Source One Director Jennifer Ulrich will discuss end-to-end supplier engagement in a webinar sponsored by ISM-New Jersey.

The KP Medical Trade Platform helps foreign buyers find certified suppliers and manufacturers of medical products in China.

Global IoT Supplier launches new company brand

John Guest ball valve supplier, Chester Paul Company, is known for being a top-tier water purification company. The recognition has come after years of dedication to their craft and to their clients.

MaxBill Helps Firmus Energy Take the Full Advantage of Modern Billing

F2G Solutions creating jobs in the technology industry and growth within the community

As part of the CARES Act, the Centers for Medicare & Medicaid Services (CMS) is authorizing accelerated and advance payments to any Medicare physicians, provider or supplier who submits a request to the appropriate Medicare Administrative Contractor (MAC) and meets… Read More

The post CMS Offers Accelerated and Advance Medicare Payments for Physicians, Providers and Suppliers appeared first on Anders CPAs.

Aldi grocery CEO Giles Huxley informed his suppliers that all products must come in 100% reusable, recyclable, or compostable packaing.

The post Aldi Heaps Pressure On Supplier Packaging Being 100% Recyclable or Compostable Within Five Years appeared first on Good News Network.

India imports 45% of completely built units of consumer durables from China and it also imports nearly 70% of the components for television, and other consumer durable products. The price increase by suppliers at a time when demand is drastically down has hit the sector hard, said the presentation by Ficci to the government.

Other markets account for approximately 27.9 per cent of Dubai's imports, a statement released here by organisers of Paper Arabia 2013.

The 280 billion euros ($320 billion) per year global luxury goods sector, already reeling from months of protests in the shopping hub of Hong Kong, was dealt a hammer blow earlier this year by the coronavirus outbreak in mainland China.

One-year-old company NovaMed has inked a deal with Hong Kong-based DHB Global that will see the start-up medical consultancy transitioning to a producer of healthcare personal protective equipment, or PPE. Under the deal finalised earlier this...

Panasonic is freezing plans to expand its role as Tesla's electric car battery supplier, a move that raises new questions about demand for Tesla's Model 3 — and the company's future.

Henry Ford spent the majority of the war as a pacifist. By 1917, however, his state-of-the-art assembly line was churning out vital engine parts to feed the war machine.

Businesses owned by individuals with disabilities and certain small businesses will now be included in the state’s supplier diversity efforts thanks to an executive order recently signed by Governor Jack Markell.

Learn how continuous monitoring of suppliers can flag issues and help prevent supply chain disruptions.

Know your supplier: How to confidently choose trustworthy suppliers was published on SAS Voices by Ellen Joyner-Roberson

•Dassault Systèmes becomes the first and only software provider today to be recognized as Groupe PSA’s preferred digital partner •Dassault Systèmes and Groupe PSA engage in long-term strategy with the intent to further deploy the 3DEXPERIENCE platform •New level of partnership will enable Groupe PSA to improve efficiency and innovation in challenging marketplace

Turkeler and RT Enerji have chosen GE Renewable Energy to supply equipment for five onshore wind farms being built in Turkey.

Global manufacturer Apple today announced it has nearly doubled the number of suppliers that have committed to run their Apple production on 100 percent clean energy, bringing the total number to 44. Because of this partnership between Apple and its suppliers, Apple will exceed its goal of bringing 4 gigawatts of renewable energy into its supply chain by 2020, with over an additional gigawatt projected within that timeframe.

Last week, Sunrun announced that its bid to supply 20 MW of residential solar + storage capacity into the New England ISO Forward Capacity Market for 2022-2023 was approved. According to Chris Rauscher, Director of Policy and Storage Market Strategy for Sunrun, this is not a pilot project or an experiment in any way.

Global manufacturer Apple today announced it has nearly doubled the number of suppliers that have committed to run their Apple production on 100 percent clean energy, bringing the total number to 44. Because of this partnership between Apple and its suppliers, Apple will exceed its goal of bringing 4 gigawatts of renewable energy into its supply chain by 2020, with over an additional gigawatt projected within that timeframe.

Global manufacturer Apple today announced it has nearly doubled the number of suppliers that have committed to run their Apple production on 100 percent clean energy, bringing the total number to 44. Because of this partnership between Apple and its suppliers, Apple will exceed its goal of bringing 4 gigawatts of renewable energy into its supply chain by 2020, with over an additional gigawatt projected within that timeframe.

Following a recent change in the law relating to the supply of electricity and gas, landlords of multi-occupancy premises must now allow their tenants to connect to energy suppliers of the tenants' choice.  The landlord can only refuse if it is...

The Crown Commercial Service (“CCS”) has now published a revised standard Selection Questionnaire and guidance in the form of Procurement Policy Note (PPN) 8/16. This can be found here. PPN 8/16 supersedes and replaces PPN 3/15 which con...

European Commission aims to level the playing field between suppliers and large customers by introducing recommendations on unfair trade practices The European Commission recently adopted a Communication encouraging EU Member States to look at ways ...

The German Federal Cartel Office (“Bundeskartellamt”, BKartA) has issued a decision stating that attempts by Germany’s largest supermarket, EDEKA, to force suppliers to grant it so called “wedding rebates”, in the form ...

BANGALORE, INDIA – HARMAN International (India) Pvt. Ltd., the premium audio, infotainment and enterprise automation group, was awarded with this year’s TATA Motors Supplier of the Year award at the TATA Motors Annual Supplier’s Conference 2014 held in Mumbai on November 12^th. The TATA Motors Supplier of the Year award recognizes the contribution and commitment of its most valued partner and involves a rigorous selection process.

It is important to identify, assess, and address current barriers to implementation of post-approval changes that are intended to ensure continued (uninterrupted) operations and drive innovation and continual improvement in a maximally efficient, agile, and flexible pharmaceutical manufacturing sector. Leveraging the International Conference for Harmonisation Quality Guideline Q10 provides regulatory relief when it comes to addressing changes related to excipients, specifically excipient supplier's name and address changes, which will ensure a sustainable, reliable global supply and the availability of high quality product to patients through the entire commercial lifecycle of a product without extensive regulatory oversight.

ITV News has seen correspondence from Debenhams’ administrator to Bangladeshi suppliers demanding a 90% discount on garments orders.

The United States has intervened in a civil lawsuit against two former suppliers to the National School Lunch Program – Hallmark Meat Packing Company and Westland Meat Company Inc. – for submitting false and fraudulent claims to the Agricultural Marketing Service (AMS), a division of the U.S. Department of Agriculture (USDA). All ground beef containing defendants’ products was recalled by USDA as of Feb. 16, 2008, and defendants no longer supply beef to the National School Lunch Program or AMS.

A federal jury in Los Angeles convicted the owners and operators of a Los Angeles-area durable medical equipment company of Medicare fraud. After a one-week trial in federal court in Los Angeles, the jury found Gevork Kartashyan, 45, guilty of conspiracy to commit health care fraud and health care fraud; and Eliza Shurabalyan, 42, guilty of health care fraud. U.S. District Judge Stephen V. Wilson of the Central District of Los Angeles scheduled sentencing for Oct. 5, 2009.

The owner and operator of a Los Angeles durable medical equipment company was sentenced to 55 months in prison today in connection with a nearly $1 million power wheelchair fraud scheme.

The owner and operator of a Los Angeles durable medical equipment company was sentenced to 46 months in prison in connection with a power wheelchair scheme to defraud Medicare.

Mamadou Sadio Barry and Moussa Baradji were convicted today for their involvement in a counterfeit DVD and CD ring.

Four individuals have been sentenced this week in Atlanta by U.S. District Judge William S. Duffey Jr., for their involvement in a counterfeit DVD and CD ring.

Charles Ndhlovu, 34, was sentenced on Dec. 12, 2011, by U.S. District Judge William S. Duffey Jr. to 51 months in prison and Scott Ahn, 42, was sentenced yesterday by Judge Duffey to 19 months in prison.

Based on the representations made by the Worker Rights Consortium, the department said that the proposal is unlikely to lessen competition in the collegiate apparel sector.

A Los Angeles medical equipment supplier, who submitted almost $1 million in false claims to Medicare for expensive, high-end power wheelchairs, was sentenced today to serve 30 months in prison.

An executive at the Ohio subsidiary of a Japanese automotive supplier pleaded guilty today for his role in a conspiracy to fix prices and rig bids of anti-vibration rubber parts sold in the United States and elsewhere.

Several California companies and individuals that formerly supplied beef to the National School Lunch Program have agreed to settle allegations of inhumane handling of cattle, circumventing appropriate inspection of nonambulatory disabled (“downer”) cattle and false representations regarding their eligibility to process beef.

The government has intervened in a False Claims Act lawsuit against Orbit Medical Inc. and Jake Kilgore alleging that Orbit Medical’s sales representatives boosted power wheelchair and accessory sales by altering and forging physician prescriptions and supporting documentation.

The Justice Department announced today that it has filed a complaint against Midwest Neurosurgeons L.L.C. and its owner, Dr. Sanjay Fonn, M.D., and DS Medical L.L.C. and its owner, Deborah Seeger, for allegedly violating the Medicare Anti-Kickback Statute and the False Claims Act by conspiring to solicit and receive commissions from medical device manufacturers related to the purchase of spinal implants and supplies used during spinal fusion surgeries performed by Dr. Fonn

Guest Blogger: Greg Weilersbacher
Founder & President, Eastlake Quality Consulting

All companies outsource. It’s a humbling fact that you simply can’t do it all yourself. This often has to do with resource allocation; your company may allocate dollars to build and sustain some activities in-house while choosing to contract higher-cost operations to qualified suppliers who already have the expertise and equipment. 

You may outsource the manufacturing of tablets, sterile injectable, or topical dosage form, or the GMP release and stability testing of your product. Once the production and testing is complete, the product may need to be stored under controlled temperature and humidity conditions and then distributed to locations around the globe. The Contract Development and Management Organizations (CDMOs) who execute these critical operations are of paramount importance to your company’s success. Choosing the right suppliers will also help to minimize stress-induced headaches throughout your organization. Here are the top five ways to get the most out of a supplier audit.



1.  Come to the Audit Prepared
This seems obvious. However, more often than not, quality auditors step into the supplier’s lobby without doing their homework. Ask yourself the following questions: Why am I auditing this supplier? Is this supplier new to my company or one that we have used before? If used previously, have I read over the audit observations as well as the supplier’s responses and do I understand them? Which audit observations do I suspect would be the most challenging for the supplier to address and which are most important to my company’s requirements for this product? Have I reviewed previously executed production batch records and testing data and are there issues that need to be resolved? Are their deviations and CAPAs to follow up on?

Your understanding the supplier’s work proposal is of great value in refining the scope of the audit. Ask yourself:  Which of our products may be manufactured and tested here and which strengths (e.g., potency) will be produced? Which equipment is likely to be used? For a tablet production, the equipment train could include balances, blenders, roller compactor, spray dryer, solvent-rated oven, comils, tablet press and tooling, gravity feeder, coating systems, de-duster, weight sorter, metal detector, tablet counter, etc. This list of equipment will assist you in requesting equipment records during the audit. 

2.  Stay On Point
Proper audit planning will help to keep the audit organized and adhere to the audit timeline. In advance of the audit, provide the audit host with a list of the technical, lab, and manufacturing staff you wish to speak with and the records you need to review. A well-organized host will have this available for your review. Stick to your audit agenda. This is critical. The best way to derail your progress is to spend precious time chasing down minor issues while glaring problems get little to no attention. Continually refer back to the audit agenda and remember to keep the content of your audit report in mind while executing the audit.


3.  Know Your Technical Expertise and Limitations
Many auditors have led previous lives in the laboratory or in manufacturing while others started their careers in quality assurance and may have little technical background with regard to equipment, manufacturing processes, GMP utilities and laboratory testing. Know your limitations and if necessary strengthen them by hiring an expert consultant to assist you during the audit.

A common problem area that is at best glossed over and at worst completely ignored during an audit is the CDMO’s compliance with GMP utilities requirements. All too often, this is due to the auditor’s lack of understanding of the operation, inputs and outputs, validation parameters, and periodic testing and maintenance requirements for utilities such as HVAC, clean or pure steam, purified water and WFI systems, autoclaves, clean compressed air, nitrogen and other gases used for operating equipment or used during processing activities in manufacturing. Typically, these areas are also less well understood by the CDMO’s employees and as a result noncompliance abound. 

Some GMP utilities may be connected to the facility’s building management system, while others may be stand-alone equipment. In either case, the CDMO should have records of alarms (e.g., out of specification or out of range conditions), an acknowledgement of each alarm by designated staff members, and documentation of corrective actions. The last item is key. This is where the execution of quality systems tends to fail. Make a point to request documentation of corrective actions for each utility alarm. 

Additionally, purified and WFI water systems along with gases, such as clean compressed air and nitrogen, require periodical sampling/testing at each point-of-use. Verify that the timelines (monthly, quarterly, or annual) for sampling and testing were performed as directed by the CDMO’s procedures. These timelines are typically not well adhered to. A clear understanding of all the operations of the supplier’s GMP utility management process will keep your thoughts clear during the audit and help identify areas that are in need of improvement. 

4.  The Auditor’s Job is to Identify the Good and the Bad (Not to Win the Debate)
An important goal of a supplier audit is to identify the supplier’s strengths and weaknesses and come away from the audit with a compliance assessment that your company can use to make important decisions. It is of no value to your company if the goal of the auditor is to show the supplier how much he or she knows by debating the fine points of compliance. GMP auditors with decades of experience generally avoid this competitive exchange as it is unproductive. Rather, it is more important to the spend the necessary time identifying compliance issues, making them known to the audit host in a professional manner, and taking detailed notes that assist in writing the audit report. Your company’s senior managers need to know the supplier’s good and not-so-good points; detailing all of these provides the greatest value. 

5.  Interview the CDMO's Lab Staff, Manufacturing Operators, and Shipping/Receiving Personnel
CDMO’s quality systems are generally written by managers and directors who have many years of industry experience. It is of utmost importance that staff members who execute these systems understand them if your company’s product is to be manufactured, tested, stored, and distributed in a compliant manner. Request to speak with manufacturing staff members who work on the production floor and are likely to work on your product. Ask them about the process they would follow to conduct lines clearance, charge powders to a blender, operate a spray dryer, use a comil, set-up of a tablet press, inspect tablets, use metal detectors, etc. Compare the information they provide to the CDMO’s SOPs to determine if the staff understands their jobs. Listen for phrases such as “I usually do it this way…” or “it’s a different every time but I typically set up the equipment like this…” These phrases reveal a lack of control and adherence to procedures. 

The Take Away
The audit itself lays the foundation for a relationship with the supplier and the take-away message should address the following questions: Will the supplier work to resolve the issues I’ve identified? Am I confident that the supplier will immediately notify and involve my company’s representatives when deviations occur during production or testing? Do the supplier’s quality systems and records meet my company’s requirements and those of regulatory agencies? How confident am I that the supplier will produce and/or test a quality product that my company can stand behind? Is the supplier simply a pair of hands or are they committed to be my partner in this product’s success? The answers will provide you with a comfort level in making the decision to move forward with the CDMO or to look to the their competition.  

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A version of this article was first published in Outsourced Pharma.

 About the Author
Greg Weilersbacher is the Founder and President of Eastlake Quality Consulting, a GMP consulting firm based in the Southern California area. Over the last 25 years, he has held director and vice president positions leading Quality Assurance, Quality Control, Analytical Chemistry, Materials Management, GMP Facilities, and Product Manufacturing in biotech and pharmaceutical companies. His unique experiences and technical background have led to the manufacture and release of hundreds of solid oral, sterile, and biologic investigational products to clinics in the U.S. and abroad. Email Greg at weilersbacher.greg@gmail.com.

The unpredictable spikes in demand that are distorting the supply chain in the current crisis has created another opportunity, in this case for herbal ingredients that help adults deal with urinary incontinence issues.

Yokogawa Electric Corporation (TOKYO: 6841) announces that it has made it onto CDP's Water Security A List and Supplier Engagement Leader Board. The A listing is for the company's sustainable water management practices and disclosure of information on these activities, and the selection to the leader board is for the company's leadership in engaging with its suppliers around the world to reduce carbon emissions and combat global warming.