QUALITY
QUALITY CONTROL
Kelker Pharma operates under only the most stringent SOPs (Standard Operating Procedures) for quality assurance and quality control. You don’t have to take our word for it. Kelker Pharma is certified for cGMPs (current Good Manufacturing Practices), which are regulated by the Food and Drug Administration. Kelker Pharma is an FDA registered facility and also certified organic by Oregon Tilth. Kelker Pharma can produce Kosher and Halal certified products as well as USDA Organic. All raw materials and components must first pass rigorous quality inspection and laboratory testing before being release for production. When it comes to quality, you can trust the integrity of Kelker Pharma.
Stringent standards that check all the boxes
Full label review
ensures accuracy and regulatory compliance
Full-time USA Health Consultant
to keep pace with the changing regulatory environment
International registration assistance
we provide and coordinate all required documentation
Formula Modifications
to adapt to the requirements of each country
Full Service Testing
including microbiological and stability studies
we are fully compliant
Kelker Pharma is a fully compliant cGMP manufacturing and packaging facility. Ensuring that each employee complies with the law and all company policies is of utmost importance at Kelker Pharma.
We are duly licensed and are regularly inspected by State and Federal health authorities. Additionally, we undergo frequent GMP audits by our premier clients, who confirm our GMP compliance either with their own teams or by engaging independent auditors.
Since the passage of the Dietary Supplements Health and Education Act in 1994, regulatory compliance has become increasingly complex. Our knowledgeable Regulatory Affairs and Information Services team can provide valuable assistance to help you to avoid costly errors.
Kelker Pharma offers the following services, at no extra charge:
• Full label review – ensures accuracy and regulatory compliance
• International registration assistance — we provide and coordinate all required documentation
• Formula modifications — to adapt to the requirements of each country
• Full-time Health USA consultant — to keep pace with the changing regulatory environment
• Full service testing, including microbiological and stability studies
The Quality Assurance Department has broad responsibilities and authority in the following areas:
• Quality Improvement — Quality improvement is based on the premise that all work activities can be planned, performed, measured, and improved. QA monitors our progress toward our corporate goal of building a culture in which improvement is continuous and an integral part of the organization.
• Personnel GMP Training and Qualification — all employees who come into contact with our products must begin GMP training within the first month of employment. GMP training continues on a regular basis throughout the length of employment. Tests are given to monitor the effectiveness of training.
• Internal Audits— QA inspectors monitor all phases of production to assess performance and adherence to GMP and SOPs of each department.
• External Audits— QA oversees and supervises inspections and audits of our facilities by domestic and international regulatory bodies, as well as by customers and independent firms.
• Supplier Qualification — Kelker Pharma maintains an audit program to verify our suppliers’ ability to provide consistent products that meet our strict quality requirements.
• Document and Record Control — QA is responsible for maintaining all documents, records and Standard Operating Procedures, making sure that they are up to date.
• Inspection and Acceptance Testing — QC has the authority to release and reject any component or finished product that does not meet specifications.
• Non-conformance — QA/QE handles the identification, documentation, control, investigation and disposition of all non-conforming materials, components and final products.
