Contract packaging is a common trend in Pharmaceutical industry where part or whole of manufacturing operations are carried out by third party organization. This organization contain and maintain its own equipment, resources, and personnel without depending on the pharma manufacturer. However, third party is responsible for following all the quality and regulatory principles.
Outsourcing of packaging operations to third party organization, requires a great responsibility on the pharma manufacturer that intends to give contract to third party. It is responsible for the quality safety, reliability and integrity of the product being outsourced in line with the latest and approved regulatory requirements.
Co-packaging operation
Contract packaging operations is outsourcing only packaging operations to the third party, rather than entire manufacturing operations. The third party maintains their packaging equipment, systems and personnel, and use to provide packaging to pharma manufacturers.
The contractor cannot market or manufacture its own product, nor can it start its own manufacturing operations.
When a pharma manufacturer opts for co-packaging, it is responsible for regulatory compliance. It is also responsible for ensuring regulatory compliance by the contract third party.
here can be many reasons of using contract packaging, some of them are mentioned below
The pharma manufacturer has not enough resources to maintain its packaging facilities
The requirement of pharma product is large, and cannot be processed by the existing resources.
There is any problem or fault, that pharma manufacturer cannot use its packaging resources for the current batch
Co-packaging regulations
Like every pharma manufacturing, contract packaging is also governed by regulatory requirements of a particular market and country. All the regulations for pharma manufacturer are applied to the third party contractor. Additionally, some regulations are also added for correct production process and product.
Let’s discuss some regulatory requirements for contract packaging in line with three most competitive markets i.e China , United States and Europe. For the China, the regulatory body is NMPA, for the Unites States, the regulatory body is FDA and for the Europe, the regulatory body is EMA.
National medical products administration – NMPA
National medical products administration regulatory body that controls the manufacturing and distribution of pharma products in the territory of China. The NMPA guidelines are called “Good Manufacturing Practice for Drugs”. It is divided into 14 chapters , with Chapter 11 being related to contract manufacturing.
For contact packaging, there are no specific guidelines. Instead good manufacturing practice provide guidelines for the general contract manufacturing of pharma products, including the packaging.
United States FDA
Food and Drug administration is a regulatory body for the United states and regulates manufacturing, production, and marketing of pharma products in the United states
For the pharma contact packaging, there is no specific guidelines. However, FDA has created various guidance for contract manufacturing, which can also be used for contract packaging. Among these guidance documents, following are the most relevant
ICH Q7 good manufacturing practice guidance: it includes generalized guidance for the manufacturing of pharma products. Although, contract manufacturing including packaging is provided with separate guidelines, it is neces...
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