When coliform bacteria are detected in drinking water

For over a hundred years, the western world has used coliform as a method of testing water contamination. A quick understanding of this method of testing the level of water contamination:

Coliforms belong to a broad class of bacteria. These bacteria are found freely in our environment. The feces of humans as well as other warm-blooded animals are a source of these bacteria. Coliforms are primarily used as a method for indicating water quality. When coliform bacteria are detected in drinking water; it may be indicative of the potential presence of other harmful, disease-causing organisms. The belief is that wherever coliform bacteria are present, there are chances that other more harmful bacteria could reside with them.


Used as a first step

Pathogens, or disease causing organisms -namely virus, bacteria and protozoa -have to be eliminated from water, or they could cause a range of waterborne diseases such as dysentery, hepatitis, and giardiasis and related ones.

Since it is difficult to physically test every sample of water for specific harm-causing bacteria, protozoa and viruses, testing water for coliform is considered. This makes sense, because it is easier to further test samples that have coliform than to test every sample.

Laboratories have been adapting this method because this is relatively much, much less expensive and less time consuming to implement this method rather than look for every specific pathogen.

Moreover, most laboratories are ill equipped to handle mass testing of huge samples of water. Coliform as a method of testing water contamination is thus a useful tool, because it prevents the incurrence of huge expenses.


Effectiveness of coliform as a method of testing water contaminationThe practical advantages of using coliform as a method of testing water contamination notwithstanding; its effectiveness is open to debate. Some scientists believe that this method is too antiquated. Later methods have been proven to be more effective methods. The Environmental Protection Agency (EPA) for instance, draws up plans for containing water contamination from time to time. Using coliform as a method of testing water contamination is just one small part of these. The agency looks more to methods such as addressing contaminants as groups, which is believed to be more effective. It encourages the development of new technologies that tackle contaminants better, faster and more economically.

However, it is too early to say if these developments will signal the discontinuation of using coliform as a method of testing water contamination in the near future.


FDA’s requirements on medical device product development process

One of the most elaborate prescriptions that the FDA has relates to the medical device product development process. This is because any error at any stage of the medical device product development process can result in serious repercussions for the patient. Since nothing is to be left to chance, the FDA has a series of steps in the medical device product development process. These are aimed at ensuring that there is total control of the device from the earliest to the last stage. All these controls are put in place to ensure that the manufacturer is able to locate an error at any stage and take remedial steps.

medicalDeviceProductDevelopmentProcessStarts with design control

The starting point of the medical device product development process is the design control process. These are a set of design control-related processes that the manufacturer has to take to make sure that the device is safe and serves its intended use. The purpose of having a proper design control system in place is to ensure that the manufacturer gets the device right through every stage and to make sure that redesign is not required at any stage. Such a scenario is something that has to be avoided, because this can result in waste of huge resources and thinning of margins.

The FDA’s requirements on medical device product development processThe FDA has an entire section, the US 21 CFR 820.30 aimed at ensuring that the medical device product development process is carried out in strict conformity with the set compliance requirements.


Roughly, the FDA’s requirements for the medical device product development process as stated in US 21 CFR 820.30 seeks to put the following requirements in place from manufacturers of medical device:

Design and development planning:This is a plan in which the design and development activities are planned by the manufacturer.

Design input:This stage of the medical device product development process takes into consideration all the parameters for making the medical device successful, such as safety, performance, risk, profit and so on.

Design output:This is a set of test, specifications or processes needed to check that the device functions properly.

Design review:The stage of the medical device product development process in which the device is thoroughly checked for defects and corrected.

Design verification:This stage confirms that the device design is able to withstand a series of tests and challenges and documents the results.

Design validation:This stage uses objective means to examine the device design and confirm if the design output meets the intended use, predictably and demonstrably over a period of time.

Design changes:These are to make sure that the changes, if and when they are incorporated at any stage of the medical device product development process, are approved and implemented.

Design transfer:The transition stage from device design to production while meeting specifications.

Design history file:A complete record of the stages of the history of the design process which demonstrates that the design was carried out in compliance with design controls prescribed by regulatory authorities.

FDA Warns on Mixing Opioid Addiction Treatments, Other Meds

TRENTON, N.J. (AP) — The Food and Drug Administration issued new warnings Wednesday about the dangers of combining medication for opioid addiction with anti-anxiety medicines and other drugs that also slow breathing and brain activity.

The FDA warned that mixing such drugs can cause difficulty breathing, coma or death, so it should be done with caution.

The agency said a growing number of people fighting opioid addiction with methadone or buprenorphine also take other prescription drugs that slow action of the central nervous system. The warning lists several dozen brand-name and generic drugs that could be risky, including Ambien and Lunesta for insomnia, Valium and Xanax for anxiety, muscle relaxers Soma and Zanaflex and antipsychotic drugs Abilify, Invega, Saphris and others.

The agency stressed that treating opioid addiction with medication can outweigh those risks and is crucial to curbing the U.S. opioid epidemic, along with counseling, rehabilitation and other support.

“Careful management of the patient and coordination of care is recommended,” rather than denying use of methadone or buprenorphine, FDA Commissioner Scott Gottlieb wrote in a statement issued with the warning.

The FDA recommends that doctors develop detailed treatment plans, warn patients on addiction treatments about the dangers of taking multiple drugs that depress brain activity, try tapering them off those other drugs and monitor them with blood and urine testing.

Buprenorphine and methadone work by binding to the same brain areas as opioids, reducing cravings and withdrawal without producing a high. The FDA is requiring makers of those two medications to update their package inserts with information about the risks of using them with other drugs.

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Q7 and Other Requirements for Active Pharmaceutical Ingredient (ASM) GMP

In late 2016, the FDA published the revised the Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry. The aim of this revision is to address Good Manufacturing Practices (GMPs) for a Quality Management System for Active Pharmaceutical Ingredients (API’s). Another of its aims is to help companies ensure that they meet the requirements of API quality and purity characteristics. While replacing Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; this guidance amends the International Council for Harmonization (ICH) codification from Q7A to Q7.

All aspects of API manufacture are addressed by this revised guidance. These include:

o  The principles set out for Quality Management

o  The quality unit’s responsibilities

o  Activities relating to production

o  Internal audits

o  Product quality reviews

o  Qualifications expected from personnel

o  Their hygiene standards

o  The qualification that consultants need to have.

The GMP requirements for facility design and construction and equipment used are also included in this FDA Q7 GMP guidance for API revision. Several other API manufacturing topics are also part of this revision. Some of these include:

o  Management of materials

o  Process controls

o  Laboratory controls

o  Packaging

o  Storage and distribution

o  Validation

o  Change Control.

Clarity on the FDA’s revised standard

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will explain the FDA’s API Quality System revision in detail.

Eyal Lerner, owner of ELC Consulting Services which offers the pharmaceutical and medical devices industries support in all quality related issues, will be the speaker at this webinar. To gain understanding of how to apply the FDA’s revised API Quality Systems GMP requirements; please register for this webinar by visiting API (ASM) GMP

Explanation of API quality requirements

This webinar will explain the basic requirements and fundamentals of API QS. It will review the quality requirements for API in accordance to global API GMP- ICH Q7. The explanations will be based on practical experience and other relevant guidelines. Eyal will review the requirements of FDA and EMA. All the areas such as materials, Active Pharmaceutical Ingredient and Advanced Starting Materials (ASM) will be discussed along with their definitions. He will also explain the distinctions between these.

Administrative issues such as registration issues concerning filling, annual review and change report to file would be discussed. In this section, Eyal will lay emphasis on the section: “Registration standard: Common Technical Document (CTD)”, as it relates to the ICH M4.

Anyone, whose work concerns the area of development and manufacture of API, such as those in R&D, Regulatory Affairs, Quality Assurance and Quality Control, who wish to get an in-depth background and understanding of API QS; will find this webinar valuable.

How to Recognize the Hazards of Blood Borne Pathogens

Bloodborne pathogens are those microorganisms present in the human blood that carry infection. These infections can cause disease in humans. The major bloodborne pathogens that cause infections in humans are:

o  Hepatitis B (HBV)

o  Hepatitis C (HCV)

o  Human immunodeficiency virus (HIV)

Although these are the main disease causing pathogens; there are many more. So, hospital staffs who deal with patients who are infected by bloodborne pathogens need to take extra care with regard to cleanliness and hygiene, since their chances of exposure to these pathogens are extremely high.

Apart from healthcare workers, other vulnerable populations that could come into contact with bloodborne pathogens consist of emergency workers, who are usually the first responders to people with these infections, and housekeepers who are required to maintain the bedding and other paraphernalia of people with bloodborne pathogens.



Detailed regulations from the CDC

Needless to say, regulatory agencies prescribe a heavy dose of regulation for the way in which to handle bloodborne pathogens, whether it is patients or the materials related to them that are being handled. Prominent agencies and departments that have guidelines on these aspects include the Centers for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OSHA). Both OSHA and the CDC have guidelines on how workers at healthcare settings, who come into contact with patients with bloodborne pathogens, need to take safety precautions. The guidelines set out by the CDC cover all aspects of preventing bloodborne pathogens, such as:

o  The number of individuals in the patient population that are infected by bloodborne pathogens

o  The type of blood contact and its numbers

o  The particular pathogen that is involved

o  The nature of the exposure and the amount of blood in it

o  The virus in this exposed blood

The CDC guidelines are given to employers on how to they need to tackle bloodborne pathogens taking these factors into consideration. Important preventive steps that need to be taken, in line with the guidelines set out by both the CDC and OSHA include:

o  Use and disposal of needle sticks

o  Taking care to prevent exposure to injuries from sharps

o  The right protective gear to be used, such as gloves, other kinds of protection for important parts of the body, the right kind of clothing to be used, and the proper ways of using them, so that infection may be prevented through the nose, eyes, skin or mouth

o  What to do when exposure occurs

o  How to implement the proper reporting procedures

o  How each of these bloodborne pathogens have to be dealt with separately

o  The proper use of vaccines, when present

o  The proper procedure for treatment, when infection happens due to exposure

o  How to prevent bloodborne pathogens from infecting pregnant women

Learn the ways of implementing the important guidelines

All the actual ways of going about implementing the guidelines set out by the CDC and OSHA will be the topic of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

The speaker at this very valuable and important learning session is Danielle DeLucy, who owns ASA Training and Consulting, LLC which provides pharmaceutical and biologics-based companies with training and quality systems assistance in order to meet regulatory compliance.

Please register for this webinar by visiting Bloodborne Pathogen Safety

Making the biosafety program more effective

This webinar will offer complete learning on the best ways to approach biosafety and on how to implement an effective management program for blood borne infections, safety and health, laboratory safety, infectious material and blood infection. This session is particular useful for personnel who work in a laboratory exposed to viruses or bacteria that are biological hazards. Danielle will explain how to optimize their Biosafety program and offer them a framework for setting up a successful management policy.

Danielle will cover the following areas at this webinar, which personnel such as EHS Staff, Occupational Health Staff, Laboratory Staff, Team Leads, Supervisors, Managers and Business Owners will find very valuable:

o  Review the regulations and guidelines recommended by the Centers for Disease Control and Prevention (CDC) for work with biological materials and, specifically, with blood borne pathogens

o  Provide up to date information about what constitutes blood borne pathogens from infectious materials, as well as other potentially infectious materials

o  The webinar provide answers about how to prevent exposures, deal with spills or exposures should they occur, and the how to recognize the hazards of blood borne pathogens

o  A thorough description of the types of infections of concern for blood borne pathogens, how one might be exposed, the differences between blood born infections and other potentially infectious materials, methods for dealing with potential exposures or spills, and the requirements from OSHA to protect workers from exposure or to track exposures if they occur.

Actions for Noncompliance of cGMPs in the Quality Control Laboratory

Quality controls in laboratories are a major area for which the FDA issues 483’s. A laboratory is the venue for many activities, all of them of varying importance to the product. When controls in laboratories are not up to the standard, such a laboratory could produce products that do not meet quality and processes expectations, and hence invite 483’s.

Quality Control Laboratory 141216186486


Issues with drug quality, drug integrity and data integrity, as well as data fabrication and human errors and even behavior towards the FDA inspectors during inspections are some of the reasons for which laboratories get hauled up by the FDA. The inappropriate or incomplete implementation of cGMPs in the Quality Control labs is a major area for which the FDA takes penal actions against them.

Most common areas of noncompliance

These are some of the most common areas in which the FDA is likely to find issues relating to cGMPs in Quality Control laboratories:

  • Out of Specification lab results
  • Laboratory error- improper analysis method, use of incorrect standards, and/or miscalculation of data
  • Operator error or non-process error
  • Fault in the manufacturing process
  • Product failures
  • Laboratory documentation and records
  • Validation of methods
  • Equipment errors
  • Problems with raw materials
  • Lack of in-process controls and specifications
  • Management of the laboratory
  • Unexplained anomalies

Ways of avoiding penal actions

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From about the 1980’s, the FDA has been targeting Quality Control laboratories ever more stringently. The way of avoiding receipt of 483’s, which could escalate into a Warning Letter if it not addressed properly, is to be aware of all the ways by which to meet the FDA’s requirements of cGMPs in Quality Control laboratories. Some of the steps a QC laboratory needs to take to avoid FDA actions include:

  • Carefully reviewing and analyzing the regulations, inspectional guidance, 483 observations and Warning Letter and internal audit observations and deviations
  • Thoroughly reviewing laboratory practice and procedures
  • Gaining knowledge of the areas the investigators review and the type of observations that are made in other organizations and using this information to ensure that their laboratory operations are improved

Implementing actions based on these is at the root of its strategy for avoiding future observations of non-compliance and the issuance of 483’s from the FDA.

A valuable learning session on implementing these

How do laboratories do all these? How do they implement the correct cGMPs in their Quality Control laboratories, so that they meet the FDA’s compliance requirements? A webinar on this highly relevant and meaningful topic from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will show how.

John Lanese, an independent consultant with a focus on Quality Systems and the components of an effective Quality System and Founder of The Lanese Group, which consults with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations; will be the speaker.

Please register for this highly valuable session by visiting and learn all that it takes to implement cGMPs in the Quality Control lab and avoid harsh penalties from the FDA, which could set your business back.

A thorough approach to imparting lessons on cGMPs

This is the approach that John will adapt for inculcating the lessons on cGMPs in the Quality Control laboratory:

He will apply one aspect of a proactive approach and review how this approach can be implemented for meeting regulatory requirements. He will then analyze 483 and Warning Letter observations to determine if similar observations that could serve as a benchmark to initiate further preventive actions could be made in the participants’ facility.

John will explain the non-conformances most often cited by the FDA, along with the relevant regulation. He will then show specific observations that relate to the laboratory cited in Warning Letters and FDA 483s. John will use these real life examples to show to participants the ways of analyzing what went wrong. He will explain the systems, procedures and records the laboratory should have in place that would prevent a similar observation. He will also familiarize the participants with several questions that a laboratory manager or an auditor might ask to assure that appropriate systems, procedures and records are in place and are being followed.


Key personnel in laboratories, such as Quality Control Laboratory Managers, Quality Control Laboratory Supervisors, Quality Control Analysts, Quality Control Microbiologists, Quality Assurance Managers, and Quality Auditors will gain immense benefits by participating in this webinar. They will be able to critically evaluate key areas in the laboratory operations for compliance and identify areas for improvement after completion of this webinar.

John will cover the following areas at this webinar:

  • System Based Inspection Guidance
  • Laboratory Control System
  • Most common observations in the laboratory
  • 483 and Warning letter observations
  • Analysis of observations
  • Areas for preventive action.

Ways of getting the PREDICT, ACE and the HTS right to smoothen shipping

In September 2014, the FDA deployed a new risk-based screening tool for imports called the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT). The main aim of PREDICT was bringing about improvement in screening and targeting of adulterated or misbranded goods or those that flout any of the FDA’s rules. The FDA seeks to bring this about by doing away with its legacy electronic system, OASIS’ admissibility screening function.

PREDICT is an important tool that helps entry reviewers target and inspect higher-risk shipments. In parallel, PREDICT also smoothens and accelerates the clearance of any cargo that carries lower risk, so long as accurate and complete data are provided by importers and entry filers.

The new import requirements have now become harsher and effective in unison with the U.S. Customs and Border Protection’s ACE software program. These programs together look for a lot more information from the foreign source of the goods than earlier. Not only are these requirements linked to the FDA’s product codes and U.S. Harmonized Tariff Schedule (HTS); there has to be a match between the information entered on the entry’s commercial or pro forma invoice with the one provided in and entered into PREDICT and ACE software.


In the event of even a minor error or mismatch in the software coding information, importers and shippers can expect expensive delays and a possible refusal of the entry. Those who participate in a voluntary Affirmation of Compliance (AOC) are allowed some lenience by the FDA from the strict requirements. Yet, providing accurate information is imperative for aligning and reconciling the information contained in PREDICT, ACE, Invoice and AOC. Any lapse in adhering to any of these procedures or ensuring the accuracy of the data match has major consequences in the form of fines and delays.

It is critical to get all the procedures in the right order

In the nearly three years that the new import entry filing requirements have been in place, users have been facing problems. What happens when the importer is unable to meet the FDA’s and the Customs and Border Protection’s requirements? There are costly delays. When these delays happen, the importer has to turn to the FDA to resolve the problem. This can be tedious. The only really effective antidote to these issues is paying full and proper attention to how to use the two programs and getting their implementation right to a T.

And then, the importer has to also complete the task of linking the FDA’s and U.S. Custom’s software to an importer’s legal requirements by using the correct Harmonized Tariff Schedule (HTS) code. This is a major determinant of how the FDA will apply its requirements. Importing, however, becomes easier if the information on the manifest, invoice and affirmation of compliance are consistent with each other and correct. So, the crucial task for the importer is to get the harmonization of all these right, because apart from marking out a wrong entry as a problem that requires greater scrutiny for data verification; the FDA will also impose fines for filing incorrect entry data in ACE.

Proper guidance on the ways of meeting these requirements

Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar aimed at helping importers, shippers and others related to these activity get the alignment and matching of the PREDICT, ACE and the HTS right.


Casper Uldriks, who owns the firm, Encore Insight LLC and has worked for over 32 years with the FDA or its divisions at various levels, will be the speaker at this webinar. His having developed enforcement actions and participated in the implementation of new statutory requirements over many years has given him sharp insights into the FDA’s way of thinking. If sharing the insights this expert brings into the FDA’s software programs is relevant to you and interests you, please register for this webinar by visiting Software Screening Program

The intention of this webinar is to explain the benefits from the new requirements of the software programs, which help importers to streamline the import documentation and let them check the status of their entry, as well as the communications between an importer or its broker and U.S. Customs.

Casper will cover the following areas at this webinar:

  • FDA’s required information for the PREDICT software screening prior to entry
  • FDA product codes
  • Custom’s required information for the ACE software system prior to entry
  • Custom’s Harmonized Tariff Schedule (HTS)
  • Affirmation of Compliance (AOC).