CONTRACTS AND AGREEMENTS


Home \| About Us \| Contact Us \| Events \| Search \| Member Area

How to Prepare for Inspections
Outside US Inspections
Qualified Third Parties
US Inspections

Consent Decrees
Form 483s
Form 483s News
Recalls News
Warning Letters
Warning Letters News

CAPA Essentials
CAPA News

Adulteration
Counterfeiting

Storage
Tracking
Unique Device Identification

US Import Screening

Data Management
Data Sharing

Auditing
GMPs
Outsourcing
Raw Materials

EU
GHTF
ICH
US Regulations
US Regulations News
Other Countries

Product Liability
Risk Assessments

Theft
EU Security Efforts
Non-US Countries
US Security Efforts

Acquisitions
Contracts and Agreements
Purchasing Controls
Qualification
Selection and Certification

Home | Contracts and Agreements

CONTRACTS AND AGREEMENTS

Active Supplier Monitoring, Tight Quality Agreements Keep Minor Changes in Check

Devicemakers need to routinely visit their suppliers to make sure they are informed about all changes that could affect their products -- including changes the suppliers may deem minor. "Only if you're an active participant will you get people to volunteer [the smaller changes]" or recognize them yourself, Saltbox Consulting founder Kim Egan said recently at FDAnews' Biopharmaceuticals Good Distribution Practices Summit in Bethesda, Md. Routine visits could turn up something as simple as a supplier changing its light source, which they may not consider a reportable change even though it could alter the temperature in a manufacturing facility. . . . more

Cardinal Takes Two-Year Facility Stricture as Supply Chain Step in DEA Settlement
Cardinal Health has agreed to halt distribution of controlled substances from its Lakeland, Fla., facility for two years and firm up anti-diversion efforts as part of a settlement with the Drug Enforcement Agency (DEA), resolving claims that its controls over such drugs were too relaxed. . . . more

Available Sample Quality Agreements
The following organizations have created quality agreements that address issues specific to their segment of the drug industry. Experts suggest that agreements should be constructed that take into account the requirements of both the suppliers and providers. . . . more

Arvilla Trag, Midwest Consulting Services, on Warehousing and Distribution Agreements
These questions and answers were drawn from an FDAnews webinar that featured Arvilla Trag, president of Midwest Consulting Services. . . . more

Jim Darnell, Tunnell Consulting, on Drafting Agreements With Warehouses and Shipping Suppliers
These questions and answers are from a recent FDAnews webinar featuring Jim Darnell, a managing consultant with Tunnell Consulting. . . . more

Steven Sharf, GMP Concepts, on Developing Supplier Quality Agreements
These questions and answers stem from a recent FDAnews webinar that featured Steven Sharf, president of GMP Concepts. . . . more

37 Tips to Negotiating a Quality Agreement
37 Tips to Negotiating a Quality Agreement . . . more

Supplier Quality Agreements Panel: Five Lessons Learned and Five Mistakes to Avoid

In this 1-hour video, learn from the experiences of a panel of experts on the hidden pitfalls and expensive mistakes that await the unenlightened pharmaceutical manufacturer when developing supplier quality agreements. . . . more

Creating Supplier Quality Agreements — Workshop

In this 3-hour video, William Reiss of Celgene and Steven Sharf, president of GMP Concepts, walk viewers through the 24 elements of a supplier quality agreement. . . . more

Some Legal and Regulatory Issues to Consider for Quality Agreements

Alan Minsk of law firm Arnall Golden Gregory, points out common mistakes made in the quality agreement drafting process and offers recommendations to maximize the benefits of a quality agreement between drugmakers and their suppliers. . . . more

24 Elements of a Quality Agreement
24 Elements of a Quality Agreement . . . more

Include Special Considerations for Unique Handling Needs in Supplier Contracts
General quality control measures cover the bulk of circumstances and requirements for quality agreements between drugmakers and contract warehouses and shippers. . . . more

Maintain Control Through SOPs, Spell Out Acceptable Deviations
Shared attention to details that fall within standard operating procedures (SOPs), developed either by the drugmaker or the contractor, help ensure that any quality agreement meets its key goal: quality control of all products handled by the vendor. . . . more

Quality Agreements Must Address Handling and Solving of Problems
Occasional problems with drug products are almost inevitable, despite the care with which firms spell out and follow both quality control and recordkeeping requirements. . . . more

Include These Key Elements in Quality Pacts With Warehouses, Logistics
Once SOPs for the development of quality agreements in general -- and contracts with warehouses and logistics providers in particular -- are firmly in place as part of a company's overall quality management plan, the firm must pay close attention to the specifics of these agreements. . . . more

Specify Critical Details for Facilities, Equipment, Buildings in Contract
Any quality agreement with a warehouse or logistics provider must contain myriad details if it is to ensure full regulatory compliance throughout a drug product's life cycle. . . . more

Quality Agreements With Wholesalers, Warehouses, Shippers Reduce Risk
FDA data reveal that 17 out of more than 50 recent agency inspections of wholesaler warehouses have resulted in Form 483s. . . . more

Spell Out Terms and Be Consistent in Enforcement of Quality Contract
In helping to assure quality control throughout the pharmaceutical supply chain, each quality agreement with a contract warehouse or shipper must spell out the type of oversight the sponsor company will exercise. . . . more

SOPs Ensure Adequate Procedures And Controls are in Place
When developing contracts for warehousing and shipping vendors, ensure that adequate procedures and controls are in place for equipment and facilities. Begin with solid standard operating procedures (SOPs). . . . more

Get Quality Agreement Right The First Time Around
Supply chain quality agreements between pharmaceutical companies and warehousing or shipping vendors are necessary to ensure the safety and efficacy of drug products stored and/or transported by contracted companies. . . . more

Complex Supply Chain Requires Comprehensive Quality Agreements
The pharmaceutical supply chain represents a complex process, whether for solid dosage or cold chain drugs. . . . more

Quality Agreements Are Integral to Risk Management Plan
Quality agreements form an integral part of any pharmaceutical company's overall quality management system, which in turn remains an important aspect of its risk management plan. . . . more

Creating Ironclad Supplier Quality Agreements

In this webinar, Arvilla Trag with Midwest Consulting Services discusses actual contract language that should be in every agreement between a pharma and its suppliers. . . . more