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GMP Audit Checklist for Food Safety

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0% found this document useful (0 votes)
99 views7 pages

GMP Audit Checklist for Food Safety

Uploaded by

Ali Raza
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

GMP Audit Checklist

for Food Production


Use this GMP audit checklist to help your team conduct internal audits and
ensure you're maintaining Good Manufacturing Practices compliance.

Regulatory requirements
The facility possesses an FDA registration number.

A food traceability system is implemented to track products from their entry to exit,
whether in their original state or as a part of another product.

Initial and annual mock recall exercises are conducted, thoroughly documented, and
proven effective.

Food safety plan


The facility maintains a comprehensive and documented food safety plan.

One or more qualified individuals are designated to oversee and administer the food
safety plan.

Records of food safety plan compliance, including daily, weekly, or monthly


inspections, are maintained on site.

Personnel qualifications and trainings


Documentation of personnel qualifications and training records is kept current
and well-maintained.

Every employee is either a qualified individual or is under the supervision of one.

All personnel receive documented annual training in food hygiene and safety relevant
to their specific roles.

Supervisory staff are specifically tasked with overseeing the GMP practices of their
subordinates.

Personal Hygiene
A Personnel Hygiene Policy (PHP) is established, enforced, and documented,
applicable to all staff and visitors.

The PHP covers essential personal hygiene practices, including clothing and footwear
requirements.

The PHP specifies the types of uniforms and personal protective equipment (PPE)
required for different roles, along with their maintenance and usage conditions.

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GMP Audit Checklist
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Use this GMP audit checklist to help your team conduct internal audits and
ensure you're maintaining Good Manufacturing Practices compliance.

The PHP details guidelines on handwashing, the use of nail polish, and hair containment.

The PHP outlines rules for storing personal items and clothing, as well as restrictions
on wearing jewelry.

The PHP contains regulations on eating, drinking, smoking, vaping, and similar
activities on premises.

The PHP addresses the prevention of allergen cross-contamination in relation to


personnel hygiene.

The PHP includes procedures for reporting, managing, and cleaning contamination
incidents involving blood or bodily fluids in food or production areas.

The PHP establishes protocols for employees to report illnesses.

The PHP stipulates conditions under which sick employees are restricted from
production areas until it is safe for them to resume specific duties.

The PHP sets forth guidelines for first aid, including the management of open lesions,
infected wounds, boils, and similar injuries.

Supply chain

A procedure is documented and maintained for the appropriate receiving and storage
of raw materials and ingredients.

Processes and Controls


All operations adhere to comprehensive sanitation principles and practices.

Quality control protocols are established, executed, and upheld to ensure the safety
and suitability of food and packaging materials.

One or more qualified individuals are tasked with overseeing facility sanitation.

A system, such as color-coded equipment, is in place and maintained to prevent


allergen cross-contamination.

Procedures for testing to detect sanitation, allergen, or other food contamination


issues are documented and followed as needed.

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ensure you're maintaining Good Manufacturing Practices compliance.

Documented controls are in place to ensure that contaminated food is rejected, treated,
or processed to eliminate contaminants.

A documented system for inspecting, handling, segregating, and storing raw materials is maintained.

Procedures are documented for washing or cleaning raw materials used in food
production to remove contaminants.

Water used in food contact processes, such as washing or rinsing, is safe and, if
treated, is regularly monitored to ensure quality.

Procedures are documented for identifying raw materials that require treatments
such as pasteurization, along with the treatment processes themselves.

Control measures and identification protocols are documented for raw materials
susceptible to aflatoxins or other natural toxins.

Control measures and identification protocols are in place for raw materials at risk of
contamination with pests, undesirable microorganisms, or extraneous materials.

Raw materials, ingredients, and rework are stored in suitable containers under
appropriate temperature and humidity conditions.

All food-related activities, including storage, processing, and packaging, are


conducted to minimize risks of contamination, spoilage, or deterioration.

Measures such as sterilization, irradiation, and pasteurization are documented and


implemented to destroy or inhibit microorganisms.

Procedures are in place to protect against contamination from the use of equipment,
containers, utensils, or tools.

Protocols are established to prevent contamination from metal or other extraneous materials.

Procedures for disposing of or reconditioning adulterated food or materials are


documented to prevent further contamination.

All food and ingredient preparation must comply with best practices to prevent
contamination.

Food is safeguarded against contaminants that might drip, drain, or be drawn into it.

Heat blanching processes are properly documented, and records of routine


equipment sterilization are maintained.

Food preparations such as batters and gravies are managed to prevent contamination
and microbial proliferation.

Food preparation procedures are designed to avoid contamination and prevent


microbial spread.

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Use this GMP audit checklist to help your team conduct internal audits and
ensure you're maintaining Good Manufacturing Practices compliance.

Controls to prevent contamination and manage microorganisms in dry mixes, nuts, and
other ingredients dependent on water activity control are in place and documented.

Measures to maintain the pH of acid and acidified foods at 4.6 or below are
implemented and monitored.

Ice used in food production is sourced from water that meets safety standards.

Defect Action
Documentation is maintained for defect action controls as necessary.

Quality control operations are carried out to minimize potential defects, with thorough
documentation and record-keeping of their implementation.

Protocols are in place to prevent defective food from contaminating uncontaminated food.

Equipment and Utensils


All equipment and utensils should be made from materials that can withstand
repeated and thorough sanitation, cleaning, and maintenance.

Equipment and utensils must be utilized in a manner that prevents the adulteration or
contamination of food.

All personnel receive documented annual training in food hygiene and safety relevant
to their specific roles.

Food-contact surfaces must be constructed from non-toxic, corrosion-resistant


materials suitable for repeated use, cleaning, and maintenance.

Food-contact surfaces should be maintained with appropriate construction details


like sanitary welds.

Non-food contact equipment within production areas must be kept in a clean and
good condition.

Equipment and systems for holding, conveying, and manufacturing must be designed
and built to enable repeated use, maintenance, cleaning, and sanitation.

Refrigeration and freezing compartments should be equipped with devices that


indicate temperature.
Instruments and controls used for measuring, regulating, or recording temperatures,
pH, and similar parameters must be accurately calibrated and maintained.

Any compressed air or gases used in food production should be filtered and free of oil.

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Use this GMP audit checklist to help your team conduct internal audits and
ensure you're maintaining Good Manufacturing Practices compliance.

Maintenance and Sanitation


Buildings, fixtures, and other facilities are meticulously maintained in a sanitary and clean state.

A documented policy for the maintenance of equipment, including its cleaning, sanitation, and
post-repair inspection, is actively implemented.

Procedures for cleaning and sanitizing are documented, ensuring methods do not lead to food
contamination or adulteration.

Cleaning and sanitizing agents are free from undesirable microorganisms and are suitable for
their intended purposes.

Chemicals are securely stored in a controlled, locked area and are clearly labeled.

An effective pest control program is documented, implemented, and maintained.

A map of pest control stations is maintained and readily accessible.

Documentation for routine maintenance and inspection of pest control equipment is available
and accessible.

Pest control device types, numbers, and placements are deemed appropriate.

The facility maintains a pest-free environment.

The use of pesticides is rigorously controlled to prevent food contamination.

All food-contact surfaces and utensils are regularly cleaned, sanitized, and the process is docu-
mented under the supervision of a competent employee.

Sanitizing and drying procedures for tools and equipment used in processing low-moisture
foods are established, implemented, and documented.

Cleaning and sanitizing procedures for tools and equipment used in wet processing are estab-
lished, implemented, and documented.

Procedures for cleaning and sanitizing food-contact surfaces are established, implemented,
and documented.
Single-service items are managed in a manner that prevents food contamination during han-
dling, storage, and disposal.

Non-food contact surfaces of equipment are cleaned and maintained properly.

Portable equipment that contacts food is kept and stored in conditions that prevent contamination.

All chemicals used within the facility are safe and appropriate for use in food production environments,
including food-grade lubricants.

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Use this GMP audit checklist to help your team conduct internal audits and
ensure you're maintaining Good Manufacturing Practices compliance.

Warehousing and Distribution


Practices for storing and transporting food are designed to prevent contamination
or adulteration and ensure suitable conditions.

Control measures are in place to inspect and document the condition of incoming goods.

Wash certificates, detailing the previous loads of tanker trucks, are available when required.

Control measures ensure that outgoing shipments of food meet appropriate


conditions and quality standards.

Packaging materials are managed in a way that prevents contamination during


storage and handling.

Retained, returned, or damaged products are segregated in a designated area and are
clearly marked.

Documented procedures are in place and followed for the correct sequence and use of
materials within their designated shelf life.

Food By-Products for Animal Food


Human food by-products for use as animal food are maintained in conditions and
equipment that avoid contamination and are regularly cleaned and maintained.

Every Human food by-products are held in a way that avoids [Link] either a
qualified individual or is under the supervision of one.

Proper labelling of human food by-products exist and are implemented.

Shipping containers and bulk transport vehicles are inspected and maintained
appropriately to avoid contamination.

Facility and Grounds


Facility design and construction is suitable for the intended use and should exhibit
properties to prevent contamination of products.

The facility grounds are maintained to avoid pest harborage including the removal of
garbage and debris.

Facility grounds are surfaced to avoid standing water, prevent dust and offensive odors.

Facility waste containers are adequate and regularly emptied, maintained, and documented.

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ensure you're maintaining Good Manufacturing Practices compliance.

The facility grounds are not affected by uncontrolled contamination risks from adjacent
properties. If a risk is identified, controls are established, implemented, and documented.

The facility has the necessary space for adequate operations, maintenance, sanitation,
and production activities.

Bulk storage vessels are constructed to avoid contamination and allow for cleaning,
sanitation, and maintenance.

Facility components including floors, doors, ceilings, walls, etc are designed to
facilitate sanitation and maintenance as required.

Adequate procedures and controls are in place to avoid overhead condensation.

Catwalks and stiles are constructed and located in a way that avoids contamination.

All areas have sufficient lighting to maintain adequate sanitary conditions and
operations.

All glass and fixtures are sufficiently protected to avoid glass contamination in case of
breakage.

Fans and air-moving equipment shall be located and adjusted to minimize


contamination.

Buildings are reasonably free of excessive dust, heat, steam, condensation, vapors,
smoke, or fumes.

Doors, windows, or openings are properly closed, sealed, or screened to avoid


contamination and pests.

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Common questions

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A comprehensive food safety plan must be well-documented, covering all aspects of compliance with Good Manufacturing Practices (GMP). It should include records of compliance through daily, weekly, or monthly inspections and designate qualified individuals to oversee and administer the plan. Procedures for allergen control, sanitation, contamination prevention, and food traceability are integral, as well as maintaining personnel hygiene policies and training. The facility must also have documented procedures for receiving and storing raw materials, ensuring that food-contact surfaces are constructed from suitable materials, and that all sanitation and cleaning processes are well-documented and adhered to .

Color-coded equipment helps in preventing allergen cross-contamination by ensuring that tools and equipment used for different allergens are visually distinct. This system minimizes the risk of accidental mixing or misidentification during production processes. By maintaining separate sets of cooking and processing equipment—distinctly marked for specific allergens—the facility can uphold stringent allergen control measures, thereby reducing the risk of contamination .

To prevent contamination or adulteration during storage and transport, mechanisms such as temperature and humidity regulation, appropriate packaging, and robust transportation procedures are employed. Facilities must ensure that shipping containers and storage areas are well-maintained and inspected regularly. Documentation of storage conditions and inspections also play a critical role in maintaining product integrity. Protocols for managing and reviewing wash certificates for tanker trucks demonstrate additional measures to ensure equipment cleanliness and prevent cross-contamination during transport .

Quality control operations contribute to minimizing potential defects by implementing thorough documentation and record-keeping of their processes. These operations involve regular inspections, testing of raw materials, and ensuring compliance with safety and quality standards. By maintaining and reviewing process documentation, facilities can identify areas where defects might occur and implement corrective actions to mitigate these risks. This systematic approach helps ensure that all food products meet the desired quality and safety criteria before reaching consumers .

An effective pest control program in a food production facility should be documented, implemented, and maintained rigorously. It should include maintaining a map of pest control stations, documentation for routine maintenance and inspection of these devices, and ensuring that device types, numbers, and placements are appropriate. The use of pesticides must be strictly controlled to avoid food contamination. Additionally, sanitation measures should ensure that buildings and fixtures are kept in a sanitary condition to prevent pest harborage .

Sanitation procedures for maintaining food-contact surfaces must include regular cleaning and sanitizing using agents free from undesirable microorganisms. The surfaces should be made from non-toxic, corrosion-resistant materials suitable for repeated use. Procedures should be documented to ensure they are followed appropriately and do not introduce any contamination or adulteration. Continuous monitoring and verification of these procedures are essential for compliance with sanitation standards, reducing potential risks of cross-contamination and maintaining hygiene .

Temperature and humidity controls are critical in warehousing and distribution as they help maintain the quality and safety of food products. These controls prevent spoilage, contamination, and deterioration of stored goods. Proper documentation and protocols ensure that raw materials and finished goods are consistently maintained under suitable conditions, thereby reducing risks of contamination throughout the handling and transportation process. These controls are essential to comply with quality standards and meet regulatory requirements .

Managing human food by-products for animal food involves ensuring that these by-products are maintained under conditions that prevent contamination. This requires regular cleaning and maintenance of equipment, accurate labeling, and adherence to safety standards that address both human and animal health concerns. The facilities must ensure that these processes are thoroughly documented and that any contamination risks are effectively managed, often requiring coordination with animal nutritionists and compliance with additional animal feed regulations .

A food traceability system is critical for tracking products from entry to exit, whether in their original state or as components of other products. Key components include documentation of all processes involving raw materials and finished goods, mock recall exercises, and comprehensive product recall processes. Traceability systems are essential to quickly identify and address contamination issues, ensuring consumer safety and regulatory compliance. They also help manage liability risks and facilitate corrective actions when necessary .

Qualifications and training are pivotal in maintaining GMP compliance as they ensure personnel are competent to perform their roles effectively. Annual training programs on food hygiene and safety tailored to specific roles, along with documented training records, help reinforce personnel awareness and accountability. Qualified supervision is necessary to oversee compliance with GMP practices, ensuring that every employee adheres to established procedures and protocols, thereby mitigating risks of contamination and non-compliance .

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