Pharmaceutical Manufacturer Compliance Team Lead – Timothy E. Allen | Former Special Agent (U.S. Secret Service & DOJ-OIG)
Pharmaceutical manufacturers in the U.S. must meet numerous requirements. The FDA has published numerous guidance statements ranging from Drug master files guidelines for offering confidential information about a facility’s processes, storage, etc., to bar code labeling requirements. Other guidance statements include compliance with the PREA (Pediatric Research Equity Act), Contract Manufacturing Arrangements, and good lab practice regulations. Complying with all these rules can be a daunting task for pharmaceutical manufacturing companies.
That’s where Corporate Investigation Consulting comes in. We have pharmaceutical manufacturing compliance consulting experts who understand FDA guidelines and requirements from other regulators. Let us handle compliance issues for your pharmaceutical manufacturing facility as you concentrate on your core business.
Understanding FDA Compliance for Pharmaceutical Manufacturing Facilities
FDA compliance guidelines for pharmaceutical manufacturers are based largely on CGMP (or Current Good Manufacturing Practices). Generally, the FDA expects pharmaceutical companies to have strong quality systems in place. They should also use high-quality raw materials when making drugs and adhere to good standard practices. What’s more, manufacturers should have robust manufacturing practices.
These guidelines prevent common risks such as drug mix-ups, drug contamination, errors, failures, and deviations in drug manufacturing facilities. As per the FDA, CGMP guidelines must be continually improved with focus on best practices.
Since the FDA audits pharmaceutical companies to assess CGMP compliance, compliance consulting services are inevitable. Violations or shortfalls in compliance can have dire consequences. Regulators like the FDA can force a pharmaceutical company to do repairs or change internal practices or policies. Non-compliance can also lead to criminal charges or closure.
Pharmaceutical manufacturers are responsible for finding and understanding the requirements applicable to them out of thousands of guidelines.
That’s where we come in. Our compliance consultants make it easy for your facility to be CGMP compliant. We go as far as uniquely tailoring pharmaceutical company processes to follow FDA guidelines while ensuring the process makes sense for business.
Put our highly experienced team on your side
Roger Bach
Former Special Agent (OIG)
Timothy E. Allen
Former Senior Special Agent U.S. Secret Service
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Maura Kelley
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Marquis D. Pickett
Special Agent U.S. Secret Service (ret.)
How Can We Help?
MPI (Manufacturing Process Instructions)
We can help pharmaceutical manufacturers establish or assess manufacturing process instructions, which are crucial in pharmaceutical compliance plans. MPIs dictate how manufacturers combine ingredients to produce different medication that is safe for patients. We have experts that are incredibly knowledgeable in designing MPI processes that yield near-perfect drug strength & potency, and document such processes.
Testing and Measuring
Test instruments need to be calibrated accordingly. CGMP guidelines have parameters that determine if test instruments pass or fail compliance tests. Enterprise Resource Planning systems have equipment guidelines and testing limits.
Standard Operating Practices
We also assist in compliance consulting on SOPs (Standard Operating Practices). We can define SOPs for your pharmaceutical manufacturing facility to ensure staff follow standard documented procedures.
Corporate Investigation Consulting has experts that can create internal processes for assessing compliance and ensuring every process has documented guidelines.
International Compliance
Pharmaceutical companies with operations outside the U.S. i.e., the EU, must be compliant with rules regarding good pharmaceutical manufacturing in such areas. If your pharmaceutical company is making drugs for sale in the EU, your company must be registered in an EU-member state by a competent/recognized authority. Manufacturers and importers also need to be subjected to inspections by competent EU authorities to assess compliance. If drugs are imported separately, importers must ensure GMP compliance.
We understand all the rules applicable to setting up a pharmaceutical manufacturing facility in the EU or exporting drugs to EU states. We can ensure compliance with other EU bodies such as the EDQM with a mandate of inspecting pharmaceutical manufacturers and issuing sustainability certificates. Corporate Investigation Consulting can go as far as ensuring ISPE compliance linked to Good Manufacturing Practices regulations in Canada, Asia, India, Japan, Australia, etc.
Good Product Practices Compliance
Drug manufacturers must produce products with care to prevent contamination & cross contamination from raw materials among other contaminants I.e., microorganisms, toxic substances, hormones and other active substances.
Pharmaceutical manufacturers must be compliant with practices that prevent cross-contamination from elements in the production process. Compliance involves but isn’t limited to having self-contained production facilities, maintain the required cleanliness standards, having extraction systems, and effective decontamination and cleaning procedures.
Drug companies also need to ensure finished products are free of foreign objects/materials that can poison customers or introduce disease.
Our pharmaceutical compliance consulting services ensure biological, physical, and chemical contaminants are dealt with accordingly, avoiding legal risk associated with selling contaminated medicine. We can craft and assist in implementing guidelines that reduce contamination risks.
Personnel Compliance
Pharmaceutical manufacturers should have adequate qualified personnel aware of GMP principles that apply to their role. These principles include appropriate hygiene standards. Manufacturers need to conduct health checks periodically. All workers involved in manufacturing must also observe the highest standards of personal hygiene. Staff who are ill and capable of compromising product quality shouldn’t handle materials or take part in other processes like packaging, or handling in-process materials before they recover fully.
Guidelines on handling products must also be followed. For instance, personnel shouldn’t have direct contact with raw materials, packaging materials, or bulk/intermediate products. Pharmaceutical manufacturing staff also need to comply with clothing and personal habit guidelines. For instance, personnel working in production lines must wear appropriate clothing. They should also avoid habits like chewing, drinking, eating, or smoking in production, lab, and storage areas.
Our pharmaceutical manufacture compliance consulting experts can formulate personnel policies and procedures that ensure your facility and personnel pass impromptu regulator audits. Formulating compliance policies and procedures isn’t your core business. Let Corporate Investigation Consulting make your work easy.
Materials Compliance
Pharmaceutical manufacturing facilities should be cleaned using appropriate cleaners meant for cleaning pharmaceutical equipment. What’s more, cleaning agents should never get into contact with products. Pest control efforts should not contaminate raw materials, equipment, packaging materials, or finished products. Drug manufacturing facilities should also use water that meets suitable quality standards.
Our compliance consulting experts can offer guidance on all matters surrounding pharmaceutical manufacturing facility compliance. While facility managers may be tempted to cut costs and run non-compliant facilities, the consequences of doing so are dire. You can face hefty fines, closure, or legal processes resulting in jail terms.
Don’t risk your investment. Contact us online or at 866-352-9324 and get a free confidential consultation on all matters regarding pharmaceutical manufacture compliance in the U.S.