Documentation – and loads of it – is essential in API manufacturing if a company wants to comply with current Good Manufacturing Practice (cGMP), and eventually seek and obtain FDA approval.
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During manufacturing site inspections, federal regulators spend a lot of time reviewing a company’s documents and records, so effective documentation practices confirm its dedication to quality controls.
So why all the paperwork? It’s not only a requirement of the government, to prove that a drug will be safe and effective for patients, but it also provides a trail of best practices and a roadmap for future products for the sponsoring company and its Contract Manufacturing Organization (CMO).
For companies documenting their cGMP compliance, it helps them ensure and prove that products are consistently produced and controlled to the quality standards appropriate for their intended use. cGMP regulations require that the pharmaceutical manufacturer or CMO maintains proper documentation and records, which helps to build up a detailed picture of what was done in the past regarding a specific product and what is being done now, to provide a basis for planning how to proceed in the future.
cGMP-labeled manufacturing facilities must adhere to their own Quality System’s requirements for the design, format and organization of all their internal documentation. To ensure that this is accomplished, below are some of the most common types of documents that are required:
So, who is responsible for developing all of this documentation? Typically, the head of each manufacturing department or project is the one ultimately responsible for developing, distributing, maintaining, controlling and archiving all documentation for his/her respective projects.
CMOs and other manufacturers are responsible for ensuring that all cGMP activities are performed according to the company’s clearly defined Standard Operating Procedures (SOP). Any time those SOPs change, they must be reported to management for proper implementation. When a document has been revised, systems must be in place to ensure proper version control.
Below are key practices CMOs and other manufacturers can take to ensure that documentation management happens more smoothly.
Documentation is a complex and time-consuming process, but a critical element in the discovery, manufacture and delivery of drug products. The key is establishing sound processes each step of the way to meet all the regulatory requirements, cGMP guidelines and your own defined internal controls.