CFR Title 21 Consulting

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Pharmaceuticals
Today, few industries face more regulations than pharmaceutical manufacturers. We work with companies that need to meet the top quality standards for drug manufacturing, including cGMP, GLP, GCP and 21FR Part 11.

cGMP
If you want to sell pharmaceuticals in the US, you must meet the US FDA’s requirements for Current Good Manufacturing Practice (cGMP). By adopting a cGMP, you can prove that you manufactured a specific batch of a regulated product to meet a pre-defined manufacturing standard.

The FDA regularly conducts cGMP inspections of companies that manufacture, produce, store or label drugs sold in the US.

The FDA will inspect facilities for a variety of reasons, including:

• As a part of the agency’s normal routine inspection process
• In response to complaints
• To verify the truthfulness of a submission

Regardless of the reason for the FDA’s inspection, your entire team must be ready. If your staff does not understand and prepare for an FDA inspection, you risk a negative outcome, which can cost you. Our consultants will help you fully understand and get ready for your FDA inspection.

cGMP Services
To prepare your facility for a FDA cGMP Inspection, our consultants will

• Review your Standard Operating Procedures (SOP)
• Conduct an audit and provide a GAP analysis
• Identify deficiencies and recommend corrective actions
• Guide you in preparing your staff and site for inspection
• Advise you on how to interact with the FDA inspector
• And more

GLP
Good Laboratory Practice (GLP) is a quality system focused on the process and conditions companies use to plan, perform, monitor, record, archive and report non-clinical health and environmental safety studies.

A company adapts a GLP to protect the integrity of its scientific data and to provide the FDA (or EPA) with a clear, auditable record of open-ended research studies.

GLP Services
With our GLP consulting services, our team can:

• Inspect your subcontractors and vendors for GLP compliance
• Analyze your data reports against GLP requirements
• Inspect your facilities and relevant computer systems
• Review your SOPs
• Advise on how to remediate any GLP deficiencies in your systems or SOPs
• Guide you through GLP certification
• And more

GCP
Good Clinical Practices (GCP) is an international quality standard for designing, conducting, recording, and reporting trials, which involve human subjects.

GCP Services
Our consultants collaborate with clients to help them develop GCP-compliant processes.

The JJK Consulting group is not a contract research organization (CRO). We only provide GCP consulting services.

With our independence from the clinical trial process, we can objectively evaluate your clinical trials without triggering any potential conflict of interest.  Our objectivity means we will always have your best interests as our main interest.

With our GCP consulting services, our team can:

• Tour your facilities
• Review your standard SOPs
• Evaluate your QMS
• Appraise your compliance with your SOPs
• Assess your vendors’ qualifications, management and certification programs
• Review the qualifications and training of the CRO team members
• And more

 

21 CFR Part 11
Title 21 CFR Part 11 refers to the section of the US FDA regulations related to electronic records and electronic signatures.

If your organization uses a computer system to manage electronic records related to an FDA-regulated product or program, your system must comply with this regulation.  Our consulting team thoroughly understands these requirements.

21 CFR Part 11 Services
To ensure that your systems comply with 21 CFR Part 11, our consultants will:

• Analyze the risks of your current electronic records systems
• Review your SOPs
• Asses your computer system against your SOPs and FDA’s compliance requirements
• Identify non-compliant elements
• Prepare a remediation plan
• Assist your team in making changes
• Provide ongoing support to assure your systems remain compliant

No matter if you are developing a new validation or qualification program, require immediate remediation to a compliance issue, or want to have your existing solutions audited, JJK will provide you with the services you need.

For a no-obligation quote, please contact us.