Foreign Material Control – A basic understanding

Foreign Material Control – A basic understanding

Foreign Material (FM) Control is often a source of major problem for the food industry in the US, as a good part of consumer complaints across the food industry in the country relates to FM inclusion in finished food products. This issue has been one of considerable debate too, in not only the industry, but society itself as a whole. It involves food, without which no human can survive, and hence the controversy.

What is FM?

Foreign material control has a major impact on business in the US. Detection of above permissible foreign material control has resulted in market withdrawals, meaning expensive costs for the business doing it. The controversy starts with defining what “foreign material” is in the industry’s context. It can be broadly defined as foreign objects and/or extraneous matter found in food that the consumer has not expected or has not been informed about. Not everyone is agreed on this definition of foreign material control, because there is a high level of subjectivity and interpretability over the critical terms of this definition.

Definitions in the Food, Drug and Cosmetic Act

There are various definitions of FM in the Food, Drug and Cosmetic Act:

–        402(a) (1): “a food shall be deemed to be adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to health.”

–        According to the 402(a) (3), “a food shall be deemed to be adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food.”

–        402(a) (4) details that “a food shall be deemed to be adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”

Reference:

http://www.foodsafetymagazine.com/article.asp?id=291&sub=sub1

 

Contact Detail

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

 

FDA guidance

FDA guidance

AnFDA guidance, as the title suggests, is a set of suggestions from the FDA on a number of its governing areas. The FDA, being a regulatory body sets standards for almost every conceivable area. It is almost impossible to list the number of guidances the FDA has issued.

Nonbinding in nature

Guidances are suggestions for best practices and methods, and are not a set of rules. The outstanding characteristic of FDA guidances is that they are nonbinding. The FDA website states as much: “This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.”

This note is to be found in guidances the FDA issues in every of its governing areas. As can be seen from the above explanation; guidances are open to interpretation, and the individual, group of individuals, organizations or laboratories that come under these guidances are free to offer their own perspective. They can discuss industry-specific guidances with the FDA and sort out matters whenever disagreements arise.

General areas for FDA guidance

These are the broad areas in which the FDA has issued guidances:

  • Food
  • Drugs
  • Medical Devices
  • Vaccines, Blood & Biologics
  • Animal & Veterinary             Cosmetics
  • Radiation-Emitting Products
  • Regulatory
  • Tobacco Products

References:

http://www.fda.gov/regulatoryinformation/guidances/default.htm

http://google2.fda.gov/search?site=FDAgov-Guidance-All&restrictBox=FDAgov-Guidance-All&restrictBox=FDAgov-Guidance-Food&q=&btnG=Search&client=FDAgov&output=xml_no_dtd&proxystylesheet=FDAgov-Guidance&ie=UTF-8&oe=UTF-8

 

Contact Detail

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

 

FDA guidance on process validation

FDA guidance on process validation

The FDA guidance on process validation is an important document that offers guidelines on Process Validation (PV), a critical aspect of medical device and pharmaceutical manufacturing.

In November ’08, the FDA issued a draft guideline that revised the old guidelines on PV. The FDA guidance on process validation was now the standard that replaced the FDA guidance on process validation that was in force from 1987.  FDA guidance on process validation underwent another revision in January 2011, which is now the current standard. It has altered the spirit of the earlier documents in a few ways.

January 2011 changes

  • It now gives greater emphasis to use ICH Q 8, 9 and 10;
  • The term ‘commercial manufacturing’ has come to replace the old word, ‘commercial production’. This means a significant change in the scope of the ICH.
  • The January 2011 FDA guidance on process validation has also given a slightly different definition of PV and Stage 1 and Stage 2.
  • The new FDA guidance on process validationdescribes PV as “The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”

Why did the FDA change guidelines on PV?

The FDA guidance on process validation underwent changes because it was observed during its investigations that drugs of inferior quality were being marketed even though they were manufactured under less demanding processes, which were being passed off as “validated”.

Manufacturers need to ask these:

In essence, FDA guidance on process validation requires manufacturers to ask themselves these questions:

  • Which scientific evidence I have used gives me the confidence that my process is capable of consistently and repeatedly delivering quality product?
  • Can I show that my process works as intended?
  • What are the ways by which I can know that my process has remained in control?

References:

http://www.gmp-compliance.org/eca_news_2380_6764,6864,6917,6971.html

http://www.gmp-compliance.org/eca_news_2600.html

 

Contact Detail

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

 

FDA Guidance on Analytical Method

FDA Guidance on Analytical Method

The FDA Guidance on Analytical Method describes analytical method or procedure thus: “The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc.”

Why is validation necessary?

FDA guidance on analytical method is given to ensure that validation is necessary for an analytical procedure. The purpose is to demonstrate that it is “suitable for its intended purpose”.

ICH and USP validation requirements and parameters

Apart from the FDA; the ICH and USP also have guidances on analytical methods. ICH Guideline for Industry Q2B, Validation of Analytical Procedures: Methodologydescribes the purpose of validation further. It states that “In practice, it is usually possible to design the experimental work so that the appropriatevalidation characteristics can be considered simultaneously to provide a sound, overallknowledge of the capabilities of the analytical procedure, for instance: specificity, linearity,range, accuracy and precision.”

Since these three bodies constitute the triumvirate of regulation; these are the parameters that the USP and ICH take into consideration:

USP:

–        Specificity

–        Linearity and Range

–        Accuracy

–        Precision

–        Limit of Detection

–        Limit of Quantitation

–        Ruggedness

–        Robustness

ICH:

–        Specificity

–        Linearity

–        Range

–        Accuracy

–        Precision

  • Repeatability
  • Intermediate Precision
  • Reproducibility

–        Limit of Detection

–        Limit of Quantitation

 

References:

http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052377.pdf

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002662.pdf

www.slideserve.com/rolf/pharm462

Contact Detail

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

 

GMP requirements from the FDA

GMP requirements from the FDA

FDA Good Manufacturing Practices (GMP) is a set of guidelines issued by the FDA for various disciplines. There are GMP requirements FDA has for areas ranging from cosmetics to food to pharmaceuticals to API’s.

Why GMP’s?

Why are GMP requirements FDA has put in place necessary? It is for the simple reason that they are good manufacturing practices, and these practices have evolved over time. Being the regulatory body for the US; the FDA has to put a few practices into place, which will help manufacturers and consumers alike get the best out of a product.

Not the same as manufacturing process

It has to be understood that GMP’s are a set of guidelines, and are hence not to be confused with scientific literature or research that goes into a manufacturing process. GMP requirements FDA has are actually a product of many years of observation of the manufacturing process, whose implementation helps a product achieve its best results. GMP in itself is not a complete science, but a set of thumb rules that help manufacturers get the best out of their products.

Current good manufacturing practices

GMP requirements FDA has prescribed are collectively called by the term “current good manufacturing practices’, and are categorized under two headings:

  • Modernization of Food Good Manufacturing Practice Regulations
  • Dietary Supplement CGMPs

These are part of GMP requirements FDA has for the drug and food industries, which it regulates. These are contained in Title 21: Food and Drugs – PART 110—Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food.

References:

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=cefdff5373327b34dfa6f87642959825&rgn=div5&view=text&node=21:2.0.1.1.10&idno=21

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/CurrentGoodManufacturingPracticesCGMPs/default.htm

http://en.wikipedia.org/wiki/Good_manufacturing_practice

Contact Detail

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Essentials of foreign materials

Essentials of foreign materials

The HACCP program is in place to counter the dangers of foreign material that could get into food and food products. The FDA has very strict regulations that govern food that enters our palate. The United States Department of Agriculture, Food Safety and Inspection Service (FSIS) defines foreign material as “…non animal objects, such as metal, plastic, rubber, wood, steel or lead shot” that could have seeped into our food.

Bone particles are very common in the meat industry. The FSIS has determined what size bones are to be considered hazardous and what size can be considered safe. According to the FSIS:

  • Bone particles under the size of one cm are not considered a safety hazard;
  • Bone particles of size one to two cm are considered low risk;
  • Bone particles of greater two cm have the potential to be a safety hazard and could cause injury

The FSIS basically looks at foreign material fromthe perspective of non-food and non-animal products. It has identified important areas in which foreign material could creep into food products. It considers foreign material as being a natural or common by product of both the raw material and the processing environment, to the consumer. No matter through which source foreign material comes in; the HACCP considers either as a potential hazard. The goal should be Zero Tolerance to foreign material and Zero Defects.

Types and sources of raw materials

These are considered the types and sources of raw material:

  • Bones and buckshot in meat products: it is essential to look for these because these can intrude into meat products when the animals are killed;
  • Rocks in grains: difficult to trace because of their deceptive similarity in appearance to grains;
  • Stems in fruits and vegetables: part of an ongoing battle, because contaminants can get into these parts at the time of harvesting;
  • Nuts, bolts and PVC in processed foods: could come in when foods are put into equipment during the manufacturing process;
  • Glass in various products: these could get into the container.

Contact Detail

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

 

 

Design History File content

Design History File content

The design history file (DHF) is a very important document for a medical device, because it is what may be called the route map for the product’s design. It is proof that the device followed the right method on the way to arriving as the final product.

What is DHF?

It is defined, rather broadly, in ISO 13485 as being the record needed to provide evidence that the realization processes and the resulting product meet their specified requirements. 21 CFR 820.3 (e) of the FDA also describes DHF broadly as a compilation of records which describe the design history of the finished medical device.

Design history file content

Design history file content is described by both the FDA and ISO 13485.

Design history file content according to the FDA

  • General: A few Class I, Class II and Class III devices are listed here. These are the devices for which design controls apply
  • Design and development planning
  • Design input
  • Design output
  • Design review
  • Design verification
  • Design validation
  • Design transfer
  • Design changes
  • Design history file

ISO 13485

According to ISO 13485, design history file content should consist of the following rules:

  • The manufacturer shall establish plans thatdescribe the design and development activities
  • The plans shall identify and describe theinterfaces with different groups or activities thatprovide input to the design and developmentprocess
  • The plans shall be reviewed, updated and, andapproved as design evolves

References:

http://www.ece.mcmaster.ca/~patriciu/QSR.pdf

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=820.30

Contact Detail

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801