Receipt and Storage of cGMP Controlled Raw Materials Regulations and Best Practices

• By: Staff Editor
• Date: July 22, 2018

Receipt and Storage of cGMP Controlled Raw Materials Regulations and Best Practices

Manufactures of drugs who lack a defined raw material processing have received FDA 483s and lost several batches of products. Designing the Receipt, Handling and Processing, Specification, Inventory Tracking, and Qualification of cGMP Controlled Raw Materials is critical to Life sciences personnel to gain drug approvals.

Steps involved From Receipt through Release for Use of cGMP Raw Materials

This article specifies regulations and briefly discusses the first two steps ‘Receipt and Storage’.

Regulations:

• 21 CFR 211.80 explains what general requirements of CGMP Materials are. For guidance, please refer ICH Q9: Quality Risk Management, and ICH Q8(R2): Pharmaceutical Development.
• 21 CFR 211.82 explains what needs to be done upon receipt and before acceptance of containers. For guidance please refer ICH Q10: Pharmaceutical Quality System and Q&A – CGMP, GGP Level 2 Guidance – Control of Components and Drug Product Containers and Closures
• Storage Guidance Q7 A(7.4)

Receipt of Raw materials:

Upon receipt, the inspection of incoming raw materials is an essential step. Inspection ensures that the correct raw material which meets the quality specifications has been received. It helps in maintaining safety, minimizing wasted time, material cost and delayed shipments if the specifications are not met.

Sampling Strategy

Storage in controlled conditions

Storage in controlled conditions requires appropriate locations such as warehouses, and quality control areas. Storage also requires compliance during receiving and transferring materials. Quality equipment such as freezers and refrigerators too play a major part in storage control.

A partial list of the good storage practices is given below:

The practices and processes set forth in this general information article apply to the receipt and storage of cGMP raw material control. There are five more steps that require understanding of the cGMPs raw materials best practices. You may wish to attend the webinar that covers these steps in detail. Click here to enroll.

The evolving global processes and products requiring special environmental controls highlights the need for continuous learning on the part of professionals in the life sciences industry.

To stay current, to be ready for the change as new solutions evolve, to develop strategies for the best practices, controls, and procedures, browse through our list of webinars.