Are You Storing Food Safely?

July 22, 2008

Storage Basics

Refrigerate or freeze perishables right away.

Foods that require refrigeration should be put in the refrigerator as soon as you get them home. Stick to the “two-hour rule” for leaving items needing refrigeration out at room temperature. Never allow meat, poultry, seafood, eggs, or produce or other foods that require refrigeration to sit at room temperature for more than two hours—one hour if the air temperature is above 90° F. This also applies to items such as leftovers, “doggie bags,” and take-out foods. Also, when putting food away, don’t crowd the refrigerator or freezer so tightly that air can’t circulate.

Keep your appliances at the proper temperatures.

Keep the refrigerator temperature at or below 40° F (4° C). The freezer temperature should be 0° F (-18° C). Check temperatures periodically. Appliance thermometers are the best way of knowing these temperatures and are generally inexpensive.

Check storage directions on labels.

Many items other than meats, vegetables, and dairy products need to be kept cold. For instance, mayonnaise and ketchup should go in the refrigerator after opening. If you’ve neglected to properly refrigerate something, it’s usually best to throw it out.

Use ready-to-eat foods as soon as possible.

Refrigerated ready-to-eat foods such as luncheon meats should be used as soon as possible. The longer they’re stored in the refrigerator, the more chance Listeria, a bacterium that causes foodborne illness, can grow, especially if the refrigerator temperature is above 40° F (4° C).

Be alert for spoiled food.

Anything that looks or smells suspicious should be thrown out. Mold is a sign of spoilage. It can grow even under refrigeration. Mold is not a major health threat, but it can make food unappetizing. The safest practice is to discard food that is moldy.

Refrigeration Tips

Marinate food in the refrigerator. Bacteria can multiply rapidly in foods left to marinate at room temperature. Also, never reuse marinating liquid as a sauce unless you bring it to a rapid boil first.

Clean the refrigerator regularly and wipe spills immediately. This helps reduce the growth of Listeria bacteria and prevents drips from thawing meat that can allow bacteria from one food to spread to another. Clean the fridge out frequently.

Keep foods covered. Store refrigerated foods in covered containers or sealed storage bags, and check leftovers daily for spoilage. Store eggs in their carton in the refrigerator itself rather than on the door, where the temperature is warmer.

Check expiration dates. If food is past its “use by” date, discard it. If you’re not sure or if the food looks questionable, throw it out.

Click here to learn more about Food Safety compliance

About Insider Trading

July 1, 2008

“Insider trading” is a term that most investors have heard and usually associate with illegal conduct. But the term actually includes both legal and illegal conduct. The legal version is when corporate insiders—officers, directors, and employees—buy and sell stock in their own companies. When corporate insiders trade in their own securities, they must report their trades to the SEC.

Illegal insider trading refers generally to buying or selling a security, in breach of a fiduciary duty or other relationship of trust and confidence, while in possession of material, nonpublic information about the security. Insider trading violations may also include “tipping” such information, securities trading by the person “tipped,” and securities trading by those who misappropriate such information.

Who is an insider?

“insider” is any person who, is or was connected with the company, and who is reasonably expected to have access to unpublished price-sensitive information about the stock of that particular company, or who has access to such unpublished price sensitive information.

Information that could be price sensitive includes periodical financial results of a company, intended declaration of dividend, issue or buyback of securities, any major expansion plans or execution of new projects, amalgamation, merger, takeovers, disposal of the whole or substantial part of the undertaking and any other significant changes in policies, plans or operations of the company.

How does insider trading work?

An insider buys the stock (he might also already own it). He then releases price-sensitive information to a small group of people close to him, who buy the stock based on it, and spread the information further. This results in an increase in volumes and prices of the stock. The inside information has now become known to a larger group of people which further pushes up volumes and prices of the stock.

Examples of insider trading cases that have been brought by the SEC are cases against:

  • Corporate officers, directors, and employees who traded the corporation’s securities after learning of significant, confidential corporate developments;
  • Friends, business associates, family members, and other “tippees” of such officers, directors, and employees, who traded the securities after receiving such information;
  • Employees of law, banking, brokerage and printing firms who were given such information to provide services to the corporation whose securities they traded;
  • Government employees who learned of such information because of their employment by the government; and
  • Other persons who misappropriated, and took advantage of, confidential information from their employers.

Source: SEC

Powered Industrial Trucks: California’s Requirements for Equipment, Workplace Postings, Safe Operation, and Training

June 26, 2008

According to federal OSHA’s most recent statistics, more than 90,000 workers each year are injured, and 100 workers die, in forklift accidents. Workers are killed when a forklift tips over, when a forklift collides with pedestrians, when the worker is crushed by a forklift, or when the worker falls from a forklift.

This Special Report will help you navigate Cal/OSHA’s sometimes—confusing industrial truck standards, which are arranged differently than federal OSHA’s regulation and have different specific requirements. This Report will also help you ensure that your equipment meets Cal/OSHA standards by providing a comprehensive checklist you can use to inspect your equipment. Safe operating rules—which must be posted in the workplace—and training and instruction requirements are all thoroughly explained.

Download the entire report (PDF)

You can check ComplianceOnline for more OSHA related webinars from experts

How to Dispose of Unused Medicines

June 24, 2008

Is your medicine cabinet filled with expired drugs or medications you no longer use? How should you dispose of them?

Most drugs can be thrown in the household trash, but consumers should take certain precautions before tossing them out, according to the Food and Drug Administration (FDA).

Guidelines for Drug Disposal

  • FDA worked with the White House Office of National Drug Control Policy (ONDCP) to develop the first consumer guidance for proper disposal of prescription drugs. Issued by ONDCP in February 2007, the federal guidelines are summarized here:
  • Follow any specific disposal instructions on the drug label or patient information that accompanies the medication. Do not flush prescription drugs down the toilet unless this information specifically instructs you to do so.
  • If no instructions are given, throw the drugs in the household trash, but first:
    • Take them out of their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter. The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash.
    • Put them in a sealable bag, empty can, or other container to prevent the medication from leaking or breaking out of a garbage bag.
  • Take advantage of community drug take-back programs that allow the public to bring unused drugs to a central location for proper disposal. Call your city or county government’s household trash and recycling service (see blue pages in phone book) to see if a take-back program is available in your community.

Source: FDA

Even you can learn more about various FDA related rules and regulations at ComplianceOnline

New edition of ISO 9001 expected in October-November 2008

June 20, 2008

A new edition of ISO 9001, the world’s most widely used quality management system standard, is being submitted for voting as a Final Draft International Standard and, subject to formal approval by the ISO membership, the publication of the revised version should be in the October-November 2008 time frame.

The proposed ISO 9001:2008 does not introduce additional requirements compared to the last edition in 2000 and does not change the intent of ISO 9001:2000.

Some Numbers

It is estimated that over one million ISO 9001 certificates have been issued to organizations in private and public sectors, in manufacturing and services, and in 170 countries.


ISO 9001:2008 will be the fourth edition of the standard which was first published in 1987. The third edition, published in 2000, represented a thorough revision, including new requirements and a sharpened customer focus, reflecting developments in quality management and experience gained since the publication of the initial version.

ISO 9001 is one of 17 standards (plus a corrigendum) developed by ISO/TC 176 on quality management supporting tools. These include ISO 9004:2000, Quality management systems – Guidelines for performance improvements, which is undergoing revision and expected to be published as a new edition in 2009.

Source: ISO

You can also view and learn online webinar from ComplianceOnline

About 510(k)

June 19, 2008

Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification – also called PMN or 510(k) . It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.

Source: FDA

Attend online webinar on Successful 510(k) submission from ComplianceOnline

Regulatory Bodies Across Globe

June 18, 2008


The US Food & Drug Administration
Home Page
Current Guidances
Dockets Management Homepage
Electronic Freedom of Information
Investigations Operations Manual 2006
Medical Device GMP Reference Information
Modernization Act of 1997 (FDAMA)
References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies (OCTGT)

Health Canada Drugs and Health Products
Home Page
Biologics and Genetic Therapies
Biologics and Genetic Therapies Fact Sheet


European Medicines Agency
Gene Therapy Expert Working Group

European Commision
Proposal for a Harmonised Regulatory Framework on Human Tissue Engineered Products: DG Enterprise Consultation Paper


National Institute for Biological Standards & Control:

Medicines and Healthcare Products Regulatory Agency:



Australian Therapeutic Goods Administration
Australian Research Council
Australian Stem Cell Centre
Biotechnology Australia

Indonesian Ministry of Health

Japan’s Pharmaceuticals and Medical Devices Evaluation Center

Korean Food and Drug Administration

New Zealand Bioethics Council

National Institute for the Control of Pharmaceutical & Biological Products (in Chinese)
State Food and Drug Administration (in Chinese)
Ministry of Health (in Chinese)

Singapore’s Health Sciences Authority
Singapore Bioethics Advisory Committee Homepage

Bureau of Food and Drug Analysis

Central Drug Standard Control Organization:


World Health Organization
Quality Assurance and Safety of Medicines

International Society for Cellular Therapy

International Society for Cellular Therapy: Regulatory Affairs Europe
International Society for Cellular Therapy: Regulatory Affairs North America

International Society for Life Sciences Professionals
International Regulatory Information

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
Topics and Guidelines

Regulatory Affairs Professionals Society
Home Page
Combination Products Resource Page

Provides access to information on the rules and also maintains an email list that actively discusses issues and concerns with industry peers and government regulators.

Source: Cell Therapy News

About REACH Compliance

June 18, 2008

REACH(Registration Evaluation and Authorisation of CHemicals legislation), the European Union regulation for the Registration, Evaluation and Authorisation of Chemicals, which entered into force on 1 June 2007, has one key central aim: to protect human health and the environment from the risks arising from the use of chemicals.

REACH has become one of the most complex and far-reaching pieces of regulation ever to originate from Brussels.

REACH intends to achieve its goal by requiring business to fully ascertain the risks posed by the use of chemicals. For certain dangerous substances this means that a company will need to define in detail exactly how to safely use a chemical.

REACH’s mechanisms is an authorisation process for substances identified as being of very high concern to human health or the environment. This will mean the hazardous chemical can only be used in ways that are authorised by a REACH central authority – the European Chemicals Agency.

But how will the agency know what chemicals require authorisation?

Much is known about certain substances but for many there are information shortfalls, which prevent a suitable risk assessment. That’s where the REACH registration process comes in-

REACH Registration

For many firms REACH registration will be the most costly and time-consuming part of compliance. Generally, anyone that makes or imports a chemical into the EU above one tonne per year will need to register it with the Agency.

Registration involves producing a dossier of information in collaboration with other manufacturers or importers. The obligations for manufacturers and importers of a substance are essentially the same.

Source: REACH compliance

Additional information can be found on the following Web sites:

US market for drug packaging worth $16bn by 2012

June 11, 2008

Advanced functionalities, including those that aid patient compliance, will come to dominate the drug packaging market over the next few years, according to a study by the Freedonia Group In April, the World Health Organization (WHO) said that poor treatment compliance costs the global drug industry around $30bn (€19.4bn) a year. The organization also suggested that “shifting the effectiveness of patient adherence may have a far greater impact on the health of the population than any improvement in medical treatment.”

Among those likely to welcome Freedonia‘s forecast will be US packaging specialist Alcan, which is involved in the development and manufacture of blister pack and wallet technologies that are designed to both encourage and remind patients of dosing regimens and to aid understanding of their disease.

Injectables and transdermals

Freedonia predicts that the US pharmaceutical packaging market will grow 5.5 per cent a year and be worth $16bn (€10.3bn) by 2012. The report expects that the demand for parenteral vials, dispensing bottles, pre-fillable inhalers and syringes, track and trace labels, unit dose pouches and other added-value containers will drive the expansion.

The group also predicted that the market for primary pharmaceutical containers such as pre-fillable syringes and vials will grow to a value of $9.6bn, driven by the production of new injectable biologic therapies.

The report goes on to predict that plastic bottles will remain the most widely used packaging system for oral medications, including both bulk and prescription drug products. Plastic bottles are also expected to maintain their dominance of the over-the-counter (OTC) market, particularly those for products that are sold in quantities of 50 capsules or more.

Source: Outsourcing Pharma

ISO 17025

June 4, 2008

Quality System Standards were developed in various countries in the 1960’s and 1970’s. The MIL-Q-9858A in the United States in 1963 and the BS 5750 in the United Kingdom in 1979 are probably the most important ones. The ISO 9000 series of quality standards have been established in 1987 for implementing and maintaining a quality system which is internationally accepted.

ISO/IEC 17025:2005 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025:2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.

The Contents of ISO 17025

The ISO 17025 standard itself is comprised of 5 elements:

1. Scope
2. Normative References
3. Terms and Definitions
4. Management Requirements
5. Technical Requirements

Click here to learn more

Source: ComplianceOnline