Regulatory

We prioritize regulatory excellence to meet the highest standards of quality and safety. Navigating the complexities of regulatory requirements can be daunting, but our team is here to guide you through every step. We are dedicated to ensuring that our products not only meet your needs but also comply with all relevant laws and standards, providing you with peace of mind and the confidence to focus on your business.

Our regulatory practices are designed to ensure that every product we manufacture is in full compliance with the laws of the countries where it will be sold. From our cGMP production facility to our comprehensive food safety management system, we exceed expectations by conducting continuous hazard analysis and regular self-audits. These rigorous protocols allow us to maintain the integrity and safety of our products across all markets.

At TEK Products & Services, Inc., we recognize the critical importance of regulatory compliance for our customers. A failure to meet these standards could lead to product recalls, legal complications, or even consumer harm. That’s why we go above and beyond to ensure every material we use and every product we produce meets the highest legal and safety standards. By doing so, we help protect both your business and your consumers.

Our commitment to regulatory excellence also means we make it easier for you to file new drug applications by ensuring that all raw material documentation is readily available and accurate. Whether it's meeting country-specific laws or exceeding global safety requirements, we take the burden of compliance off your shoulders so you can focus on what matters most: delivering safe, trusted products to your customers.

As a valued customer, you can trust that regulatory excellence is built into everything we do.

Resources

Pharmaceutical Quality Standards and Excipients

Countries/Regions: United States
Regulatory Description: The United States Pharmacopeia (USP) defines public standards for the identity, quality, purity, strength, and consistency of drugs, including excipients. These standards are enforceable by the FDA and are critical for compliance in the pharmaceutical industry.
Relevant Resource Links:

Good Manufacturing Practices (GMP) for Excipients

Countries/Regions: United States, European Union, Worldwide
Regulatory Description: Good Manufacturing Practices (GMP) for excipients are part of global regulations to ensure quality and safety. In the U.S., GMP for excipients is governed by FDA's CFR Title 21, while Europe follows EudraLex guidelines.
Relevant Resource Links:

Excipient Risk Assessment

Countries/Regions: United States, European Union, Worldwide
Regulatory Description: Risk management principles for excipients are outlined in ICH Q9, applicable globally. The guideline helps manufacturers assess and mitigate potential risks related to excipient quality and safety.
Relevant Resource Links:

Labeling and Documentation Requirements

Countries/Regions: United States, European Union
Regulatory Description: Accurate labeling is essential for excipients used in pharmaceutical products. In the U.S., labeling regulations are defined under CFR Title 21 Part 201, while the European Medicines Agency provides detailed excipient labeling guidelines.
Relevant Resource Links:

Regulatory Framework for Edible Ink in Pharmaceuticals

Countries/Regions: United States, European Union, Canada
Regulatory Description: Edible ink used in pharmaceuticals is subject to stringent regulations under food additive laws. In the U.S., the FDA governs food additives under 21 CFR, while other countries like Canada and the EU follow their own frameworks.
Relevant Resource Links:

Pharmaceutical Excipient Toxicology

Countries/Regions: United States, European Union, Japan
Regulatory Description: Excipients must be evaluated for toxicological risk. ICH M7 provides a framework for the assessment of mutagenic impurities, ensuring excipients do not pose a safety hazard in pharmaceuticals.
Relevant Resource Links:

FDA Guidance Updates

Color Additives

FD&C Blue #1 Lake, FD&C Blue #2 Lake, FD&C Yellow #5 Lake, FD&C Red #40: These color additives are used widely in cosmetics, drugs, and food products. FD&C Blue No. 1 and FD&C Red No. 40 are permitted for use in drug and cosmetic applications under good manufacturing practices (GMP) as specified in Title 21 of the Code of Federal Regulations (CFR).
- FDA Regulatory Status of Color Additives
- FDA Access Data
D&C Red #30 Lake, D&C Yellow #10 Lake: These color additives are approved for use in drugs and cosmetics under specific GMP guidelines. D&C color additives are often restricted in terms of dosage or application areas, especially for drug formulations
- FDA Regulatory Status of Color Additives

Titanium Dioxide (USP)

Titanium Dioxide is often used as a pigment in both pharmaceuticals and cosmetics. The FDA has set clear guidelines for its use, especially concerning its purity standards for drug applications. It is recognized as safe under GMP regulations.
- FDA Regulatory Status of Color Additives

Carmine

Carmine is a natural red pigment derived from cochineal insects and is permitted for use in food, cosmetics, and drugs under FDA guidelines. Its use, particularly in food and cosmetic products, requires specific labeling to indicate its presence due to potential allergic reactions in sensitive individuals.
- FDA Regulatory Status of Color Additives

Ethyl Alcohol and Isopropyl Alcohol (USP)

Alcohols like ethyl and isopropyl alcohol are commonly used in pharmaceutical preparations and personal care products. The FDA regulates these substances for purity, ensuring they meet USP standards. For example, ethyl alcohol is often used as a solvent in drugs and isopropyl alcohol is used for antiseptic purposes.
- FDA Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol

EMA Guidance on Excipients in Medicinal Products

This guideline outlines the information required in marketing authorization applications for excipients used in human medicines. It includes novel excipients, antioxidants, and preservatives. It is critical for compliance in the European Union for any formulation using excipients.
- Read more

FDA Regulations on Color Additives (e.g., FD&C Dyes)

This FDA guidance offers a regulatory framework for manufacturers using color additives like FD&C Blue, Red, and Yellow dyes in pharmaceuticals, food, and cosmetics. It includes certification requirements and purity specifications.
- Explore the document

IPEC Guidelines for Excipients and GMP Compliance

The International Pharmaceutical Excipients Council (IPEC) offers comprehensive guidelines that focus on good manufacturing practices (GMP) for excipients. This document is vital for excipient manufacturers to meet international quality and safety standards.
- Visit the IPEC website
- The Joint Good Manufacturing Practices Guide

Edible Ink and Food Printing

A comprehensive review of edible ink used in food printing, packaging, and medical applications (e.g., on pills). This source highlights the safety and compliance requirements for food-grade inks and their expanding applications across industries.
- Learn more here
For more detailed information on FDA guidelines concerning these and other chemicals, you can explore the FDA Color Additive Status List and the Code of Federal Regulations Title 21. These documents provide essential regulatory frameworks and manufacturing practices that must be followed by excipient and edible ink producers.