HACCP VALIDATION REPORT

HACCP VALIDATION REPORT

LIST OF CONTENTS

S. No.CONTENTSPAGE No.
1.0Objective
2.0Scope
3.0Reason for Validation
4.0Responsibility
5.0Procedure for Validation
6.0Sampling Plan
7.0Data Recording
8.0Acceptance Criteria
9.0Deviations
10.0Conclusion and Recommendation
  • OBJECTIVE:

HACCP validation is the element of verification focused on collecting and evaluating the hazards of Physical, chemical, Biological & Quality.

The food safety objectives are as follows:

  • To achieve the total hours of food safety training to minimum 12 hours per year per employee.
  • Not more than 4 delayed orders for food safety reasons in the year.
  • To ensure 100% investigation of customer complaints & written response within 7days.
  • Not more than 0.1% of packed products are returned because of failing packaging per month.
  • None of the packed products are returned because of failing in manufacturing as per year.

The above food safety objectives are monitored and reviewed quarterly by Directors 

  • SCOPE:

A pharmaceutical company with a view of improving its overall efficiency and effectiveness has focused on the custom and process approach and has adopted the Hazard Analysis Critical Control Point system. 

  • RESPONSIBILITIES :

HACCP / Food Safety Team

As it is a collective effort or teamwork to produce a good product, the following are the responsibilities so the team members to do so.

Sr. No.NameDesignationRole in a TeamQualificationExperience
1Product ManagerTeam Leader
2Managing DirectorMember
3General ManagerMember
4Head- QAMember
5Sr. Executive-QAMember
6Manager-ProductionMember
7PPC-ManagerMember
8Head-QCMember
9Incharge-MaintenanceMember
10Manager – H.R.Member

 PROCEDURE FOR VALIDATION:

  • HACCP is a detailed food safety procedure that is based on assessing and controlling chemical, biological, Physical & Quality Hazards.
  • The HACCP plan was implemented during the entire steps of the food preparation and production including the raw material receiving, processing, and dispatch.
  • The main objective is to detect and prevent potential food safety hazards rather than just auditing the final product.

Validation Procedure of control Hazards at following steps:

Processing StepsHazardControl measuresMonitoring Procedures
Raw Material ReceiptBIOLOGICAL 

Pathogenic and Fungal contaminants can occur

1.      Cleaning and sanitization shall be performed twice a day.

2.      Personal hygiene test of all employees engage in the warehouse.

3.      Environment monitoring weekly basis.

4.      Pest control of receiving area.

To collect the sample and analyzed it in In-house QC labs and Another testing from an External laboratory.

 

Pest control shall be performed by third Party

CHEMICAL

Heavy Metals

1.      All the material shall be de-dust before receiving.

2.      Material shall be accepted only approved vendor as per approved specification.

3.      All the received material shall be analyzed for Chemical test

Inspect delivery vehicles, drivers. Visual Inspection (e.g. monitoring labels of incoming material to ensure that they come from an approved vendor and are according to specification).To collect the sample and analyzed it in In-house QC labs and Another testing from an External laboratory.
PHYSICAL
Extraneous Matters
Temp < 25
RH 45
All the material received and stored as per predefined limit i.e.

Temperature – NMT 15° C to 25° C & RH Limit NMT 35% to 65 %. for Empty Hard gelatin capsule Store. Temperature – NMT 25° C & RH Limit NMT 45% in all other storage areas.

Supervise the storage practices. Visual inspection of packages. Check & record temperature and humidity in storage in the morning and evening.
RM DispensingBIOLOGICAL  Microbial contamination from either personnel or environment can contaminate the RMCleaning and sanitization shall be performed twice a day.

Personal hygiene test of all employ engage in the warehouse.

Environment monitoring weekly basis.Pest control of receiving area.

To collect the sample and analyzed it in In-house QC labs and Another testing from an external laboratory.

To collect the personal hygiene sample and analyzed in In-house QC labs.

Pest control shall be performed by third Party

CHEMICAL

Heavy Metals

All the received material shall be analyzed for Chemical testTo collect the sample and analyzed it in In-house QC labs and Another testing from an external laboratory.
PHYSICAL: Temp, RH, Physical lumpsAll the materials dispense in Control Temperature – NMT 25° C & RH Limit NMT 45% in all other storage areas.Check & record of temperature and humidity in storage in the morning and evening.
Powder MixingEnteric pathogens in water (water used for cleaning of equipment) increase the microbial load of the product through equipment. Presence of foreign objects in product.Only purified water should be used for cleaning of equipment (obtained from water main supply)Visual inspection of water. Microbiological analysis of water main periodically.

 

Cross-contamination by infected material handlers.

Cross-contamination from unhygienic equipment, utensils, etc.

All cuts and unwanted openings must be completely covered by a suitable cover, and all the equipment and utility shall be verified visually and analyzed by QC for example. Swab sample analysisSupervise the practices. Inspect cleaning schedules and monitor cleaning procedures.To collect the Swab sample analysis and analyses in In-house QC
Cross-contamination of raw materials due to unhygienic practice/ utensils. Pathogenic growth.Hygienic performance, clean equipment/utensils. The material should be handled as little as possible.

Always wear gloves during handling of material, do not touch any material with the naked hand

Monitor the practices specified in the control measure category. Supervise the practices. Check the temperature records. Training shall be performed for all Personal engage in Powder Mixing. To collect the personal hygiene sample and analyzed it in In-house QC labs.
Capsule FillingPotential contamination from the environment or as a result of improper handling.Ensure hygienic practice, ensuring required time and temperature have been achieved prior to filling.

Always wear gloves during handling of material, do not touch any material with the naked hand

The temperature is measured before filling. Inspect cleaning schedules.

To collect the personal hygiene sample and analyzed it in In-house QC labs.

 

Sampling Plan of control Hazards at following steps

Process StepCCPJustificationCritical Limit
Raw Material ReceiptGrowth of PathogenMicrobial growth in RM that are suited for itTemperature NMT 25C and RH NMT45 % Total Bacterial Count: NMT 103  CFU/gm
Total Yeast/Mold : 102 CFU/gm
Specified Pathogens (S. Aureus, E.Coli, Salmonella, P. Aeriginusa): Absent
Fungal ToxinsHarmful to human health. The last stage n process to eliminate /reduceAflatoxin B1: Absent

Alfatoxin B2: Absent

Aflatoxin G1 : Absent

Aflatoxin G2 : Absent

Heavy Metal ContentHarmful to human health. The last stage n process to eliminate /reduceArsenic: NMT 5 ppm

Mercury: NMT 5 ppm

Lead: NMT 5 ppm
Cadmium: NMT 5 ppm

RM DispensingGrowth of PathogenHarmful to human health. Prevent the introduction of contamination at this stageTemperature NMT 25C and RH NMT 45 % Area free from pests
Powder MixingGrowth of PathogenHarmful to human health. Prevent the introduction of contamination at this stageTemperature NMT 25C and RH NMT 45 % Area free from pests Ensure PPG
Physical ImpuritiesExtraneous materials like bands, staples, fiber, etc. Need to eliminate as this is the last stage to reduce/prevent this hazardSifting 100% of all materials through a sifter machine with 40 mesh sieve size
Capsule FillingGrowth of PathogenHarmful to human health. Prevent the introduction of contamination at this stageTemperature NMT 25C and RH NMT 45 %  Area free from pests. Ensure PPG

 

Process stepTesting Parameter & Frequency of Testing  In-House/ ExternalTesting method (Standard reference/ SOPs reference
RM receiving & StorageDuring receiving of material and Storage of material in warehouse, following the test need to evaluate

1. Biological
Presence of  fungal or bacterial contamination

2. Chemical

3. Physical (Extraneous matter)

Micro testing in In-house QC  labs and Other testing from External laboratoryIn-house, STPs & Specification have been developed that meet and/or exceed FSSAI Norms
Effectiveness of  Cleaning of Dispensing area and storage area

following test need to evaluate

1. Area Monitoring Presence of  fungal or bacterial contamination by Plate expose in area

Micro testing in In-house QC  labsIn-house STPs & Specification have been developed that meet and/or exceed FSSAI Norms
Effectiveness of  Personal Hygiene activity in dispensing and store area

1. Personal Hygiene Test for Presence of  fungal or bacterial contamination

Micro testing in In-house QC  labsIn-house STPs & Specification have been developed that meet and/or exceed FSSAI Norms
Calibration of all devices used for the recording of Data – like Balance, HygrometerExternal Laboratory and Weight & measure departmentAs per Metrology regulation
DispensingDuring Dispensing of material and issuance of material in manufacturing, following the test need to evaluate 

 Physical (Extraneous matter)

Micro testing in In-house QC  labs and Other testing from External laboratoryIn-house STPs & Specification have been developed that meet and/or exceed FSSAI Norms
Effectiveness of  Cleaning of Dispensing area and storage area following test need to evaluate

1. Area Monitoring Presence of  fungal or bacterial contamination by Plate expose in area

Micro testing in In-house QC  labsIn-house STPs & Specification have been developed that meet and/or exceed FSSAI Norms
Effectiveness of  Personal Hygiene activity in dispensing and store area

1. Personal Hygiene Test for Presence of  fungal or bacterial contamination

Micro testing in In-house QC  labsIn-house STPs & Specification have been developed that meet and/or exceed FSSAI Norms
Calibration of all devices used for the recording of Data – like Balance, HygrometerExternal Laboratory and Weight & measure departmentAs per Metrology regulation
Powder MixingDuring mixing of Powder and Storage of material in manufacturing, following test, need to evaluate

Physical (Extraneous matter)

2. Chemical

 

Micro testing in In-house QC  labs and Other testing from External laboratoryIn-house STPs & Specification have been developed that meet and/or exceed FSSAI Norms
Capsule FillingDuring Capsule Filling and Storage of material in warehouse, following the test need to evaluate

 Physical (Extraneous matter)

2. Chemical

Micro testing in In-house QC  labsIn-house STPs & specifications have been developed that meet and/or exceed FSSAI Norms.
Calibration of all devices used for the recording of Data – like Balance, HygrometerExternal Laboratory and Weight & measure departmentAs per Metrology regulation
Finished

products

Every batchIn-house as well as External LabMLT/Pathogen Testing- In-house. As per IP.

Exceeding IP Standards for weight variation and uniformity of weight.

Exceeding  FSSAI Norms for Aflatoxin and Heavy Metals presence

 TEST DATA DETAILS:

Processing StepsHazardMonitoring ProceduresTest Results
Raw Material ReceiptBIOLOGICAL 

Pathogenic and Fungal contaminants can occur.

To collect the sample and analyzed it in In-house QC labs and Other testing from External laboratory.

Pest control shall be performed by third Party

Satisfactory and report attached.
CHEMICAL

Heavy Metals

Inspect delivery vehicles, drivers.

Visual Inspection (e.g. monitoring labels of incoming material to ensure that they come from an approved vendor and are according to specification).

To collect the sample and analyzed it in In-house QC labs and Other testing from External laboratory.

Satisfactory and report attached.

 

PHYSICAL
Extraneous Matters
Temp < 25
RH 45
Supervise the storage practices. Visual inspection of packages. Check & record temperature and humidity in storage in the morning and evening.Satisfactory and report attached.

 

RM DispensingBIOLOGICAL  Microbial contamination from either personnel or the environment can contaminate the RMTo collect the sample and analyzed it in In-house QC labs and Other testing from External laboratory.

To collect the personal hygiene and area monitoring test report and analyzed it in In-house QC labs.

Pest control shall be performed by third Party

Satisfactory and report attached.

 

CHEMICAL 

Heavy Metals

To collect the sample and analyzed it from the External laboratory.Satisfactory and report attached.
PHYSICAL: Temp, RH, Physical lumpsCheck & record temperature and humidity in storage in the morning and evening.Satisfactory and report attached.
Powder MixingEnteric pathogens in water (water used for cleaning of equipment) increase the microbial load of the product through equipment. Presence of foreign objects in product.Visual inspection of water. Microbiological analysis of water periodically.Satisfactory and report attached.
Cross-contamination by infected material handlers.

Cross-contamination from unhygienic equipment, utensils, etc.

Supervise the practices. Inspect cleaning schedules and monitor cleaning procedures.

To collect the Swab sample analysis and analyses in In-house QC

Satisfactory and report attached.
Cross-contamination of raw materials due to unhygienic practice/ utensils. Pathogenic growth.Monitor the practices specified in the control measure category. Supervise the practices.

Check the temperature records.

Training shall be performed for all Personal engage in Powder Mixing.

To collect the personal hygiene and area monitoring test report and analyzed it in In-house QC labs.

Satisfactory and report attached.
Capsule FillingPotential contamination from the environment or as a result of improper handling.The temperature is measured before filling. Inspect cleaning schedules.

To collect the personal hygiene and area monitoring test report and analyzed it in In-house QC labs.

Satisfactory and report attached.

 Conclusion and recommendation:

HACCP validation has been performed as per predefined procedure and analyzed all the validation samples as per pre-defined parameters and found that all the test results meet with the specification.

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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