Check Raw Material Compatibility with Containers During GMP Storage

Verify Container Compatibility for All Raw Materials in GMP Storage

Remember: Raw materials must be stored only in compatible containers to prevent degradation, contamination, or chemical interaction.

Why This Matters in GMP

Raw materials can be sensitive to factors such as moisture, light, and chemical reactivity. Using incompatible containers may lead to degradation, leaching of substances from the container, or physical changes in the material. This compromises material quality and impacts downstream processing. GMP requires that containers be selected based on material compatibility and validated for long-term storage. Compatibility studies ensure that storage does not introduce foreign contaminants or affect potency. Ignoring this aspect can result in product failures, delayed batches, and non-compliance with GMP regulations.

Also Read: Prohibit Forklift Use in Primary Packaging Areas to Prevent Contamination

Regulatory and Compliance Implications

FDA 21 CFR Part 211.80 and 211.94 mandate appropriate containers for storage and handling of components. WHO GMP and EU GMP Chapter 5 require that materials be stored in clean, labeled, and compatible containers. Schedule M emphasizes suitability of containers with respect to raw material nature and intended use. During audits, regulators verify container specifications, compatibility studies, and vendor qualifications. Lack of compatibility validation is often cited as a potential risk to material quality and GMP compliance.

Implementation Best Practices

Perform compatibility studies for all new raw materials and their intended storage containers.
Store moisture-sensitive materials in HDPE drums with desiccants; light-sensitive ones in amber containers.
Maintain a database of container specifications linked to each material ID.
Train warehouse staff to identify signs of container damage or incompatibility.
Document container material, grade, and supplier in raw material SOPs and specifications.

Also Read: Do Not Allow Incomplete Documentation During GMP Batch Record Review

Regulatory References

FDA 21 CFR Part 211.80 – General Requirements for Components
FDA 21 CFR Part 211.94 – Drug Product Containers and Closures
EU GMP Chapter 5 – Production
WHO GMP – Storage and Packaging Material Guidelines
Schedule M – Raw Material Container Compatibility