cGMPs for Drug Manufacturers: Five Key Points from FDA’s Seminar
On July 16, 2015, the U.S. Food and Drug Administration (FDA) presented a seminar about basic Current Good Manufacturing Practice (cGMP) requirements for drug manufacturers as part of a two-day regulatory education event hosted in Silver Spring, Maryland, USA. If a manufacturer does not follow FDA’s cGMPs, drugs manufactured at the facility may be considered adulterated. Below are some of the key points regarding cGMPs discussed at the seminar.
1. Manufacturers should maintain detailed, written procedures and be sure to follow those procedures.
21 CFR 211.80(a) states: “There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures; such written procedures shall be followed.” To support consistency, written procedures mustbe appropriate for the specific place of operation and its processes. Failure to properly follow procedures is a common observation by FDA.
2. Manufacturers should ensure proper storage and identification of all products at their facilities.
Products should be stored in such a way that the manufacturer can inspect all aspects of the container and clean the area thoroughly. For example, FDA raised questions about a box being stored on the ground. If a leak occurred and the bottom of the box was soaked through, the manufacturer may not know until the box is later lifted and the contents are found to be contaminated or destroyed.
Manufacturers should also be sure to correctly identify and label materials as soon as they arrive at the facility. Once an item is stored without being labeled, there is always the potential for misuse or accidental use, which could be disastrous.
3. Manufacturers should examine each lot of components, containers, and closures before use.
FDA noted that due to liability and patient-safety issues, it is unacceptable for manufacturers to use untested materials in their production lines. Bulk materials should be quarantined until they undergo appropriate testing to ensure they are ready for use.
4. Manufacturers should monitor and review their suppliers’ performance.
According to FDA, maintaining a reliable and secure supply chain does not start with a manufacturer’s finished product. The manufacturer needs to understand its products’ components and know what its suppliers are doing. Registrar Corp’s FDA Compliance Monitor can help drug manufacturers monitor their supply chains for FDA compliance issues.
5. Manufacturers should create policies for hazard prevention and avoidance.
FDA expects manufacturers to maintain reliable, efficient, and risk-mitigated operations and provide safe, effective, high-quality drug products. In order to do this, manufacturers need to know where their risks are and be proactive in preventing and mitigating them.
FDA suggested that drug manufacturing companies task someone with consistently reviewing FDA’s current guidances and its updates to regulations. Registrar Corp stays up-to-date on U.S. FDA regulations for drug manufacturers. Follow Registrar Corp’s FDA News blog for regulatory updates. For questions about or assistance with FDA regulations for drug manufacturers, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
Click here to read about “What to Expect During a FDA Drug Manufacturer Inspection”, another FDA seminar presented during the regulatory education event.