Contract Manufacturing of Regulated Products (Device, Drugs, and Biologics) in the Global Marketplace

Many in the industry are struggling to understand the necessary requirements to certify and register in countries Outside the United States. This is especially true for contract manufacturers that must meet their client’s regulatory needs to ensure they have in place the necessary manufacturing controls of the regulatory requirements of each country.


Contract manufacturing is a significant resource that is often utilized in both medical device and pharmaceutical industries. These activities can range from medical device components to finished devices or bulk API to final drug products. One of the challenges a contract manufacture has is they are typically supporting several clients who each have unique Quality Systems and Regulatory needs depending on the products and materials they use. These clients place a great deal of trust in the Contract Manufacturer to comply with their Quality and Regulatory requirements, but to also support those regulatory requirements to market their products outside the US.


 As the political and social climates in many of these countries are changing, the regulatory requirements are often not well defined.


The complexity and maturity of many countries regulatory system varies, and as such the contract manufacturer may struggle in understanding their role in to ensure that those regulatory requirements are met. For example:

• Is the country independent or do they fall under a recognized body? i.e., EU, GCC, etc.

• Does the country require that the contract manufacturer to be certified?
• What type of certification is required and by whom?
• If certification is required, what are the requirements to submit the request and what is the process?
• How does the contract manufacture identify the appropriate regulations and what changes need to be reflected in their Quality System?
• What actions should the contract manufacturer take to address any risk and what if any contracts/agreements should be in place? i.e., quality agreements.


Safis Solutions, LLC has evaluated these questions for contract manufacturers of large Pharmaceutical companies for several countries;

• Russia
• Ukraine
• China
• Taiwan
• Korea
• Hong Kong
• Saudi Arabia
• Australia
• Chili
• Brazil
• Spain
• Germany


Good Manufacturing Practices    

Our research found that many of these countries had well defined requirements for registering and marketing of drugs in their countries, as well as clear requirements for the establishment of GMP’s(Good Manufacturing Practices). Inconsistencies were found in the objective evidence requirements that the contract manufacture was compliance with the GMP and registration requirements. For example;

• GMP certification – in some countries a valid certification from a regulatory body would be adequate to meet their certification needs i.e., ISO, FDA, etc.
• Several countries require that the contract manufacture become certified under their specific countries requirements. This would require the contract manufacture to request an audit of their facility directly with that countries agency.


In-Country Registration
Most countries require that an individual be identified in the country to assist in communication and registration requirements. This is very similar to the requirements of the FDA for foreign manufacturers in which a US agent must be identified. Several countries are consolidated under a global union to consistently manage not only standardized regulatory requirements, but political and economic benefits. For example;

• Gulf Cooperative Council (GCC) – which includes Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and UAE.
• European Union (EU) – Belgium, France, Germany, Italy, Luxembourg, Netherlands Denmark, Ireland, United Kingdom Austria, Finland, Sweden, Portugal, Spain, Greece, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, Slovenia, Croatia, Bulgaria and Romania.
• China Food and Drug Agency (CFDA)
• Hong Kong – Department of Health (DOH), the Pharmaceuticals Service Department of Health (PSDH)
• Taiwan Ministry of Health – Taiwan Food and Drug Agency (TFDA)
• Latin America (LATAM) – Mexico, Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panama, The Caribbean, Cuba, Dominican Republic Haiti, Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Paraguay, Peru, Uruguay, Venezuela

An overview of the regulatory requirements is provided below. (Note: many of these countries are undergoing significant changes as a result of political and economic impacts. As a result, it is important to verify the requirements as they may have changed since this publication).


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It is key that contract manufacturers understand the needs of their clients and have an adequate understanding of the regulatory environment so that key activities can be planned and executed as required. For example, establishment of a Quality System which will meet the regulatory requirements of that country, such as;

• Good Manufacturing Practices, Lab Testing, Clinical
• Site Audit – request/application process
• Site Master File/Drug Master File



Safis Solutions, LLC has the expertise and resources to assist contract manufacturers in the certification process and the necessary updates to their Quality systems to ensure compliance. You can reach a consultant at
www.safis –

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