Tag Archives: drug products

FDA Announces Meeting on Implementing DSCSA’s Product Identification Requirements

Sentry BioPharma Services continues to strengthen its leadership position in providing high quality and secure pharmaceutical supply chain services to pharmaceutical clients and companies utilizing biotechnology to manufacture biological products and vaccines.  Therefore, we would like to draw attention to an upcoming public meeting concerning the Drug Supply Chain Security Act (DSCSA) hosted by the FDA.

fda-dscsaThe Food & Drug Administration (FDA) will be holding a public meeting to provide members of the pharmaceutical distribution supply chain and interested stakeholders an opportunity to discuss with FDA the implementation of the Drug Supply Chain Security Act’s (DSCSA’s) product identification requirements. To be held on October 14, 2016, from 9:00 a.m. to 4:00 p.m. at FDA’s White Oak Campus in Silver Spring, MD, the meeting, “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act,” will include presentations from the public and follow-up questions from an FDA panel. The objective of the meeting is to discuss the pharmaceutical supply chain’s progress toward implementing the DSCSA’s product identification requirements, including best practices in each sector of the pharmaceutical distribution supply chain to conduct product tracing, verification, and identification.

More Background on the Drug Supply Chain Security Act (DSCSA)

Title II of the Drug Quality and Security Act of 2013

The Drug Quality and Security Act (DQSA), was signed into law by President Obama on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act, outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.

Ten years after enactment, the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain. The new system will:

  • enable verification of the legitimacy of the drug product identifier down to the package level;
  • enhance detection and notification of illegitimate products in the drug supply chain; and
  • facilitate more efficient recalls of drug products.

Drug manufacturers, wholesale drug distributors, repackagers, and many dispensers (primarily pharmacies) will be called on to work in cooperation with FDA to develop the new system over the next 10 years.

Among key provisions implemented over the next 10 years are requirements for:

  • Product identification: Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically.
  • Product tracing: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) in the drug supply chain to provide information about a drug and who handled it each time it is sold in the U.S. market.
  • Product verification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to be able to verify the product identifier on certain prescription drug packages.
  • Detection and response: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous.
  • Notification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found.
  • Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to FDA. This information will then be made available in a public database.
  • Third-party logistics provider licensing: Third-party logistic providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license.

The law requires FDA to develop standards, guidance documents, and pilot programs and to conduct public meetings, in addition to other efforts necessary to support efficient and effective implementation. FDA is developing a schedule for implementing the law’s requirements.

This system will enhance the U.S. Food and Drug Administration’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers. Failure to comply with the requirements of the law can result in penalties.

The development of the system will be phased in with new requirements over a 10-year period. These requirements will include providing product and transaction information at each sale with lot level information, in paper or electronic format, and placing unique product identifiers on individual drug packages.

The FDA is soliciting either electronic or written comments related to this public meeting by November 14, 2016. To register or request to make a presentation, visit the public meeting web page.

For more information about how Sentry’s secure drug supply chain management programs can ensure drug product integrity in every phase of the pharmaceutical supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Sentry Strengthens the Pharmaceutical Supply Chain

Biological drugs are generally more delicate and sensitive to temperature than their
pharmaceutical counterparts, thus introducing risks into the global biopharma supply chain.
Longer transit times, extreme climate change between origination and destination, and shipping delays all increase the risk profile during transport.  Product compromise due to temperature fluctuation can cause millions of dollars in revenue loss and delay delivery of drugs and therapeutics to patients.  Sentry Biopharma Services strengthens the pharmaceutical supply chain by helping clients manage these risks.

MATURITY OF PHARMACEUTICAL COLD CHAIN MANAGEMENT

15 years ago cold chain management was still a buzz phrase that only a few companies could actually deliver.  However, the unique transportation challenges of biopharma products have driven the need to control temperature variability throughout the drug supply chain which has transformed pharmaceutical cold chain management into a burgeoning industry.  Specialized providers like Sentry BioPharma Services now offer dedicated services designed to preserve the integrity of biological products throughout all phases of the pharmaceutical supply chain. Large and small biotech organizations increasingly turn to these specialized providers in a shift from the traditional in-house pharmaceutical logistics model to an outsourced one.

SELECTING A PHARMACEUTICAL SUPPLY CHAIN PARTNER

Although outsourcing to a pharmaceutical supply chain provider can provide many benefits, not every potential partner has the capability to provide services on a global scale. A qualified cold chain logistics expert must be experienced and compliant in all facets of biopharma cold chain management.  This includes domestic and international shipping, drug product handling and tracking, GMP storage and international drug distribution. The provider must have the experience, systems and processes in place to handle the diverse and changing needs of the global biopharmaceutical industry. Criteria that biopharma manufacturers should consider when evaluating potential partners include:

  1. A robust quality systemglobe
  2. Specialized GMP storage facilities and equipment
  3. A reputation for technological innovation
  4. Compliance with global pharmaceutical cold chain regulations
  5. An efficient and reliable biopharma and logistics network
  6. Anti-counterfeiting capabilities
  7. Impeccable customer service record

PHARMACEUTICAL COLD CHAIN REGULATIONS & BEST PRACTICES

As pharmaceutical cold chain management has become a more critical component in the global biopharmaceutical supply chain, regulatory agencies and industry associations have been launched solely to develop standards for compliance in this market.  Achieving regulatory compliance was a much simpler task in traditional supply chain models of the past. Now, due to an increasingly complex set of social, scientific and political pressures, industry mandates and international regulations have become significantly more stringent. Each country has its own body of rules and guidelines governing the shipment and handling of pharmaceutical and biological products. A qualified pharmaceutical cold chain management and 3PL partner must demonstrate compliance with international guidelines.

In addition to mandates prescribed by external regulatory agencies, the industry has begun to develop its own body of industry-accepted standards for biopharmaceutical distribution and handling. Several prominent groups have been formed throughout the world to discuss regional challenges and issues; collaborate on problem-solving; examine emerging trends; and define industry best practices. A pharmaceutical cold chain management partner should be familiar with the standards being developed by leading international pharmaceutical discussion groups.

REPUTATION FOR PRISTINE QUALITY AND IMPECCABLE CUSTOMER SERVICE

A GMP-compliant third-party logistic (3PL) partner must be committed to excellence in quality control and customer service.  As an extension of the drug or vaccine manufacturer’s business, the pharmaceutical 3PL provider must operate as a vested stakeholder to protect product integrity as well as the manufacturer’s business viability and reputation in the marketplace. Measures of excellence in the pharmaceutical cold chain include:

  • A corporate culture of accountability and commitment to the mission
  • Knowledge of best practices for GMP storage, global drug distribution and vaccine management
  • Independent quality assurance personnel, processes and evaluations
  • Careful biological product handling and temperature-sensitive product shipping
  • A uniformed process for continuously improving quality, operations and customer service
  • A singular focus that allows the contract service provider to be an expert

SPECIALIZED GMP STORAGE FACILITIES

At various points in the pharmaceutical supply chain, active pharmaceutical ingredients (APIs), excipients, components, intermediates and finished pharmaceutical products may need to be stored for varying lengths of time, from a few days to a several months.  Short-term or long-term GMP storage facilities might be needed to temporarily house: inventory overflow from a primary GMP warehouse; primary or secondary packaging components that are awaiting assembly; finished drug products that are awaiting international drug distribution; and/or inbound pharmaceutical product shipments that are clearing U.S. Customs. While several pharmaceutical small molecule formulations remain stable at ambient temperature conditions, many biologic products must be maintained within tighter temperature tolerances in refrigerated (+2°C to +8°C), frozen (-10°C to -20°C) and ultra-low storage (-70 to -90°C). Traditional pharmaceutical supply chain facilities are not always designed to accommodate these conditions.

In these situations, a cold chain logistics partner can provide immediate access to a state-of-the-art GMP storage facility that has been designed to meet the unique requirements of temperature-sensitive drug products. It must offer: validated, temperature controlled storage and temperature-monitoring equipment; redundant power, cooling and environmental monitoring systems; redundant data storage capabilities; and sophisticated data security systems.

For more information about how Sentry’s cold chain management programs can ensure biological product integrity in every phase of the pharmaceutical supply chain, contact Sentry via email or by phone at 1-866-757-7400.