GMP, Supply Chain

MITIGATING RISKS WITH BLACK CHAIN TECHNOLOGY

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This blog is related to how block chain contributes to drug supply management

WHAT IS BLOCK CHAIN?

Block chain, or a distributed ledger, is a way of organisation information is a way that gives all appropriate parties access to the information they need and keeps that information secure from people who should not see it

In terms of quality, block chains can ensure that every part of a supply chain can have assurance that the materials & products moving through it have reached a particular standard passed checks and compiled with necessary regulations

In its simple form,block chain is information that is shared across a group of computers so that if one person updates that information others are able to see it

HOW BLOCK CHAIN CONTRIBUTES TO DRUG SUPPLY-CHAIN MANAGEMENT

Imagine a simple supply chain: Company A produces raw material;company B makes it into a product,while company C sells it. With block chain,company A can alert company B & company C of changes in supply chain-such as overproduction-that they can then use to moderate their manufacturing process. Company B could extend their working hours and sales strategy, while company C could plan a marketing campaign to move the extra product

Sharing decentralized information in this way means that business relationships will become much more flexible,benefiting the participants and requiring no outside help. This can be a highly effective means of self regulation

HOW BUSINESSES ARE USING BLOCK CHAIN IN THEIR SUPPLY CHAIN:

Global research firm, Gartner, predicts that by 2023,some 30% of manaufacturing complanies with revenue of more than $5bn will be using block chain to drive down costs and improve tracebility and transperancy

Block chain as a strategy will force companies to look beyond the boundaries of their own firm & establish shared process and consensus mechanisms with their supply chain partners

CHALLENGES OF THE MODEL

  • The benefits are great,but they may come at a cost
  • Block chain represents a challenge for businesses “Companies that have an ageing information technology infrastructure will struggle to interact effectively with digitally native companies
  • Tech companies have a responsibility to make the user experience as easy & seamless as possible for everyone in the supply chain

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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

BIO Medical, Healthcare Institutions, Life Sciences, Medical Devices, Regulatory Focus News Letter

USFDA Class I Recall,the most serious type of recall

Good Morning, Welcome to FWQRC Regulatory Focus News Letter…

Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy

The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death.

Recalled Product

  • Medfusion® 4000 Syringe Pump with Firmware Version 1.7.0
  • Model numbers 4000-0107-01 and 4000-0106-01
  • Manufacturing Dates: June 25, 2019
  • Distribution Dates: September 27, 2019 to October 31, 2019
  • Devices Recalled in the U.S.:  627
  • Date Initiated by Firm: October 28, 2019
  • Device Use

The Smiths Medical ASD Medfusion 4000 Syringe Pump is used to deliver blood, blood products or prescribed drugs into a patient’s body in a controlled manner.  Syringe pumps are primarily used in the neonatal and pediatric populations and in operating rooms and intensive care units for the adult population.

Reason for Recall

Smiths Medical has become aware of a software issue in the most recently updated Medfusion® 4000 Syringe Pump Firmware, Version 1.7.0, that could potentially cause the low battery alarms to stop working. If the battery alarms do not work, the healthcare provider using the pump will not receive audible or visual notification that the battery is shutting down. This may lead to an interruption of therapy which may lead to serious injury, adverse events, or death.

Smiths Medical has received 74 complaints related to the software update. No injuries or deaths have been reported.

  • Who May be Affected
  • Healthcare providers using the Smiths Medical ASD, Inc.  Medfusion® 4000 Syringe Pump
  • Patients who receive therapy delivered by the Smiths Medical ASD, Inc. Medfusion® 4000 Syringe Pump

What to Do

On October 28, 2019, Smiths Medical sent a Recall Notice to customers informing them of the affected models and instructing them to immediately return all affected products.

The Recall Notice from Smiths Medical advised customers to:

  • Locate all Medfusion® 4000 Syringe Pumps with Firmware Version 1.7.0 in their possession. The firmware version of the pump can be identified by powering on the unit and observing the firmware version displayed on the screen.
  • Determine the number of affected devices in their possession and complete the provided Recall Notice Response Form within 10 days of receipt, returning it to fieldactions@smiths-medical.com even if they do not have any affected product in their possession. All affected product must be returned to Smiths Medical for processing.
  • Upon returning the Response Form, Smiths Medical will provide a shipping label to return the affected product. Include a copy of the completed Response Form inside each box of returned product to facilitate processing. Ensure boxes are sealed and labeled with the facility name prior to shipping.
  • If they distributed any of the potentially affected products identified in this Recall Notice, they should immediately notify the recipients of the potentially affected products by forwarding them a copy of this Recall Notice.

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GMP, Life Sciences, Regulatory Focus News Letter, Rules

FDA Finalizes Rule to Go From Paper to Electronic Devices Submissions

Hi, Welcome to FWQRC Regulatory Focus News Letter.

Here we are going to discuss about the finalised rule for the submission process.

As part of an effort to improve the US Food and Drug Administration’s (FDA) medical device submission process, the agency on Friday issued a final rule to remove the requirements for multiple paper copy submissions and replace them with a single electronic submission.

The agency said the rule, proposed in September 2018 and will take effect in 30 days, is in response to an executive order from the Trump Administration in 2017 made famous as the “one-in, two-out” order. FDA’s rule is meant to improve the device premarket submission program and create a more efficient submission system.

“The requirement for a single submission in electronic format applies to all submission types that fall within the provisions listed in section 745A(b) of the FD&C Act; under this final rule, FDA is only amending those regulations that specifically mention paper and/or multiple copies of such regulatory submissions and are not consistent with this final rule,” FDA said.

The agency responded to four comments on the proposal but did not update the rulemaking. The agency noted that the final rule will produce cost savings for firms without imposing any additional regulatory burdens for submissions or affect the agency’s ability to review submissions.

“Firms will incur minimal administrative costs to read and understand the rule. We expect the economic impact of this regulation to be a total net costs savings yielding positive net benefits,” FDA said.

The agency also noted that submissions in electronic format can include those created and submitted on CD, DVD or flash drive and mailed to FDA.

For premarket approval applications (PMAs), the final rule changes one section to take out a section requiring an applicant to submit three copies of any updated safety and effectiveness report for pending applications.

FDA also previously required that PMAs be submitted in six copies, each bound in one or more numbered volumes, but that language has been removed with this final rule.

In another section, FDA removes the requirement that a PMA applicant has to provide copies of information that it believes to be trade secret or confidential commercial or financial information in the PMA.

FDA in September also published a draft guidance with “both binding and nonbinding provisions”

Please contact FWQRC for electronic submissions. (+91 8072483812)

Medical Devices, Regulatory Focus News Letter

Evaluation of Automatic Class III Designation (De Novo) Summaries

Hi, Welcome to FWQRC Regulatory Focus News Letter

Here we are going to discuss about the Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a “not substantially equivalent” (NSE) determination in response to a premarket notification [510(k)] submission. Section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), on July 9, 2012, to allow a sponsor to submit a De Novo classification request to the FDA for without first being required to submit a 510(k).

There are two options for De Novo classification for novel devices of low to moderate risk.

Option 1: Any person who receives an NSE determination in response to a 510(k) submission may, within 30 days of receipt of the NSE determination, submit a De Novo request for the FDA to make a risk-based evaluation for classification of the device into Class I or II.

Option 2: Any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may submit a De Novo request for the FDA to make a risk-based classification of the device into Class I or II, without first submitting a 510(k) and receiving an NSE determination.

Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.

Since 2010, the FDA has begun releasing summary documents for devices classified through the De Novo process. The De Novo summary is intended to present an objective and balanced summary of the scientific evidence that served as the basis for the decision to grant a De Novo request. The De Novo summary also serves as a resource regarding the types of information necessary to support substantial equivalence for device manufacturers that may wish to use the device as a predicate for future 510(k) submissions.

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