FAQ

Food manufacturing for distribution or exportation is subjected under various rules and regulations from the manufacturing process to product quality and standard. Before making an investment decision, for the efficient and effective planning and management, the manufacturers must be aware of the following:

• Food categorization: which category does the product fall into under the regulations
• Regulators: there are several regulators on food quality and standard such as Food and Drug Administration (FDA), National Bureau of Agricultural Commodity and Food Standards (ACFS), Department of Fisheries (DOF), Department of Livestock Development (DLD), etc.
• Special requirement: some foods require special permit in order to be able to process or manufacture and are regulated under several regulators. It is necessary that the rules and regulation for each specific food is observed and abided by. Furthermore, regulations on product naming, labelling and advertisement should also be practiced accordingly.

Specifically regulated plants are plants that the Department of Agriculture, Ministry of Agriculture and Cooperatives require that microbiological testing and testing for substances that are harmful to human. The list of specifically regulated plants, countries and testing requirement can be found at Department of Agriculture or from our customer service.

AMARC is appointed designated laboratory for specifically regulated plants for exportation by the Department of Agriculture, Ministry of Agriculture and Cooperatives since July 2018. Currently, over 14,000 samples and 80,000 tests for fruit and vegetable for exportation has been performed annually.

Filths in food and products are contaminants that do not constitute part of product and can be harmful to consumers. The source of filths could be from unsanitary production, storage and distribution processes. There are 2 types of filths in food and products:

• Heavy Filth is filth with comparatively heavy weight which can be separated from subject via precipitation such as excrements from insects and rodents, and soil and sand.
• Light Filth is filth with light weight which can be separated from subject such as insects, parts of insects and animal feathers.

Filth in food and products could be harmful to consumer causing unfavorable symptoms and allergy. Therefore, food and products should be tested for filth.

Allergen is a substance that cause allergic reaction causing allergy to those sensitive to that substance but not to others. Allergens can be found in air, dust as well as food and drugs. Symptoms vary and depend on type of substance as well as individuals. For example: sneezing, shortness of breath, itching, rash, swollen lips, watering eye, runny nose, blocked nose, vomiting, diarhoea, anaphylaxis etc.

Currently, the Food and Drug Administration (FDA) requires that all food factories, subcontractors and original equipment manufacturers (OEM) included, must be accredited with Good Manufacturing Practice: GMP in order to uplift the quality and standard of food.

Food manufacturers and OEM must understand and adopt GMP and HACCP into their process, and with especial care for allergen, as follows:

• The business must have a system to detect allergen in raw materials.
• Food manufacturers must have an inspection process to ensure that within the manufacturing process there is no contamination of allergen from the previous processes.

1. GMOs process is used in solving problems and eliminating downsides of agriculture or livestock products as well as enhacing distinctive features of the products. This causes the GMOs product to have lower costs and more health benefits. Although genetic modification contributes to the growth of the agriculture and food industries; health organizations all over the world and a significant number of people are concerned that the GMOs products may cause a negative impact on health and environment.
2. DNA testing ensures authenticy and purity of food, for example, porcine DNA testing in food product is requisite for Halal food testing. The purposes of DNA and GMOs testing include:

• reducing consumer’s health concern
• complying with import and export rules and regulations
• increasing market competitiveness

AMARC report of analysis complies with ISO/IEC 17025 for maximum benefits from the report. The utilized test method has been through validation process for accuracy. The necessary results reported are provided for international usability e.g.

• Specificity
• Limit of Detection, which is specificed by the Limit of Detection: LOD* and the Limit of Quantitation: LOQ**
• Linearity

Regarding “Not Detected” and “< LOQ (Less than LOQ)”:

• Not Detected means that the subject of interest is found to be less than LOD or is not detected.
• < LOQ (Less than LOQ) means that the subject of interest is found to be more than LOD but less than LOQ.

*LOD is the lowest concentration of the test parameter within the sample that the test method can detect.
**LOQ is the lowest concentration of the test parameter within the sample subject that the test method can detect with the confidence of 95%. At this concentration, the result can be reported in quantity with accuracy.

AMARC provides Rapid Test for the following microbes:

• Salmonella spp. using 3M Molecular Detection System technique
• Coliform using Petrifilm technique
• Escherichia coli using Petrifilm technique
• Yeast and Mold Count using Petrifilm technique

AMARC provides product shelf-life testing for the products intended for room-temperatured storage. Please provide sample in original package intended for retailing and other related information such as ingredients, packaging, sterilization method, net weight, intended shelf-life as well as irregularities found that may cause consumer’s rejection. For chilled products, microbiological testing is used as a basis for shelf-life calculation.

AMARC provides physical, physics and chemical testing services per standards and regulations for the following test subjects:

• Food contaminants: heavy metals (Cadmium, Tin, Lead, Mercury and Arsenic), mycotoxin (Aflatoxin M1, Total Aflatoxin, Deoxynivalenol: DON, Ochratoxin A), etc.
• Food additives: color, preservative, antioxidant, sweetner, etc.
• Nutrition (Protein, Carbohydrate, Fat, Vitamin) and Nutrition Labelling (Thai, America, Europe, China, Japan, etc.)
• Quality control or chemical standard of food according to the Notification of the Ministry of Public Health to register with the Food and Drug Administration
• Heavy metals and minerals in food and feed
• Carcinogens: 3MCPD, PCBs, PAHs, etc.
• Residues: veterinary drug residue, pesticide residue in food and water, etc.

AMARC provide filth testing service according to AOAC standard. For example: filth in cereals and cereal products, and filth in sugar, chili flakes, chili paste and herbs. Additionally, AMARC also filth testing using macroscopic and microscopic analysis in foreign matter sample, biological identity by histology method and parasite testing in muscles.

AMARC’s molecular laboratory provides the following services:

• GMOs testing: food, soy, rice, maize, feed, etc.
• DNA testing: pork, chicken, meat, etc.
• Allergen testing: wheat, egg, peanut, soy, fish, milk, shrimp, etc.
• Genetic material of SARS-CoV-2 (COVID-19) testing in food and food contact meterials
• Specific plant gene testing: soy (Lectin gene), maize (Zein gene), rice (PLD), etc.
• GMOs Identification: Roundup Ready Soybean (EPSPS gene)

MPN Technique is used. It is a method for detecting the quantity of microbe using statistic estimation.

It is done by diluting the samples to selected dilutions and then put each diluted in the liquid media tubes, 3 per each dilutions, according to the standard. Incubate per specific time and temperature. Read the result per the MPN table (Most Probable Number) and report the result in the MPN unit such as MPN/g and MPN/ml.

For the following test result, Escherichia coli may or may not be found as it belongs to the Coliform group of bacteria. The Coliform bacteria include:

• Escherichia
• Citrobacter
• Enterobacter
• Hafnia
• Klebsiella
• Serratia

It means “not detected.” This result reported is per standard of international reporting methodology.

0.1 g unit provides more accurate result than 0.01 g unit. As the 0.1 g unit has a sample dilution of 0.1 g which is less than the 0.01 g unit that has a sample dilution of 0.01 g, therefore the 0.1 g unit can detect microbe better than than the 0.01 g unit.

• Department of Medical Sciences (DMSC)
  
• Department of Science Service (DSS)
  

• Department of Livestock Development (DLD)
•  National Bureau of Agricultural Commodity and Food Standards (ACFS)
  

AMARC is the only private laboratory in Thailand with pharmaceutical testing service. Our testing services include testing for raw materials and products whether modern drugs, traditional drugs or herbal drugs.

Please see modern drug testing service list at Pharmaceutical

AMARC provides bioequivalence study service. Our clients include local and international manufacturers.

AMARC provides method development and validation services per USP and BP standards as well as the client’s method. Please contact us for more information.

Please see the service list for traditional and herbal drugs testing at Pharmaceutical.

• Thai Herbal Pharmacopoeia (THP)
• The United States Pharmacopoeia (USP)
• Association of Official Agricultural Chemists (AOAC Internationals)

The Department of Medical Science mandates that cannabis, cannabis oil and health products containing cannabis such as food, drinks and cosmetics be tested for CBD and THC as well as tested according to the regulations of each product group.

• Department of Medical Sciences (DMSC)
• Department of Science Service (DSS)

Agricultural production factors include soil, water, fertilizer and agrochemicals. They are vital to agriculture for farmers selecting the right land and water source, applying fertilizer correctly, and using pesticide to control pest at the right amount upon necessity will minimize cost and maximize production.

The purpose of agricultural production factor testing includes:

• For farmers to manage and utilize agricultural production factors. For example, water and soil quality testing before farming will help in selecting the right crops and improving soil quality, which can result from previous farming. Utilizing the right fertilizer according to soil conditioning method will help preparing soil for the selected crops, simultaneously reducing cost and increasing production.
• For fertilizer manufacturer, distributor, importer and exporter to register fertilizer. AMARC’s report of analysis can be used in fertilizer registration with Department of Agriculture.
• For manufacturer and importer of fertilizer and agrochemical to control quality.

Please see available service list at Agricultural Production Factor.

• Department of Medical Sciences (DMSC)
• Department of Agriculture (DOA)

AMARC provides physical, physics and chemical testing services per standards and regulations for the following test subjects:

• Water analysis: drinking water, process water, ice, water steam in food manufacturing contact process and waste water, etc.
• Residues: veterinary drug residue in food, agrochemical residue in food and water, etc.

Please see soil and water test service list in Environment.

• Department of Medical Sciences (DMSC)
• Department of Science Service (DSS)

• Department of Industrial Works 

AMARC provides pick-up and delivery service for calibration items. Please contact our customer service for more information.

Evaluation can be done using Correction ± Uncertainty. For example, provided that the tolerance is ±1ºC, (Correction + Uncertainty) = 0.2 + 0.39 = 0.59 ºC and (Correction – Uncertainty) = 0.2 – 0.39 = -0.19 ºC.
If the value is within ± 1ºC, the result is “pass”; if the value is not within ±1ºC, the result is “fail.”

Apply correction value by combining it with the measured result.

For room-temperature measurement, select 2-3 calibration points each for temperature and humidity to cover usage points.

• Consider if the tolerance is appropriate or not.
• Readjust or modify the device.

It is recommended that thermometer with sensor with higher accuracy than that of the chamber be installed at the middle of the chamber.

From the calibration result, use the measured temperature (ºC) at spread location #1, #2, #3, #4, #5, #6, #7, #8, #9 ± uncertainty; if the result of any location is within the tolerance, the result is “pass,” if the result exceeds the tolerance, the result is “fail” and that point cannot be used. Inform the responsible and related personnel not to use the point.
For example, if measured temperature (ºC) at spread location ± uncertainty is within the tolerance, this result is “pass” and the point can be used.
Given the tolerance 45 ±3ºC i.e. 45+3 = 48 and 45-3 = 42. This means that the measured temperature (ºC) at spread location must be within 42 and 48. E.g. (location+uncertainty) = 45.30+1.02 = 46.32 ºC and (location-uncertainty) 45.30-1.02 = 44.28 ºC; the results are within 42 and 48, the results are “pass.”

Objects must be removed from the chamber as the objects hinder air circulation and absorb temperature causing the measurement to be inaccurate.

Adjust the room temperature to be lower than the calibration temperature at least 5 ºC. For example, for the temperature calibration at 30 ºC, the room tempertature should be equal to or lower than 25 ºC.

Distilled water or reverse osmosis water should be used to reduce limescale in the autoclave machine.

Consider Calibration and Measurement Capability (CMC) of the calibration laboratory. The CMC should be within 1/3 of the tolerance.

Volumetric glassware that do not pass the tolerance can still be used by reclassing the glassware: from Class A to Class B and from Class B to usage that does not require high accuracy.

The recommendation from Thai Industrial Standards Institute (TISI), is:

• Class A glassware – random at 10%
• Class B glassware – 100%

Verifying or calibrating volumetric glassware using balance as standard. In choosing the standard, the accuracy must be more than the calibrated subject at least 3 to 10 times. E.g. flask with tolerance ± 0.1mL, the balance should have an accuracy of 0.01 g or reading digit of 0.01g

In evaluating the 3 equipments, ISO/IEC 8655 is used by referring to the systematic error and random error with the table in the ISO/IEC 8655.

ISO/IEC 8655 requires calibration at 10%, 50% and 100% of nominal volume (e.g. if the volume is 10-100 µl, the nominal volume is 100 µl). Clients can also select the calibration points that are frequently used.

Aging tools and deviced could be due to deterioration from usage and misuage. Pipetting corrosive substances can cause O-ring deterioration, which should be replaced. Preventive maintenance should be performed at least every 6 months to ensure readiness for usage.

• Electrode might not be clean or have oil stain at the tip of the probe. Clean electrode with electrode washing liquid or soaking in warm water for 30 minutes before trying again.
• If in reading the measurement, the result is not stable, leave the subject at room temperature until the result is stable and them remeasures. Temperature of the subject affects the pH and conductivity.

Electrode of pH meter should be replaced if after the verification or calibration, the %Slope is less than 95% or more than 105% or the measurement does not match the buffer standard of the manufacturing specification.

Please see reference standard document for test method. If not, there is one reference for pharmaceutical teting which is USP; it indicates that after verfication or calibration, the result must be within ±0.05 pH and %slope 90-105 (2018 USPC Official 5/1/17 – 7/31/17 General Chapters: <791> pH).

Balance should be calibrated at least once a year to ensure accuracy and adjust the balance in case of error.

1. Table and surface
The table and surface for balance and balance stand must be stable and strong and must not vibrate or be magnetic. For example, marble or granite slab with a thickness at least 40 mm. Wood board should not be used for its risk of bending and metal board for its magnetic quality.
2. Balance Room
The balance room should situated in a non-vibrating location which could be from machine being operated or from traffic. The floor of the room should be smooth concrete surface without wood flooring and carpentry. There should be no carpet, blinds and curtains as to reduce dust being accumulated as well as for cleaning convenience.

• There should be only one entrance-exit to reduce windflaw and dust.· Window should be minimal to reduce sunlight exposure and heat from outside.
• If the room is air-conditioned, the airflow direction should be adjusted not to go to the balance.
• The location of the balance should not receive direct sunlight as it will cause heat and results in measurement error. Lighting within the room also should be away from the balance to reduce the impact of heat from the light bulb

3. Temperature
Temperature within the balance room should be stable. Any increase or decrease of temperature during its usage could cause an error of 1-2 ppm per Celsius.
4. Humidity
The recommended humidity within the balance room should be between 45% to 60%. During usage, there should not be any sudden change that may impact the result of sensitive balance.
5. Air
Surrounding airflow is a hindrance to balance operation. Therefore, the balance should not be placed near air conditioner or a machine or devices with fan.
6. Electric field and electro-magnetic field
The intended location for electronic balance should be inspected for disturbance and error that may be stemmed from electric field and electro-magnetic field. User should be aware of signal disturbance from operation of devices within the nearby area such as electrical induction oven and switching on-off of machine, oven, incinerator or other devices that generate heat might create electrical signal through electric line within the area. Mobile phone and communication radio might also create signal disturbance and cause change in the measurement displayed.

Tolerance for weight refers to the internation standard OIML R111-1.

In calibrating weight, the reference document use is the internation standard OIML R111-1.

• Standard weights should be kept in box or container made from wood or plastic to protect the standard weights from dust and humidity. Standard weights should be kept in dense electro-magnetic field.
• Standard weights should be kept clean. They must not be touched bare-handed; use pick-up tools, gloves and forceps in handling the weights. The point touching the weights should be made from or covered with materials that do not scratch or damage the weights such as plastic, leather or cotton.
• Be careful not to drop the standard weights.
• Surface for placing the standard weights on must be clean, smooth or soft to product the weight from dirt or scratch.
• To prevent the standard weights from wearing, in moving standard weights on the plate, use pick-up and place-down movement. Do not drag or slide.

Medical devices and tools should be routinely check at least once a year similar to other tools and equipment. Maintenance will ensure readiness for usage.

General check-up includes external check through visual check, check for sound notification, and functioning display; measurement testing in the low, medium and high range to ensure that the measurement is within the tolerance; and issuing Certificate of Calibration. The standard used is by the Emergency Care Research Institute: ECRI.

Devices that are not used frequently should also be checked and maintained to ensure measurement accuracy.

Devices that are used frequently should be checked and maintained more frequently than those infrequently used. Devices can thus be categorized by risk as:
· High-risked devices
· Medium-risked devices
· Low-risked devices

Our medical device team will attach a sticker indicating the calibration status, dates of current and next testing and maintenance, device code and report number for clients’ convenience.

Preliminary, please inform the medical device maintenance team to examine the devices. Should any corrective measures cannot be applied, the devices should not be used and the need for a replacement might arise.

Some tools and devices require the accessories from the same brand of the tools and devices to be able to provide accurate measurement.

AMARC is ISO/IEC 17025 accredited for medical devices calibration in the following scope: mechanical and automated sphygmomanometers.

• Thai Industrial Standards Institute (TISI)
• Department of Medical Sciences (DMSC)
  

Please see Inspection & Certification

Gaining trust and recognition whether for value increase, selling through modern trade or exportation.

1-2 days depending on workplace size

Should the nonconformity not be rectified within specified timeline, the certificate will not be granted and the inspection and certification process must be reinitiated.

45 working days

• GAP, GMP, GHPs and HACCP: 3 years
• Organic: transition period certificate of 1 year for the initial audit, and 1 year for the organic certification

After certification, an annual surveillance throughout the the certification period is required. Should the surveillance be denied, the certification would be invalid due to regulation nonconformity.

Submission for recertification should be made at least 180 days before the certificate expiration.

• Good Agriculture Practice: GAP
  • TAS 1000-2003 : good agricultural practices for Longans
  • TAS 1001-2008 : Good Agricultural Practices for Aromatic Coconut
  • TAS 2500-2005 : Good agricultural practices for Asparagus
  • TAS 2501-2005 : Good agricultural practices for Okra
  • TAS 2503-2007 : Good agricultural practices for Baby Corn
  • TAS 3502-2018 : Good Agricultural Practices for Herbs
  • TAS 4400-2009 : Good Agricultural Practices for Thai Hom Mali Rice
  • TAS 4401-2008 : Good Agricultural Practices for Rice
  • TAS 4402-2010 : Good Agricultural Practices for Maize
  • TAS 5901-2010 : Good Agricultural Practices for Cassava
  • TAS 5902-2010 : Good Agricultural Practices for Sugarcane
  • TAS 9001-2013 : Good Agricultural Practices for Food Crop
• Organic
  • TAS 9000-2021 : Good Agricultural Practice Standards for Food Crops

• TAS 7401-2023  : Good Aquaculture Practices for Marine Shrimp Farm
• TAS 7417-2016 : Good Aquaculture Practices for Freshwater Animal Farm
• TAS 7421-2018 : Good Aquaculture Practices for Freshwater Animal Hatchery and Nursery
• TAS 7422-2018 : Good Aquaculture Practices for Marine Shrimp Hatchery and Nursery
• TAS 7426-2012 : Good aquaculture practices for Ornamental Freshwater Animals Farm
• TAS 7429-2016 : Good Aquaculture Practices for Marine Finfish Farm
• TAS 7436-2020 : Good Aquaculture Practices for Food-Aquatic Animal Farm
• TAS 7438-2023 : Good aquaculture practices for Food-Aquatic Animals Hatcherry and Nursery
• Good Aquaculture Practices (GAP) for Aquatic animal Hatcheries and Nursery, and Aquatic animal Culture Farm B.E.2553, Department of Fisheries (Marine Shrimp and Freshwater Animal)

• TAS 1004-2014 : Code of Practice for Sulphur Dioxide Fumigation of Fresh Fruits
• TAS 4403-2010 : Good Manufacturing Practices for Rice Mill
• TAS 6401-2015 : Good Manufacturing Practices for Milk Collection Center
• TAS 7420-2009 : Good Hygienic Practices for Pre-processing of Fishery Products
• TAS 9023-2007 : Code of Practice : General Principles of Food Hygiene
• TAS 9024-2007 : Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for Its Application
• TAS 9035-2010 : Good Manufacturing Practices for Packing House of Fresh Fruits and Vegetables
• TAS 9039-2013 : Good Manufacturing Practices for Ready-to-Eat Fresh Pre-cut Fruits and Vegetables
• TAS 9041-2014 : Code of Practice for The Manufacturing of Frozen Agricultural Commodities
• TAS 9046-2017 : Good Manufacturing Practices for Frozen Durian
• TAS 9047-2017 : Good Manufacturing Practices for Collecting House of Fresh Fruits and Vegetables
• The General Principles of Food Hygiene : Good Hygiene Practices (GHPs) and the Hazard Analysis and Critical Control Point (HACCP) System (CXC 1-1969), Revised in 2020

• Carbon Footprint
• General manufacturing industries (in progress)
• Agriculture, forestry and other land use (AFOLU) (in progress)
• General service industries (in progress)
• Tourism Standard
• Diving Standard for Tourism (in progress)
• Accommodation Standard for Tourism (Resort): 1-4 Stars (in progress)

It is necessary for laboratory to continuously improve its process through the analysis and synthesis of data in pursuit of opportunity for improvement and in determining improvement plan. Laboratory can continuously improve the efficacy of its management system through: quality policy, quality purposes, quality control through data analysis, correction measures, preventive measures and process revisions.

To ensure that the laboratory process and management comply with international stanards and increase academic competency and competitiveness.

AMARC provides laboratory auditing services per ISO/IEC 17025:2017 both chemical and microbiological laboratories.

• Internal quality control: sample blank, QC sample, and internal control
• External quality control: interlab comparison, and proficiency test provider

• ISO/IEC 17025:2017
• Quality Assurrance document preparation per ISO/IEC 17025
• Method of Validation
• Uncertainty of Measurement
• Internal quality control
• Testing quality control
• Tools and equipment management per ISO/IEC 17025
• Understanding and interpreting calibration report

Training and workshop on food safety testing process by a team of experts, both internal and external.