GMP, Guidelines, Life Sciences, Regulatory Focus News Letter

Small Entity Compliance Guide (SECG)

February 3, 2020

The Food and Drug Administration today announced the availability of a Small Entity Compliance Guide (SECG) to help packaged food manufacturers meet federal standards in the final rule “ Food Labeling: Revision of the Nutrition and Supplement Facts Labels.” The final rule, which was published on May 27, 2016, amends the labeling regulations for foods and dietary supplements to provide updated nutrition information on the label to help consumers maintain healthy dietary practices.

The SECG is aimed at small businesses and restates, in plain language and in a question and answer format, the provisions in the final rule. It includes the following sections in addition to references:

Who is subject to the rule?
What foods are covered by the rule?
What foods are not covered by the rule?
Which nutrients must newly be declared, and what changes have been made to nutrients previously required or allowed to be declared?
How do I comply with recordkeeping requirements?
How have the values of nutrients been updated?
How do I comply with the formatting requirements?’
When must I comply with the rule?
Why must I comply with the rule?

Compliance with the updated Nutrition Facts labeling regulations was required by January 1, 2020, for manufacturers with $10 million or more in annual food sales, while manufacturers with less than $10 million in annual food sales will have an additional year to comply. During the first 6 months following the January 1, 2020, compliance date, FDA plans to work cooperatively with manufacturers to meet the new Nutrition Facts label requirements and will not focus on enforcement actions regarding these requirements during that time. FDA intends to exercise enforcement discretion to give manufacturers of single-ingredient sugars such as honey and maple syrup, and certain cranberry products, until July 1, 2021, to comply.

For Compliance,please write to fwqrcservices@gmail.com

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COSMETICS, GMP, Healthcare Institutions, Life Sciences, Medical Devices, Regulatory Focus News Letter

Cosmetic Registration Reports

Hi, Welcome to FWQRC Regulatory Focus News Letter

About Blog FWQRC Regulatory focus pharma news, views and analysis of healthcare in a rapidly changing world. Not only do we keep you connected with the latest trends in pharma, we can also help you develop and bring to life your own thoughts, ideas and inspirations to enable you and your business to become key pharma influencers

The information in the tables below is a monthly report of activity in FDA’s Voluntary Cosmetic Registration Program (VCRP)

VCRP Monthly Status Report

Because the law does not require cosmetic firms to register their establishments or file their product formulations with FDA, participation in this program is voluntary. For this reason, the information below does not indicate the total number of companies manufacturing or marketing cosmetics in this country, or all cosmetic products on the market.

Activity for December 2019

  • Number of online accounts activated this month: 103
  • Number of products filed this month: 593
  • Total activity since the launch of the new online system, September 20, 2018
  • Number of active online accounts: 2,816
  • Number of active cosmetic establishment registrations: 1,395
  • Number of labelers that have filed product formulations*: 650
  • Number of filed products: 8,333
  • Number of product formulations discontinued**: 373
  • Number of product formulations rejected***: 958
  • Total activity since the VCRP was established, in 1972
  • Number of active cosmetic establishment registrations: 4,392
  • Number of labelers that have filed product formulations*: 3,071
  • Number of active products on file: 68,838
  • Number of product formulations discontinued**: 82,094
  • Number of product formulations rejected***: 5,101
GMP, Healthcare Institutions, Life Sciences, Medical Devices, Pharma

FWQRC™ intended to provide a decision pathway for drug & medical devices manufacturers in their first steps towards implementation of eCTD publishing and submission

Hi, Welcome to FWQRC™ Regulatory Focus News Letter

About Blog: FWQRC™ Regulatory focus pharma news, views and analysis of healthcare in a rapidly changing world. Not only do we keep you connected with the latest trends in pharma, we can also help you develop and bring to life your own thoughts, ideas and inspirations to enable you and your business to become key pharma influences

Many of us aware that eCTD is mandatory for DMF submissions from Jan 2020.

  • At the beginning of the decision process it is very important to make an evaluation of the current submission processes (“where are we”) in comparison with the eCTD requirements (“where do we need to be”).
  • The conclusions drawn from this analysis, together with a careful evaluation of the boundary conditions within the company are the basis for the definition of the User Requirements Specifications (URS). 
  • In the URS all the needs and boundaries of the expected processes are described and this information is used to find the optimal solution.Three possible solutions are described in detail, with their related advantages and disadvantages
  1. In-house software,
  2. Software as a Service (SaaS) and
  3. Outsourcing  
  • The last step of the process is the implementation of the chosen solution.
  • It has to be considered whether a consultant should help with the creation of this URS document. Especially for the generation of the new processes the experience of a consultant can be helpfulThe URS is part of the official validation documentation according to GAMP and should be established for any new system
  • Selection of solution
  • Once the URS has been finalised, the most suitable solution has to be found.  For this analysis the URS requirements should be classified in some way, e.g. “crucial” and “nice to have”.
  • The three possible solutions (In-house Software, Software as a Service and Outsourcing) are described in detail in the following sections.  Table 1 compares the most relevant characteristics of the 3 solutions, Table 2: Running an eCTD software system in-house: advantages and disadvantages and Table 3: Host system option: advantages and disadvantages

Table 1: Comparison of the 3 solutions

ItemIn-House softwareSoftware as a ServiceOutsourcing
Freedom of configurationHigh limitedNo
Responsibility for update and MaintenanceHighNoNo
IT support in-house needed YesNoNo
Link to other IT systems in-house possibleYesNoNo
Initial costs High LowNo
Ongoing costs In-houseYesYes
Lead timeLongMediumShort
ScalabilityDepends on set-upEasy Easy
Need of resources and competence for use of eCTD softwareYesYesNo
confidentiality / data security issuesNoYesYes

Table 2: Running an eCTD software system in-house: advantages and disadvantages

AdvantagesDisadvantages
Full freedom for configurationHigh initial costs for setting up the system
Free choice of hardware and software componentsRelatively long lead time needed to set up the system
The software is part of the company-owned software and fits into the IT concept of the companyFull responsibility for update and maintenance
Everything stays in house (no data-transfer via internet / confidentiality etc.)Personnel for technical set-up and maintenance must be available.
Link-up to other IT-systems possible (e.g. SAP) 
Maintenance costs stay in-house 
On-going costs are lower compared to the host software or outsourcing options 

Table 3: Host system option: advantages and disadvantages

AdvantagesDisadvantages
Speed: time from the decision to a pilot eCTD is often shorter compared to the in-house software solutionDependency on an external partner which increases if also the DMS shall be hosted
Lower cost for initial implementation as there is no or a smaller initial investment (e.g. initial set-up, user and software licenses, maintenance)Data transfer via internet (confidentiality, upload / down load capacity)
Scalable: ability to scale as business needs changeData hosted at an external company (confidentiality)
No on-going system maintenanceLimited freedom for software configuration
 On-going costs for renting the system/service

Table 4: Outsourcing option: advantages and disadvantages

AdvantagesDisadvantages
Speed: time from the decision to a pilot eCTD is very shortDependency on an external partner for each project and throughout the life cycle of a submission
No initial investment and no reoccurring costs for system maintenance and technical supportOn-going costs for each service during the whole lifecycle of a product/submission (initial submission(s), variations etc.)
No direct costs for software, licenses, hardware, system validation and maintenance, trainingData transfer (confidentiality, upload / down load capacity)
No need to establish, maintain technical knowledge in building and publishing eCTDs, no need for respective in-house resources (eCTD builder/publisher)Data hosted at an external company (confidentiality)
Scalable: ability to scale as business needs change 
Can also substantially-reduce risk of failed initial submissions 
  • There are 4 main scenarios that can drive the decision for outsourcing
  1. there is no in-house software available to build / publish eCTDs or
  2. the in-house capacities are too little
  3. to gain experience for the creation of eCTD ready documents and eCTD submissions in-house
  4. the number of eCTD submissions is too small, seldom use of the system
  • Conclusion: The option with the lowest impact on processes and systems in a company is outsourcing. There are various different extents of outsourcing. Common to all is that the external partner will provide the necessary infrastructure / software as well as the personnel to prepare the eCTD.

Stay in connected with FWQRC™ for implementation of eCTD publishing & submission

Healthcare Institutions, Life Sciences, Regulatory Focus News Letter

First FDA-approved vaccine for the prevention of Ebola virus disease

Hi, Welcome to FWQRC Regulatory focus news letter……….

The U.S. Food and Drug Administration announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older.

Cases of EVD are very rare in the U.S., and those that have occurred have been the result of infections acquired by individuals in other countries who then traveled to the U.S., or health care workers who became ill after treating patients with EVD.

“While the risk of Ebola virus disease in the U.S. remains low, the U.S. government remains deeply committed to fighting devastating Ebola outbreaks in Africa, including the current outbreak in the Democratic Republic of the Congo,” said Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs.

“Today’s approval is an important step in our continuing efforts to fight Ebola in close coordination with our partners across the U.S. Department of Health and Human Services, as well as our international partners, such as the World Health Organization.

These efforts, including today’s landmark approval, reflect the FDA’s unwavering dedication to leveraging our expertise to facilitate the development and availability of safe and effective medical products to address urgent public health needs and fight infectious diseases, as part of our vital public health mission.”

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Food, Healthcare Institutions, Life Sciences, Regulatory Focus News Letter

Investigation of Listeria monocytogenes

Welcome to FWQRC Regulatory focus news LetterHere we are going to review on the Outbreak Investigation of Listeria monocytogenes Linked to Hard-Boiled Eggs, December 2019FDA, CDC, and state and local partners are currently investigating a multistate outbreak of Listeria monocytogenes infections linked to foods that contain hard-boiled eggs. On December 20, 2019, Almark Foods recalled and suspended production of hard-boiled and peeled eggs in pails due to the potential for contamination with Listeria monocytogenes. These hard-boiledand peeled eggs were sold in pails under the following names: Rainbow Select Hard-cooked Eggs, Rainbow Select Hard-cooked Eggs in Vinegar, Nic’s Salad Hard-boiled Eggs, Almark Hard-cooked Eggs, and Sutherland Select Hard-cooked Eggs. A full list of recalled products is included below.RecommendationFood processors, restaurants, and retailers should not sell or serve any of the recalled hard-boiled and peeled eggs in pails from Almark Foods. These products were not sold directly to consumers.Additionally, FDA recommends that food processors, restaurants and retailers who have received Almark Foods bulk, fresh hard-boiled eggs, use extra vigilance in cleaning and sanitizing any surfaces that may have come in contact with these products, to reduce the risk of cross-contamination.Background:As of December 17, 2019, a total of seven people infected with the outbreak strain of Listeria monocytogenes have been reported from five states. In interviews, ill people answered questions about the foods they ate and other exposures in the month before they became ill. Of the five people for whom information was available, four reported eating products containing eggs. Three of these people reported eating hard-boiled eggs in deli salads purchased from grocery stores and in salads eaten at restaurants. Illnesses started on dates ranging from April 10, 2017 to November 12, 2019.Additionally, based on whole-genome sequencing, the Listeria monocytogenes found in environmental samples collected at the firm’s processing facility during an FDA inspection conducted in February 2019 is a genetic match to the outbreak strain. FDA is conducting additional inspections and sampling. Almark Foods has been cooperating with the ongoing investigation and announced a voluntary recall of hard-boiled and peeled eggs in pails on December 20, 2019.This outbreak strain was found during environmental sampling in 2017 of one other food facility. That facility is not currently handling food and ceased operation in 2018.Thank you for viewing FWQRC blogs….