analysis Worksheet, Monitoring Records, Corrective Action Report Forms, Verification Reports

7) Reference, if any

Regulatory guidelines such as FDA Guidance for Industry: HACCP Principles & Application Guidelines, WHO Guidelines on HACCP in Small and/or Less Developed Food Businesses, Codex Alimentarius: Recommended International Code of Practice – General Principles of Food Hygiene

8) SOP Version

Version 1.0