How New Drug Companies Find Out About the FDA’s CGMPs
Regulatory compliance is at the top of the pharmaceutical industry’s priority list. From data privacy to drug manufacturing safety, the consequences for poor compliance are severe legal penalties and a massive loss in trust with customers and business partners.
Among the regulations to keep track of are the Food and Drug Administration (FDA)’s Current Good Manufacturing Practices (CGMPs) regarding pharmaceuticals. The law mandates a level of quality control during the manufacturing process.
What Exactly Does It Cover?
To be specific, following CGMP guidelines is all about having control over your manufacturing processes and facilities to achieve a clean and effective drug product. Following CGMP means that you have:
- Facility management
- Quality raw materials
- Accurate processing operations
- Strong quality management systems and Ability to detect and investigate deviations
- Proper testing methodologies
Specific fields of pharma regulatory compliance and CGMP requirements for pharmaceutical manufacturers mandated by the FDA include the following:
- A well-defined manufacturing process with tight controls to ensure consistency. The language used in the instructions must be “clear and unambiguous.”
- A clean and hygienic factory floor that requires you to sanitize equipment regularly. Cross-contamination must be prevented through proper environmental controls.
- Proper training for staff members on the factory floor for carrying out quality control and other protocols.
- Proper testing of the finished product and documentation of any deviations from what’s expected of the drug. Changes made to the formula during the drug development process must be validated, and recordkeeping must be done throughout the process to record steps and instructions.
- Procedures must be available for recalling any batch of medicines sent out that’s later found to have defects.
- Complaints and concerns from the market post-launch should be examined, and proper investigations alongside preventative action should take place to remedy the issue.
In general, you can expect a lower chance of experiencing product failure, drug contamination, or other mistakes when you keep track of these FDA minimum regulatory requirements. Either way, following CGMP and other laws like it will overall result in a positive return on investment for your organization, whether we’re talking about drug manufacturing or cosmetic regulatory compliance.
Why “Current”?
The “current” nature of the practices refer to the importance of staying up-to-date with current regulations. Much like medical science and technology, the rules and requirements will always evolve and change. Even if you passed an inspection a few years ago, you might not necessarily be fully CGMP compliant today when considering current needs.
For this reason,
regulatory compliance training
is heavily recommended on a regular basis. Keep your staff up to date with the current laws and how they apply to your workflow to avoid costly fines and lost trust from noncompliance penalties.
How Does the FDA Test For It?
The FDA formally inspects pharmaceutical manufacturing plants across the globe. It combines these inspections with any reports of defects from the market itself and makes judgments on whether further investigation is needed. If a violation is found, multiple events may occur depending on the nature of the drug and its safety status.
- The drug becomes “adulterated,” meaning that it was produced without CGMP standards. An adulterated drug is not necessarily unsafe, however.
- Customers currently taking an adulterated drug may choose to continue the treatment under guidance of a medical professional to prevent health hazards from sudden withdrawal.
- The FDA may require the company to cancel further manufacturing and distribution of a drug deemed unsafe.
While most CGMP violations result in a voluntary recall by the company, in extreme cases the FDA may bring up a seizure case in court so that the government can take possession of the adulterated products. If appropriate improvements like sanitation, testing, equipment, and training are not provided, the business may be subject to fines and even arrests.
Inspections occur whenever a business submits an application for a new drug product, but they can also happen if the business is suspected of breaching GMP guidelines by another regulatory authority.
The First Step to CGMP Compliance: Staff Training And Compliance Certification
A pharmaceutical company’s management team doesn’t have full control over every step of a complex manufacturing process. The details are all the responsibility of employees on the factory floor, and your compliance level ultimately lies in their hands.
So how do you ensure that you avoid costly incidents? The answer is pharmaceutical training courses. Whether you’re looking for medical device topics, biotechnology lessons, or cosmetics training courses, get in touch with CfPIE and its professional instructors experienced in all sorts of pharmaceutical topics.
Get your clinical compliance training up to speed
to prevent noncompliance and boost the abilities of your staff.
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