Muhammad Asim NiaziOctober 18, 2024
Tag: Contract packaging , pharma , FDA
Some reasons that contract packaging can be a good option include
Pharma packaging contractors work with a diverse range of clients, which gives them the advantage of diverse knowledge and skills gained while working , and each client has its specific requirements.
For example, some clients' requirements could be low temperature; for some, it could be frozen storage. Working with these clients enables contractors to gain valuable and diverse knowledge, which they often use for commercial purposes.
The most significant advantage of a contractor's diverse skills is the ability to solve problems that a product owner faces in its product life cycle. Since the product owner has a limited portfolio could need more skills and knowledge if trapped in an unknown problem.
When product owner outsources their packaging operations to contractors, they are relieved of making arrangements for packaging operations, such as area, machine, and environmental conditions.
When outsourcing packaging operations to the contractor, the product owner doesn't need to procure and install machinery on its premises; validation is also optional. As a result, it could save a considerable amount of money, which can be saved or utilized for other purposes.
When a contractor outsources the packaging operations for a product, the product owner is freed from the various intermediate functions, as mentioned earlier. This enables the owner to focus more on planning and making high-level decisions.
The packaging contractor makes low-level decisions, such as component procurement. This allows the product owner to focus more on their business development by increasing market share and developing new products.
The FDA guidelines for contract packaging are mentioned in the document "Contract Manufacturing
Arrangements for Drugs: Quality Agreements Guidance for Industry." This guideline covers the entire manufacturing operations of a pharma organization, including packaging.
Some highlights of these guidelines are mentioned below.
Every party involved is responsible for cGMP compliance, and if not followed, the drugs are adulterated.
The owner's quality department is responsible for approving or rejecting drugs.
The contractor is also responsible for its quality department, including its documentation.
There shall be a written quality agreement between the product owner and the contract facility to describe cGMP roles, responsibilities, and activities.
The quality agreement should include elements as mentioned in this guideline.
According to these guidelines, the most critical pieces include
□ Manufacturing activities
◆ Quality unit activities
◆ Facilities and equipment
◆ Material management
◆ Product specific consideration
◆ Laboratory controls
◆ Documentation
● Change Control Associated With Manufacturing Activities
Components and their suppliers
Establishment locations
Manufacturing processes
Products or product types that use the same production line, equipment train, or facility
Testing procedures
Major manufacturing equipment
Shipping methods
Lot numbering scheme
Container closure systems
Tamper evidence features
Product Distribution
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